Appendix A: In-house clinical advice to Commissioner

The following in-house advice was obtained from GP Dr David Maplesden:

‘1. My name is David Maplesden. I am a graduate of Auckland University Medical School and I am a practising general practitioner. My qualifications are: MB ChB 1983, Dip Obs 1984, Certif Hyperbaric Med 1995, FRNZCGP 2003. Thank you for the request that I provide clinical advice in relation to the complaint from [Mrs C] about the care provided to her late daughter, [Ms A], by [Dr B] and [the urgent care clinic]. In preparing the advice on this case to the best of my knowledge I have no personal or professional conflict of interest. I agree to follow the Commissioner’s Guidelines for Independent Advisors.

2. I have reviewed the following information:

• • Complaint to [the urgent care clinic] from [Mrs C]
  • Response from [the urgent care clinic] to [Mrs C]
  • Response from [the urgent care clinic] to HDC including: relevant operating guidelines; clinical notes [the urgent care clinic] and [the public hospital]; statement to Coroner from [two GPs]; Coronial autopsy report.

3. [Ms A] … had a diagnosis of … a rare genetic disorder which can be complicated by cardiovascular disease including pulmonary stenosis, hypertension and valvular disease^[16]. She had undergone mitral valve repair in 2001 and was under the care of [a cardiologist]. Regular medications were metoprolol and cilazapril for hypertension and Pulmicort and Bricanyl inhalers for asthma. [Ms A’s] most recent echocardiogram was 2017 (normal left ventricular function) with most recent cardiology review March 2020 (asymptomatic, review in two years). She was not known to have ischaemic heart disease and there is no record of coagulopathy. [Ms A] had previously lived independently but was currently residing with her mother [Mrs C].

4. On [date] [Ms A] received her first dose of the Pfizer mRNA Covid vaccine Comirnaty at [the medical centre]. [The cardiologist] had given specific advice that vaccination could proceed. [Mrs C] states [Ms A] had an immediate reaction to the vaccine with her becoming pale, cold hands, breathing faster and rapid pulse (statements provided from others accompanying [Ms A]). There was prompt nursing attention but some difficulty obtaining [Ms A’s] blood pressure and oxygen levels and an issue with computer software prevented documenting of observations. The observations were eventually handwritten and provided to [Mrs C] to take to [the public hospital] with [Ms A] for review by a doctor. [Mrs C] describes a wait of an hour at [the hospital] before nursing staff took further tests including an ECG. She states [Ms A] was still complaining of dizziness and was pale with rapid pulse during this time. There was a further wait of almost two hours before [Ms A] was eventually reviewed by [Dr B]. [Mrs C] is concerned that [Dr B] took a casual attitude to [Ms A’s] condition, not seeking additional information from her about [Ms A’s] pre-existing condition and not examining [Ms A] himself. [Mrs C] states [Dr B] made a diagnosis of anxiety without discussing this with [Ms A] or her whānau who were present, and he stated [Ms A] did not meet the criteria for filing an adverse reaction with CARM. [Ms A] was discharged with advice she could get her second vaccine at the appropriate time. Over the next three days [Ms A] remained lethargic and cold and was apparently more short of breath than usual particularly on exertion. Tragically she was found deceased in her bed [four days later]. [Mrs C] has questions regarding the clinical care provided to [Ms A] which will be the focus of this advice. She has further issues regarding the Covid vaccination programme in general which might be best addressed by the Ministry of Health. Issues regarding the computer software have been addressed by [the medical centre].

5. [Ms A’s] death was referred to the Coroner and she underwent an autopsy on [date]. Extracts from the report include:

• • The most significant post mortem findings were of pulmonary thromboembolism (clot in the left lung) and severe atherosclerosis (narrowing) of the left anterior descending coronary artery. The source of the thromboembolism was not established however may have arisen from a deep vein thrombosis.
  • The degree of coronary atherosclerosis was such that a sudden death could have occurred at any time as a result of myocardial ischaemia causing a fatal cardiac arrhythmia. There was no evidence of acute myocardial infarction. Death most likely arose from the combined effects of pulmonary thromboembolism, severe coronary atherosclerosis, hypertensive heart disease and mitral valve disease in association with [the rare genetic disorder].
  • A blood sample showed a normal serum tryptase level (a raised level may be an indication of anaphylaxis).
  • There was no indication that the deceased had suffered an acute reaction to Covid 19 vaccination. Given the pre-existing conditions present, there was a risk of sudden death which could have occurred at any time.

6. [Dr B’s] statement includes the following points:

(i) [Dr B] commenced his overnight call shift at [the urgent care clinic] around 1630hrs on [date]. [Ms A] presented to [the clinic] that afternoon. Her history was of feeling heavy and weak while sitting in the recovery room after receiving her first Covid 19 vaccine that morning.[17] Immediately following the vaccination she had been observed to have a low blood pressure and elevated pulse, which were unusual observations for her. [Dr B] was provided with a written note from [the medical centre] staff and an ECG which was timed 1401hrs.[18] He accessed [Ms A’s] medical file and noted her diagnosis of [a rare genetic disorder] and reviewed her most recent cardiology clinic notes. He noted the ED nurse observations and comments (see section 7).

(ii) [Dr B] reviewed the ECG noting features (not otherwise specified) which he was unsure represented a normal finding for [Ms A] given her medical history. [Dr B] states: My plan at that stage was to consider the ECG further in the context of my assessment of [Ms A]. [Dr B] spoke with [Ms A] who appeared well perfused and able to give me a good account of the events that had unfolded during the day. In the consulting room observations were BP 112/68, O2 sats 98% on air and pulse 130. [Dr B] states: From the examination, my assessment was that [Ms A] was not suffering an acute allergic reaction to the Covid vaccination. She did not appear in distress or short of breath. Nor did she report any pain, nausea or light-headedness etc. [Dr B] sought to reassure [Ms A] and attending whānau that it appeared unlikely she had suffered a physical reaction to the vaccine. [Mrs C] mentioned [Ms A] had been somewhat short of breath in the two days preceding the vaccination and he advised that should the symptom continue [Ms A] should consult her usual GP and, if required, seek advice from her cardiologist. [Dr B] perceived [Ms A] to become more relaxed following the explanation and although he did not recheck her pulse, he concluded she most likely had an anxiety reaction.

(iii) [Dr B] states: Having reached the view that [Ms A] was not acutely unwell, my plan was to either discuss the ECG with the medical director or review it further myself in the context of any prior ECGs available from [Ms A’s] clinical records. If this raised any concerns we would be able to ask her to come back in. [Dr B] recalls providing his usual safety netting advice for [Ms A] to return for review if there were any ongoing concerns. He states he then had to attend a patient with an acute head injury who required evacuation to [another hospital] and this distracted him from the need to review [Ms A’s] ECGs which he omitted to do and was not reminded until he was informed of [Ms A’s] death. In removing copies of confidential patient information [Dr B] had accumulated during his locum at [the urgent care clinic] [Dr B] tore up the copy of [Ms A’s] ECG without realizing this had not been incorporated into her electronic file. He subsequently reassembled the document so it could be placed on [Ms A’s] file. I could not find a copy of the reassembled ECG in the documentation provided to me.

7. Clinical notes review

(i) Notes are consistent with the provider responses. It appears standard pre-vaccine related documentation was completed and expected processes were followed in this regard. It is noted the cardiologist had requested [Ms A] be vaccinated against Covid and there were no apparent contraindications (per IMAC guidance^[19]) to administration of the vaccine. I am unable to comment on the vaccine pre-administration process but assume this was undertaken in line with IMAC guidance and local operating guidelines. I could see no indication to administer [Ms A] other than the standard adult dose of Comirnaty. A vaccine reaction such as [Ms A] exhibited should be recorded contemporaneously in the electronic vaccine register (CIR) and notified to CARM but I understand there were technical issues with the software at the time of the events in question although the provider response indicates efforts were made to complete this notification.

(ii) Nursing notes from [the medical centre] record that [Ms A] felt heavy and weak after Covid vaccine. She was brought to an observation room and laid flat then transferred to a quieter room to facilitate recording of vital signs. Notes include: [Ms A] feeling ok … BP 112/98 L arm, unable to auscultate BP in R arm, pulse = 130 auscultated, cold hands — pulse oximetry not picking up a pulse … Subsequent notes refer to [Ms A’s] condition improving but a decision to transfer her to [the hospital] for review (contact made with [hospital] nursing staff regarding transfer). There is reference to observations not saving in the PMS and these were apparently provided in a handwritten handover note to [the hospital]. I have not been provided with a copy of this note and am unable to determine what additional observations were recorded prior to transfer (eg O2 sats, respiratory rate).

(iii) The provider response indicates ambulance transfer was considered but given [Ms A] was feeling better and it was felt she had most likely suffered a vaso-vagal reaction to the injection, this was not felt necessary. It is also noted, in hindsight, that the limited availability of ambulances at that time meant that even had ambulance transfer been arranged, this would not necessarily have resulted in any significant difference to the timing of [Ms A’s] subsequent reviews. [Ms A] arrived at [the hospital] about 1530hrs and was triaged by a nurse around 20 minutes later. Notes include:

Sent in from [medical centre]. Feeling weak after covid vaccine. Mum mentioned that she has been short of breath in the past 2 days when she goes and carry firewood. She also has to stop a couple of times to catch her breath when walking uphills. On metoprolol and cilazapril.

Exam: Temp= 37.3, Pulse= 115, 02sat=97% RA, BP= 110/80, Tongue appears to be coated ECG rate 140 JVP < 4cm Clear lung fields Heart rate dual and regular            
Ambulatory and Independent. Passing and BM OK. Denies chest pain or tightness, diarrhea or vomiting

Action: ECG done

Action: Duty doctor to review

(iv) [Dr B] reviewed [Ms A] at 1720hrs. The provider response indicates the approximately 90 minute wait is outside their expected wait time but [the hospital’s] urgent care clinic was busy in terms of demand and capacity on the day in question. [Dr B’s] notes read as follows:

History: Seen following Covid vaccine today. Has [a rare genetic disorder] and is under the care of [a cardiologist] who is due to see her again in March of next year. Lives with her mother. A note from the Covid vaccination centre today says that she felt heavy and weak after the vaccine and had a pulse of 130. There is a background story of decreasing exercise tolerance and shortness of breath.

Exam: On exam today she is settled and has a pulse of 130 per minute BP= 112/68, Pulse= 143 , SpO2= 98

Anxiety
P: reassure — review again as required

If exercise tolerance drops further for re-referral to [the cardiologist]

8. Comments

(i) As far as I can determine, [medical centre] staff followed accepted practice in relation to the administration of the Comirnaty vaccine to [Ms A] … However, as evident from the Vaccine Operating Guidelines there are significant requirements covering all aspects of vaccine preparation and administration and the environment in which it occurs and I am unable to comment on every aspect. I have assumed the clinic had staff and equipment available to deal appropriately with an anaphylactic reaction should one occur.

(ii) Based on the description of [Ms A’s] reaction to vaccination, and without the benefit of hindsight, it appears she most likely suffered a vasovagal reaction (pre-syncope) to the vaccination process. However, given her cardiac history it was appropriate to advise medical review even when [Ms A] apparently reported feeling better. The symptoms described are not characteristic of an anaphylactic reaction. My comments on the adequacy of [Ms A’s] assessment at [the medical centre] are limited by the apparent absence of some of the reported observations undertaken at the time. I would expect a comment on any signs of respiratory distress (respiratory rate, increased work of breathing) and (if technically possible) recording of oxygen saturations. If [Ms A] appeared to be objectively stable and subjectively improving following a period of observation at [the medical centre], and given the likely diagnosis of vasovagal reaction, I believe it was reasonable to arrange transport to [the hospital] by private car given it was reasonable to have low expectation of any deterioration en-route, and the referral was being undertaken as a precaution given [Ms A’s] complex medical history rather than because she was suspected to be significantly unwell.

(iii) The apparent 20 minute wait for triage nurse assessment at [the hospital] is outside what I would expect for a hospital emergency department but I understand the clinic in question was functioning more as a primary care urgent care facility rather than an ED, and it could be argued the assessment at [the medical centre] represents the initial nurse triage. Noting [Ms A] did not appear as acutely unwell, the wait, while not representing best practice, was probably acceptable. I believe the provider intent to provide additional training around the Australasian Triage Scale is an appropriate quality improvement measure. Once the triage occurred, nursing assessment was reasonable although measurement of respiratory rate might have been expected given the history obtained of recent effort-related shortness of breath. The most significant finding was a persistent tachycardia but this in itself did not necessitate urgent clinician review. Oxygen saturations were satisfactory and the absence of any complaint of chest pain or tightness is of some relevance with respect to [Ms A’s] eventual diagnosis. It was appropriate to perform an ECG and if it [is] possible to obtain a copy of the tracing, this should be done.

(iv) The provider has noted the 90 minute wait for [Ms A] to be seen by a clinician was longer than desirable but, given the circumstances of review (precautionary assessment following likely vasovagal reaction to a vaccine, stable patient), I would not say such a wait would be unusual in a busy primary care urgent care clinic or secondary care ED.

(v) The care provided by [Dr B] must be examined in the context of the referral and without the benefit of hindsight. While it is possible [Ms A’s] recent increase in shortness of breath on exertion (which preceded her vaccination) may have been due to pulmonary thromboemboli, the breathing history was presented as incidental to the primary reason for her presentation which was the potential vaccine reaction. [Ms A’s] presentation was not typical for ischaemic heart disease in terms of her age, circumstances of the presentation and symptoms presented. I am currently unable to comment on whether the ECG findings might have raised concerns regarding underlying ischaemia. With respect to diagnosis of pulmonary embolism (PE), a review article on this topic^[20] notes: the clinical presentation of PE is variable and often nonspecific making the diagnosis challenging … Pulmonary embolism (PE) has a wide variety of presenting features, ranging from no symptoms to shock or sudden death. The most common presenting symptom is dyspnoea (73%) followed by chest pain (classically pleuritic in nature, but not always — 66%), cough (37%), and symptoms of deep venous thrombosis (44%). With severe PE, patients can present with shock, arrhythmia, or syncope. Many patients, including some with large PE, are asymptomatic or have mild or nonspecific symptoms. Thus, it is critical that a high level of suspicion be maintained such that clinically relevant cases are not missed. Common presenting signs on examination include: tachypnoea (54 percent); calf or thigh swelling, erythema, oedema, tenderness, suspicious for DVT (47 percent); tachycardia (24 percent). While [Ms A] did have a persistent tachycardia, this is a very non-specific finding and was reasonably attributed by [Dr B] to a degree of anxiety. ECG abnormalities, although common in patients with suspected PE, are nonspecific. The most common findings are tachycardia and nonspecific ST-segment and T-wave changes (70 percent). Abnormalities historically considered to be suggestive of PE (S1Q3T3 pattern, right ventricular strain, new incomplete right bundle branch block) are uncommon (less than 10 percent).

(vi) The scenario with which [Dr B] was presented was of a [woman] with a rare genetic syndrome which involved cardiovascular pathology (hypertension and previous valve repair) which appeared, on review of recent specialist reports, to be stable and of no specific concern. Nursing notes suggested a likely vasovagal reaction to the Comirnaty vaccine with there being no particular suspicion the reaction was anaphylactoid in nature. While there had been previous publicity regarding increased incidence of thromboembolic complications associated with some Covid vaccines, this was not felt to be a particular issue with Comirnaty and certainly a vaccine-related thromboembolic complication would not occur in the time frame relevant to [Ms A’s] witnessed reaction. There was no history provided of leg pain or swelling suggestive of deep vein thrombosis (DVT) and [Ms A] did not appear to be at increased risk of venous thromboembolic disease. Incidental history of some shortness of breath in the two days prior to the vaccine was obtained but this was not the primary reason for the assessment and had not resulted in [Ms A] seeking medical attention specifically for this symptom. In addition, [Ms A] was known to be asthmatic which could cause such a symptom. There was no history of cough or chest pain. Although respiratory rate has not been recorded, it appears [Ms A’s] oxygen saturations were normal and I would expect significant tachypnoea at rest to have been obvious and noted if it was present. It appears the only abnormal physical finding was a persisting tachycardia which is a very non-specific observation. ECG findings remain unconfirmed at this point. Taking all of these factors into account, I do not believe [Ms A’s] presentation raised particular suspicion for a diagnosis of PE and I am not critical [Dr B] failed to consider this diagnosis. Even had he considered the diagnosis and applied a validated risk tool (Wells criteria for PE)^[21], on the basis of the findings recorded [Ms A] would have fallen into a low risk group for the diagnosis.

(vi) Taking into account the nursing observations available to [Dr B] (including heart and lung auscultation findings), I believe it was reasonable for him to recheck [Ms A’s] observations with no particular need to perform cardiorespiratory auscultation again, although some of my colleagues might have repeated the examination. I believe the clinical scenario was suggestive of a vaso-vagal reaction to the vaccination process with some persisting anxiety, with [Ms A] apparently recovering and not requiring any specific treatment. In that context, I believe it was reasonable for [Dr B] to reassure [Ms A] and her whānau regarding the assumed nature of the reaction and to discharge her with standard safety-netting advice although I believe some of my colleagues might have repeated observations prior to discharge to ensure [Ms A’s] tachycardia was settling. These comments are subject to my review of the ECG tracing which, if there were abnormalities which might have suggested significant cardiac pathology, places [Dr B’s] review into a different context. If there were obvious and potentially significant ECG changes present but [Dr B] was unsure of their significance, I believe accepted practice would be to have sought cardiology advice or a previous ECG for comparison prior to discharging [Ms A], particularly given [Ms A’s] history of cardiac disease and cardiologist involvement. If the changes were more subtle and appeared unlikely to be of significance, [Dr B’s] intended plan to further review the ECG in more detail as time allowed, might have been acceptable. [Dr B] might reflect on strategies he can use in the future to ensure intended clinical actions (in this case broader review of [Ms A’s] ECG) are completed in a timely manner.

(vii) The provider response indicates this incident and the complaint have been thoroughly reviewed and I believe the response, including proposed remedial actions, is appropriate. I have no further recommendations in this regard. This has been a tragic event and I pass my condolences on to [Ms A’s] whānau at their loss.

9. Addendum 13 June 2022

I have been provided with a copy of the reassembled ECG dated [2021]. The ECG (Appendix 1) is markedly abnormal but accepted practice, noting [Ms A’s] cardiac history, would be to compare the ECG with a previous ECG to determine whether the abnormalities were longstanding or acute, and/or to seek specialist advice. Notable features in the ECG include: narrow complex tachycardia 143 bpm suggestive of a supraventricular tachycardia; left axis deviation; difficult to define P waves with sawtooth baseline in some leads suggestive of atrial flutter; possible pathological Q waves in V2 and V3; machine reporting of possible left anterior fascicular block, anteroseptal infarct and possible inferior and left-precordial acute ischaemic changes.[22] A cardiologist will be able to provide a more detailed interpretation of the tracing, but I am confident my peers would recognise the tracing as being abnormal with some potentially significant abnormalities. While some of these features may be longstanding and not relevant to [Ms A’s] eventual clinical course, I believe a majority of my peers, when faced with this ECG result in the context of a patient with a known cardiac history who has suffered a likely syncopal or similar event and has a persisting tachycardia, would seek specialist advice or at least an old ECG for comparison and would do this as a matter of urgency[23] despite [Ms A’s] apparent recovery from the earlier episode. Viewing the ECG places the comments made earlier in this report in a different clinical context and I am now of the view that the failure by [Dr B] to seek timely expert advice in regard to the potential significance of the ECG changes observed represents at least a moderate departure from accepted practice. However, I am unable to state whether or how the changes might relate to [Ms A’s] subsequent clinical course. I realise [Ms A’s] whānau may now question whether/how the ECG findings relate to her death and this might be best answered by seeking the opinion of [Ms A’s] cardiologist who would have access to her previous records, although it may be difficult to provide a definitive answer in this regard.’

Further in-house advice was obtained from GP Dr David Maplesden on 13 November 2023:

‘I have reviewed the information provided by [Ms A’s] family members in response to the PO.  Once again, I would like to express my condolences at their tragic loss.  I can empathise with the family’s frustration at there being no specific cause found for the pulmonary embolism (PE) that contributed to [Ms A’s] death and acknowledge their strongly held belief that [Ms A’s] death was directly related to the Comirnaty vaccine.  However, it is outside my remit to make a conclusion as to the cause of the PE and I have no further comments in this regard. The response refers to dissatisfaction with the coroner and the coronial process which is again outside the scope of my advice or role.  I note the comments from family members regarding aspects of [Ms A’s] presentation both immediately following the vaccine and prior to her discharge from [the hospital] and that observations noted in the provider records and responses differ from the family’s recollections in some respects. I have considered such discrepancies in my original advice and remain of the view that medical review of [Ms A] was required following her vaccine reaction and note that such a review was undertaken. I remain of the view there was a deficiency in that review by [Dr B], mainly in relation to consideration of ECG findings, and there is no new information provided that alters my view in this regard.  However, I am unable to state that had [Dr B] sought further advice in relation to [Ms A’s] ECG findings, this would necessarily have altered the tragic outcome for her. I note the concern of the family that there has been no cardiologist input into the review of her death but it is not appropriate to seek such advice in regard to comment on [Dr B’s] management of [Ms A] (a cardiologist not being a peer of [Dr B]) and it is not the role of HDC to determine the cause of death or the relationship between the Comirnaty vaccine and [Ms A’s] death — those issues being the concern of the coroner.  It is not clear if [Ms A’s] family have pursued a Treatment Injury claim with ACC in regard to their belief [Ms A’s] death was vaccine-related, but such a claim is likely to involve input from relevant specialist clinicians which may or may not assist with determining the likelihood of her death being vaccine-related.’