Now that many new vaccines are rolling out all over the world, and people are lining up getting them, you may be wondering about the side effects of these things–Right?

A serious adverse event is a life-threatening event, or a hospitalization. It’s a big deal. I will go into more detail below.

I thought it would be great to bring together all the clinical trials data into one document and just look at the Serious Adverse Events that were reported in them. Because……I know, I’m super boring! I do have a wild side though 😉 TGIF

No, seriously, when these questions pop into my head, it seems like this is on the collective unconscious, and I think this is information that we all want to know. Especially now.

On a side note, have you noticed that all the variants have emerged in locations where the clinical trials took place??

Are Any Vaccines Against SARS-Cov-2 FDA approved?

There are a total of ZERO vaccines that are FDA approved for use against the virus SARS-Cov-2.

Neither the Pfizer, Moderna, or the Janssen vaccine is FDA approved.

FDA approval requires many years of safety data, as opposed to a few months. Each vaccine that is in use today is authorized for “emergency use only”, is considered “experimental”, under the Emergency Use Authorization, which skirts around some of the much-longer safety data necessary for a typical FDA approval.

What Is A Serious Adverse Event?

An adverse event is any undesirable experience associated with the use of a medical product in a patient.

The event is serious and should be reported to FDA when the patient outcome is:

• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability or Permanent Damage
• Congenital Anomaly/Birth Defect
• Required Intervention to Prevent Permanent Impairment or Damage (Devices)
• Other Serious (Important Medical Events)

Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.

If you experience a serious adverse event (SAE) from a vaccine that is authorized under the EUA, you must report the reaction to the Vaccine Adverse Event Reporting System (VAERS), which is how the FDA and CDC monitors serious adverse events.

Then you may file a claim with the Countermeasures Compensation Program (for hospital bills, or if you or your loved one experiences temporary or permanent disability, or death, etc.)

Moderna Clinical Trial

Vaccine Group: 15,184

Placebo Group: 15,165 (placebo appears to be 0.9% sodium chloride which do contain trace amounts of aluminum)

Adverse Reactions Vaccine Group

• 78 yo: Cardiac arrest 21 days after dose 1 (death)
• 77 yo: Myocardial infarction 45 days after dose 2 (death)
• 70 yo: Found deceased at home 57 days after dose 2 (death)
• 56 yo: Found deceased at home 37 days after dose 1 (death)
• 72 yo: Multiorgan failure 59 days after dose 2 (death)
• 62 yo: Suicide 21 days after dose 1 (death)
• 1 person hospitalized with COVID19 (2 months after dose 2)
• 2 Serious Adverse Events of facial swelling / dermatological fillers
• 1 65 yo hospitalization due to intractable nausea and vomiting 1 day post dose 2
• 64 lymphedenopathy
• 3 Bell’s palsy
• 7 appendicitis
• 3 acute myocardial infarction (heart attack)
• 3 cerebrovascular accident

Adverse Reactions Placebo Group:

• 9 people hospitalized with COVID19
• 6 lymphedenopathy
• 1 Bell’s palsy
• 2 appendicitis
• 0 acute myocardial infarction (heart attack)
• 0 cerebrovascular accident

Adverse Reactions From Moderna Clinical Trial

In clinical studies, the adverse reactions in participants 18 years of age and older were pain at the injection site (92.0%), fatigue (70.0%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23.0%), axillary swelling/tenderness (19.8%), fever (15.5%), swelling at the injection site (14.7%), and erythema at the injection site (10.0%).

FDA Factsheet: https://www.fda.gov/media/144585/download

Pfizer Clinical Trial

BNT162b2 Vaccine group: 18,801

Placebo Group: 18,785 (placebo is listed as saline, which as I stated above, may contain aluminum in trace amounts)

Serious Adverse Events:

Deaths A total of six (2 vaccine, 4 placebo) of 43,448 enrolled participants (0.01%) died during the reporting period from April 29, 2020 (first participant, first visit) to November 14, 2020 (cutoff date). Both vaccine recipients were >55 years of age; one experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1.

The placebo recipients died from myocardial infarction (n=1), hemorrhagic stroke (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age). All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.

Non-fatal SAEs:

In the all-enrolled population of (total N=43,448), the proportions of participants who reported at least 1 SAE during the time period from Dose 1 to the data cutoff date (November 14, 2020) were 0.6% in the BNT162b2 vaccine group and 0.5% in the placebo group.

The most common SAEs in the vaccine group which were numerically higher than in the placebo group were:

• appendicitis (0.04%)
• acute myocardial infarction (0.02%)
• cerebrovascular accident (0.02%)

And in the placebo arm numerically higher than in the vaccine arm were:

• pneumonia (0.03%)
• atrial fibrillation (0.02%)
• syncope (0.02%)

Occurrence of SAEs involving system organ classes and specific preferred terms were otherwise balanced between treatment groups, including no imbalance overall in cardiovascular serious adverse events.

Appendicitis was reported as a SAE for 12 participants, and numerically higher in the vaccine group:

• 8 vaccine participants ([appendicitis [n=7], appendicitis perforated [n=1])

vs.

• 4 placebo participants (appendicitis [n=2], appendicitis perforated [n=1], complicated appendicitis [n=1]).

All of the vaccine participants (n=8) and 2 placebo participants were younger than 65 years of age.

The cases were considered unrelated to vaccination by the study investigators and occurred no more frequently than expected in the given age groups. FDA agrees that there is no clear basis upon which to suspect that this imbalance represents a vaccine-related risk.

Reports of lymphadenopathy were imbalanced with notably more cases in the vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination.

Bell’s palsy was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination. One case (onset at 3 days postvaccination) was reported as resolved with sequelae within three days after onset, and the other three were reported as continuing or resolving as of the November 14, 2020 data cut-off with ongoing durations of 10, 15, and 21 days, respectively.

Suspected COVID-19 Cases

Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group.

According to senior editor of the BMJ (British Medical Journal) Peter Doshi:

With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization setbyregulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).

FDA Factsheet: https://www.fda.gov/media/144245/download

Johnson & Johnson Clinical Trial

Janssen Vaccine Group: 21,895

Placebo Group: 21,888 (saline injection, same as above)

Unsolicited adverse events: Individuals within the safety subset in study COV3001 (N=6,736) were monitored for unsolicited adverse events (AEs) for 28 days following vaccination with 99.9% (N= 6,730) of individuals completing the full 28 days of follow-up. The proportion of individuals who reported one or more unsolicited AEs was similar among those in the Janssen COVID-19 Vaccine group (13.1%) and those in the placebo group (12.0%).

Non-serious adverse events: Urticaria (all non-serious) was reported in five vaccinated individuals and 1 individual who received placebo in the 7 days following vaccination. In addition, an SAE of hypersensitivity, not classified as anaphylaxis, was reported in 1 vaccinated individual with urticaria beginning two days following vaccination and angioedema of the lips with no respiratory distress beginning four days following vaccination. The event was likely related to the vaccine.

An SAE of severe pain in the injected arm, not responsive to analgesics, with immediate onset at time of vaccination, and that was ongoing 74 days following vaccination was reported in an individual who received the Janssen COVID-19 Vaccine. An SAE of severe generalized weakness, fever, and headache, with onset on the day following vaccination and resolution three days following vaccination was reported in an individual who received the Janssen COVID-19 Vaccine. Both SAEs are likely related to the vaccine.

Numerical imbalances, with more events in vaccine than placebo recipients, were observed for the following serious and other adverse events of interest in individuals receiving the vaccine or placebo, respectively:

• Deep vein thrombosis: 6 events (2 serious; 5 within 28 days of vaccination) vs. 2 events (1 serious; 2 within 28 days of vaccination).
• Pulmonary embolism: 4 events (3 serious; 2 within 28 days of vaccination) vs. 1 event (serious and within 28 days of vaccination).
• Transverse sinus thrombosis: 1 event (serious and within 28 days of vaccination) vs. 0.
• Seizures: 4 events (1 serious; 4 within 28 days of vaccination) vs. 1 event (0 serious and 0 within 28 days following vaccination).
• Tinnitus: 6 events (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of vaccination) vs. 0.

According to the Johnson & Johnson Clinical Trial, there were more seizures, DVTs, pulmonary embolisms in the vaccine group than in the placebo group.

What is even more distressing is there was a person in the Johnson & Johnson clinical trial vaccine arm who experienced a transverse sinus thrombosis and cerebral hemorrhage, which would be the very serious adverse reaction that would eventually get this vaccine paused indefinitely.

This was uncovered in the clinical trial, and the investigator dropped the ball. He rejected that it was causally related, and now unknown numbers of people are dead or severely injured because of this.

Here is the detailed description reported in the J&J Janssen clinical trial:

A 25-year-old male with no past medical history and no concurrent medications experienced a transverse sinus thrombosis on Day 21 following vaccination. On Day 9 the participant experienced symptoms of fever, myalgia, headache, fatigue, abdominal pain, congestion and rhinorrhea. He tested negative for SARs-CoV-2 during this acute illness. Aside from headache, his symptoms improved. On Day 19 he experienced a tonic colonic seizure. A CT scan without contrast demonstrated a cerebral hemorrhage. On Day 21, a transverse sinus thrombosis was reported on a venogram. The participant underwent a thrombectomy as well as stent placement for stenosed right sigmoid sinus on Day 22. On Day 23 repeat venogram showed the presence of a new clot in the transverse sinus. A second thrombectomy with venoplasty was performed. Treating clinicians reported observing rapid thrombus formation during the two thrombectomy procedures that was consistent with a clinically hypercoagulable state. In their assessment, the transverse sinus thrombosis most likely occurred days before the participant’s clinical presentation with a seizure; the seizure was reported to be a consequence of a secondary bleed caused by elevated venous pressure from the venous flow obstruction. Workup for hematologic and infectious causes of the thrombosis did not reveal an etiology. This event was initially thought to be related to the study product by the investigator and prompted a study pause. After thorough investigation and expert consultation no clear cause of the event was identified; however possible contributing factors, such as preceding infection and an anatomical anomaly, were suggested. The investigator’s brochure and informed consent form were updated accordingly, and the study pause was lifted. The investigator and Sponsor’s final assessment of this event was that it was not related to the study product.

It’s amazing that a healthy 25 year old male with no past medical history or concurrent medications has a serious medical crisis happen that begins days after vaccination, and the pharmaceutical company’s investigators deem it WAS NOT RELATED.

This is completely criminal!!

FDA Factsheet: https://www.fda.gov/media/146304/download

AstraZeneca

This is not currently given in the United States.

The clinical trial data is not available in a simple FDA factsheet, and it appears they are lagging on releasing the results.

Please see this article for the AstraZeneca vaccine.