CORRECTION: We previously referred to SAE as a ‘Secondary Adverse Event’, but Pfizer’s Vaccine Protocol paper defines is as a ‘Serious Adverse Event’. The document still shows that Pfizer knew that direct exposure through the vaccine, called ‘intervention’, exposure of the skin to the contents of the injection, inhalation of the contents, and even contact with a person who received the injection could lead to adverse events, which is significant.
Abbreviations:
Study intervention – injection
AE – Adverse Event
SAE: Serious Adverse Event
EDP: Exposure During Pregnancy.
Excerpt from Health Impact News:
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study intervention under study during pregnancy or breastfeeding and occupational exposure are reportable to Pfizer Safety within 24 hours of investigator awareness.
8.3.5.1. Exposure During Pregnancy
An EDP occurs if:
• A female participant is found to be pregnant while receiving or after discontinuing study intervention.
• A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.
• A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy:
• A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact.
• A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The initial information submitted should include the anticipated date of delivery (see below for information related to termination of pregnancy).
• If EDP occurs in a participant or a participant’s partner, the investigator must report this information to Pfizer Safety on the Vaccine SAE Report Form and an EDP Supplemental Form, regardless of whether an SAE has occurred. Details of the pregnancy will be collected after the start of study intervention and until 6 months after the last dose of study intervention.
• If EDP occurs in the setting of environmental exposure, the investigator must report information to Pfizer Safety using the Vaccine SAE Report Form and EDP Supplemental Form. Since the exposure information does not pertain to the participant enrolled in the study, the information is not recorded on a CRF; however, a copy of the completed Vaccine SAE Report Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for all EDP reports with an unknown outcome. The investigator will follow the pregnancy until completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural integrity of the neonate can be assessed at the time of birth. In the event of a termination, the reason(s) for termination should be specified and, if clinically possible, the structural integrity of the terminated fetus should be assessed by gross visual inspection (unless preprocedure test findings are conclusive for a congenital anomaly and the findings are reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly), the investigator should follow the procedures for reporting SAEs. Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs follows:
• Spontaneous abortion including miscarriage and missed abortion;
• Neonatal deaths that occur within 1 month of birth should be reported, without regard to causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs when the investigator assesses the infant death as related or possibly related to exposure to the study intervention.
Additional information regarding the EDP may be requested by the sponsor. Further follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on preterm infants to identify developmental delays). In the case of paternal exposure, the investigator will provide the participant with the Pregnant Partner Release of Information Form to deliver to his partner. The investigator must document in the source documents that the participant was given the Pregnant Partner Release of Information Form to provide to his partner.
8.3.5.2. Exposure During Breastfeeding
An exposure during breastfeeding occurs if:
• A female participant is found to be breastfeeding while receiving or after discontinuing study intervention.
• A female is found to be breastfeeding while being exposed or having been exposed to study intervention (ie, environmental exposure). An example of environmental exposure during breastfeeding is a female family member or healthcare provider who reports that she is breastfeeding after having been exposed to the study intervention by inhalation or skin contact.
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The information must be reported using the Vaccine SAE Report Form. When exposure during breastfeeding occurs in the setting of environmental exposure, the exposure information does not pertain to the participant enrolled in the study, so the information is not recorded on a CRF. However, a copy of the completed Vaccine SAE Report Form is maintained in the investigator site file.
An exposure during breastfeeding report is not created when a Pfizer drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in accord with authorized use. However, if the infant experiences an SAE associated with such a drug, the SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure
An occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE. Such persons may include healthcare providers, family members, and other roles that are involved in the trial participant’s care.
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the investigator’s awareness, regardless of whether there is an associated SAE. The information must be reported using the Vaccines SAE Report Form. Since the information does not pertain to a participant enrolled in the study, the information is not recorded on a CRF; however, a copy of the completed Vaccines SAE Report Form is maintained in the investigator site file.
In spite of these warnings during the trials, the criminal FDA went ahead anyway and gave emergency use authorization to use these experimental shots in pregnant women and nursing mothers.
But the greater concern now is that even those who did their own research and chose not receive the shots, are still being infected somehow.
Text from the Pfizer document published int he New England Journal of Medicine (page 61): https://www.nejm.org/doi/suppl/10.1056/NEJMoa2027906/suppl_file/nejmoa2027906_protocol.pdf
We are being used as human guinea pigs. Depopulation seems to be the goal of the whole scamdemic.
It should be obvious by now that this shots are dangerous and should be avoided like the plague. If I’m wrong, no big deal, but if I’m right, there will be a disaster in the future. Those who have been injured are finding out there is no help for them, and the medical profession avoids them like the plague. The shot cannot be undone.
We’ve been looking at this document for last few days and wondering – is it possible to take all these vaccine companies to the court for creating and using bioweapons? We’ve had several cases in Canada, possibly including death of a baby – it’s from social media, so it’s not a proof, but possible outcome
ITP is definitely triggered – whether it’s an acute and deadly case or emerges as a chronic condition – by strong foreign toxins in vaccines. Remember the MD in Miami who was an early jab recipient and died of ITP.
I have chronic ITP (suspect my two MMR vax in youth) and not only need to avoid this jab as everyone should but avoid public situations where the reported “toxic transfer” may be happening!
Yes, be careful, I have to work with vaccinated people, and I have strange things happening afterwards. I use homeopathy, so these effects do not last longer than couple of days, but still – it’s unpleasant, and some people could get really sick from close physical contact
I have not had any vaccines in the 57 years since I got out of the Army when shots were mandatory. I am 78 now and am getting tired of having vaccinated people nag me to get the shot. According to this article I should be glad that these people are wearing masks!
The whole CoVid thing has been mishandled, and they can’t blame President Trump for it. The left had this plan in motion for several years. Go back and listen to Fauci back in the 80’s and 90’s. He said that a severe infection was going to happen in 2020. How would he know that? Is he some biblical prophet? No, he is a socialist sycophant who can not give a decent answer because he is trying to extend his 20 minutes of media glory. CoVid is nothing more than the flu, and this one was man made. Look at all… Read more »
About the variants – you see, lots of cold viruses are coronaviruses, and they mutate very quickly, I read somewhere that they can mutate every 10 hours. That’s why vaccines against cold viruses were not used before.
And right now we have massive vaccine marketing event happening globally. Because that’s what it is, all this pandemic event is just marketing. Look at the people – where I live, they drive to other cities/towns to get the vaccine!
Depopulation is their mission…question is, how do we protect ourselves or is it even possible to at this point?