Age: 43.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cancer pain, Hepatic mass, Intestinal mass, Malignant peritoneal neoplasm
Clinical narrative: Peritoneal surface disease; Cancer pain in testes/had cancer cells; Mass in liver/might be in the colon; Mass in liver/might be in the colon; FACILITATED COLLECT  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): 22K-163-4246137-00.  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), 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. Vaccination history included: Bnt162b2 (1st Dose, Route of Admin: Intramuscular), administration date: 24Jan2021, when the patient was 42 years old, for COVID-19 Vaccination; Bnt162b2 (2nd Dose, Route of Admin: Intramuscular), administration date: 14Feb2021, when the patient was 42 years old, for COVID-19 Vaccination. The following information was reported: MALIGNANT PERITONEAL NEOPLASM (medically significant), outcome "not recovered", described as "Peritoneal surface disease"; CANCER PAIN (medically significant), outcome "unknown", described as "Cancer pain in testes/had cancer cells"; INTESTINAL MASS (non-serious), HEPATIC MASS (non-serious), outcome "unknown" and all described as "Mass in liver/might be in the colon". The action taken for adalimumab was unknown.  Solicited report from the (Privacy) by a consumer of an adult male with events of peritoneal surface dis-ease cancer pain in testes/had cancer cells and non-serious mass in liver/might be in the colon with Humira (Adalimumab). Primary reporter did not have the lot number information, because the packaging was discarded.   Causality for Humira(Adalimumab) The reporter's causality for the event(s) of peritoneal surface disease cancer pain in testes/had cancer cells unknown onset, peritoneal surface disease cancer pain in testes/had cancer cells un-known onset, mass in liver/might be in the colon unknown onset and mass in liver/might be in the colon unknown onset was not provided.  (Privacy) opinion is that the events of peritoneal surface disease cancer pain in testes/had cancer cells unknown onset, peritoneal surface disease cancer pain in testes/had cancer cells unknown on-set, mass in liver/might be in the colon unknown onset and mass in liver/might be in the colon un-known onset are not assessable.  Product-Reaction level: Drug: Humira(Solution for injection in pre-filled pen)(Adalimumab)  Causality:Peritoneal carcinoma (Malignant peritoneal neoplasm) Action(s) taken with drug :  Unknown Causality as per reporter (drug/vaccine) : Not Reported Causality as per Mfr. (Drug/Vaccine): Not assessable Dechallenge : N/A Cancer pain (Cancer pain) Action(s) taken with drug :  Unknown Causality as per reporter drug/vaccine) : Not Reported Causality as per Mfr. (Drug/Vaccine): Not assessable Dechallenge : N/A Large intestine mass (Intestinal mass) Action(s) taken with drug :  Unknown Causality as per reporter (drug/vaccine) : Not Reported Causality as per Mfr. (Drug/Vaccine): Not assessable Dechallenge : N/A Hepatic mass (Hepatic mass) Action(s) taken with drug :  Unknown Causality as per reporter (drug/vaccine) : Not Reported Causality as per Mfr. (Drug/Vaccine): Not assessable Dechallenge : N/A  Drug: Pfizer Biontech Covid-19 Vaccine(Tozinameran)(Tozinameran),Unknown,Unknown,Unknown Causality: Peritoneal carcinoma (Malignant peritoneal neoplasm) Action(s) taken with drug :  Unknown Causality as per reporter (drug/vaccine) : Possible Dechallenge: N/A  Cancer pain (Cancer pain) Causality as per reporter (drug/vaccine) : Possible Dechallenge: N/A Large intestine mass (Intestinal mass) Causality as per reporter (drug/vaccine) : Possible Dechallenge: N/A Hepatic mass (Hepatic mass) Causality as per reporter (drug/vaccine) : Possible Dechallenge: N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information , the causal association between the event and the suspect drug cannot be 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.