Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Immunodeficiency, Infection, Malaise, Post procedural infection
Clinical narrative: FEELING ILL; IMMUNE SYSTEM WAS COMPROMISED; HAD INFECTION AFTER SURGERY; GOT VERY INFECTED INSIDE OUT SIDE; TUBERCULOSIS; REACTION TO COVID VACCINE; 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-163-4154896-00 (Agency).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Jul2021 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk (citrate free) for psoriasis; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administration date 02Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jun2020 (unspecified if ongoing), notes: outcome: unknown; "ABDOMINAL SURGERY", start date: 30Dec2020 (unspecified if ongoing), notes: outcome: unknown; "HERNIA SURGERY IN ABDOMINE/HERNIA", start date: 13Dec2020 (unspecified if ongoing), notes: outcome: unknown; "HERNIA SURGERY IN ABDOMINE/HERNIA", start date: 13Dec2020 (unspecified if ongoing), notes: outcome: resolving. The patient's concomitant medications were not reported. The following information was reported: TUBERCULOSIS (medically significant), outcome "recovered", described as "TUBERCULOSIS"; VACCINATION COMPLICATION (non-serious) with onset 15Jul2021, outcome "recovered", described as "REACTION TO COVID VACCINE"; MALAISE (non-serious), outcome "recovered", described as "FEELING ILL"; IMMUNODEFICIENCY (non-serious), outcome "recovered", described as "IMMUNE SYSTEM WAS COMPROMISED"; POST PROCEDURAL INFECTION (non-serious), outcome "unknown", described as "HAD INFECTION AFTER SURGERY"; INFECTION (non-serious), outcome "unknown", described as "GOT VERY INFECTED INSIDE OUT SIDE". The action taken for adalimumab was unknown.  The reporter considered "reaction to covid vaccine" related to bnt162b2.  Additional information: In Jun2020, the patient experienced COVID. The event Abate After Stopping Drug was NA. The lot number for bnt162b2 was not provided and will be requested during follow up. There was no reported medical history. In Jun2020, the Patient had Covid. On 23Dec2020 he had hernia surgery and had an abdominal surgery in 30Dec2020. she got infected inside and outside that gave her this hernia, her immune system was also compromised. In Jul2021 he had reaction to Covid vaccine. In Sep2021 on vaccination he had fever, chills, body aches and also heart palpitation was reported for two months. She had hernia surgery in abdominal a year ago was diagnosed. She had getting one moderna covid vaccine and feeling ill shortly afterwards. She got tuberculosis.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 02 Sep2021, She received first dose COVID-19 Vaccine manufactured by Moderna. Concomitant Drugs Not Reported.  Causality for HUMIRA(ADALIMUMAB): Tuberculosis (Tuberculosis), Causality as per reporter (Drug/Vaccine) : Reasonable possibility, Causality as per Mfr.(Drug/Vaccine) : Not assessable, Vaccination adverse reaction (Vaccination complication), Causality as per reporter (Drug/Vaccine) : No reasonable possibility, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Ill feeling (Malaise), Causality as per reporter (Drug/Vaccine) : No reasonable possibility, Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility, Immunocompromised (Immunodeficiency)Causality as per reporter (Drug/Vaccine) : Not Reported, Causality as per Mfr.(Drug/Vaccine) : Reasonable possibility, Post procedural infection (Post procedural infection), Causality as per reporter (Drug/Vaccine) : No reasonable possibility, Causality as per Mfr.(Drug/Vaccine) : Not assessable, Infection (Infection): Causality as per reporter (Drug/Vaccine) : Not Reported, Causality as per Mfr.(Drug/Vaccine) : Not assessable, Dechallenge: N/A for all events.  Causality of MODERNA COVID-19 VACCINE(ELASOMERAN)(Injection)(ELASOMERAN),UNKNOWN:  Causality as per reporter (Drug/Vaccine) : Tuberculosis, Infection, Vaccination adverse reaction (Vaccination complication), Immunocompromised (Immunodeficiency), Post procedural infection, Not reported. Ill feeling (Malaise): Causality as per reporter (Drug/Vaccine) : Probable.   Causality of PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN Causality as per reporter (Drug/Vaccine): Tuberculosis Tuberculosis), Ill feeling (Malaise), Immunocompromised (Immunodeficiency), Post procedural infection, Infection: Not reported. Causality as per reporter (Drug/Vaccine): Vaccination adverse reaction (Vaccination complication): Possible.  Dechallenge : N/A For all events.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event s - Tuberculosis, vaccination site complication, malaise, immunodeficiency, post procedural infection, infection, and the suspect drug "BNT162B2" cannot be completely excluded.  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.