Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diarrhoea, Disorientation, Dizziness, Fatigue
Clinical narrative: dizziness; disoriented; She was tired because she could not get much sleep; She was tired because she could not get much sleep; She has been experiencing lots of diarrhea.; 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-163-4442877-00.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 21Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation; gabapentin (GABAPENTIN); adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen from Apr2022 (Batch/Lot number: unknown) to Jun2022 at humira 40mg/0.4ml(citrate free (40 mg,1 in 2 wk), all subcutaneous for colitis ulcerative; duloxetine (DULOXETINE), (Batch/Lot number: unknown). The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: penicillin allergy manifested by hives; "Adhesive allergy" (unspecified if ongoing), notes: allergic to adhesives like bandages; "penicillin allergy manifested by hives" (unspecified if ongoing), notes: penicillin allergy manifested by hives; "no tobacco use" (unspecified if ongoing) and no alcohol use. Concomitant medication(s) included: CARVEDILOL PHOSPHATE; LISINOPRIL; ALPRAZOLAM; LOPERAMIDE HYDROCHLORIDE; MIRTAZAPINE. Vaccination history included: BNT162b2 (dose 2, Intramuscular, EN6206), administration date: 09Mar2021, for covid-19 immunization; BNT162b2 (dose 1, Intramuscular, EN6200), administration date: 15Feb2021, for covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Jun2022, outcome "not recovered", described as "She has been experiencing lots of diarrhea."; SLEEP DISORDER (non-serious) with onset Jun2022, outcome "unknown", FATIGUE (non-serious) with onset Jun2022, outcome "not recovered" and all described as "She was tired because she could not get much sleep"; DISORIENTATION (hospitalization) with onset 21Jun2022, outcome "recovered" (22Jun2022), described as "disoriented"; DIZZINESS (hospitalization) with onset 21Jun2022, outcome "recovered" (22Jun2022). The patient was hospitalized for dizziness, disorientation (start date: 21Jun2022, discharge date: 22Jun2022, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Computerised tomogram: Normal; Magnetic resonance imaging: Normal. The action taken for gabapentin and duloxetine was unknown. The action taken for adalimumab was temporarily withdrawn in Jun2022. Clinical course: Solicited report by a consumer of a 72-year-old female with events of in hospital, dizziness and disoriented and non-serious diarrhoea and tired with Humira (Adalimumab) and Humira 40mg/0.4ml (Adalimumab). In 2022, the patient experienced in hospital. The patient was dizzy, not herself, and it came and went. She experienced dizziness, not knowing where she was, and disoriented. She was in the hospital on the evening of the 21st and was discharged on the afternoon of the 22nd. She was only given her usual medications. She had some computed tomography scan on her and some magnetic resonance imaging and she noted everything was normal. She stated the reason for her dizziness was that her pain medication Gabapentin and her anti-depression medication Duloxetine do not get along together. She was tired because she could not get much sleep and had a physician appointment. She missed her Humira for three weeks. She had been experiencing lots of diarrhoea. She was afraid to walk out of the house. 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 In Hospital with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of dizziness, disoriented, diarrhoea and tired was not provided. Agency's opinion is that there Is no reasonable possibility that the event of in hospital disoriented, diarrhoea and tired are related to Humira (Adalimumab). Causality for Humira 40mg/0.4ml (Adalimumab): The reporter's causality for the event (s) of In Hospital with Humira 40mg/0.4ml (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of dizziness, disoriented, diarrhoea and tired with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of in hospital, dizziness, disoriented, diarrhoea and tired are related to Humira 40mg/0.4ml (Adalimumab). Drug: Humira (Adalimumab): Causality: Hospitalisation, action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Probable. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Dizziness, disorientated, diarrhoea, tiredness, action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Drug: Humira 40mg/0.4ml (40 Milligram, Solution for injection in pre-filled pen) (Adalimumab), Unknown. Hospitalisation (Hospitalisation), action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Probable. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Dizziness, disorientated, diarrhoea, tiredness. Action(s) taken with drug: Drug discontinued. Outcome after reintro. of dose: Not applicable. Causality as per reporter (Drug/Vaccine): Not Related. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Product-Reaction level: Gabapentin (Gabapentin), (Gabapentin), Unknown. Causality: Hospitalisation, disorientated, diarrhoea, tiredness. Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported. Dizziness. Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Possible. Drug: Duloxetine: Causality: Hospitalisation, disorientated, diarrhoea, tiredness. Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported. Dizziness. Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Possible. Pfizer-BioNTech Covid-19 Vaccine: Causality: Hospitalisation, disorientated, diarrhoea, tiredness Action(s) taken with drug: Possible. Causality as per reporter (Drug/Vaccine): Not Reported. Dizziness: Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Possible.  The reporter's assessment of the causal relationship of "dizziness", "disoriented", "she was tired because she could not get much sleep" and "she has been experiencing lots of diarrhea." with the suspect product(s) gabapentin 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 "dizziness" related to BNT162b2. The reporter's assessment of the causal relationship of "disoriented", "she was tired because she could not get much sleep" and "she has been experiencing lots of diarrhea." 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.  Follow Up (30Jun2022): This is a follow up solicited report based on the information received by Pfizer from Agency. (Manufacturer Control No: 22K-163-4442877-00). A contactable consumer (patient) reported Updated Information which included patient height and weight; lab data and RMH, historical vaccine, suspect products, suspect dosage regimen and indication, concomitant drug, events, start and stop date of events, seriousness, hospitalization details; event outcome.  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 in the case report, a possible causal relationship between the reported events and the suspect drugs BNT162B2 and GABAPENTIN 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