May Cure Your Headache

Say goodbye to the old standby “Not tonight, Dear. I have a headache.” It turns out sex can help with pain, and that includes some kinds of headaches, such as migraines. Not feeling frisky? Try: “Not tonight, Honey. I have a highly contagious stomach bug.” Works every time.

NCT04368728 was designed as a 1,2,3 trial with all phases running concurrently.

Iain Davis
Jan 3, 2021
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With regards to assessing safety Pfizer described systemic events as:

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.

Swelling as an “immunological” reaction

Thursday, January 21, 2021
by: Zoey Sky
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In an interview with ABC7, Dr. Shirley Chi, a dermatologist, explained that the reaction to the vaccine was immunological.

Like Zhang, Chi insists that these negative side effects are perfectly fine.

The immune system that causes inflammation is triggered when you get vaccinated, which is allegedly normal. Chi suggests that an immune response in certain areas is normal if there is a “not a naturally occurring substance” in the body.

She said Americans with cosmetic facial fillers should still go ahead and get the vaccine because the patients who experienced facial swelling eventually recovered from the side effect.

The committee recommended the FDA issue emergency use authorization for Moderna’s coronavirus vaccine after hearing about the trial and other concerns. The FDA issued the authorization last Dec. 18.

According to the briefing document, Pfizer and BioNTech’s coronavirus vaccine wasn’t linked to any dermal filler-related side effect. However, officials warn that people who are allergic to components of either vaccine shouldn’t get inoculated.

Moderna also issued a similar warning on its website. The company also advised that the adverse reactions detailed in its clinical trial include:

Chills
Fatigue
Headache
Pain at the injection site
“Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 vaccine,” added Moderna.

The company concluded that vaccine providers should complete and submit reports to the Vaccine Adverse Event Reporting System that tracks adverse vaccine events.

Adverse effects of the Moderna vaccine

Thursday, January 21, 2021
by: Zoey Sky
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Data showed that the swelling was related to the COVID-19 vaccine. Back in December, FDA medical officer Dr. Rachel Zhang presented the findings at the Vaccines and Related Biological Products Advisory Committee on Moderna’s coronavirus vaccine.

In Moderna’s Phase 3 trial, three participants experienced facial or lip swelling after they received the vaccine. Two of them had prior dermal fillers in their cheeks within six months before inoculation.

Meanwhile, the third volunteer had received dermal filler in the lip two days after getting vaccinated. According to the FDA, the two incidents of facial swelling are classified as “severe adverse events.”

As of writing, the two participants have already recovered from the swelling.

The FDA claims that the lip swelling incident was “medically significant but not a severe adverse event.” The patient with the lip swelling also experienced similar swelling in the past after receiving a flu vaccine. 

Experts believe that coronavirus and other viral infections can trigger these immunogenic reactions in people who have recently been injected with dermal fillers. Zhang said that the swelling in the three clinical trial volunteers was treated with steroids or antihistamines, which are also often associated with negative side effects.

Antihistamines may cause adverse effects like agitation, blurred vision,
constipation, drowsiness, dry mouth, and urinary retention (trouble urinating). Steroids can cause side effects like cataracts, glaucoma, headaches, high blood pressure and muscle weakness.

Zhang even attempted to brush off the side effects as minor, claiming that the three patients who experienced facial and lip swelling were only affected with localized swelling.

She added that “no systemic symptoms observed.”

Through a briefing document presented to the Vaccines and Related Biological Products Advisory Committee, the FDA explained that the localized swelling in these cases could have been caused by “an inflammatory reaction from interaction between the immune response after vaccination and the dermal filler.”

The cases were allegedly reported after natural infection or after an influenza-like illness, continued the document.

Physicians suggest that injectable hyaluronic acid (HA)-based dermal fillers could be linked to occasional late-onset inflammatory reactions.

HA is a gel-like substance that is found naturally in the body. HA-based dermal fillers are used to add volume to the skin, particularly in the cheeks. The fillers are also used to smoothen out wrinkles near the eyes, lips and forehead.

Like vaccines, HA-based dermal fillers are associated with the following negative side effects that occur near the injection site:

Bruising
Itching
Pain
Rash
Redness
Swelling

Moderna coronavirus vaccine causes dermal filler reactions, warns FDA

Thursday, January 21, 2021
by: Zoey Sky
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Last December 2020, health experts from the Food and Drug Administration (FDA) warned that Moderna’s coronavirus (COVID-19) vaccine has yet another negative side effect: Upon vaccination, people with cosmetic facial fillers experienced “swelling and inflammation.”

Most of the recipients of Moderna’s coronavirus vaccine have experienced mild side effects like headache, fatigue and pain at the injection site. Vaccine recipients who have had prior dermal fillers, but not Botox injections, may also experience temporary facial swelling.