Please read if you HAVEN’T had the flu shot already!

PegLeg2na

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Edit Oct. 16, 2011: Unbolded everything and removed "personal comments"!

I’m probably going to get a lot of crap for posting this and “scaring” people, but I’ve been thinking about doing this for a while now. I should have done this earlier. My goal is NOT to scare you- so if you’ve already had the shot, PLEASE don’t read this. My goal is to help those who haven’t had the shot make an informed decision about getting it. Here are all the FACTS that your doctor may or may not tell you. I’m a librarian and this information is the result of long hours of research. I’ve given links to all my (online) sources so you can read the information first hand, but it’s all here, too.

Approved vaccines for the U.S.: https://www.cdc.gov/flu/protect/vaccine/vaccines.htm

-FLUZONE: “Pregnancy Category B: A developmental and reproductive toxicity study has been performed in female rabbits at a dose approximately 20 times the human dose (on a mg/kg basis) and has revealed no evidence of impaired female fertility or harm to the fetus due to Fluzone Intradermal. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Fluzone Intradermal should be used during pregnancy only if clearly needed.” https://www.fda.gov/downloads/biologicsbloodvaccines/.../ucm195479.pdf

-FLUVIRIN: “Pregnancy Cetgory C: Animal reproduction studies have not been conducted with FLUVIRIN. It is also not known whether FLUVIRIN can cause fetal harm when administered to pregnant women or can affect reproduction capacity. FLUVIRIN should be given to pregnant women only if clearly needed.” https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123694.pdf

-FLUARIX: “Pregnancy Category B: A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 56 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to FLUARIX. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLUARIX should be given to a pregnant woman only if clearly needed.
In a reproductive and developmental toxicity study, the effect of FLUARIX on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered FLUARIX by intramuscular injection once prior to gestation, and during the period of organogenesis (gestation days 6, 8, 11, and 15), 0.1 mL/rat/occasion (approximately 56-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.
Pregnancy Registry: GlaxoSmithKline maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with FLUARIX during pregnancy. Women who receive FLUARIX during pregnancy should be encouraged to contact GlaxoSmithKline directly or their healthcare provider should contact GlaxoSmithKline by calling 1-888-452-9622.” https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM220624.pdf

-FLULAVAL: Pregnancy Category B: A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 56 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to FLULAVAL. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLULAVAL should be given to a pregnant woman only if clearly needed.
In a reproductive and developmental toxicity study, the effect of FLULAVAL on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered FLULAVAL by intramuscular injection once prior to gestation, and during the period of organogenesis (gestation days 6, 8, 11, and 15), 0.1 mL/rat/occasion (approximately 56-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.
Pregnancy Registry: GlaxoSmithKline maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with FLULAVAL during pregnancy. Women who receive FLULAVAL during pregnancy should be encouraged to contact GlaxoSmithKline directly or their healthcare provider should contact GlaxoSmithKline by calling 1-888-452-9622.” https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm112904.pdf

-AFLURIA: “Pregnancy Category C: Animal reproduction studies have not been conducted with AFLURIA. It is also not known whether AFLURIA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AFLURIA should be given to a pregnant woman only if clearly needed.” https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm220730.pdf

-FLUMISTA: “Pregnancy Category C: Animal reproduction studies have not been conducted with FluMist. It is not known whether FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FluMist should be given to a pregnant woman only if clearly needed. The effect of the vaccine on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rats receiving the frozen formulation. Groups of animals were administered the vaccine either once (during the period of organogenesis on gestation day 6) or twice (prior to gestation and during the period of organogenesis on gestation day 6), 250 microliter/rat/occasion (approximately 110-140 human dose equivalents), by intranasal instillation. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.” https://www.medimmune.com/pdf/products/flumist_pi.pdf


Approved vaccines for the U.K.:
-PANDEMRIX: Pregnancy and lactation: Pandemrix has been administered to women in each trimester of pregnancy. Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited. There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Animal studies with Pandemrix do not indicate reproductive toxicity (see section 5.3).
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.
Pandemrix may be administered in lactating women.” https://www.emea.europa.eu/docs/en_...duct_Information/human/000832/WC500038121.pdf

-FOCETRIA: Pregnancy and lactation: It is estimated that more than 90,000 women have been vaccinated during pregnancy with Focetria H1N1v. However information on the number of outcomes is currently limited. Preliminary data on outcomes from spontaneously reported events and ongoing post-marketing studies (pregnancy registry and prospective interventional study) do not suggest direct or indirect harmful effects with respect to pregnancy.
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity. An animal study with H5N1 mock-up vaccine did not indicate reproductive toxicity (see section 5.3). The use of Focetria during pregnancy has to take into account official recommendations. Focetria may be administered to lactacting women. https://www.ema.europa.eu/docs/en_G...duct_Information/human/000710/WC500023749.pdf

Peer-reviewed articles related to fetal harm and the vaccine OR showing no relationship between the two:
Moro, Pedro L. et al. “Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System”. American Journal of Obstetrics & Gynecology (2011).
ABSTRACT:
OBJECTIVE: The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received influenza A (H1N1) 2009 monovalent vaccine to assess for potential vaccine safety problems.
STUDY DESIGN: We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from Oct. 1, 2009,
through Feb. 28, 2010.
RESULTS: VAERS received294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine women (20.1%) were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (20 weeks or less); 18 stillbirths(greater than or equal to 20 weeks); 7 preterm deliveries(less than 37 weeks); 3 threatened abortions; 2 preterm labor; 2 preeclampsia; and 1 each of fetal hydronephrosis, fetal
tachycardia, intrauterine growth ******ation, and cleft lip.
CONCLUSION: Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.

Moro PL, Broder K, Zheteyeva Y, et al. “Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009”. American Journal of Obstetrics & Gynecology 204:146.e1-7 (2011).
ABSTRACT:
OBJECTIVE: The objective of the study was to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant
women who received seasonal influenza vaccines to assess for potential vaccine safety concerns.
STUDY DESIGN: We searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine (TIV) from July 1, 1990 through June 30, 2009, or live attenuated influenza vaccine (LAIV) from July 1, 2003, through June 30, 2009.
RESULTS: A total of 148 reports after TIV and 27 reports after LAIV were identified. Twenty TIV (13.5%) and 1 LAIV (4%) reports were classified as serious. No specific AEs were reported in 30 TIV (20.3%) and 16 LAIV (59%) reports. The most common pregnancy-specific AE was spontaneous abortion: 17 after TIV (11.5%) and 3 after LAIV (11%). The reporting rate of spontaneous abortion was 1.9 per million pregnant women vaccinated.
CONCLUSION: No unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after
the administration of TIV or LAIV.

Christian, Lisa M., Jay D. Iams, Kyle Porter, and Ronald Glaser. “Inflammatory responses to trivalent influenza virus vaccine among pregnant women.” Vaccine (2011).
ABSTRACT:
Objective
In the U.S., seasonal trivalent influenza virus vaccine (TIV) is currently universally recommended for all pregnant women. However, data on the maternal inflammatory response to vaccination is lacking and would better delineate the safety and clinical utility of immunization. In addition, for research purposes, vaccination has been used as a mild immune trigger to examine in vivo inflammatory responses in nonpregnant adults. The utility of such a model in pregnancy is unknown. Given the clinical and empirical justifications, the current study examined the magnitude, time course, and variance in inflammatory responses following seasonal influenza virus vaccination among pregnant women.
Methods
Women were assessed prior to and at one day (n = 15), two days (n = 10), or approximately one week (n = 21) following TIV. Serum interleukin (IL)-6, tumor necrosis factor (TNF)-α, C-reactive protein (CRP), and macrophage migration inhibitory factor (MIF) were determined by high sensitivity immunoassay.
Results
Significant increases in CRP were seen at one and two days post-vaccination (ps < 05). A similar effect was seen for TNF-&#945;, for which an increase at two days post-vaccination approached statistical significance (p = .06). There was considerable variability in magnitude of response; coefficients of variation for change at two days post-vaccination ranged from 122% to 728%, with the greatest variability in IL-6 responses at this timepoint.
Conclusions
Trivalent influenza virus vaccination elicits a measurable inflammatory response among pregnant women. There is sufficient variability in response for testing associations with clinical outcomes. As adverse perinatal health outcomes including preeclampsia and preterm birth have an inflammatory component, a tendency toward greater inflammatory responding to immune triggers may predict risk of adverse outcomes, providing insight into biological mechanisms underlying risk.The inflammatory response elicited by vaccination is substantially milder and more transient than seen in infectious illness, arguing for the clinical value of vaccination. However, further research is needed to confirm that the mild inflammatory response elicited by vaccination is benign in pregnancy.

The KNOWN risks of getting the flu while pregnant include:
-Higher chance of developing pneumonia (always a risk anyway)
-Higher chance of dying as a result of serious illness (flu or pneumonia, always a risk anyway)
-Higher chance of preterm labor
-Slightly higher chance of fetal deformities
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I'm still researching this but wanted to share what I've found so far. If you have QUESTIONS or CONCERNS, please post them..I don't need to hear how I'm just scaring people. What definitely scares me is that these vaccines are RECOMMENDED to ALL pregnant women despite not being proven safe.
 
There are a million things out there which could, but it's not likely, hurt your baby. Flu vaccines are one of them. Why do doctors, the CDC and government recommend them, then? What is worse to those organizations, that a few women who are pregnant have trouble, or that an outbreak of flu happens, harming tens of thousands and killing some people? Obviously the outbreak. The good of the many outweighs the good of the few who might have trouble with vaccines.
I don't blame these organizations for making that call, it's what is best for the country overall. But, it's up to individuals to decide what they want, that's our right here. Having the flu when you are pregnant isn't good for the baby. Vaccine may or may not be good for the baby. Tough call and a personal decision for everybody.
 
the concern particularly with H1N1 is the risk posed to young healthy women in their 20s and 30s. I work in an ICU, and the number of women I saw requiring life support because of H1N1 was incredible. You have a greater chance of being in a car accident than facing complications from a vaccine. Im going to assume that no one is going to stop driving or leaving the house.
 
I have never had a flu shot and probably wouldn't get one this year, but I'm now uncertain since I'm pregnant. I have been fortunate to avoid the flu since I was a kid. This is definitely something I will be discussing with my doctor. Thanks for passing on the info.
 
I got the flu shot during all of my pregnancies and plan on getting it with this one to...if my doctors thought it wasn't safe they wouldn't RECOMMEND it...There are way more dangerous things during pregnancies than the flu shot...Research all you want to and it will not help you make the decision, When you are laid up in a hospital at 5 or 6 months pregnant with flu induced pneumonia then you will be saying God why didn't I just get the shot...Everyone is different and has there own opinions and everything is not for everyone, but as long as my doctor recommends something I say hey go ahead why not...doctors know way more than we do hence why they go to school for so long.....GOOD LUCK in your decision
 
I got the flu shot during all of my pregnancies and plan on getting it with this one to...if my doctors thought it wasn't safe they wouldn't RECOMMEND it...There are way more dangerous things during pregnancies than the flu shot...Research all you want to and it will not help you make the decision, When you are laid up in a hospital at 5 or 6 months pregnant with flu induced pneumonia then you will be saying God why didn't I just get the shot...Everyone is different and has there own opinions and everything is not for everyone, but as long as my doctor recommends something I say hey go ahead why not...doctors know way more than we do hence why they go to school for so long.....GOOD LUCK in your decision

Just so you know, getting the vaccine is is not a guarantee that you won't get the flu. You can still get it. It does reduce the risk, though, as does hand washing, eating healthy, staying away from sick people, getting plenty of rest, and recognizing early on when you are sick helps prevent it from getting out of hand.

And your doctor should be providing you the information I posted above, so long as you request it. You have a right to know what the manufacturer says about the vaccine you get.
 
let me just say that I had very rarely gotten the flu and the one year I got the flu vaccine when I was 16 I got the flu 3 times that year. I may sound crazy but I believe they have a different agenda when they suggest getting vaccinated
 
I also get severely sick everytime I get the flu shot - for 2 weeks. I am sick enough with morning sickness as it is. Turns out I'm allergic to some of the preservatives in the shot. I've never gotten sick since they came "popular" and never suffered for anything other than a cold which I don't even get once per year anymore. I think I'm going to stick to my decision. Thanks.
 
Right, the things you are taking from the data are your own inferences and not what's actually there. If you can't find corresponding data for the number of spontaneous abortions that take place per million women without the flu jab being administered then this data has no relevence.

A total of 148 reports after TIV and 27 reports after LAIV
were identified. Twenty TIV (13.5%) and 1 LAIV (4%) reports were classified
as serious. No specific AEs were reported in 30 TIV (20.3%) and
16 LAIV (59%) reports. The most common pregnancy-specific AE was
spontaneous abortion: 17 after TIV (11.5%) and 3 after LAIV (11%). The
reporting rate of spontaneous abortion was 1.9 per million pregnant
women vaccinated. (Personal note: this means that 1.9 women per 1 million REPORT spontaneous abortions, not there are only 1.9 spontaneous abortions per 1 million women.)
CONCLUSION: No unusual patterns of pregnancy complications or fetal
outcomes were observed in the VAERS reports of pregnant women after
the administration of TIV or LAIV.

This just means that the outcomes were as would be expected in a normal range of pregnancies. I spend all day looking at scientific reports just like this at the moment.

I think you're right hun and people should listen to their own concerns and discuss it with their Doctor if worried, but it's not fair to list your own comments with the data, you are not providing an unbiased view and it's unfair.

What flu does:
RESULTS

In the case group, 1328 (5.8%) mothers had influenza at some time during their pregnancies compared to 1838 (4.8%) mothers in the control group (adjusted prevalence odds ratios [PORs], 1.3; 95% confidence interval [CI], 1.2&#8211;1.4). In the calculation of the adjusted PORs, the use of antifever drugs and maternal employment status were considered. When cases and their matched controls were compared, there was a higher prevalence of maternal influenza during the second and/or third month of pregnancy for the group of newborns with cleft lip ± palate (adjusted POR, 3.2; 95% CI, 2.0&#8211;5.3), neural-tube defects (adjusted POR, 1.9; 95% CI, 1.1&#8211;3.3), and cardiovascular malformations (adjusted POR, 1.7; 95% CI, 1.3&#8211;2.3). However, a direct teratogenic effect from influenza viruses appears to be unlikely, and we suggest that the higher prevalence of the CAs indicated above can be explained mainly by fever, because this risk was reduced by the use of antifever drugs. Periconceptional folic acid supplementation also showed some preventive effect for these CAs.

I'm aware this is scientific jargon haha but the abstract for the study etc can be seen here https://onlinelibrary.wiley.com/doi/10.1002/bdra.20195/full as can the full article.

I will see what I can find to provide full information, not half a story. I agree that people need to know the risks I really do, but from both sides.
 
Oh, thanks for posting a bunch of scaremongering crap. I find it fascinating reading about rats who have been pumped with 50-100 times the equivalent amount a human would get and seeing what it did to them. Relevant.
Its starting to get boring now!! :haha:
 
I'm not sure why a second flu vaccine thread was started...

Regarding the classification of the flu vaccines, most pregnant woman are given the vaccines that are classified as category B pregnancy drugs. Other drugs in this category include tylenol, ibuprofin and insulin.

The information you present is very interesting and from valid sources. I personally disagree with some of your interpretations. For example, the articles by Moro suggest to me that there is no cause for concern. It is true that adverse pregnancy outcomes are reported after vaccination. The real question is whether there are more adverse effects reported after vaccination than occur in unvaccinated populations. These articles conclude that the rates in both groups are similar so there is no evidence of the vaccines causing harm. The full text of the first article can be read here. You will see that in this full article, not only does the author suggest that his research does not show any evidence of harmful effects, he also cites many other studies that reach the same conclusion. In particular, a study that followed mothers and babies for 7 years following prenatal vaccine and found no evidence of any adverse effects.

I had posted this in the other thread but I think it is relevant here too. This is from the cdc website. The term TIV refers to Trivalent inactivated influenza virus vaccine (ie the vaccine).

Pregnant Women and NeonatesFDA has classified FluLaval, Fluarix (GlaxoSmithKline Biologicals) and Agriflu (Novartis Vaccines and Diagnostics Limited) influenza vaccines as “Pregnancy Category B” medications, indicating that animal reproduction studies have not demonstrated a fetal risk, but there are no controlled studies in pregnant women; all other influenza vaccines are classified as “Pregnancy Category C” medications, indicating that adequate animal reproduction studies have not been conducted. Available data do not indicate that any influenza vaccine causes fetal harm when administered to a pregnant woman, and any of the approved TIV formulations may be used for vaccinating pregnant women. One study of approximately 2,000 pregnant women who received TIV during pregnancy demonstrated no adverse fetal effects and no adverse effects during infancy or early childhood. A matched case-control study of 252 pregnant women who received TIV within the 6 months before delivery determined no adverse events after vaccination among pregnant women and no difference in pregnancy outcomes compared with 826 pregnant women who were not vaccinated. During 2000–2003, an estimated 2 million pregnant women were vaccinated, and only 20 adverse events among women who received TIV were reported to VAERS during this time, including nine injection-site reactions and eight systemic reactions (e.g., fever, headache, and myalgias). In addition, three miscarriages were reported, but these were not known to be related causally to vaccination. Similar results have been reported in certain smaller studies, and a recent international review of data on the safety of TIV concluded that no evidence exists to suggest harm to the fetus. The rate of adverse events associated with TIV was similar to the rate of adverse events among pregnant women who received pneumococcal polysaccharide vaccine in one small randomized controlled trial in Bangladesh, and no severe adverse events were reported in any study group.
 
Thank you for the post. Every person needs to make her own decision, hopefully after reviewing facts and weighing the pros and cons. As for myself, I've never gotten a flu vaccine and I never will, especially not during pregnancy. BTW, I've never gotten the flu, either (and that's when I used to work in a large company, exposed to all kinds of germs). I'd rather bone up on vitamin D (something that can help, not harm, the baby) and keep my hands well cleaned, than have a cocktail of various chemicals and preservatives into my bloodstream.
 
The flu vaccine gives various immunities to your baby... My doctors highly recommend it. Also, for anyone who has never experienced the flu, you are very lucky. It is beyond horrible.
 
Disclaimer---this is just my opinion!!

**should be used during pregnancy only if clearly needed** can really be interpreted in many different ways. :) for me it was "clearly needed" because I am a registered nurse who comes in contact with hundreds of patients a month. It's "clearly needed" to protect me AND those patients I come in contact with. To those who don't feel they need it, that is their opinion and their choice. BUT Herd Immunity is a well proven way to stop the spread deadly diseases (like polio, measles, mumps, rubella etc).
The hospital I work in mandates flu shots for the entire population of workers, and pregnant women are first on the list when the shots become available.

**Also, just as a flip-side to the women who get sick with the shot--The only two times I missed the flu shot in the last 16 years I ended up in the emergency room for a day getting nausea medication and hydration for no less than 8 hours...so it does go both ways!!
 
I love the bickering this causes. I'll NOT be getting the flu jab, it's bad for you. None of our doctors care about us really - they may say they do but they only care about all the money THEY make by pumping us with injections following a media led scaremongering campaign.
 
I think it's great that people are doing their own research, for what I've stated is a PERSONAL decision.
Loverguts and 3buutifulgirl, it is completely uncalled for to try to attack someone who is sharing their OPINION.
I have found all of the info shared here helpful, as I try to make my own decision about the vaccine.
 
I dislike my doctors 'pushing' drugs on me so much I've not even told them I'm pregnant - the less time they know, the less time they can try to fill me with drugs :)
 
None of our doctors care about us really - they may say they do but they only care about all the money THEY make by pumping us with injections following a media led scaremongering campaign.

That's an extreme statement!
 
**I'll NOT be getting the flu jab, it's bad for you. None of our doctors care about us really**

I'm sorry you have a bad Dr. Maybe you should find a new one?
 

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