Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, COVID-19, Drug ineffective, Interchange of vaccine products, Pneumonia
Clinical narrative: Interchange of vaccine products; COVID; COVID; Exacerbated Pneumonia; Upset Stomach; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4127258.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant), outcome "unknown"; DRUG INEFFECTIVE (caused and prolonged hospitalization, medically significant), COVID-19 (caused and prolonged hospitalization, medically significant), outcome "unknown" and all described as "COVID"; PNEUMONIA (caused and prolonged hospitalization, medically significant), outcome "unknown", described as "Exacerbated Pneumonia"; ABDOMINAL DISCOMFORT (caused and prolonged hospitalization), outcome "unknown", described as "Upset Stomach". The patient was hospitalized and prolonged hospitalization for drug ineffective, covid-19, pneumonia, abdominal discomfort (hospitalization duration: 5 day(s)). The action taken for adalimumab was unknown. Clinical Course: The patient experienced events of COVID, exacerbated pneumonia, and upset stomach, with Single Dose Pen, Adalimumab Solution for Injection. Pfizer BioNTech COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient experienced COVID while on vacation. She had vomiting, runny nose, upset stomach and exacerbated pneumonia. She was in the hospital for five days. All appropriate to adverse reaction involved or prolonged inpatient hospitalization  The reporter's assessment of the causal relationship of "interchange of vaccine products", "covid", "exacerbated pneumonia" and "upset stomach" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 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: The reporter's causality for the event(s) of COVID, Exacerbated Pneumonia and Upset Stomach with Adalimumab Solution for Injection was Not Provided. Agency's opinion was that the causality for the event(s) of COVID, Exacerbated Pneumonia and Upset Stomach with Adalimumab Solution for Injection was No Reasonable Possibility. Agency's opinion was that the causality for the event(s) of COVID, Exacerbated Pneumonia and Upset Stomach with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency's Alternative Etiology for Exacerbated Pneumonia with Adalimumab Solution for Injection: Most likely related to concurrent Covid-19 infection. Agency's Alternative Etiology for Upset Stomach with Adalimumab Solution for Injection: Most likely related to concurrent Covid-19 infection. Agency's Alternative Etiology for COVID with Adalimumab Solution for Injection: Most likely related to exposure to pandemic outbreak of SARS COV-2 infection in an elderly age patient with underlying rheumatoid arthritis.  Assessment Results: HUMIRA Citrate Free - Pneumonia aggravated, Global Introspection, No Reasonable Possibility. HUMIRA Citrate Free - Pneumonia aggravated, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA Citrate Free - Upset stomach, Global Introspection, No Reasonable Possibility. HUMIRA Citrate Free - Upset stomach, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - COVID-19. Pfizer BioNTech COVID-19 vaccine - COVID-19, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Pneumonia aggravated. Pfizer BioNTech COVID-19 vaccine - Pneumonia aggravated, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Upset stomach. Pfizer BioNTech COVID-19 vaccine - Upset stomach, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA Citrate Free - COVID-19, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA Citrate Free - COVID-19, Global Introspection, No Reasonable Possibility.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relation, the association between the events of interchange of vaccine products, pneumonia aggravated, drug ineffective, COVID-19 and abdominal discomfort  and the suspect product BNT162B2, BNT162B2 OMI BA 4-5 cannot be completely ruled out.  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.