Age: 33.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Anxiety, Crohn's disease, Influenza, Myalgia, Pain
Clinical narrative: Crohn's disease aggravated; Anxiety; Injection site pain; Muscle pain; Flu symptoms; Generalized aching/Body Ache; 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-163-4394330-00 (AbbVie).  A 33-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 24Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years, all intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; adalimumab (HUMIRA), (Lot number: 1159929) at citrate free, subcutaneous for crohn's disease; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "Flu symptoms"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Generalized aching/Body Ache"; CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease aggravated"; ANXIETY (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain". The action taken for adalimumab was unknown. It was reported that it was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality of reporter for suspect TOZINAMERAN and events was: Not Reported for Injection site pain (Injection site pain), Possible for Flu symptoms (Influenza) and Generalized aching (Pain). For suspect, MODERNA COVID-19 VACCINE: Not Reported for Injection site pain (Injection site pain), Possible for Flu symptoms (Influenza) and Generalized aching (Pain). For suspect, INFLUENZA VACCINE and HUMIRA (ADALIMUMAB) it was not reported. Patient with events of non-serious anxiety, stinging/burning with injections, flu symptoms with first two covid vaccines, body aches, crohn's disease worsen and muscle pain with Humira (Adalimumab). On unknown dates, the patient experienced anxiety, stinging/burning with injections and crohn's disease worsen. In 2021, the patient experienced flu symptoms with first two covid vaccines, body aches and muscle pain. Influenza vaccine, Pfizer BIONTECH COVID-19 vaccine (Tozinameran) and MODERNA COVID-19 vaccine (Elasomeran) were 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 Anxiety, Stinging/Burning with Injections, Flu Symptoms with First Two Covid Vaccines, Body Aches, Crohn's Disease Worsen and Muscle Pain was not provided. On 28Jun2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of "Anxiety", "Crohn's Disease Worsen" and "Muscle pain" were added. Suspect drugs included Humira (Solution for injection in pre-filled pen) (Adalimumab) with daily dose as  Citrate free via subcutaneous route of administration taken for moderate to severe adult Crohn's disease. Causality details included Anxiety with actions taken with drug was unknown and causality as per reporter (Drug/Vaccine) was Not Reported and dechallenge was N/A, injection site pain with action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was not reported and dechallenge was N/A, Flu symptoms (Influenza) with action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was not reported and dechallenge was N/A, generalized aching (pain) with action taken with drug as unknown and causality as per reporter (Drug/Vaccine) was Not Reported with dechallenge as Unknown, Crohn's disease aggravated (Crohn's disease) with action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was not reported and dechallenge was NA, muscle pain with action taken with drug was unknown with causality as per reporter (Drug/Vaccine) was not reported and dechallenge as NA. Suspect drug included Influenza Vaccine causality details included Anxiety and action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was Not Reported with dechallenge was N/A, injection site pain and action taken with drug was unknown with the causality as per reporter (Drug/Vaccine) as Not Reported and dechallenge was N/A, Flu symptoms (Influenza) and action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was Not Reported with dechallenge was N/A, Generalized aching (Pain) and action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was not reported and dechallenge was unknown, Crohn's disease aggravated (Crohn's disease) with action taken with drug was Unknown and causality as per reporter (Drug/Vaccine) was Not Reported and dechallenge was NA, muscle pain with action taken with drug as unknown and causality as per reporter (Drug/Vaccine) was not reported and dechallenge was NA. Suspect drug included Pfizer Biontech Covid-19 Vaccine (Tozinameran) with route of administration as Intramuscular taken for Covid-19 Vaccination and action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was Not Reported with dechallenge was N/A, injection site pain and action taken with drug was unknown with the causality as per reporter (Drug/Vaccine) as Not Reported and dechallenge was N/A, Flu symptoms (Influenza) and action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was possible with dechallenge was N/A, Generalized aching (Pain) action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was possible with dechallenge was unknown, Crohn's disease aggravated (Crohn's disease) with action taken with drug was Unknown and causality as per reporter (Drug/Vaccine) was Not Reported and dechallenge was NA, muscle pain with action taken with drug as unknown and causality as per reporter (Drug/Vaccine) was possible and dechallenge was NA. Suspect drug included Moderna Covid-19 Vaccine (Elasomeran) via intramuscular taken for Covid-19 Vaccination and action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was Not Reported with dechallenge was N/A, injection site pain and action taken with drug was unknown with the causality as per reporter (Drug/Vaccine) as Not Reported and dechallenge was N/A, Flu symptoms (Influenza) and action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was possible with dechallenge was N/A, Generalized aching (Pain) action taken with drug was unknown and causality as per reporter (Drug/Vaccine) was possible with dechallenge was unknown, Crohn's disease aggravated (Crohn's disease) with action taken with drug was Unknown and causality as per reporter (Drug/Vaccine) was Not Reported and dechallenge was NA, muscle pain with action taken with drug as unknown and causality as per reporter (Drug/Vaccine) was possible and dechallenge was NA. If event abated after stopping drug was NA.   The reporter's assessment of the causal relationship of "crohn's disease aggravated", "flu symptoms", "generalized aching/body ache", "anxiety" and "injection site pain" 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 "muscle pain" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (06Jul2022): This is a solicited follow up report based on the information received by Pfizer from AbbVie Inc.(MFR control number: 22K-163-4394330-00). A contactable 33-year-old male consumer(patient) reported. Updated information included reporter action taken, dechallenge and reporter's causality for the suspect products as was merged and updated with the initial narrative.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination site pain, influenza, pain, Muscle pain ,crohn's disease aggravated , anxietycannot be totally excluded.