Age: 89.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Lower limb fracture, Weight, Weight decreased
Clinical narrative: She broke both bones in left leg; She is almost blind cant drive; Sick to her stomach; Losing her memory; Lost weight/she weighed 165 lbs and now weighs 133 lbs; She has also lost strength in her arms since receiving the covid vaccines; Dizziness; This case was received by Agency on 28-Jan-2022 (reference number: US-MIC-a0P5b00000SOWjlEAH). This spontaneous case was reported by a consumer and describes the occurrence of LOWER LIMB FRACTURE (She broke both bones in left leg) in an 89-year-old female patient who received LANSOPRAZOLE (Prevacid SoluTab) orodispersible tablet (batch no. SPDFI, expiration date: 26-Mar-2022), for GERD. The occurrence of additional non-serious events is detailed below. Co-suspect product included TOZINAMERAN (Covid 19 Vaccine Pfizer) unk for an unknown indication. Previously administered products included for Shingles: Prilosec; for GERD: Prilosec. Concurrent medical conditions and procedures included Pancreatitis, Allergy (Allergic to a lot of stuff, which she cant take.), Surgery and Colectomy (18 inches of her colon removed.). Concomitant products included Lorazepam for Sleep problem, Cyanocobalamin, Cyanocobalamin (Vitamin B-12) for an unknown indication, Atorvastatin calcium (Lipitor) and Colecalciferol (Vitamin D 3). On an unknown date, the patient started LANSOPRAZOLE (Prevacid SoluTab) (Oral) 15 milligram once a day and TOZINAMERAN (Covid 19 Vaccine Pfizer) (unknown route), at an unspecified dose and frequency. On an unknown date, the patient experienced LOWER LIMB FRACTURE (She broke both bones in left leg) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Sick to her stomach), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Prevacid/dosage (text): 30 mg solutab-1/2 tab qd/po), INCORRECT PRODUCT ADMINISTRATION DURATION (Patient has been taking Prevacid solutab for about 40 to 50 years now), AMNESIA (Losing her memory), WEIGHT DECREASED (Lost weight/she weighed 165 lbs and now weighs 133 lbs), VISUAL IMPAIRMENT (She is almost blind cant drive), ASTHENIA (She has also lost strength in her arms since receiving the covid vaccines) and DIZZINESS. At the time of the report, LOWER LIMB FRACTURE (She broke both bones in left leg) and VISUAL IMPAIRMENT (She is almost blind cant drive) outcome was not reported, ABDOMINAL DISCOMFORT (Sick to her stomach), AMNESIA (Losing her memory), WEIGHT DECREASED (Lost weight/she weighed 165 lbs and now weighs 133 lbs), ASTHENIA (She has also lost strength in her arms since receiving the covid vaccines) and DIZZINESS was resolving and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Prevacid/dosage (text): 30 mg solutab-1/2 tab qd/po) and INCORRECT PRODUCT ADMINISTRATION DURATION (Patient has been taking Prevacid solutab for about 40 to 50 years now) outcome was unknown. The patient concomitant medication includes mediciona for shingles, unknown medication for blood pressure. The patient called to asked about the availability of Prevacid Solutab. Patient had been taking Prevacid solutab for about 40 to 50 years now and insurance switched to Prilosec manufactured by Astra Zeneca. The patient asked if there was something wrong with Prevacid solutab, was it still available. The patient stated Prevacid solutab had worked well. Since patient got both Covid shots, patient had been going down hill further described as losing memory, lost weight, sick to stomach and dizziness however patient thought was felt better. Patient stated patient was almost blind and could not drove. Prior to Covid shots patinet weighed 165 lbs and now weighs 133 lbs. and had also lost strength in arms since receiving the covid vaccines. The patient continues to took prevacid solutab. The patient's blood pressure was usually 120/75 to 80. The dose of LANSOPRAZOLE (Prevacid SoluTab) (Oral) was not changed. The action taken with TOZINAMERAN (Covid 19 Vaccine Pfizer) (Unknown) was not reported. For LANSOPRAZOLE (Prevacid SoluTab) (Oral), the reporter did not provide any causality assessments. For TOZINAMERAN (Covid 19 Vaccine Pfizer) (Unknown), the reporter did not provide any causality assessments. This case was assessed as serious due to criterion of medical significance for the event lower limb fracture and rest all events were considered as non-serious. Follow-up information has been requested and if received the report will be updated and re-distributed.  Reporter comment :The reporter's causality assessment was not reported for the events with Prevacid SoluTab and other co-suspect therapy.  Agency comment: The company assessed the reported serious event of Lower limb fracture as unlikely related to lansoprazole. There is no compelling evidence to implicate suspect drug with the event. Patient's advanced age could be risk factor.  Prevacid SoluTab (LANSOPRAZOLE) is under agreement with Agency.  Causality Assessment: Drug administration duration too long, Tablet split incorrectly, Strength loss of, Vision decreased, Dizziness, Abdominal discomfort, Loss of weight, Memory loss, Leg fracture. Prevacid SoluTab, Covid 19 Vaccine Pfizer, Per Reporter: Not Reported; Per Company (Agency): Related.; Reporter's Comments: The reporter's causality assessment was not reported for the events with Prevacid SoluTab and other co-suspect therapy.