HomeMy WebLinkAbout12.5.21 Board Correspondence FOIA Requested
From:Paulsen, Shaina
To:Valencia, Shyanne
Subject:FW: FOIA Request
Date:Sunday, December 5, 2021 10:19:45 AM
Attachments:5.3.6-postmarketing-experience.pdf
Please process this PRA – attn PH – Dannette York/Sang Kim
Shaina Paulsen
Associate Clerk of The Board
Butte County Administration
25 County Center Drive, Suite 200, Oroville, CA 95965
T: 530.552.3304 | F: 530.538.7120
From: lance dreiss <lancedreiss@att.net>
Sent: Friday, December 3, 2021 5:03 PM
To: Connelly, Bill <BConnelly@buttecounty.net>; Kimmelshue, Tod
<TKimmelshue@buttecounty.net>; Lucero, Debra <DLucero@buttecounty.net>; Clerk of the Board
<clerkoftheboard@buttecounty.net>; District Attorney <District_Attorney@buttecounty.net>;
Ritter, Tami <TRitter@buttecounty.net>; Teeter, Doug <DTeeter@buttecounty.net>; Waugh,
Melanie <mwaugh@buttecounty.net>
Subject: FOIA Request
.ATTENTION: This message originated from outside Butte County. Please exercise judgment before
opening attachments, clicking on links, or replying..
Board of Supervisors, Clerk of the Board, DA Ramsey, Sheriff Honea:
FOIA Request documents reveal there were over 1,200 deaths in the first 90 days of Pfizer VAX.
Is that $1,000 every second or $95,000,000 dollars a day?
Reminds me of a Bible verse I once heard: “For the love of money is the root of ALL evil.” 1
Timothy 6:10 KJV
Thanks,
Diana Dreiss
https://urldefense.com/v3/__https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-
experience.pdf__;!!KNMwiTCp4spf!X_atAxkF3S7G5xf0xrg-6MQ-
oGVtkHPfwzVMbb0hVvLsKr3ibx2M3W1cFan1NlPZsCsFE6d_iwQ$
Sent from my iPad
FDA-CBER-2021-5683-0000054
FDA-CBER-2021-5683-0000055
FDA-CBER-2021-5683-0000056
FDA-CBER-2021-5683-0000057
and include information not relevant to a BLA submission such as line lists of adverse events
by country. We aremost interested in a cumulative analysis of post-authorization safety data
to support your future BLA submission. Please submit an integrated analysis of your
cumulative post-authorization safety data, including U.S. and foreign post-authorization
experience, in your upcoming BLA submission. Please include a cumulative analysis of the
Important Identified Risks, Important Potential Risks, and areas of Important Missing
Information identified in your Pharmacovigilance Plan, as well as adverse events of special
interest and vaccine administration errors (whether or not associated with an adverse event).
Please also include distribution data and an analysis of the most common adverse events. In
FDA-CBER-2021-5683-0000058
)c*!)5*
)c*!)5*
)c*!)5*
FDA-CBER-2021-5683-0000059
FDA-CBER-2021-5683-0000060
FDA-CBER-2021-5683-0000061
FDA-CBER-2021-5683-0000062
Total
FDA-CBER-2021-5683-0000063
FDA-CBER-2021-5683-0000064
FDA-CBER-2021-5683-0000065
o
o
o
o
o
o
FDA-CBER-2021-5683-0000066
Lack of efficacy cases
Drug ineffective cases (1649)
o
o
o
o
o
o
o
o
o
o
o
o
FDA-CBER-2021-5683-0000067
Vaccination failure cases (16)
o
o
FDA-CBER-2021-5683-0000068
Search criteria: Anaphylactic
reaction SMQ (Narrow and Broad,
with the algorithm applied),
selecting relevant cases according
to BC criteria
Search criteria: PTs Acute
myocardial infarction;
Arrhythmia; Cardiac failure;
Cardiac failure acute;
Cardiogenic shock; Coronary
artery disease; Myocardial
infarction; Postural orthostatic
tachycardia syndrome; Stress
cardiomyopathy; Tachycardia
<
FDA-CBER-2021-5683-0000069
Search criteria: Covid-19 SMQ
(Narrow and Broad) OR PTs
Ageusia; Anosmia
>
Search criteria: PT Chillblains;
Erythema multiforme
FDA-CBER-2021-5683-0000070
<
Search criteria: Leukopenias NEC
(HLT) (Primary Path) OR
Neutropenias (HLT) (Primary
Path) OR PTsImmune
thrombocytopenia
Thrombocytopenia OR SMQ
Haemorrhage terms (excl
laboratory terms
<
Search criteria: Liver related
investigations, signs and symptoms
(SMQ) (Narrow and Broad) OR
PT Liver injury
FDA-CBER-2021-5683-0000071
<
Search criteria: PTs Facial
paralysis, Facial paresis
FDA-CBER-2021-5683-0000072
Search criteria: Immune-
mediated/autoimmune disorders
(SMQ) (Broad and Narrow) OR
Autoimmune disorders HLGT
(Primary Path) OR PTs Cytokine
release syndrome; Cytokine storm;
Hypersensitivity
Search criteria: PTs Arthralgia;
Arthritis; Arthritis bacterial;
Chronic fatigue syndrome;
Polyarthritis; Polyneuropathy;
Post viral fatigue syndrome;
Rheumatoid arthritis
FDA-CBER-2021-5683-0000073
Search criteria: Convulsions
(SMQ) (Broad and Narrow) OR
Demyelination (SMQ) (Broad and
Narrow) OR PTs Ataxia;
Cataplexy; Encephalopathy
Fibromyalgia; Intracranial
pressure increased; Meningitis;
Meningitis aseptic; Narcolepsy
Search criteria: Herpes viral
infections (HLT) (Primary Path)
OR PTs Adverse event following
immunisation; Inflammation;
Manufacturing laboratory
analytical testing issue;
Manufacturing materials issue;
Manufacturing production issue;
MERS-CoV test; MERS-CoV test
negative; MERS-CoV test positive;
Middle East respiratory syndrome;
Multiple organ dysfunction
syndrome; Occupational exposure
to communicable disease; Patient
FDA-CBER-2021-5683-0000074
isolation; Product availability
issue; Product distribution issue;
Product supply issue; Pyrexia;
Quarantine; SARS-CoV-1 test;
SARS-CoV-1 test negative; SARS-
CoV-1 test positive
Search criteria: PTs Amniotic Use in Pregnancy and While Breast Feeding
cavity infection; Caesarean
section; Congenital anomaly;
Death neonatal; Eclampsia;
Foetal distress syndrome; Low
birth weight baby; Maternal
exposure during pregnancy;
Placenta praevia; Pre-eclampsia;
Premature labour; Stillbirth;
Uterine rupture; Vasa praevia
Search criteria: PTs Acute kidney
injury; Renal failure.
<
Search criteria: Lower respiratory
tract infections NEC (HLT)
FDA-CBER-2021-5683-0000075
(Primary Path) OR Respiratory
failures (excl neonatal) (HLT)
(Primary Path) OR Viral lower
respiratory tract infections (HLT)
(Primary Path) OR PTs: Acute
respiratory distress syndrome;
Endotracheal intubation; Hypoxia;
Pulmonary haemorrhage;
Respiratory disorder; Severe acute
respiratory syndrome
Search criteria:Embolism and
thrombosis (HLGT) (Primary
Path), excluding PTs reviewed as
Stroke AESIs, OR PTs Deep vein
thrombosis; Disseminated
intravascular coagulation;
Embolism; Embolism venous;
Pulmonary embolism
>
Search criteria: HLT Central
nervous system haemorrhages and
cerebrovascular accidents
FDA-CBER-2021-5683-0000076
(Primary Path) OR HLT
Cerebrovascular venous and sinus
thrombosis (Primary Path)
>
o
o
Search criteria: Vasculitides HLT
<
FDA-CBER-2021-5683-0000077
FDA-CBER-2021-5683-0000078
FDA-CBER-2021-5683-0000079
FDA-CBER-2021-5683-0000080
FDA-CBER-2021-5683-0000081
FDA-CBER-2021-5683-0000082
FDA-CBER-2021-5683-0000083
FDA-CBER-2021-5683-0000084
FDA-CBER-2021-5683-0000085
FDA-CBER-2021-5683-0000086
FDA-CBER-2021-5683-0000087
FDA-CBER-2021-5683-0000088
FDA-CBER-2021-5683-0000089
FDA-CBER-2021-5683-0000090
FDA-CBER-2021-5683-0000091