Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Adverse drug reaction, Amnesia, Blood pressure measurement, Drug hypersensitivity
Clinical narrative: HOSPITALISATION; BROKE HIP; SHORT AND LONG TERM MEMORY LOSS; PAIN IN RIGHT EYE; HIGH BLOOD PRESSURE/BLOOD PRESSURE WENT HIGHER; UPSET STOMACH; REACTIONS TO POLYETHYLENE GLYCOL; LOT OF ALLERGIC REACTIONS; ALLERGIC TO BLOOD PRESSURE MEDICATION; This solicited report received from a consumer via MC-2015-135: Patient Support Program by a Business partner (Company, US-ABBVIE-22K-163-4354162-00) concerned an 80 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic lymphocytic leukaemia, and The patient had no known allergies and had not taken concomitant drugs and had no relevant medical history. The patient received Imbruvica (Ibrutinib) (capsule, oral, batch number was not reported) dose and frequency were not reported from an unspecified date in JUN-2018 for chronic lymphocytic leukemia. The drug was discontinued on an unspecified date for one week and again started on an unspecified date.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received macrogol (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced broken hip, and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unspecified if the patient discharged from the hospital. On an unspecified date, the patient had stopped Imbruvica for one week, had high blood pressure/blood pressure went higher for which she went to hospital and she ended up in the hospital due to Johnson and Johnson immunization, allergic to blood pressure medication (drug allergy), had upset stomach, pain in her right eye for couple of weeks and was suffering from short term and long term memory loss in regards to to her hip surgery. Patient stated she had reactions to polyethylene glycol, she was dealing with lot of allergic reactions. Laboratory data (dates unspecified) included: Blood pressure High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; dose of ibrutinib was not changed; and action taken with macrogol was not reported. The outcome of the broke hip, hospitalisation, allergic to blood pressure medication, short and long term memory loss, pain in right eye, high blood pressure/blood pressure went higher, upset stomach, reactions to polyethylene glycol and lot of allergic reactions was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and broke hip, short and long term memory loss, pain in right eye, high blood pressure/blood pressure went higher, upset stomach, reactions to polyethylene glycol, lot of allergic reactions, and allergic to blood pressure medication as related, and between covid-19 vaccine ad26.cov2.s, and hospitalisation as possible; Company causality between covid-19 vaccine ad26.cov2.s, and hospitalisation, broke hip, short and long term memory loss, pain in right eye, high blood pressure/blood pressure went higher, upset stomach, reactions to polyethylene glycol, lot of allergic reactions, and allergic to blood pressure medication was related; The reporter did not provide a causality assessment between ibrutinib, and broke hip, hospitalisation, short and long term memory loss, pain in right eye, high blood pressure/blood pressure went higher, upset stomach, reactions to polyethylene glycol, lot of allergic reactions, and allergic to blood pressure medication. Company causality between ibrutinib, and hospitalisation, broke hip, short and long term memory loss, pain in right eye, high blood pressure/blood pressure went higher, upset stomach, reactions to polyethylene glycol, lot of allergic reactions, and allergic to blood pressure medication was related. The reporter did not provide a causality assessment between macrogol, and broke hip, hospitalisation, short and long term memory loss, pain in right eye, high blood pressure/blood pressure went higher, upset stomach, lot of allergic reactions, and allergic to blood pressure medication, and between macrogol, and reactions to polyethylene glycol as possible. Company causality between macrogol, and hospitalisation, broke hip, short and long term memory loss, pain in right eye, high blood pressure/blood pressure went higher, upset stomach, reactions to polyethylene glycol, lot of allergic reactions, and allergic to blood pressure medication was related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, involving the same patient is linked to 20220644715. This case, from the same reporter is linked to 20211215540, 20211140269, 20211045398, 20211018396, 20210666706 and 20210424648.  It has been determined that this case is a duplicate of the Manufacturer Case Number 20220422050. This case Manufacturer Case number 20220644715 will be deleted. All relevant information regarding the case (20220644715) will be submitted under Manufacturer Case Number 20220422050. Additional information was received from the reporter on 15-JUN-2022 and 21-JUN-2022. The following information was updated and incorporated into the case narrative: events (broke hip, reactions to polyethylene glycol, and a lot of allergic reactions) added, events RRT updated from went to hospital to hospitalisation and  short term memory loss to short and long term memory loss, suspects products of  covid-19 vaccine ad26.cov2.s (Janssen covid-19 Vaccine) and macrogol added.