Age: 66.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Magnetic resonance imaging abnormal, Muscle rupture, Nausea, SARS-CoV-2 test negative, Spinal fusion surgery
Clinical narrative: Tear in gluteal muscle; endophthalmitis left eye/left eye surgery; Uses roller walker; bilateral back pain/Chronic bilateral low back pain without sciatica; spinal fusion done L3-L5; Secondary hyperparathyroidism; right hip right outer thigh lipoma removed; right hip hematoma/right hip hematoma I&D; Dizziness; Hypoglycemia; Nausea; Vomiting; This serious case was reported by a nurse via other manufacturer and described the occurrence of lipoma excision in a 67-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   The patient's past medical history included colorectal adenoma, nasal septum deviation (Bilateral Deviated septum), cyst removal, cryotherapy, shoulder arthroplasty (Since the Shoulder arthroplasty on 26Fe2015, her arm is not feeling or healing  right), gout, shoulder operation, bronchospasm, cataract operation, cataract operation (also in 05Feb2017 and 02May2017, OD), chronic kidney disease (GFR 15-29 ml/min (HCC)), thrombosis, cataract operation, tobacco abuse, eye operation (2017 and 2018), cataract (unsuccessful), neurectomy, knee arthroplasty, nerve block, joint aspiration, product use issue, retinal bleeding, acute macular neuroretinopathy, rubber sensitivity (Rash/Urticaria), facet joint block (Facet injection R lower back), asthma (Mild intermittent asthma without complication), high frequency ablation, epidural injection and epidural injection. Previously administered products included MIDAZOLAM HCL with an associated reaction of drug hypersensitivity, PENTAZOCINE LACTATE with an associated reaction of swollen tongue, INFLUENZA VACCINE, PROPANTHELINE with an associated reaction of respiratory distress, HYDROCODONE/ACETAMINOPHEN with an associated reaction of mental status changes, HYDROCODONE/ACETAMINOPHEN with an associated reaction of dizziness, INFLUENZA VACCINE (one more dose on 29-Sep-2012), NITROGLYCERIN with an associated reaction of dizziness, MORPHINE with an associated reaction of drug intolerance, INFLUENZA VACCINE, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), THYME with an associated reaction of laryngeal oedema, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), ASPARTAME with an associated reaction of diarrhoea, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), CYCLOBENZAPRINE with an associated reaction of drug hypersensitivity, PNEUMOCOCCAL VACCINE (DOSE NUMBER UNKNOWN, SINGLE), BENZENE, NAPROXEN SODIUM, HYDROCODONE, INFLUENZA VACCINE (DOSE NUMBER UNKNOWN, SINGLE), INFLUENZA VACCINE (INACT SPLIT 4V) and PNEUMOCOCCAL VACCINE POLYVALENT (DOSE NUMBER UNKNOWN, SINGLE). Concurrent medical conditions included hypoxia, obesity (BMI of 40 - 44.9, adult (HCC)), food allergy (respiratory distress, diarrhea), allergy to fermented products, food allergy (Respiratory distress, Fennel, Licorice, Fennel, Licorice) and allergy to chemicals. Concomitant products included acetylsalicylic acid (Aspirin Ec).   On 10-SEP-2019, the patient received Tdap Vaccine. On 23-SEP-2019, the patient received Influenza vaccine. On 23-SEP-2019, 13 days after receiving Tdap Vaccine, the patient experienced lipoma excision (Verbatim: right hip right outer thigh lipoma removed) (serious criteria clinically significant/intervention required), hematoma (Verbatim: right hip hematoma/right hip hematoma I&D) (serious criteria clinically significant/intervention required), dizziness (Verbatim: Dizziness), hypoglycemia (Verbatim: Hypoglycemia), nausea (Verbatim: Nausea) and vomiting (Verbatim: Vomiting). On 06-FEB-2020, the patient experienced hyperparathyroidism secondary (Verbatim: Secondary hyperparathyroidism). On 02-MAR-2020, the patient experienced fusion lumbar spine (Verbatim: spinal fusion done L3-L5) (serious criteria clinically significant/intervention required). On 08-APR-2020, the patient experienced low back pain (without radiation) (Verbatim: bilateral back pain/Chronic bilateral low back pain without sciatica) (serious criteria clinically significant/intervention required). On 04-AUG-2020, the patient experienced endophthalmitis (Verbatim: endophthalmitis left eye/left eye surgery) (serious criteria GSK medically significant and clinically significant/intervention required) and walker user (Verbatim: Uses roller walker). On an unknown date, the patient experienced gluteal muscle tear (Verbatim: Tear in gluteal muscle) (serious criteria GSK medically significant). On 23-SEP-2019, the outcome of the lipoma excision was resolved.  On 02-MAR-2020, the outcome of the fusion lumbar spine was resolved. The outcome of the hematoma, endophthalmitis, gluteal muscle tear, dizziness, hypoglycemia, nausea, vomiting and walker user were not reported and the outcome of the low back pain (without radiation) and hyperparathyroidism secondary were not resolved.   It was unknown if the reporter considered the lipoma excision, hematoma, fusion lumbar spine, endophthalmitis, gluteal muscle tear, low back pain (without radiation), dizziness, hypoglycemia, nausea, vomiting, hyperparathyroidism secondary and walker user to be related to Tdap Vaccine.     The company considered the lipoma excision, hematoma, fusion lumbar spine, endophthalmitis, gluteal muscle tear and low back pain (without radiation) to be unrelated to Tdap Vaccine. It was unknown if the company considered the dizziness, hypoglycemia, nausea, vomiting, hyperparathyroidism secondary and walker user to be related to Tdap Vaccine.   Linked case(s) involving the same patient:  US2024AMR135366, US2024AMR165842, US2024AMR165843   Additional Information: GSK Receipt Date: 30-OCT-2024 The nurse reported that a patient received Tdap vaccine on 10-Sep-2019. The patient had right hip right outer thigh lipoma removed, right hip hematoma/right hip hematoma inscision and drainage, spinal fusion done L3-L5, endophthalmitis left eye/left eye surgery, tear in gluteal muscle, bilateral back pain/Chronic bilateral low back pain without sciatica, dizziness, hypoglycemia,  nausea, vomiting, and secondary hyperparathyroidism. This case linked with cases US2024AMR135366, US2024AMR165842 and US2024AMR165843 for the same patient from the same reporter. (Please refer to the linked cases for the medical history prior to the prior to 20-May-2010); Sender's Comments: Lipoma excision, Haematoma, Spinal fusion surgery, Endophthalmitis, Muscle rupture, Back pain are unlisted events which are considered unrelated to GSK Tdap Vaccine. US-GSK-US2024AMR135366:same patient US-GSK-US2024AMR165842: US-GSK-US2024AMR165842: US-GSK-US2024AMR165843: