Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Crohn's aggravated; Acid reflux; Pain in arm; Adverse food reaction; Vaccination site pai; Abdominal distension; Exposure to COVID-19; This is a non-interventional study report (solicited) from marketing program facilitated collect received from a non-contactable consumer (Patient) based on the information received by Pfizer.  A 31-years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via intramuscular route of administration on an unspecified date as DOSE 2, SINGLE and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via intramuscular route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization (at the age of 31 years). Patient also received dose of adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported) via subcutaneous route of administration on an unspecified date for crohn's disease and experienced Acid reflux and sore arm, aches. The patient medical history and concomitant medications was not reported. On unspecified date, the patient experienced acid reflux and pain in arm. It was a Solicited report from the USA by a consumer of an adult male with an event of non-serious Pain Arm with Humira (Adalimumab). On an unknown date, the patient experienced Pain Arm. On an unknown date, pain arm resolved. Pfizer Biontech Covid-19 Vaccine  was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer. Patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE (TOZINAMERAN) via intramuscular route of administration on unspecified date as booster dose 3.The reporter's causality for the event of pain in arm was not provided. The outcome for the event pain in arm and the event acid reflux was recovered on unspecified date in 2021. Upon follow up on 29Dec2021:  Solicited report from the USA by a consumer of a 31 year old male with events of  non-serious ATE SOMETHING SPICY AND HAD A CROHN'S FLARE UP, SORENESS IN ARM ON THIRD VACCINATION, PATIENT MIGHT HAD BEEN EXPOSED TO COVID, STOMACH INFLATED IN LOWER ABDOMEN and ATE SOMETHING SPICY AND HAD A CROHNS FLARE with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced ATE SOMETHING SPICY AND HAD A CROHN'S FLARE UP, SORENESS IN ARM ON THIRD VACCINATION, STOMACH INFLATED IN LOWER ABDOMEN and ATE SOMETHING SPICY AND HAD A CROHNS FLARE. On 20Dec2021, the patient experienced PATIENT MIGHT HAD BEEN EXPOSED TO COVID. On unknown dates, ATE SOMETHING SPICY AND HAD A CROHN'S FLARE UP, SORENESS IN ARM ON THIRD VACCINATION, STOMACH INFLATED IN LOWER ABDOMEN and ATE SOMETHING SPICY AND HAD A CROHNS FLARE resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. He received 1st dose COVID-19 Vaccine  manufactured by Pfizer/BioNTech. He received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. He received 3rd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for HUMIRA(ADALIMUMAB):  The reporter's causality for the event(s) of ATE SOMETHING SPICY AND HAD A CROHN'S FLARE UP, SORENESS IN ARM ON THIRD VACCINATION, PATIENT MIGHT HAD BEEN EXPOSED TO COVID, STOMACH INFLATED IN LOWER ABDOMEN and ATE SOMETHING SPICY AND HAD A CROHNS FLARE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Suspect Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB), #  Daily Dose: CF  Therapy dates: UNK  Causality:  1)Adverse food reaction  (Adverse food reaction)  Action(s) taken with drug: Unknown  Causality as per reporter (Drug/Vaccine) : No reasonable possibility  Dechallenge : N/A  2)Vaccination site pain (Vaccination site pain)  Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : No reasonable possibility  Dechallenge :  N/A  3)Exposure to COVID-19  (Exposure to SARS-CoV-2 )  Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) :  No reasonable possibility  Dechallenge : N/A  4)Abdominal distension (Abdominal distension)  Action(s) taken with drug :  Unknown  Causality as per reporter (Drug/Vaccine) :  No reasonable possibility  Dechallenge : N/A  5)Crohn's aggravated (Crohn's disease)  Action(s) taken with drug :  Unknown  Causality as per reporter (Drug/Vaccine) :  No reasonable possibility  Dechallenge: N/A  Suspect Drug:  Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown  Daily Dose : 1)1st dose (1 in 1 Once)  2)2nd dose (1 in 1 Once)  3)3rd dose (1 in 1 Once)  Route of Admin: 1)Intramuscular  2)Intramuscular  3)Intramuscular  Causality:  1)Adverse food reaction (Adverse food reaction)  Action(s) taken with drug: Unknown  Causality as per reporter (Drug/Vaccine) : Not Related  Dechallenge : N/A  2)Vaccination site pain  (Vaccination site pain)  Action(s) taken with drug :  Unknown  Causality as per reporter (Drug/Vaccine) :  Not Related  Dechallenge : N/A  3)Exposure to COVID-19(Exposure to SARS-CoV-2  Action(s) taken with drug :  Unknown  Causality as per reporter (Drug/Vaccine) : Not Related  Dechallenge :  N/A  4)Abdominal distension (Abdominal distension)  Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccineot Related  Dechallenge :  N/A  5)Crohn's aggravated (Crohn's disease )  Action(s) taken with drug :  Unknown  Causality as per reporter (Drug/Vaccine) : Not Related  Dechallenge : N/A  Follow-up (07Oct2021): This is a follow-up solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer.  No follow-up attempts are needed. No further information expected.  Follow-up(29Dec2021):This is a follow-up solicited report received by Pfizer. A contactable consumer reported that: Clinical information updated in narrative.The reporter's assessment of the causal relationship of the events with the suspect product 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.   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  BNT162B2 and the events (Crohn's disease, Gastro esophageal reflux disease, Pain in extremity,Adverse food reaction , Vaccination site pain,Exposure to SARS-CoV-2,Abdominal distension) 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.