table 1 search for the term “fatal”
You are reading it correctly, except that I don’t think you could state “Note”4 individuals in the anaphylaxis evaluation who died on the same day they were vaccinated one individual appeared to also have COVID-19 pneumonia, that likely contributed .. deaths” “ https://freerepublic.com/focus/chat/4015365/posts?page=1449#1449
CAVEAT: Postmarketing data is very ‘dirty’ and from inside a pharma company it is often difficult to get a very clear idea of what happened. It is spotty, from people trained and untrained in reporting AEs, then someone from Pfizer, or their agent, should be following up on the most important and severe ones, to get more clarity.
1223/42086 fatal outcomes = 2.9%
note unknown case outcome = 9400/42086 = 22.3%
fatal anaphylaxis = 9 of 1833 possible = 0.49%
VAED = 9
Lack of efficacy = 65 / 1665 = 3.9%
Thromboembolic Events = Relevant event outcome: fatal (18), resolved/resolving (54), resolved with sequelae (6), not resolved (49) and unknown (42).
Respiratory = fatal (41), resolved/resolving (47), not recovered (18) and unknown (31).
Renal = fatal (23),resolved/resolving (10), not resolved (15) and unknown (22).
Other AESIs (check out list) = Relevant events outcome: fatal (96), resolved/resolving (5008), resolved with sequelae (84), not resolved (1429) and unknown (1685).
Neuro = Relevant events outcome: fatal (16), resolved/resolving (265), resolved with sequelae (13), not resolved (89) and unknown (161)
Liver = fatal (5), resolved/resolving (27), resolved with sequelae (1), not resolved (14) and unknown (47).
Blood = fatal (34), resolved/resolving (393), resolved with sequelae (17), not resolved (267) and unknown (371).
covid 19 - fatal (136), not resolved (547), resolved/resolving (558), resolved with sequelae (9) and unknown (2110).
cadiovascular = fatal (136), resolved/resolving (767),
resolved with sequelae (21), not resolved (140) and unknown
(380)
stroke = fatal and resolved/resolving (61 each), resolved with sequelae (10), not resolved (85) and unknown (83).
ALL OF THE ABOVE HAVE THE STATEMENT — Conclusion: This cumulative case review does not raise new safety
issues. Surveillance will continue
THIS IS THE ONLY CATEGORY WITH A DIFFERENT STATEMENT —
Facial Paralysis = Number of cases: 449i (1.07% of the total PM dataset), 314 medically confirmed and 135 non-medically confirmed; Relevant event outcome: resolved/resolving (184), resolved with sequelae (3), not resolved (183) and unknown (97);
“Overall Conclusion: This cumulative case review does not raise new safety issues. Surveillance will continue. Causality assessment will be further evaluated following availability of additional unblinded data
from the clinical study C4591001, which will be unblinded for final analysis approximately mid-April 2021. Additionally, non-interventional post-authorisation safety studies, C4591011 and C4591012 are expected to capture data on a sufficiently large vaccinated population to detect an increased risk of Bell’s palsy in vaccinated individuals. The timeline for conducting these analyses will be established based on the size of the vaccinated population captured in the study data sources by the first interim reports (due 30 June 2021). Study C4591021, pending protocol endorsement by EMA, is also intended to inform this risk.