Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19 immunisation, Eye pain, Fluid retention, Heart rate
Clinical narrative: Pain in right eye; Hypertension/ hypertensive; swelling in legs; Skin thinning; Atelectasis lung bases; nails crumbling; Fluid retention; losing hair; Asthma; Stomach ache / Upset stomach; Short and long term memory loss; Lymph node issue came and went; Lot of allergic reactions; Interchange of vaccine products; Revaccination with different COVID-19; respiratory distress; broke hip/ fractured hip; This spontaneous case was reported by a patient and describes the occurrence of HIP FRACTURE (broke hip/ fractured hip) and RESPIRATORY DISTRESS (respiratory distress) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination, IBRUTINIB (IMBRUVICA) capsule, hard for Chronic lymphocytic leukaemia and POLYETHYLENE GLYCOL [MACROGOL] for an unknown indication.    Previously administered products included for Product used for unknown indication: Benadryl. Past adverse reactions to the above products included Amnesia with Benadryl. Concurrent medical conditions included Autoimmune disorder (autoimmune things/ odd autoimmune disease at the age of 20's to 30's), Allergy (in her 20's-30's) and Chronic lymphocytic leukaemia.   In June 2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and POLYETHYLENE GLYCOL [MACROGOL] (unknown route) at an unspecified dose. On 08-Nov-2021, the patient experienced HIP FRACTURE (broke hip/ fractured hip) (seriousness criterion medically significant). On an unknown date, the patient experienced RESPIRATORY DISTRESS (respiratory distress) (seriousness criterion medically significant), EYE PAIN (Pain in right eye), HYPERTENSION (Hypertension/ hypertensive), PERIPHERAL SWELLING (swelling in legs), SKIN ATROPHY (Skin thinning), ATELECTASIS (Atelectasis lung bases), ONYCHOCLASIS (nails crumbling), FLUID RETENTION (Fluid retention), ALOPECIA (losing hair), ASTHMA (Asthma), ABDOMINAL PAIN UPPER (Stomach ache / Upset stomach), AMNESIA (Short and long term memory loss), LYMPHADENOPATHY (Lymph node issue came and went), HYPERSENSITIVITY (Lot of allergic reactions), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19). At the time of the report, HIP FRACTURE (broke hip/ fractured hip), RESPIRATORY DISTRESS (respiratory distress), EYE PAIN (Pain in right eye), HYPERTENSION (Hypertension/ hypertensive), PERIPHERAL SWELLING (swelling in legs), SKIN ATROPHY (Skin thinning), ATELECTASIS (Atelectasis lung bases), ONYCHOCLASIS (nails crumbling), FLUID RETENTION (Fluid retention), ALOPECIA (losing hair), ASTHMA (Asthma), ABDOMINAL PAIN UPPER (Stomach ache / Upset stomach), AMNESIA (Short and long term memory loss), LYMPHADENOPATHY (Lymph node issue came and went), HYPERSENSITIVITY (Lot of allergic reactions), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High. On an unknown date, Heart rate: Increased.         No concomitant medications were reported. The Patient was stopped taking the IBRUTINIB for one week, went to the hospital and ended up in the hospital due to the johnson and johnson immunization. It was reported that last couple of weeks patient was suffering from short term memory loss and long-term memory loss regarding hip surgery. Patient had reactions to the Polyethylene glycol and was dealing with a lot of allergic reactions and allergic to blood pressure medication. On 08-Nov-2022, patient's left hip got broken and cannot remember the birthday. Also, patient had shortness of breath, increased heart rate and reported asthma symptoms, wheezy cough, allergy. It was reported that benadryl caused short- or long-term memory loss. Patient was living in the house that was built in the 30's and maintained memories of house and had forgotten things. Patient was toxic from chemo and Intravenous immune globulin was received, it was working and white count coming down. Moderna caused respiratory distress. It was reported that odd autoimmune diseases were related to CLL (Chronic lymphocytic leukaemia). Lymph nodes came and went. Patient was hypertensive and leave the notes and felt like to throw the food to outside and reacting to sprays which were used in the garden.  The reporter's causality for the events of allergic to blood pressure medication, asthma, atelectasis lung bases, fluid retention, hypertension/ hypertensive, increased heart rate, losing hair, lot of allergic reactions, lymph node issue came and went, nails crumbling, pain in right eye, reactions to polyethylene glycol, short- and long-term memory loss, skin thinning, stomachache, upset stomach, broke hip/ fractured hip, respiratory distress and swelling in legs with Janssen covid-19 vaccine, polyethylene glycol, ibrutinib capsule was not provided.  No treatment medications were reported.  Company Comment: This spontaneous case concerns an 80-year-old female patient, with medical history of autoimmune disorder, allergy and Chronic lymphocytic leukaemia , who experienced the unexpected serious (Medically significant) events of Respiratory distress and Hip fracture that occurred in the context of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. It was reported that, the patient had autoimmune disease and allergies. She stopped the IMBRUVICA for one week, had hypertension, went to the hospital and she ended up in the hospital due to the johnson and johnson immunization. Allergic to blood pressure medication, blood pressure went higher, upset stomach, pain in her right eye for the last couple of weeks and short term memory loss and long term memory loss were reported. She had reactions to the POLYETHYLENE GLYCOL,  was dealing with a lot of allergic reactions. Also had shortness of breath, increased heart rate, swelling in legs, fluid retention, stomachache, atelectasis lung bases. She reported asthma symptoms, wheezy cough, allergy. She reported that her autoimmune diseases were related to CLL. Her lymph nodes came and went. She was hypertensive, lost hair, her nails crumbling and experienced skin thinning. Patient has also received a dose of Janssen Covid-19 vaccine (Interchange of vaccine products). The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 80-year-old female patient, with medical history of autoimmune disorder, allergy and Chronic lymphocytic leukaemia , who experienced the unexpected serious (Medically significant) events of Respiratory distress and Hip fracture that occurred in the context of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. It was reported that, the patient had autoimmune disease and allergies. She stopped the IMBRUVICA for one week, had hypertension, went to the hospital and she ended up in the hospital due to the johnson and johnson immunization. Allergic to blood pressure medication, blood pressure went higher, upset stomach, pain in her right eye for the last couple of weeks and short term memory loss and long term memory loss were reported. She had reactions to the POLYETHYLENE GLYCOL,  was dealing with a lot of allergic reactions. Also had shortness of breath, increased heart rate, swelling in legs, fluid retention, stomachache, atelectasis lung bases. She reported asthma symptoms, wheezy cough, allergy. She reported that her autoimmune diseases were related to CLL. Her lymph nodes came and went. She was hypertensive, lost hair, her nails crumbling and experienced skin thinning. Patient has also received a dose of Janssen Covid-19 vaccine (Interchange of vaccine products). The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.