OPINION
New Zealand Doctors Speaking Out with Science
Cafe Locked Out: The Ceduna Architect
Encephalitis is inflammation of the brain, and can have many causes, mostly commonly a viral infection. It is a serious condition and requires medical treatment. Jessica told Michael Gray Griffith her story of developing auto immune encephalitis following an mRNA vaccine in 2021, at Cafe Locked Out.
Glossary
ACC Accident Compensation Corporation
AEFI Adverse Event Following Immunisation
AEFI-A Adverse Event Following Immunisation – Assessed
AESI Adverse Event of Special Interest
CARM Centre for Adverse Reactions Monitoring
CSF cerebrospinal fluid
CT computed tomography
ECA External Clinical Advice
EEG electroencephalograph
FDA Food and Drug Administration
GVDN Global Vaccine Data Network
ICU Intensive Care Unit
ISMB Independent Safety Monitoring Board
IVIG Intravenous immunoglobulin
MA Medical Advisor
MOG Myelin oligodendrocyte glycoprotein
MRI magnetic resonance imaging
NMDA N-methyl-D-aspartate
PCR polymerase chain reaction
USS Ultrasound Scan
VRBPAC Vaccines and Related Biological Products Advisory Committee
WCC white cell count
WHO World Health Organisation
The following is the story of Jessica. She was a healthy active 37 yr old self-employed architect, enjoying her life. She had no medical conditions, was on no medication and did not consider herself to be at significant risk from Covid infection. She did not want to receive the covid injection but had family overseas who she might have needed to visit at short notice so reluctantly, against her gut instinct, and only due to coercion around travel restrictions, she received her first Pfizer vaccine on 8 Dec 2021.
A few days later she developed a severe headache that persisted. She had to leave work early on 16 Dec 2021 and, as the headache did not improve, she went to the doctor on 18 December. She was treated with anti-inflammatories and sent home.
Two days later on 20 December, an ambulance was called because she had an ongoing headache, fever and was behaving oddly. She recalls being confused, slipping in and out of consciousness and feeling partially paralysed. She was retrieved by helicopter and needed to be sedated and intubated on the journey to hospital due to agitation. On arrival she was admitted to ICU.
An initial diagnosis of encephalitis (brain inflammation) was made, and she was treated with an antibiotic and an antiviral, then had diagnostic imaging and testing done.
- CT head (no acute intracranial abnormality)
- MRI Brain (essentially normal, no cause for symptoms)
- Lumbar Puncture (raised protein – 0.84 g/l and raised white cell count (WCC) 60×106/l – 100% lymphocytes, RCC <1).
- PCR negative for bacteria (Ecoli/H flu/Listeria/Neisseria/Strep B/StrepPneumo)
- PCR negative for viruses (HSV1,2/CMV/Enterovirus/VZV/Parecho/HHV6)
- PCR negative for yeast (Cryptococcus)
- Drugs of abuse screening was negative
- A pan CT (chest, abdo, pelvis) to look for hidden malignancy that might drive an antibody mediated encephalitis was negative
- A pelvic USS excluded an ovarian mass (ovarian teratoma can be associated with autoimmune encephalitis)
- Other blood tests were negative – HIV, VDRL, Leptospira
- Repeat Lumbar Puncture which showed a higher raised WCC of 97 x106/l with negative PCR again
- Repeat MRI Brain (as per earlier MRI)
- EEG showed a non-specific encephalopathic pattern, no epileptiform activity was noted and it was thought some or all of the EEG changes were likely to be related to medication
- A selection of antibodies associated with limbic encephalitis were requested – NMDA, MOG and antineuronal – and results were pending during her hospital admission but later proved negative
In short, at the end of the extensive testing – viral, bacterial, fungal, toxic and paraneoplastic causes of encephalitis had all been excluded. In addition, a large array of known autoimmune antibodies were tested and these results were all negative as well.
The acyclovir (antiviral) was continued but ceftriaxone (antibiotic) was discontinued after 2 doses. She was then treated with IV methylprednisolone (a potent immune-suppressing steroid) 1gm and IVIG (intravenous immunoglobulin) for 5 days for presumed immune-mediated encephalitis.
She started to improve so sedation was stopped on 23 Dec 2021, she was moved out of ICU on 24 Dec, then discharged home on 31 Dec 2021. On discharge, she still had significant symptoms of headache, brain fog, concentration difficulties and fatigue. She was to be followed up by a neuropsychologist.
An exemption from receiving the second dose of Pfizer vaccine was applied for, a CARM report was submitted on 29 Dec 2021 and the hospital specialist filed an ACC claim for ‘treatment injury’ due to covid vaccination.
These events signalled the start of a process that is ongoing nearly two years later.
No Permanent Exemption
An exemption was applied for on 24 Dec 2021, and on 20th January 2022 Dr Bloomfield approved a 3 month temporary exemption. When Jessica re-applied for this, as she had ongoing symptoms, it was declined. The initial exemption proved useless though, as when she travelled to Australia to spend time being cared for by her parents she had to go to a quarantine facility for a week despite having the vaccine pass. She discusses this ludicrous situation more in her interview with Cafe Locked Out which was recorded only a few months after she was discharged from hospital.
CARM/ISMB (Centre for Adverse Reactions Monitoring/ Independent Safety Monitoring Board)
Jessica had had no follow-up from the CARM report. She wanted to understand the process so wrote to the Pharmacovigilance Centre to ask for her AEFI (Adverse Event Following Immunisation) and AEFI-A numbers as well as the details and outcome of the assessment of her adverse event following covid injection. Did the authorities think the encephalitis was related to the injection, how did they decide and how many other New Zealanders were experiencing a similar thing?
AEFI number: AEFI051370
AEFI-A number: AEFI-A-058082
On 30 Jun 2023 she was advised:
“Your case was seen by the Independent Safety Monitoring Board on 9th February 2022 and they had not provided any further advice or comment.”
Dr Michael Tatley confirmed that a report had been made to COVID-CARM regarding her adverse event following COVID-19 vaccination.
She had to send several further emails to find out what had happened to her report and on 28 Jul 2023 Dr Jennifer Lee of the Pharmacovigilance Centre replied and advised Jessica that her case –
“was assessed using standardised pharmacovigilance processes and was discussed by the ISMB. This Specialist Medical panel did not identify a direct causal link between the Pfizer covid-19 vaccination and your significant health event.”
“The assessment was made in the context of your hospital clinical assessment, and in consideration of the other potential causes of encephalitis. The international data on encephalitis and myelitis was also reviewed by the ISMB, with note of insufficient global evidence for a causal relationship with this specific covid-19 vaccination.”
The ‘standardised pharmacovigilance assessment processes’ at the link provided mentioned only two criteria.
1) Time between vaccination and medical event which gave an arbitrary cutoff of 60 days. Jessica’s adverse event was diagnosed 12 days after vaccination, but the symptoms started only 8 days after the vaccine, so she was well within this time frame.
2) Observed versus expected rates and no information was provided about those numbers with regards to autoimmune encephalitis.
Jessica was also curious to know what was meant by ‘other potential causes’ as she understood that extensive testing had not demonstrated any other cause for the encephalitis. She requested the full assessment report as well as meeting notes from the ISMB discussion and asked which causality assessment criteria had been considered.
On 17 Aug 2023 Jessica received a further response from Dr Jennifer Lee advising that the WHO criteria were used for causality determination. However, she then went on to say:
“The pharmacovigilance process is focused on assessing reports for the purposes of recording into the national centre database and not for individualised review of each case for the purposes of a clinical review process.
She also said:
“…clinical assessment of your reaction following vaccination is best undertaken by a clinician (a Neurologist preferably) who is able to undertake an extensive review of the detailed circumstances pertaining to your adverse event and background history. CARM is not able to undertake individual clinical consultations and reviews.”
Jessica was confused after this communication and was not clear whether her case of encephalitis has been assessed by CARM and/or ISMB or not. She asked:
“Can you please clarify if my case has been assessed for causality using the WHO criteria and provide the paperwork that relates to that assessment.”
On 11 Oct 2023 she received an email from Health NZ:
“We also wish to advise that we have reached out to MedSafe Pharmacovigilance team, and they confirmed that although your case presented at the ISMB meeting, it was not discussed.”
The minutes of the ISMB meetings are publicly available (except, seemingly, those that are convened ‘in an emergency’ to deal with a new case that has ‘gone public’) but the meeting of 9 Feb 2022 provided no useful information under the heading “Fatal reports and other adverse event reports were presented to the Board for commentary”
Jessica is none the wiser whether the CARM/ISMB team assessed the likelihood of the encephalitis being due to the Pfizer injection or not. They certainly have not provided any documentation of a thoughtful assessment process or an outcome despite several requests through a variety of channels.
There is obfuscation at every level, as we have complained about to the chief coroner and documented in other cases.
WHO Causality Assessment
In the absence of a causality assessment by the pharmacovigilance experts we have filled a WHO 2019 Causality Assessment Worksheet and Flowchart and come to the conclusion that the encephalitis has a consistent causal association to immunisation.
ACC
The treating physician filed an ACC claim for encephalitis caused by Pfizer vaccination in Jan 2022. Dr Michael Tatley of CARM provided an external clinical advice (ECA) report to ACC in March 2022 stating that there was no physical injury and no evidence (‘from well-respected large-scale epidemiological studies’) that the vaccine caused Jessica’s encephalitis. The ACC claim was declined two days later.
Jessica didn’t think this was appropriate so asked for a review. For various reasons, this took a long time to come to pass and the Review Hearing was finally completed in Sept 2023. A further ECA report had been submitted by a neurologist and Jessica submitted evidence she thought would show that there was no other cause for the encephalitis than the vaccine. She provided supportive medical information from her doctors and health professionals.
A medical advisor assessed the additional information from both parties and the ACC review specialist reviewed the totality of evidence and made her recommendation to ACC not to accept the claim, again on the basis that there was no physical injury and there was no proof that the vaccine caused the encephalitis. The Review Hearing was undertaken over Zoom where each side got to speak to their written evidence. In her written decision, the ACC reviewer sided with the review specialist, and against Jessica, and declined the claim on 2 Oct 2023.
Jessica was unable to work for many months, needed follow up medical visits and further treatment to help her brain recover, and is still experiencing ongoing symptoms from the encephalitis. She has had no financial assistance to help with any of this.
The ACC process is adversarial, intimidating and unfit for purpose, especially in the context of a novel genetic treatment whose adverse effects are unknown.
Jessica is part of the data that is being collected. However, it seems that no one is analysing the data.
For a detailed look at the ACC process, see Part 2 of Jessica’s experience. This includes the large amount of evidence she put forward to demonstrate that it was highly likely that the Pfizer vaccine caused the encephalitis. Jessica is not the only New Zealander to have developed encephalitis in close proximity to a Pfizer vaccine. At least thirteen other cases had been recorded by Nov 2022 when the Safety Reports stopped being published by Medsafe.
Jessica is just one of many Kiwis who are being gaslit in the extreme, suffering terribly, and denied due process. The decision makers in her case, at every level, should hang their heads in shame at their apparent willful blindness and denial. We continue to try to support Jessica and others like her in the fight for justice and the truth of their experiences.