Failure to diagnose post-Covid-19 vaccine neuromuscular disorder and the diagnosis of neuritis
23. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong.
24. Mrs J complains Leeds Trust failed to diagnose her with a post-Covid-19 vaccine neuromuscular disorder. She tells us this this has now been diagnosed at a different organisation.
25. Leeds Trust said it conducted extensive investigations into her symptoms, but the tests did not show any neurodegenerative cause for her symptoms. It did not rule out a post-vaccination syndrome, but it could not diagnose this. She was discharged in October 2023 with a working diagnosis of multiple neuritis.
26. Mrs J says she began experiencing symptoms after her Covid-19 vaccine in 2021. She reported symptoms including cramping and twitching, muscle weakness, shrinking of various parts of her body, difficulty controlling urine and facial weakness.
27. In March 2022, she was reviewed by a neurologist who noticed she had facial asymmetry (features differing on each side of the face). Due to the persistence of her reported symptoms, Leeds Trust arranged Electromyography (EMG) testing (a diagnostic test that evaluates the health and function of the skeletal muscles and the nerves that control them) and an MRI. Her MRI showed asymmetry of the muscles in her face and neck. At first, Leeds Trust suspected there may be a physical cause for her symptoms, potentially some nerve damage.
28. Between March 2022 and October 2023, it arranged further investigations including lumbar puncture testing (a procedure to collect spinal fluid), a physiotherapy review, further MRIs, CT scans, blood testing, a muscle biopsy, and genetic testing.
29. Section 15a of the GMC guidance says a clinician must promptly provide or arrange suitable advice, investigations or treatment where necessary.
30. Leeds Trust performed extensive investigations into Mrs J’s symptoms to find the cause of her symptoms in line with the above guidance. Our neurology adviser said minor abnormalities were found in the EMG testing, but these did not suggest a diagnosis of a neurological disorder related to the COVID-19 vaccine. Our neurology adviser said Mrs J underwent a comprehensive set of investigations, and her results did not suggest she needed treatment.
31. Our neurology adviser said there is generally no accepted condition of ‘post-vaccine neurological disorder’ and there is no specific testing for it. They said there are multiple rare neurological disorders that have been associated with the COVID-19 vaccine, including muscle aching, inflammation of the brain and spinal cord, and strokes. Our neurology adviser said these were excluded in Mrs J’s extensive investigations.
32. They said there is no general recognised syndrome of multiple neuritis associated with the COVID-19 vaccination, but in the Cereus case report, it reported a patient who suffered with multiple neuritis following a COVID-19 vaccination. This case report encouraged physicians to consider the possibility of multiple neuritis after the COVID-19 vaccination.
33. The BMJ guidance says a history of asymmetry, EMG findings, pain, and weakness are key diagnostic factors for multiple neuritis.
34. Our neurology adviser said Mrs J’s EMG testing in March 2023 showed a slight change in the muscles of the head. Our neurology adviser said there was no obvious cause of this longstanding change, but minor damage to a nerve was reasonable. Considering this, and Mrs J’s facial asymmetry, our neurology adviser said a working diagnosis of multiple neuritis was appropriate. This was in keeping with the BMJ guidance.
35. We are sorry Mrs J feels Leeds Trust failed in diagnosing her with a post-Covid-19 vaccine neurological disorder. We consider Leeds Trust performed extensive investigations into Mrs J’s symptoms in line with the GMC guidance, and it was reasonable for Leeds Trust to come to the working diagnosis of multiple neuritis at that time. We have not seen an indication of failing, and we will not investigate this further.
Investigation into her symptoms
36. Mrs J complains about how Leeds Trust investigated her symptoms between April 2022 and December 2023. She complains the Trust took unnecessary lumbar punctures, performed a biopsy in the wrong area and did not carry out necessary EMG testing.
37. In the Trust’s complaint response, it said further EMG testing would not provide any further information which is why it was not done.
38. The Trust carried out EMG testing on Mrs J in July 2022, October 2022, and March 2023. EMG testing helps diagnose the cause of symptoms such as muscle weakness.
39. In July 2022, her symptoms included asymmetry with facial weakness on the right side of her face, muscle loss, muscle cramps, and weakness on the right with mild tongue atrophy (weakening of the tongue muscle).
40. In March 2023, she had atrophy on the right side of the tongue, right side facial weakness, cramping and muscle weakness.
41. In March 2023, the EMG results showed neurogenic units which were mild and chronic (a subtle finding on the EMG result which could indicate a nerve-related issue) but there was no evidence of any progression of these findings comparing to the previous studies.
42. By October 2023, Mrs J was still reporting abdominal pain, facial weakness, muscle weakness, right sided tongue atrophy.
43. Our neurology adviser said Mrs J had undergone EMG testing three times since July 2022, and her symptoms had not significantly changed during this period. After her last EMG testing in March 2023, which reported no evidence of progression, her symptoms did not change. Our neurology adviser said on this basis, there was no indication to perform any further EMG testing.
44. Section 15b of the GMC guidance states that a clinician must promptly provide or arrange suitable advice, investigations or treatment where necessary.
45. We consider Leeds Trust acted in line with the above guidance by only providing necessary investigations into Mrs J’s symptoms. In October 2023, there was no clinical indication for further EMG testing, so it was appropriate for Leeds Trust to decline further testing.
46. Mrs J complains Leeds Trust performed a biopsy on her right thigh, instead of an affected part of her body.
47. During the period of care, she mostly complained about muscle loss on the right side of her face and muscle weakness. She also complained about the dropping of her left shoulder.
48. In April 2023, she reported weakness and loss of muscle bulk in various parts of her body, including her right quads (a group of muscles located in the thigh). In July 2023, she reported ‘dints’ in her body, particularly around the right thigh.
49. In July 2023, Leeds Trust performed a muscle biopsy, to help diagnose a muscle related condition.
50. The UCL advice says a muscle biopsy is usually taken from the upper, outer thigh muscle but it can be taken from other muscles sometimes.
51. Our neurology adviser said muscle biopsies are usually targeted to large muscles where healing would be expected to be rapid and complete. They said the choice of the right thigh was appropriate given Mrs J had complained about dints in that muscle, and muscle weakness in her right quads, and she had observed widespread muscle twitching.
52. Section 16a of the GMC guidance says a clinician must provide effective treatments based on the best available evidence. Leeds Trust acted in line with this by following the UCL advice and considering her history of muscle pain in her right thigh.
53. We consider it was in line with the UCL advice to choose the right thigh for a muscle biopsy, and this is supported by her history of widespread muscle issues including in the right thigh. We have not seen evidence to suggest she should have had it in a different muscle.
54. Mrs J complains she had unnecessary lumbar punctures. A lumbar puncture involves a needle being inserted into the lower back, between the bones in the spine. A lumbar puncture may be used to find out if symptoms are caused by a brain or spine condition. She had lumbar punctures in July 2022, March 2023 and September 2023, to help investigate if her symptoms were caused by a brain or spine condition.
55. She had a failed attempt in August 2023, with doctors being unable to obtain fluid despite manipulation. She had a guided X-ray lumbar puncture in September 2023 due to the previous failed attempt.
56. Mrs J strongly felt she had a neurological condition. She suspected motor neuron disease (MND, a progressive condition affecting the brain and spinal cord).
57. Leeds Trust did not think it was MND, but they felt her symptoms were unusual, and she needed neurological investigations, including lumbar punctures.
58. Our neurology adviser said this was an appropriate investigation to examine the spinal fluid for evidence of inflammation, abnormal proteins, and abnormal antibodies. Since the risk of performing a lumbar puncture is low, they said repeated lumbar punctures was appropriate if the clinical team felt an abnormality might be detected.
59. Leeds Trust advised spinal fluid has a short shelf life, and repeated tests cannot be done on stored samples, so repeated testing is required.
60. Section 15b says a clinician must promptly arrange suitable advice, investigations or treatment where necessary.
61. Between 2022 and 2023, Leeds Trust had advised Mrs J she did not have MND, and it did not identify any neurological condition. By June 2023, Mrs J said her symptoms had got worse, and the consultant believed her tongue wasting was worse.
62. The consultant agreed to refer her for further lumbar punctures as well as some further tests. Due to her symptoms worsening and Mrs J wanting further investigations, we consider it was appropriate for Leeds Trust to consider further lumbar punctures. Mrs J was noted to be happy with this plan for further investigations.
63. The records indicate the lumbar punctures were elective (chosen by the patient) and consent was gained from Mrs J for each procedure. Mrs J suspected a neurological condition and wanted a diagnosis. Leeds Trust used the lumbar puncture testing to carry out various tests.
64. We recognise Mrs J feels she had unnecessary lumbar puncture testing, that did not lead to a diagnosis she agreed with. We consider repeated lumbar punctures were appropriate and in line with the GMC guidance given her persistent symptoms and Mrs J’s belief this was a neurological condition. Mrs J also consented to these further investigations. We have not seen an indication of failing by Leeds Trust in deciding to perform further tests.
65. We are sorry Mrs J feels Leeds Trust did not investigate her symptoms appropriately. We recognise why she feels this way as it did not lead to a diagnosis she agreed with. We consider Leeds appropriately investigated the cause of her symptoms and we have not seen an indication of failing in how these were carried out.
Leeds Trust’s mental health support
66. Mrs J complains about the lack of mental health support offered to her by Leeds Trust, despite her expressing how she was struggling with her mental health in October 2023.
67. Between June 2023 and August 2023, Mrs J’s GP asked Leeds Trust for help with Mrs J’s mental health and asked for a referral for onward psychology support services.
68. In October 2023, she was reviewed by psychiatry at Leeds Trust. It was noted she presented as highly anxious and was experiencing symptoms of post-traumatic stress, moderate depression, and her medical journey was causing her a high level of distress. Leeds Trust said she was not suitable for psychiatric outpatient care as she does not believe there is a psychiatric component to her sensations.
69. In this review, the psychiatrist referred to a letter from SWYPT which said it will not accept a CMHT referral while there are ongoing investigations with neurology. The assessment says Mrs J was fixed on an underlying physical cause for her symptoms. The psychiatry team suspected there may be a psychological functional reason for her symptoms, due to her high levels of anxiety and there being no definitive cause for her symptoms.
70. The psychiatry team felt while Mrs J thought there was a physical cause for her symptoms, the role of the mental health services was limited. Mrs J declined any onward mental health referrals, and she was awaiting a private trauma focused therapy.
71. It is noted her GP had prescribed medication to treat her anxiety. When she was discharged in October 2023, Leeds Trust prescribed her Trazadone (an anti-depressant medication).
72. Our psychiatry adviser said the notes suggest Mrs J declined any mental health referrals and she was presumed to have capacity to make decisions about this. Our psychiatry adviser said as the psychiatry team suspected Mrs J’s symptoms were caused by a psychological element, and Mrs J was not accepting of this, there was no further mental health support it could offer, other than prescribing anti-depressants.
73. Section 16a of the GMC guidance says a clinician must prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs.
74. In line with the above guidance, Leeds Trust only offered treatment that served Mrs J’s needs. It did not feel psychiatry input would help as Mrs J did not feel there was a psychiatry element to her illness, and Leeds Trust prescribed anti-depressants to help treat her depression going forward. We consider Leeds Trust acted in line with the above guidance, and we have not seen an indication of a failing in the mental health support offered. We are not going to investigate this further.
Leeds Trust complaint handling and response
75. Mrs J complains Leeds Trust’s complaint response did not answer her concerns, and she says there was discrepancies in the response.
76. Mrs J submitted a formal complaint to Leeds Trust in December 2023.
77. Mrs J received two complaint responses from Leeds Trust, in March 2024 and August 2024.
78. In the first response, it outlined how a consultant neurologist has led the investigation into the care provided to Mrs J and provided a response covering the decisions Leeds Trust had made throughout Mrs J’s care.
79. In May 2024, Mrs J contacted Leeds Trust saying the matter is now with us. Leeds Trust considered as it was with us, it would wait for us to contact it instead of reopening her complaint. We then asked Mrs J to return with her outstanding questions to Leeds Trust. Leeds Trust provided a further response, but this reached the same findings as its original response and did not answer Mrs J’s specific questions.
80. Our NHS Complaint Standards say an effective complaint handling system ensures it provides a thorough, proportionate, and balanced look into the issues raised in a complaint.
81. In Mrs J’s follow up complaint, she asked specific questions about why certain decisions were made. We can see that the Trust did not address these specific questions but instead addressed the complaint more generally in explaining what happened in her care.
82. Whilst we acknowledge that Leeds Trust did not answer some of Mrs J’s specific questions in its second response, as Mrs J’s primary concern related to the investigations into her condition and diagnosis, we consider it was proportionate for the Trust to take this general view in addressing her complaint.
83. We consider the complaint responses did provide a thorough response about her care and the decisions made about her diagnosis. Therefore, we consider Leeds Trust did act in line with Our NHS Complaint Standards.
84. We are sorry Mrs J had outstanding concerns which she feels Leeds Trust did not answer in either of the complaint responses. Our NHS Complaint Standards also say complaints should be investigated thoroughly and proportionately. We consider Leeds Trust provided a proportionate but thorough response to Mrs J’s complaint by deciding to provide an overview of her care and diagnosis, instead of providing answers to each question specifically.
85. We are sorry for any additional time Mrs J spent returning to Leeds Trust with her outstanding questions. We consider the response is in line with our NHS Complaint Standards, and we would not investigate this any further.
86. Mrs J also complains about discrepancies in the complaint response. She says in Leeds Trust’s response, it denied her having a dropped shoulder in her recent admission in October 2023.
87. Leeds Trust said there was no clinical finding of her dropped shoulder in October 2023.
88. The records indicate she had a history of a dropped shoulder in previous admissions. In April 2023, it had noted her left shoulder dropped slightly lower than the right. In October 2023, this was listed in her history but there was no diagnosis made.
89. Our neurology adviser said there is no evidence in the October admission that Mrs J was diagnosed with a dropped shoulder.
90. We consider Leeds Trust’s response that there was no clinical finding in October 2023 reflects Mrs J’s records. It is listed in her history of symptoms, but she was not diagnosed or treated for having a dropped shoulder. We appreciate any confusion this response caused Mrs J.
91. We did not see evidence of any discrepancies in Mrs J’s complaint response, and we hope we have provided further clarification in relation to the shoulder dropping issue.
92. We are sorry Mrs J was unhappy with the complaint response from Leeds Trust, and she did not get answers to all her questions. From our consideration, we think Leeds Trust provided a thorough response to Mrs J’s concerns, and we did not find evidence of discrepancies. We are declining to investigate this any further.
SWYPT mental health referral
93. Mrs J complains SWYPT rejected her referral, not offering any mental health support.
94. Mrs J’s GP referred her to SWYPT in November 2023, due to her struggles with her mental health. The referral said this was due to having ongoing medical problems and struggling to get a diagnosis, and Mrs J said she was at a point where she needed input from a mental health professional.
95. In December 2023, SWYPT rejected Mrs J referral, stating she had been assessed and accepted into the mental health services on numerous occasions without any significant changes in her presentation. It said Mrs J believed she suffered from a neurological disorder, and psychological interventions will unlikely yield any further response. It said once Mrs J had a definitive diagnosis, she could be referred to Health Psychology which could provide support in managing her condition.
96. Our psychiatry adviser said a neurological diagnosis for her symptoms needed to be excluded before psychiatry could offer support, as psychiatry suspected there was a psychological cause for her symptoms. Our psychiatry adviser said once neurology had concluded its investigations, an appropriate treatment plan could be offered.
97. In line with 16a of the GMC guidance (quoted above), where a clinician should only provide treatment if they are satisfied it serves the patient’s needs, SWYPT did not offer further psychiatry treatment as it did not think this would be beneficial to Mrs J.
98. As Mrs J had previously been under the service, which did not help her symptoms, and she was not accepting of a psychological cause for her illness, so she would not accept the treatment it could offer, we consider it was appropriate for SWYPT to decline her referral.
99. As Mrs J’s distress was related to her neurological condition, SWYPT asked Leeds Trust to confirm whether she had a neurological condition, in order for Mrs J to start the correct treatment. We consider SWYPT could not offer mental health treatment to support her with her condition without a definitive diagnosis. As SWYPT was not satisfied treatment would serve Mrs J’s needs, as required by the GMC guidelines, we consider it was appropriate for it to decline the referral at that stage.
100. We are sorry Mrs J did not receive the mental health support she wanted at the time. From our consideration, we think SWYPT acted in line with guidance by rejecting her referral, as it was not able to provide treatment that would serve Mrs J’s needs. As we have not seen an indication of failing, we are declining to investigate this further.
101. We are very sorry to hear how Mrs J has suffered with ongoing symptoms since 2021 without a clear diagnosis. We recognise how distressing and difficult this time as been for her. As we have not seen any indications of failings in Mrs J’s care, we are declining to investigate any further.