On June 15, 2022, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) advised the FDA to grant an Emergency Use Authorization (EUA) for Moderna/NIAID and Pfizer/BioNTech’s mRNA COVID-19 biologics be given to infants and children under age five and as young as six months old. With that approval, the U.S. became the first country in the world to give COVID vaccine to babies under age two.1
FDA Denies Serious Adverse Reactions to mRNA COVID Shots in Children Under Age Five
On the same day, VRBPAC released a report listing adverse events reported following mRNA COVID shots in the under age five age group, which included fever; chills; injection site pain; fatigue/excessive sleepiness; irritability/crying; headache and body pain; swollen lymph nodes; vomiting and diarrhea, etc.2 The document stated:
Among U.S. Vaccine Adverse Event Reporting System (VAERS) reports for individuals aged 6 months through 4 years, which may reflect unauthorized use of the vaccine or may reflect a reporting error, the majority (96.3%) were non-serious.3
The report does state safety concerns identified from post-authorization safety surveillance data in VAERS for other age groups, which includes anaphylaxis, myocarditis and pericarditis, but it does not specifically discuss any of these safety concerns as related to the younger age group of six months to five years old.4 The report states:
Review of passive surveillance adverse event reports and the Sponsor’s periodic safety reports does not indicate new safety concerns. Most adverse events are labeled events and consistent with the safety profile for this vaccine. No unusual frequency, clusters, or other trends for adverse events were identified that would suggest a new safety concern.5
June 2022 VAERS Data Cited 58 Life Threatening Reactions to mRNA COVID Shots in Children Under Age Three
A June 13, 2022 analysis of VAERS data reported by RT Magazine in Israel showed reports of at least 58 life-threatening adverse events to COVID shots in infants and toddlers under the age of three.6
Before the analysis was conducted, reports in which a child was exposed to mRNA COVID shots through breast milk were removed from the data pool, as were cases identified as errors in the age registration. Most VAERS reports do not indicate under which circumstances the individual received the vaccine, such as whether they were a participant in a clinical trial or vaccinated for any other reason, including “off-label use.7
Children between six months and five years of age were not eligible for mRNA COVID shots until June 15, 2022 in the U.S. unless they were part of a clinical trial. However, VAERS has many reports of babies and toddlers who were vaccinated prior to this date. Some reports state that children suffered life-threatening adverse events but it is not always clear what happened to the child following the adverse reaction.8
The VAERS analysis showed that the most common serious adverse reactions were life-threatening bleeding, anaphylactic shock, anticholinergic syndrome, encephalitis, hypoglycemia and neuroleptic syndrome. In most of the reported cases in VAERS, these were multi-system injuries.9
Case Histories of COVID Shot Reaction Reports in Infants
Authors of the June 2022 VAERS analysis published in RT Magazine looked at 58 reported cases in children under the age of three, who suffered serious adverse reactions to COVID mRNA shots. Following are summaries of three case histories that include two babies under two months old.10
One of the most serious adverse reaction reports in VAERS is that of a 43-day old female baby who received Pfizer’s Comirnaty biologic on Jan. 30, 2021. The incident description (VAERS ID 1133837) states:
A 43-days-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jan2021 (Lot Number: EK9788) as SINGLE DOSE for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient’s concomitant medications were not reported. The patient experienced circulatory disorder, lightheadedness, asthma exacerbation, dyspnea and respiratory distress on 30 Jan 2021. The outcome of the events not recovered. Senders comment: Asthma / feeling sick, dyspnoea, asthma exacerbation.11
The report further states that the six-week old baby experienced:
Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad).12
Pfizer and Moderna clinical trials only included babies over the age of six months. The VAERS report does not state why a 43-day-old baby was given the vaccine, and does not indicate whether the baby recovered or died.13
Another VAERS report (VAERS ID 976433) states:
A 2-months-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1688) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. Relevant medical history included asthma. Concomitant medication included beclometasone dipropionate/formoterol fumarate (FOSTAIR) for asthma. On 06Jan2021, the patient experienced rash on chest, which was considered serious as medically significant. The patient has not had symptoms associated with COVID-19 and she has not been tested/or has had an inconclusive test for COVID-19. The patient was not enrolled in clinical trial. The patient has not tested positive for COVID-19 since having the vaccine. The patient had not recovered from the event. No follow-up attempts possible. No further information expected.14
Adverse reactions listed on the report were as follows:
Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad).15
Similar to the previous case, there was no mention of why a two-month-old baby was given the COVID vaccine.16
In another case (VAERS ID 1012508), the report states:
A 1-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient fit and well, nil previous concerns. The patient developed left postauricular pain (20Jan2021) 4/7 after vaccine, progressed to full left sided bells palsy (20Jan2021).17
The adverse reactions reported were as follows:
Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Medication errors (narrow).18
Review Vaccine Adverse Event Reports on MedAlerts
VAERS is a publicly accessible database that was part of the safety provisions secured by parents of DPT vaccine injured children in the National Childhood Vaccine Injury Act of 1986. It has been used by CDC and independent researchers to publish analyses of vaccine adverse events since 1990.
The CDC states that, “VAERS accepts reports of adverse events that occur following vaccination. Anyone, including healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness… VAERS reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable.”
Since 2006, the National Vaccine Information Center (NVIC) has sponsored MedAlerts.org, a user-friendly search engine established in 2003 that allows anyone to access vaccine adverse event reports made to VAERS. The search engine examines vaccines, doses, and demographics, and you can produce tables, graphs, maps and full case reports. MedAlerts includes U.S. and foreign case reports, while other search engines only include U.S. reports. MedAlerts also includes “The Wayback Machine” to include older government data to track any changes in posted data.
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Click here to view References:
1 Fisher BL. U.S. Becomes First Country to Give mRNA COVID Vaccine to Babies. The Vaccine Reaction June 21, 2022.
2 U.S. Food and Drug Administration. FDA Briefing Document EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age. June 15, 2022.
6 Feinberg R, Shir-Raz Y. Breaking: 58 babies who received mRNA COVID-19 vaccines suffered life-threatening adverse events RT Magazine June 13, 2022.
11 MedAlerts.org. This is VAERS ID 1133837.
13 Feinberg R, Shir-Raz Y. Breaking: 58 babies who received mRNA COVID-19 vaccines suffered life-threatening adverse events RT Magazine June 13, 2022.
14 MedAlerts.org. This is VAERS ID 976433.
17 MedAlerts.org. This is VAERS ID 1012508.