Pierce Schuman
Pfizer and the government are not tracking directly the adverse effects of the vaccine, either in New Zealand or elsewhere. However, in New Zealand, we have voluntary reporting to the Centre for Adverse Reactions Monitoring (CARM), as reported by Medsafe.
What adverse effects (or events) after vaccination are doctors, nurses, DHB staff, pharmacists required to report to the Centre for Adverse Reactions Monitoring (CARM)?
There is no legal requirement for healthcare professionals to report adverse events following immunisation (AEFIs). However, we encourage healthcare professionals to report all AEFIs. Consumers can also report any reactions they experience to medicines and vaccines.
Are adverse events occurring within a specified period after vaccination required to be reported to CARM?
There is no time limit for reporting adverse events.
medsafe.govt.nz/COVID-19/q-and-a.asp
As of 7 August, there were 9,157 adverse events logged, of which 385 classed as “of concern”, including herpes zoster (50 cases), haemorrhage (33), Bell’s palsy/facial paralysis (30), anaphylaxis (26), myocarditis/pericarditis (25), deep vein thrombosis (DVT) (21), and stroke (20).
26 deaths after vaccination have been logged in the same database (curiously, exactly the same number as officially have died from the disease).
CARM classify these as: 17 deaths “unlikely related to the COVID-19 vaccine”, 4 deaths “could not be assessed due to insufficient information”, 5 cases are “still under investigation”.
I do not know the medical meaning of “unlikely”. Those reporting adverse events to CARM will include GPs and other medical professionals.
To date, the observed number of deaths reported after vaccination is actually less than the expected number of deaths.
medsafe.govt.nz/COVID-19/safety-report-23.asp#death
In the large EU database (EUDRA Vigilance), 48% of reporting is by medical professionals; a higher percentage for deaths and serious events. I do not know the ratio for New Zealand.
I presume that the individuals reporting these deaths will have believed or suspected them to be related to the vaccine.
Reporting of adverse effects to voluntary databases usually involves under-counting. In Medsafe’s own words:
“The likelihood of experiencing an adverse reaction to a medicine cannot be estimated from this database as there is no information on how many people have taken the medicine and the extent of under-reporting is not known.”
medsafe.govt.nz/Projects/B1/ADRDisclaimer.asp
I have seen estimates of under-reporting to voluntary adverse events databases overseas ranging from 3x to 5x to 10x to 160x. Here for example is a peer-reviewed, government-funded study from Harvard (data from 2007 to 2010) stating that “fewer than 1% of vaccine adverse events are reported”. Now I am not saying that we have the same extent of under-reporting in New Zealand, but it gives pause for thought.
The data is historic and may be presumed to grow with the current ramping up of vaccination efforts.
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