Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Exposure to SARS-CoV-2, Immunodeficiency, Infection, Investigation
Clinical narrative: Tuberculosis; Immune system was compromised; Infection after surgery; Feeling Ill; Exposure to COVID-19; experienced reaction to covid vaccine; fever; Chills; Body Aches; Heart Palpitation; 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.  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) at single (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: "Abdominal hernia", start date: 23Dec2020 (unspecified if ongoing), notes: On 13Dec2020, the patient experienced hernia surgery in ABDOMINE/HERNIA, On 23Dec2020 he had hernia surgery and had an abdominal surgery in 30Dec2020.; "Abdominal operation", start date: 30Dec2020 (unspecified if ongoing), notes: On 23Dec2020 he had hernia surgery and had an abdominal surgery in 30Dec2020.; "Covid", start date: Jun2020 (unspecified if ongoing), notes: In Jun2020, the Patient had Covid. The patient's concomitant medications were not reported. The following information was reported: TUBERCULOSIS (medically significant), outcome "recovered", described as "Tuberculosis"; IMMUNODEFICIENCY (medically significant), outcome "recovered", described as "Immune system was compromised"; INFECTION (medically significant), outcome "unknown", described as "Infection after surgery"; CHILLS (medically significant) with onset 2021, outcome "unknown", described as "Chills"; PAIN (medically significant) with onset 2021, outcome "unknown", described as "Body Aches"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "Heart Palpitation"; MALAISE (medically significant), outcome "recovered", described as "Feeling Ill"; PYREXIA (medically significant) with onset 2021, outcome "unknown", described as "fever"; EXPOSURE TO SARS-COV-2 (medically significant), outcome "recovered", described as "Exposure to COVID-19"; VACCINATION COMPLICATION (medically significant) with onset 15Jul2021, outcome "recovered", described as "experienced reaction to covid vaccine". The patient underwent the following laboratory tests and procedures: investigation: hernia surgery, notes: She had hernia surgery in abdomine a year ago was diagnosed. The action taken for adalimumab was unknown.Clinical information: Solicited report by a consumer of a 55-year-old female with events of hernia surgery in abdomine/hernia, abdominal surgery and tuberculosis and non-serious reaction to covid vaccine, feeling ill, immune system was compromised, contracting covid-19, had infection after surgery, fever, chills, body aches, heart palpitation, got very infected inside out side and covid with humira (adalimumab). there was no reported medical history on unknown dates, the patient experienced tuberculosis, feeling ill, immune system was compromised, contracting covid-19, had infection after surgery and got very infected inside out side. In Jun2020, the patient experienced COVID. On 13Dec2020, the patient experienced hernia surgery in ABDOMINE/HERNIA. On 30Dec2020, the patient experienced abdominal surgery. In 2021, the patient experienced fever, chills, body aches and heart palpitation. On 15Jul2021, the patient experienced REACTION TO COVID VACCINE. On unknown dates, tuberculosis, reaction to covid vaccine, feeling ill, immune system was compromised and contracting covid-19 resolved. moderna covid-19 vaccine (elasomeran) and Pfizer biontech covid-19 vaccine (tozinameran) were also considered suspect.  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 abdomine 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 02Sep2021, She received first dose COVID-19 Vaccine manufactured by Moderna.  The reporter's assessment of the causal relationship of the event 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.  Causality for humira (adalimumab): The reporter's causality for the event(s) of hernia surgery in abdomine/hernia, abdominal surgery, reaction to covid vaccine, feeling ill, contracting covid-19, had infection after surgery, fever, chills, body aches and heart palpitation with humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of tuberculosis with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of immune system was compromised, got very infected inside outside and covid was not provided. Company's opinion is that there is no reasonable possibility that the events of hernia surgery in abdomine/hernia, abdominal surgery, reaction to covid vaccine, feeling ill, contracting covid-19, fever, chills, body aches, heart palpitation and covid are related to humira(adalimumab). Company's opinion is that the events of tuberculosis, had infection after surgery and got very infected inside outside are not assessable. Company's opinion is that there is a reasonable possibility that the event of immune system was compromised is related to humira(adalimumab).  Causality for Pfizer Biontech Covid-19 Vaccine: The reporter's causality for the events for Abdominal operation, Tuberculosis, Vaccination adverse reaction, Ill feeling, Immunocompromised, Exposure to COVID-19, Post procedural infection, fever chills, Generalized aching, palpitation, infection, COVID-19 causality  was not reported.  Causality for MODERNA COVID-19 VACCINE: The reporter's causality for the events for Abdominal operation, Tuberculosis, Vaccination adverse reaction, Ill feeling , Immunocompromised, Exposure to COVID-19, Post procedural infection, fever chills, Generalized aching, palpitation, infection, COVID-19  causality was not reported.  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 provide and plausible temporal association, the causality between BNT162B2 and all the reported  events 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.