CDC VAERS: Records of persons under the age of 18 receiving Covid-19 Vaccinations as of April 16, 2021

4/28/2021 | vanity

[ransomnote]

This thread post is long because it contains hundreds of records of Data from VAERS at the bottom. If you want to read the comments, it's probably best to return to the forum and click on 'replies' under the thread's title.

Below is a VAERS export of all persons under the age of 18 who received the Covid-19 vaccine. These are mostly reported not for an adverse event, but because the vaccine was not supposed to be given to those under 18.

My remarks below pertain to only those records which I reviewed; I have not reviewed all of them.

Those reporting said they were instructed to tell VAERS if they vaccinated someone of inappropriate age.

The reasons the young people were vaccinated are a puzzling array of errors. "She said she was 18" "We didn't notice it on her registration form" "Her mother got angry and insisted" etc. 

There's a few which states they were underage, vaccinated, and should receive the 2nd dose as well even though underage (e.g., record #165).

A few reports state that the parent authorized the under age administration.

I don't know how often it occurred, but some of these accounts read as if the student/young person received the vaccine without their parent's prior consent. 

Record #12 "Patient was given the Moderna vaccination at our clinic today. No adverse reactions are known at this time.  Patient was not at the appropriate age to receive this vaccination.  Patient was 16 years of age (03/17/2004), where Moderna only covers people 18 years of age and above.  The administrator was notified and contacted the patient and spoke with their mother explaining what had happened at the clinic today.  Patients mother was very upset and agitated and stated that she would be calling the physician in the morning."

VAERS only contains a tiny percentage of actual events so the number of children receiving this experimental 'vaccine' is expected to be much larger. Many who vaccinated in error are just not going to report themselves. 

Below, I'll put the table of records for Covid-19 vaccinations of persons under the age of 18 for December to April 16, 2021.

I encourage all interested to copy and paste the data into Excel and share it, because I suspect the CDC does not want this information made available. Vaccinations for those under 18 never surfaced in all my other exports from VAERS. Those other exports only contained '18 years and up' data even though I had not specified an age range.

Then, last night VAERS user interface 'changed' and I cannot get the same exports going forward. 

So if interesed, please share.

Note the the VAERS ID can be enterred into the CDC's database to read a little more, including the identity of the vaccine manufacturer and lot number, etc.

There are some reports of actual medical adverse events in this record, which I do know have not yet been proven 'causal' and are observations (e.g., #120 - just says severe seizure).

 Covid-19 vaccinated persons under the age of 18 as of April 16, 2021.

Line	Vaccine	Onset Interval	Age	Month Vaccinated	VAERS ID	Adverse Event Description
1	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0905644-1	"felt like throat scratching""""
2	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0907882-1	THERE WAS NO ADVERSE EVENT. We realized after administration that we had inadvertently given the vaccine to a 15 year old girl. She is not having any symptoms or problems. We have been monitoring her and encouraged her to speak with us if she has any issues at all.
3	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0908624-1	No adverse event reported. Found in paperwork that this person was only 16 years of age and should not have received Moderna Vaccine.
4	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0909410-1	Client is 17 year old and vaccine given. Unknown adverse reaction. Underage for vaccine approved.
5	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0910883-1	Individual was under 18 years of age
6	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0911988-1	Moderna has an EUA from the FDA for patients aged 18 and older.  This vaccine was used inappropriately to vaccinate a 17 year old staff member at a clinic hosted by Pharmacy.  Patient experienced no adverse effects, but this improper usage of the vaccination requires reporting to VAERS.
7	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0912103-1	Dizziness and nausea 10 minutes after injection, continued to wax and wane over approx 90 minutes.  No vitals taken.  Patient ambulated back to work at 1800.
8	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0913129-1	patient was 17 years old at time of administration, vaccine only approved for 18 and older
9	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0914401-1	No adverse event but administration error. This female was not 18 years of age and the vaccine is indicated for those 18 and older.
10	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0914608-1	Client was a 16 yr old female
11	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0914874-1	PATIENT IS 16, MODERNA COVID 19 IS ONLY RECOMMENDED IN PATIENTS 18 AND OLDER
12	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915117-1	Patient was given the Moderna vaccination at our clinic today. No adverse reactions are known at this time.  Patient was not at the appropriate age to receive this vaccination.  Patient was 16 years of age (03/17/2004), where Moderna only covers people 18 years of age and above.  The administrator was notified and contacted the patient and spoke with their mother explaining what had happened at the clinic today.  Patients mother was very upset and agitated and stated that she would be calling the physician in the morning.
13	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915440-1	PROVIDED DOSE NUMBER 1 DURING VACCINATION CLINIC AND DISCOVERED DURING RECORD REVIEW THAT RECIPIENT WAS 17 YEARS, 9 MONTHS OLD. NO ADVERSE EVENTS, TREATMENT, OUTCOMES REPORTED TO DATE.
14	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915460-1	Vaccine given to 16 year old, not licensed for this age.
15	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915584-1	This individual was given the Covid-19 vaccine at on offsite clinic at the age of 15 when the vaccine is only approved for 16 and older. No adverse reaction reported.
16	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915846-1	Patient suffered no adverse reaction. Patient was underage according to the EUA. Clinic was using paper forms and missed the patients age of 17 years and 8 months
17	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915849-1	Clinical indication noted from EUA indicate that patient is required to be 18 years or older and that vaccination providers must report any errors. Noted patient was 17 years and 10 months at the time of inoculation. At the time of immunization and post observation period, patient showed no symptoms or adverse reactions. Patient to be informed to follow up with primary care provider in regards to any reactions.
18	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915873-1	Patient received the Moderna vaccine and is only 16 years old.  Patient arrived with mother to the clinic, patient's mother argued that the website stated the vaccine is for ages 16 and up.  The nurse told the parent the Pfizer vaccine is for 16 and up; however, the Moderna is for 18 and up.  Parent demanded and nurse went ahead and administered the vaccine at the parent & patient's request.
19	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0915958-1	During Covid Clinic, 17 year old was given Moderna vaccine approved for age 18 and older, Screening In system does not alert to age. Age not noted during screening. No adverse reation noted following Injection.   Telephone call to mother on 12/31/20 twice with no response. Voice mail left to check status of child and request return call..
20	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0916074-1	MODERNA COVID-19 VACCINE EUA:  Individual presented to COVID-19 vaccination clinic sponsored by Health Department being held for Healthcare Providers.  Individual marked on Vaccination Consent form that she was a Medical Assistant at her father's  medical practice. After administration of vaccine it was discovered that she is 17 years old. This vaccine is not for individuals < 18 years old.  Call made to CDC who advised us to call Moderna.  Called Moderna and awaiting guidance/advice from Moderna Medical Information division.
21	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0916248-1	NO ADVERSE EVENT OCCURRED  A 17 year old EMS worker who was coming through out COVID-19 vaccination clinic received the vaccine.  At the time, no one realized he was only 17 years old.  Since the vaccine is only indicated for 18 years or older adults, I thought it best to report it here since it was technically an error.   I spoke with the patient on 12/31/2020 to notify him of the error and he felt fine.  He had no adverse reaction to the vaccine
22	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0916428-1	hives and itching face after receiving the vaccination
23	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0919181-1	Patient stated they were 18 years old on their form, and it was later found that they were 17 years old. They should not have received the vaccine, but were given it by mistake. No serious side effects
24	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0919292-1	I am reporting that the Moderna vaccination was given inadvertently before the minimum age 18 requirement.
25	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0919834-1	Age at the time of vaccination was 16.  Not identified until after the vaccine was administered.
26	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0920541-1	DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, NAUSEA. RESOLVED BY MORNING OF 12/31/20
27	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0920880-1	Patient vaccinated outside of age range for vaccine
28	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0922632-1	Patient was vaccinated and is under 18. Patient has had no adverse reactions
29	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0922657-1	Patient was vaccinated and is under the age of 18. No complications from being vaccinated at this time.
30	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0923134-1	0.5mL Moderna COVID19  vaccine inadvertently given to individual under the age of 18. Vaccine administrator immediately notified patient and assessed for any adverse reactions (none noted). Provider also called to follow up with patient the following day and patient stated he was not experiencing any negative side effects.
31	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0930278-1	Patient is 14 years old, and the vaccine is not indicated for patients under the age of 18.  We have been checking in with the patient and the patient has not experienced any signs or symptoms of any adverse event.
32	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0933433-1	Vaccine was given to a 16 year old. Patient was monitored for 15 mins post vaccination. Patient showed no signs/symptoms of a reaction.
33	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0934387-1	slight sore arm
34	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0935461-1	Patient was given vaccine by mistake.
35	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0938812-1	Vaccine was given to 16 year old employee. Mother was in attendance at the time. No side effects have been reported to date.
36	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0939364-1	Pediatric patient got vaccinated; A spontaneous report was received from a nurse concerning a 16-year-old, female pediatric patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, pediatric patient got vaccinated.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28 Dec 2020, the pediatric patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, reporter stated, she, and her 16-year-old daughter both received the Moderna COVID-19 vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, pediatric patient got vaccinated, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of drug administered to patient of inappropriate age. This event occurred the same day of vaccine administration. The reporter did not provide the causality assessment for the events. The event is assessed as unrelated to Moderna COVID-19 Vaccine.
37	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0940847-1	Error: Booster Given Too Early
38	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0941400-1	Error: Booster Given Too Early
39	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0944191-1	Wrong Dose of Vaccine - Too High; symptoms lasted 0 days
40	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0945759-1	COVID-19 vaccine to a 16 year old; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, COVID-19 vaccine to a 16 year old.  The patient's medical history was not provided. Concomitant medications were not reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported. The reporter stated, the patient would like to receive dose two to complete the vaccine series.    The event, COVID-19 vaccine to a 16 year old, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of drug administered to patient of inappropriate age. The event is assessed as not related to Moderna COVID-19 Vaccine.
41	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0945769-1	Gave vaccine to a 17 year old; A spontaneous report was received from a healthcare facility staff member concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, gave vaccine to a 17 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the healthcare staff member reported the Moderna COVID vaccine was given to a 17 year old patient. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, gave vaccine to a 17 year old, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
42	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0945774-1	17-Year-old patient was vaccinated; Sore arm; A spontaneous report was received from a nurse concerning a 17-year-old female patient who received Moderna's COVID-19 Vaccine and experienced sore arm and 17-year-old patient was vaccinated.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The vaccine was administered at a University's campus.  On 30 Dec 2020, the patient, a medical assistant, received the vaccine and did not inform the vaccinator of her age until after the vaccine was given. The patient experienced a sore arm after receiving the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, 17-year-old patient was vaccinated, was resolved on 30 Dec 2020. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 17 year old, female, patient.  The patient's medical history is not provided. The event occurred on 30 Dec 2020 during administration of the first dose of the mRNA-1273, lot # 026L20A. This report refers to an unexpected event of administration of mRNA-1273 to patient of inappropriate age (17 year old). The patient had an expected event of pain in arm during the injection.   The sponsor considered the event of vaccine administration to patient of inappropriate age as not related to mRNA-1273. The event of pain in arm is related to mRNA-1273 as 'pain at the site of injection' is the listed event on the company's fact sheet for the healthcare providers.
43	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0946849-1	Error: Booster Given Too Early
44	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0946915-1	There was no adverse event from the vaccination itself but we were advised to file a report in VAERS by the vaccine manufacturer because we were notified that a 17 year old received a first dose of the Moderna vaccine before it was realized that she was under age. She and her family reported no adverse reactions from the vaccine.
45	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0947448-1	Female patient 17 years of age received the vaccine; A spontaneous report  was received from a pharmacist concerning a 17-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced female patient 17 years of age received the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 0 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, a 17 year old female patient was administered the vaccine. No additional information was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The event, female patient 17 years of age received the vaccine, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
46	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0949519-1	Patient under the age of 18 given the vaccine.  No known adverse symptoms.
47	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0951902-1	Administered vaccine to 17 year old patient; A spontaneous report was received from a nurse concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, administered vaccine to 17 year old patient.  The patient's medical history was not provided. Concomitant medications were not reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 220, the nurse reported the 17-year-old vaccinated patient did not have any symptoms that they knew of. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered vaccine to 17 year old patient, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
48	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0951958-1	Vaccine administered to pediatric patient; A spontaneous report was received from a nurse concerning a 16 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine was administered to a pediatric patient.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot #026L20A) on 31 Dec 2020, intramuscularly in the left arm, for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the Moderna vaccine was administered by error to a pediatric patient. The patient experiences no symptoms and was absolutely fine.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine was administered to a pediatric patient, resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
49	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0954301-1	16 year old male child received the first Moderna vaccine; A spontaneous report was received from a consumer concerning a 16-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in the event, 16 year old male child received the first Moderna vaccine.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient was 16 years of age when he received the mRNA-1273 vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, 16 year old male child received the first Moderna vaccine, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
50	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0957353-1	17 year old administered vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old consumer who received Moderna's COVID-19 vaccine and was at an inappropriate age at vaccine administration.                           The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 or 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 29 or 30 Dec 2020, a 17-year-old patient was given the vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine. No adverse events were reported.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, inappropriate age at vaccine administration, was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who was administered vaccine outside the lower age limit for Moderna's mRNA-1273 vaccine, lot # unknown, Exp. unknown. There were no reported AEs associated with this case of vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine.
51	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0958555-1	Administered Moderna COVID-19 Vaccine to a 17 year old patient; Sore arm; A spontaneous report was received from a health professional concerning a 17-years-old male consumer who was administered Moderna's COVID-19 vaccine (mRNA-1273) at 17-years-old and developed a sore arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.     On 23 Dec 2020, the patient received the vaccine at 17 years of age. After he received the vaccination, he developed a sore arm. Per source document, patient and patient's father reported experiencing a slight sore arm for a short duration. No other ongoing symptoms reported. No treatment information was reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, sore arm, was not provided. The outcome for the event, administered Moderna COVID-19 vaccine at 17-years-old, was resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a 17-year old,  male patient. The patient's medical history was not provided. The patient experienced an unexpected event of product administered to inappropriate age and possibly related event of soreness of arm. The event occurred on 23 Dec 2020 after the patient received the first dose of  mRNA-1273 (Lot number: 025J20-2A). Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
52	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0966898-1	patient <18 yo when he got his first covid vaccine. He was meant to get Pfizer but got signed up for the Moderna clinic. He managed to get by registration unnoticed with age and recieved a shot at a mass covid vaccine event. He did not have any side effects. His mother would like him to get the 2nd dose
53	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0979405-1	Error: Too Young for Vaccine
54	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0979431-1	Error: Too Young for Vaccine
55	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0984885-1	age 16 received vaccine; A spontaneous report was received from a consumer relative, concerning a 16 year-old white female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for COVID-19 infection prophylaxis.   On 22 Jan 2021, the patient's mother stated that her daughter received the vaccine, which was required by her employer. No adverse reactions were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, age 16 received vaccine, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 16 year-old white female patient, who received the first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for COVID-19 infection prophylaxis. No adverse reactions were reported to this event pf product administered to patient of inappropriate age
56	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	0986963-1	No adverse reactions, administration error only (does not meet age criteria per EUA)
57	COVID19 VACCINE	0 days	6-17 years	Dec., 2020	1074397-1	Vaccine given to 17 year old; A spontaneous report was received from a registered nurse concerning a 17 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No concomitant product use was reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient returned for the second dose and the mistake that the vaccine was given to a 17 year old male had come to light. Treatment information was not applicable.  The second dose of mRNA-1273 was discontinued in response to the event.  The outcome of the event was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old male who experienced a nonserious unexpected event of Product administered to patient of inappropriate age for first dose mRNA-1273 (lot # 011J20A)  with no associated adverse events.  The second dose of mRNA-1273 was not administered. Event considered resolved.
58	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0919233-1	Covid-19 vaccine was administered to individual < 18 years of age in error. No adverse event was observed or reported.
59	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0919455-1	Vaccine administered to 16 year old patient in error; FDA authorized emergency use of administered vaccine for patient's 18 years and older. Patient was monitored for  15 minutes following  vaccine administration; no adverse reaction noted.
60	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0921526-1	Moderna Covid Vaccination administered to patient less tan 18 years old
61	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0921566-1	Covid Vaccine given to person less that 18 years old. No complications at this time
62	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0921594-1	Covid Vaccination given to person less than 18 years. No complications at this time
63	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0921641-1	Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.
64	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0921851-1	None stated.
65	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0921854-1	Patient under age 18 at time of vaccine
66	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0923844-1	Patient had completed the VAR form prior to the clinic. Staff was aware that only ages 18 and over could get immunization. They allowed her to have the shot with parental approval, which we as the vaccinators did not notice or approve of.
67	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0923913-1	Patient was given the immunization despite her being outside of the appropriate age range.  Patient and workplace had signed VAR stating they were 18 years old and able to receive the vaccine. Immunizing staff wasn't aware of her age due to the fact that the VAR was filled out and approved by the workplace.
68	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0924171-1	Late at night patient began having chills and extreme muscle pain all over her body, sore throat, nausea, extreme fatigue. She also had a fever of 102.
69	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0924205-1	Patient given COVID-19 Moderna vaccine at age of 14 years old. Pharmacist (myself) realized patient was under the age of 18 years after administering the vaccine.
70	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0924641-1	Patient was under the age of 18 when she received the vaccine.
71	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0924940-1	"Moderna COVID-19 Vaccine EUA""  Vaccine administered to wrong age patient. No known allergies or medical conditions. Nurse who administered vaccine did not know vaccine not approved for anyone under the age of 18.""
72	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0925174-1	No reported adverse reaction...Just that patient was given Moderna and is < 18 yrs of age.
73	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0925282-1	No adverse reaction noted. Pt was just noted to be < 18 after vaccine administration.
74	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0926295-1	Patient was given Moderna vaccine, but was found that  she was only 17 during billing process.
75	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0926322-1	Patient was 17 years old
76	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0926748-1	Medication Error - 0.5 mgs of Moderna Vaccination administered to person less than 18 years old (14 year old patient). No Symptoms or complaints.  Parent  contacted - advised to watch for any untoward signs or symptoms.
77	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0926798-1	Medication error: first dosage of Moderna Covid Vaccine 0.5 cc given to patient under 18 years of age (17 years old). No complaints or adverse reactions noted.  Parent (EMT) contacted & advised to observe for any adverse reaction, if any.
78	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0926888-1	Patient is 17 years old, and signed up for vaccination with Pfizer vaccine, however decided to attend an earlier clinic with his Mother. At the earlier clinic, only the Moderna vaccine was available, and the vaccinator did not realize his age, and administered Moderna vaccine. It was not realized until after vaccination that he was due to receive the other vaccine because of his age. Patient attended the vaccine clinic with his Mother both were aware of the mistake. Patient had no ill effects after receiving the vaccination.
79	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0926918-1	No adverse event noted. Patient is 17 years old (17.5) and the approved age for this vaccine is 18. This was inadvertently missed at check-in. Patient suffered no untoward effects
80	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0926987-1	Administered vaccine to a 16yr old
81	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0927086-1	Moderna vaccine given to patient under the age of 18.
82	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0927167-1	Entered observation @ 1935.  Mother stated to this nurse @ 1950, that daughter felt ""light-headed"".  Water was given.  @ 1954, patient started to gag.  Went to restroom.  @ 1958, she was walked with this nurse and others to ""bed"" that's located in vaccination clinic.  Mother explained to this nurse and others that her daughter shows s/s of these symptoms upon each vaccination.  Lightheadedness and nausea lasted for about 10-15 minutes.  Cold compress was applied to help relieve s/s from vaccine.  States she felt better around 2005.  Left observation @ 2005, showed no s/s of distress.""
83	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0928625-1	COVID VACCINE WAS GIVEN TO UNDERAGE PT. PT IS ONLY 17 YRS OLD, TURNS 18 IN MARCH.  VACCINE NOT APPROVED FOR SOMEONE UNDER THE AGE OF 18. NURSING FACILITY WAS NOTIFIED. THEY SAID THEY WOULD NOTIFY PARENTS. PATIENT HAS NO ADVERSE SYSMPTOMS AT THE TIME VACCINE WAS GIVEN. FACILITY SAID THEY WILL MONITOR PT.
84	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0929153-1	no a/e, pt is under the age limit
85	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0929805-1	Patient is asymptomatic, but vaccine was given to a 16 year old, where manufacturer recommends 18 years and above.
86	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0930218-1	Patient was administered the Moderna vaccine despite being only 17 years old and the CDC not recommending the vaccine for people under 18 years old.
87	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0930541-1	no side effects or symptoms at time of dose or observation time. reporting because of patient age
88	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0930567-1	patient had a syncopal episode at time of injection. lasted <10 seconds. Also reporting due to patient age 17 years old. Patient stated she thought she could take vaccine so she registered for it.
89	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0932973-1	on 1/9/2021 -, 16 year old female was given Moderna vaccine.  10 minutes after injection, this was discovered. Pt reports no adverse reactions during the 15 minute observation period.  Telephone call on 1/10/2021 at 3:00 pm mother reports child had some arm soreness and a little dizzy yesterday but today feels fine.
90	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0933882-1	Moderna vaccine given to patient under the age of 18.
91	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0933906-1	VACCINE GIVEN TO PATIENT UNDER THE AGE OF 18.
92	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0934091-1	Patient was vaccinated but was out of out of recommended age range.  Pharmacist did not recognize error until after injection was complete.  Patient did not have any post-injection reaction.
93	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0934580-1	Patient is 16 yo female. She was given Moderna COVID-19 vaccine during an off-site vaccine POD reserved for First Responders and persons aged 65 and older. She should not have been scheduled for this event and nurse administered vaccine without verifying patient's age. Phone call to patient's mom, to inform of error. Mother states patient has had no side effects or adverse reactions to Moderna COVID-19 vaccine. Informed that patient will not receive second dose in 4 weeks and also is not eligible to receive Pfizer COVID-19 vaccine due to manufacturer's recommendation that vaccie is not interchangeable with other COVID-19 products.
94	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0935326-1	Moderna is for age 18 and older.  Patient is 17 years old.
95	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0935424-1	GAVE A COVID-19 MODERNA VACCINE TO A 17 YEAR OLD.
96	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0935671-1	Vaccine given to a 16 year old.  No noted or reported adverse outcome.  Vaccine clinic was held at clinic. Clinic was asked if any residents or staff was under 18 and they responded no.  Patient turned out to be 16 and a staff worker.  Administering RN did not catch the age and when it was entered in to database it flagged.
97	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0935866-1	Vaccination inadvertently given to patient outside of ACIP approved ages
98	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0936716-1	NO ADVERSE EVENT
99	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0936904-1	Volunteer was 17 years 6 months. She had no adverse reaction . Associate was under 18 was notifying Moderna and seeking guidance.
100	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0937544-1	Patient was given Moderna Vaccine at age of 17.  Moderna indicated for >18 years of age.
101	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0939095-1	Patient was administered Moderna vaccine, age 17 years and 4 months. No adverse reaction
102	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0939181-1	Patient was administered COVID Vaccine (Moderna). Patient's age is 17 years 4 months.
103	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0939592-1	Dosing error. 16 year old given moderna vaccine when approved age is 18 years and older  No adverse effects. Reporting error to vaers per EUA criteria.
104	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0940033-1	Patient 15 years of age presented to COVID vaccine clinic for initial dose, received 0.5 mL dose of Moderna COVID vaccine.  Discussion with parents, pediatrician around plan for second dose and monitoring for any impact.  No know adverse effects noted from the vaccination.
105	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0940259-1	Error: Wrong Patient (documentation in EMR)symptoms lasted 0 days
106	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0940277-1	Error: Wrong Patient (documentation in EMR); symptoms lasted 0 days
107	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0941013-1	Less than 18 years of age received the vaccine.    No adverse effects noted.  Moderna COVID- 19 Vaccine EUA
108	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0941151-1	Client is 17 years old and 8 months.   Moderna should be given to 18 years of age and older.
109	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0941539-1	Error: Booster Given Too Early
110	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0941590-1	Mistakenly gave Covid-19 Moderna vaccination to under 18 y.o. Reporting to VAERS as per WA DOH recommendation.
111	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0941620-1	Mistakenly gave Covid-19 Moderna vaccination to under 18 y.o. Reporting to VAERS as per WA DOH recommendation.
112	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0941986-1	Moderna COVID- 19 Vaccine EUA Patient recieved first dose of COVID-19 Vaccine utilizing MODERNA Vaccine on January 13, 2021 at the current age of 17 years 5 months. Moderna EAU is for patients 18 years of age and older.
113	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0942143-1	Patient was under the age of 18 at time of administration.  Followed up with her Mother and  she is doing okay.
114	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0942990-1	Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
115	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0942998-1	Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
116	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943006-1	Error: Booster Given Too Early; symptoms lasted 0 days
117	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943037-1	Error: Booster Given Too Early; symptoms lasted 0 days
118	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943183-1	Error: Booster Given Too Early
119	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943198-1	Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
120	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943307-1	Systemic: Seizure-Severe
121	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943674-1	Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
122	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943708-1	Error: Wrong Patient (documentation in EMR)
123	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0943805-1	Error: Booster Given Too Early
124	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0944166-1	Booster Given Too Early
125	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0944840-1	Error: Wrong Vaccine Formulation  (ex. different
126	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0945029-1	The patient is 16 years old and received the Moderna vaccine. The patient's mother was contacted immediately after this event was noted approximately 30 minutes after the patient received the vaccination. The mother verbalizes knowing that they were aware of the age requirement but felt due to his physical built of 200lbs and that he should be able to receive the vaccine. The patient not experiencing any adverse reactions as of the last phone call inquiry by this nurse at 4:20 pm. Mother was instructed to seek medical attention for any adverse reactions, she verbalized understanding. Follow up call will be placed to the mother tomorrow,
127	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0945030-1	Patient was given Moderna vaccine at 15 years old accidentally, which is less than the minimum age in the EUA. Patient was supposed to receive Pfizer vaccine, although he still would have been too young for that as well. Patient is a volunteer at hospital where this occurred. There were no adverse effects other them arm soreness
128	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0945362-1	MODERNA COVID-19 VACCINE EUA HOSPITAL CONTRACT EMPLOYEE (AGE 17) WAS SCHEDULED, AND SUBSEQUENTLY WAS ADMINISTERED THE MODERNA COVID-19 VACCINE. NO ADVERSE REACTION NOTED TO VACCINE, BUT ADMINISTRATION ERROR DUE TO AGE OF PATIENT.
129	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0945898-1	Person who first dose of Moderna vaccine...was a 17 year old; A spontaneous report was received from a pharmacist concerning a 17-year-old consumer who received Moderna's COVID-19 vaccine and was at an inappropriate age at vaccine administration.                           The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 01 JAN 2021, a 17-year-old patient was given the vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine. No adverse events were reported.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, inappropriate age at vaccine administration, was considered resolved on 01 Jan 2021.; Reporter's Comments: This case concerns a 17 year old patient.  The patient's medical history is not provided.  The event occurred on 01 Jan 2021 during administration of the first dose of the mRNA-1273. This report refers to a case of medication error where mRNA-1273  has been administered to the patient of inappropriate age.  There were no reported adverse  reaction associated with this case.
130	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0946137-1	Red rash appeared in both arms from shoulders to almost the elbows.  No itching. Nurse gave Benadryl & Pepcid to slow symptoms.  Rash went away within half an hour. No other symptoms.
131	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0946298-1	17 y/o receiving vaccine for 18 and older.
132	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0946311-1	Received vaccine at 17 y/o. No reactions.
133	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0946607-1	Moderna vaccine administered off label to 17 year old.
134	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0947004-1	Pt developed a bilateral rashes on the arms 10 min s/p COVID vaccine administration.  No other symptoms were experienced.  Pt received 20 mg of Famotidine and 25 mg of Diphenhydramine.  Rash improved.  Pt was monitored for 30 minutes, and was able to return home with no issues
135	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0947074-1	After vaccine had been administered it was discovered that patient was under the age of 16. Parent was present at time of vaccination.
136	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0948225-1	Vaccine given to 16 year old patient
137	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0948417-1	no symptoms reporting because patient is only 17 years old at time vaccine was administered.
138	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0948496-1	Patient under age limit guideline but was given vaccine.  No adverse event (medical) noted.
139	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0948501-1	no adverse effects. reporting due to patient under the recommended age at time of administration
140	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0949487-1	Patient is 16 years old and pregnant. She received one dose of the Moderna COVID19  vaccine.  She has not called the clinic to complain of any side effects. This report is being made because the patient is under the age limit to receive the vaccine at this time.
141	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0949690-1	None.  Gave 12 days before 16th birthday
142	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0950623-1	Patient is 17 years and 10 months and she works at a physical therapy clinic. She answered the screening questions on the website and got the ok to get the vaccine.  Vaccine was given to the patient but the EUA for Covid-19 Moderna vaccine is for 18 years and older.  The patient did not develop any type of reaction. BUT due to the EUA we had to call the patient after she has already received the vaccine and inform her that we are not able to administer the second dose until further instruction from the AICP.
143	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0951087-1	30 mins after IM injection: Left arm tingling 45 mins after IM injection: Left arm, Left shoulder, Left upper back tingling, Headache, chills, fatigue
144	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0951410-1	Patient is under the age of 18 and received the vaccine. Patient denies any s/s, adverse affects and is aware of the situation.
145	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0951750-1	Patient  received a Moderna COVID19 Vaccine.
146	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0951780-1	A 6 foot adult appearing male, received the Moderna vaccine. The afternoon of his vaccination we recognized the patient was 15 years old.  We immediately called the mother. The child had been completely asymptomatic four hours after receiving the vaccine. The following morning the patient continued to have no symptoms, as we communicated with the Mother.
147	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0951962-1	17 year old received the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 17 year old received the vaccine.  The patient's medical history was not provided. No concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the 17-year-old patient received the mRNA-1273 vaccine. The patient did not experience any symptoms and did not receive any treatments.   Action taken with mRNA-1273 in response to the event was unknown.  The event, 17 year old received the vaccine, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of 17- year-old female patient who received the mRNA-1273 vaccine (Inappropriate age at vaccine administration)  Lot # was not provided. There were no reported AEs associated with this case of Incomplete dose administered
148	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0954161-1	RespDepression, Palpitations & Tachycardia Narrative:
149	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0957769-1	body aches, nausea, vomiting, and chills
150	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0957906-1	None. Patient is 17 years old and received Moderna vaccine . Will moniter for reactions.
151	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958092-1	Vaccine to someone who was less than 18 years old.; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age.  No side effects were reported. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, vaccine given to a patient less than 18-years-old, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 011J20A. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
152	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958207-1	Error: Wrong Patient (documentation in EMR)
153	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958248-1	No adverse event, just submitting because someone called and said the MIIC let them know that pt was under 18.  She is staff at the facility we serve and her underage status was not noticed at the time.  However, since she is so close, and patient age with regard to this vaccine can be thought to be arbitrary (even if pt age <18 wasn't studied), common sense indicates pt has no increased danger of adverse effects, and further, should receive the 2nd dose on schedule even if before 18 years of age.
154	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958535-1	Vaccine administered to a 17 year old; A spontaneous report was received from a health care professional concerning a 17-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine administered to a 17-year-old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20E) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the 17-year-old patient was vaccinated. The patient was 10 days away from turning 18. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered to a 17-year-old, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 17 year old femaile subject with who experienced a non serious unexpected event inappropriate age at vaccine administration. There were no reported AEs associated with this event of inappropriate age at vaccine administration.
155	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958554-1	Immunized at age 12; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 12-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 12 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 12 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: Company comment: This report refers to a case of 12- year-old patient who was administered vaccine outside the lower age limit for Moderna's mRNA-1273 vaccine,  and received a vaccine dose that had been left at room temperature more than 12 hours (lot # unknown, Exp. unknown). There were no reported AEs associated with this case of vaccine and is outside the lower age limit for Moderna's mRNA-1273 vaccine and  vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours.
156	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958627-1	A 17yo was scheduled for vaccination via invite link shared with his parent's dental office. His parents signed consent for him to receive the vaccine and the patient was able to slip in through the system unnoticed. Pt has not reported any side effects or adverse outcomes to us.
157	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958693-1	ON 01/15/2021, WAS PLACED ON THE COVID VACCINE SCHEDULE. WE HAD ?NO SHOWS? DURING THE CLINIC WHICH WARRANTED ADDITIONAL PATIENTS/ EMPLOYEES BEING PLACED ON THE SCHEDULE THE SAME DAY. WAS CHECKED IN BY THE PSR. I INSTRUCTED HIM TO BE SEATED IN THE WAITING ROOM WHERE HE WAS TO RECEIVE HIS VACCINE. I ASKED PATIENT TO VERIFY HIS NAME AND DATE OF BIRTH FOR THE PURPOSES OF ?DOUBLE IDENTIFICATION?. UNFORTUNATELY, I DID NOT RECOGNIZE THAT HE WAS UNDER THE AGE OF 18, AS I WAS WORKING UNDER THE UNDERSTANDING THAT ONLY ADULTS WERE BEING PLACED ON THE SCHEDULE FOR COVID VACCINE. DURING THE VACCINE CLINIC I AM NOT ACCESSING PATIENT CHARTS IN ECW, WHERE THE AGE OF THE PATIENT IS CLEARLY VISIBLE IN THE CHART. I DISCOVERED THIS MISTAKE ON 01/18/2021 WHILE WORKING FROM HOME. I HAPPENED TO BE REVIEWING THE SCHEDULE FROM 01/15/2021 AND DISCOVERED THE PATIENTS AGE. I IMMEDIATELY REACHED OUT TO MY SUPERVISOR.
158	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0958895-1	Patient was under the age allowed to vaccinate
159	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0959059-1	No adverse reactions.  The patient is underage and was not supposed to receive the shot until turning 18.  We were advised to give the second dose after the patient turns 18 per the CDC.
160	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0959455-1	Client is 17 years old
161	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0959623-1	Vaccine was administered outside the FDA approved age range. There were no adverse events/reactions.
162	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0959624-1	Vaccine was administered outside the FDA approved age range. There were no adverse events/reactions.
163	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0959694-1	Patient is 16 years old. Patient did not have side effects after vaccine.
164	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0959796-1	No adverse event reported. The vaccine was administered to a 17 year old female in error.
165	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0960816-1	Immunized at age 8; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 8-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 8 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 8 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a 8-year old patient, who was administered the first dose of mRNA-1273 from the vials that were exposed to room temperature for more than 12 hours. This report refers to a case of Product storage error  and Product administration error for mRNA-1273, where out of specification product was administered to the patient of inappropriate age.
166	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0960817-1	Immunized at 14 years old; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 14-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 14 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 14 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age and Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.
167	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0963813-1	Moderna vaccine given to a 16 year old; A spontaneous report was received from a nurse concerning a female 16 year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16 year old.    The patient's reported medical history included severe intellectual disabilities. No relevant concomitant medications were reported.   On 7 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 7 Jan 2021, the nurse reported the Moderna COVID vaccine was given to a 16 year old female patient. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to 16 year old, was considered resolved on 7 Jan 2021.; Reporter's Comments: This case concerns a 16-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 037K20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
168	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0964349-1	Vaccine given to someone less than 16 years of age.
169	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0964573-1	Client attended a POD held at the School, where the Moderna COVID-19 vaccines were being administered to group. She received the vaccine without event and after she left, it was noted that she is 16 years old and does not meet the minimum age requirement of 18 years for the Moderna vaccine. Client?s father was immediately contacted when the error was realized and informed about it. CDC has been contacted regarding the incident and we are awaiting their response. 1/16/2021 CDC responded by saying that there was no harm in giving the vaccine, but when she turns 18 her next dose would be counted as Dose 2.
170	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0964737-1	This event is a vaccination administration error due to patient's age as opposed to what the suggested appropriate age range is.
171	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0965010-1	Client was 17 years and 10 months old at time of vaccination
172	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0965130-1	The 14 year old patient received the Pfizer BioNTech Vaccine; this vaccine is not authorized for use in individuals less than 16 years of age.
173	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0965144-1	Too young of age to administer the vaccine .
174	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0965149-1	The 10 year old patient, received the Pfizer BioNTech Vaccine; this vaccine is not authorized for use in individuals less than 16 years of age.
175	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0965469-1	17-year-old was administered the vaccine; A spontaneous report was received from a physician concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), resulting in the event, 17-year-old was administered the vaccine.  The patient's medical history was not provided. Concomitant product use was not reported.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the mRNA-1273 vaccine was administered to a 17-year-old. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, 17-year-old was administered the vaccine, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 17 year old, male patient.  The patient's medical history is not provided.  The event occurred on 06 Jan 2021, during administration of the first dose of the mRNA-1273(Lot number: 012L20A). This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.
176	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0965669-1	No Adverse event, reporting age differential from approved. During a covid vaccine clinic vaccinated. While processing the vaccine, the vaccine was given to the patient and it wasn't until later they saw the rejection for the patient that she was not 16. Patient had no adverse reaction and patient and facility are aware she cannot get second dose until she is 16.
177	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0965790-1	minor age 15 received COVID vaccine.   no adverse reaction
178	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0966573-1	Patient received the vaccine on 1/4/21 and she is 17 years of age (Moderna is 18+).
179	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0966589-1	Patient is 16 years old
180	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0969673-1	17 years and a half got the first shot; A spontaneous report was received from a pharmacist concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and 17 years and a half got the first shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 17 years and a half got the first shot, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
181	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0971606-1	nausea, vomiting, sensitivity to light, hearing was muffled, a bit of dizzines.  She vomited 3 times. in a span of 30 minutes.
182	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0973237-1	This event was not an adverse event, however, it was an invalid dose because the patient was less than 18 years of age when she received her first dose of the Moderna COVID vaccine. Patient did state she experienced some light dizziness about 5 minutes after she was given the vaccine and that this has happened before with the influenza vaccine. She also stated that she did not have anything to eat or drink at all that morning so she may have been experiencing weakness from that as well.  It resolved within 10-15 minutes and patient was fine to go home per other healthcare providers.
183	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0973749-1	age under 18; sore arm for day 1 post vaccine only, completely resolved by day 2
184	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0973751-1	age under 18; sore arm for day 1 post vaccine only, completely resolved by day 2
185	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0973756-1	age under 18; sore arm for day 1 post vaccine only, completely resolved by day 2
186	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0973834-1	Error: Too Young for Vaccine
187	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0973855-1	Error: Too Young for Vaccine
188	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0974065-1	Error: Too Young for Vaccine
189	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0974077-1	Error: Too Young for Vaccine
190	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0974089-1	Error: Too Young for Vaccine
191	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0974101-1	Error: Too Young for Vaccine
192	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0974135-1	Error: Too Young for Vaccine
193	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0974167-1	Error: Too Young for Vaccine
194	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0976811-1	temperature 101; vaccine was administered to 7-year-old son; This is a spontaneous report from a Pfizer sponsored program, received from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports.  A 7-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 12Jan2021 at a single dose for Covid-19 immunization. Medical history included respiratory distress (at birth had persistent respiratory distress requiring oxygen for 10-12 days), Febrile seizure in Jan2017, and pneumonia in Jan2017. The patient's concomitant medications were not reported. A mother went to get vaccinated for Covid-19. She took her kids ages 7 and 15. The kids were also vaccinated. The vaccine was administered to the 7-year-old son on 12Jan2021. Her son (patient) had a temperature of 101 on 13Jan2021. The mother was concerned because the vaccine was not recommended for his age. She was wondering if he should be in the ER. The reporter does not know if the child still has a fever. She said that the vaccination providers went ahead and gave the vaccine to the children as well even if they were not scheduled to get them. Outcome of the event was unknown.  Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021041926 Same reporter, product, and event, different patient
195	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0977169-1	Error: Too Young for Vaccine
196	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0977498-1	Patient was 17 years old at time of vaccine
197	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0979029-1	DEVELOPED FEVER OF 103
198	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0979036-1	DEVELOPED FEVER OF 103
199	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0979153-1	Administered the Moderna COVID-19 vaccine to a patient under the age limit according to the EUA. Minimum age reported by EUA is 18 years-old and the patient was 17 years-old when the vaccine was administered. Patient is a healthcare provider (medical intern) and had a letter from Dr.   who works at her clinic with a note authorizing vaccination.
200	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0979360-1	Error: Too Young for Vaccine
201	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0979494-1	Adverse event in vaccinating patient less than 18 years old
202	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0984883-1	Moderna vaccine administration to a 17 year old; A spontaneous report was received from a pharmacist concerning a 17-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)  vaccine given to a 17-year-old patient.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 14 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The reporter reported the vaccine was given to 17-year-old. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to a 17-year-old, was considered resolved on 14 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (t 025J20-2A), reporting Product administered to patient of inappropriate age.
203	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0984900-1	Vaccine given to a 16 year old; A spontaneous report was received from a parent concerning a 16-year-old, male, patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient received his first dose of the Moderna vaccine and he is only 16 years old. The patient was fine and has had no side effects. Consent given for Safety to follow up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine was administered to a 16 year-old, was considered resolved on 22 Jan2021.; Reporter's Comments: This case concerns a 16-year-old, male, patient who received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. There were no reported adverse events per reporter for this case of product administered to patient of inappropriate age
204	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0985252-1	Patient Received the vaccine, she was outside the age Parameters.  (16 years Old)
205	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0985560-1	Administered 1st dose to patient under the age limit parameter for the Moderna Vaccination. Patient under the age of 18 (currently 16 years, 11 months).
206	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0985788-1	Moderna COVID-19 Vaccine administered to 17 year old.
207	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0985802-1	Moderna COVID-19 vaccine administered to a 17 year old.
208	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0985865-1	Patient mistakenly was administered the Covid-19 (Pfizer) vaccine at age 15 years old. Patient will turn 16 on 2/15/21 and will be 16 years of age at that point and eligible to receive dose #2 at this time. Patient's  mother was notified and did not report any adverse effects from the vaccine.
209	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986289-1	17 year old.
210	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986314-1	Patients received an off EUA approval use. Patient's age group was was not a part of the Moderna study.
211	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986353-1	17 Year old
212	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986422-1	17 Year Old
213	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986454-1	17 Year old
214	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986489-1	We had a COVID 19 vaccine clinic that was held on 01/27/21. We had an employee who was given a first dose of the vaccine in December 2020, and was 17 years old. The employee had a signed consent from her mother who is a ED nurse. The employee had no adverse reaction from the vaccine, and she and her mother wanted the vaccine series completed. She was given her second dose of Moderna vaccine on 01/27/21 at 10:45am, or the dose would have been wasted.  Patient has not reported any adverse symptoms except pain in her left deltoid where the immunization was given.
215	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986825-1	Client was inadvertently scheduled at a Moderna  Covid vaccination POD per mother, client is 17 y/o and Moderna is licensed for 18 years and above. Mother aware that the vaccination POD was for the Moderna vaccine and for 18 years and above. After realizing that the recipient of the Moderna  vaccine was 17 y/o, parent was notified and alerted that the booster dose would not be able to be given due to age of the client.
216	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986883-1	During the covid clinic where 2 stores teamed up to help with the event, one dose of moderna vaccine was given to a minor.  Nothing happened to the patient.  Pharmacy found out after the fact.
217	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0986980-1	Client is 17 years old at time of first dose.
218	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0987057-1	Patient age is less than approved age of vaccine. She reported a very sore arm on 1/29/21 but no other side effects
219	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0987291-1	Patient is under FDA EUA approved age of 18.
220	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0991152-1	no Too young
221	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0991292-1	Error: Too Young for Vaccine
222	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0991870-1	Error: Too Young for Vaccine
223	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0991897-1	Error: Too Young for Vaccine
224	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	0991939-1	Error: Too Young for Vaccine
225	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1001638-1	Vaccine was given to a 15 year old; A spontaneous report was received from a pharmacist, concerning a 15-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had event vaccine was given to a 15-year-old.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 20-Jan-2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 20-Jan-2021, there might have been a mix up and the 15-year-old patient received the Moderna COVID-19 vaccine instead of the Pfizer vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine was given to a 15-year-old was considered resolved on 20-Jan-2021.; Reporter's Comments: This case concerns a 15-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
226	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1001643-1	Administered to a 16 year old by mistake; Sore arm; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced  sore arm.    The patient's medical history was not provided. Concomitant product use was not reported.  On 23 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient was 16 years of age when she was administered the mRNA-1273 vaccine by mistake. Additionally, the patient experienced a sore arm. No treatment information was provided.   The second dose of mRNA-1273 was discontinued in response to the events. It was reported the patient would be receiving Pfizer's COVID-19 vaccine as their second dose.   The outcome of the event, given vaccine to a 16-year-old by mistake, was considered resolved. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 16 year old female patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced a non-serious unlisted event of sore arm. There were no other reported adverse events after the vaccine was administered in this event of product administered to patient of inappropriate age. Patient cannot be contacted and no further queries are issued.
227	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1004437-1	She passed out.; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284) on 22Jan2021 11:45 AM at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No known allergies. Patient was not pregnant. Patient did not have COVID prior vaccination, and did not have other vaccine in four weeks, did not other medications in two weeks. The patient experienced passed out on 22Jan2021 12:00 PM. Treatment included they had her lay on the ground with her knees up and cold compresses. Patient did not test COVID post vaccination. The outcome of event was recovering.
228	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1011198-1	No Adverse event occurred, but patient in retrospective review of data was discovered to have incorrectly been given Moderna vaccine while under 18 year old as approved in the EUA. The manufacturer was contacted and they provided information about an ongoing clinical trial in patients 12-18 years old receiving the same (100mcg) 2 dose series of Moderna COVID-19 vaccine, however this age group is not currently approved. This is being reported as an error having occurred with the Moderna COVID-19 vaccine. Patient/Guardian will be contacted by a prescriber to inform the patient of the historical event and explain when a 2nd dose can be given.
229	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1045557-1	Administered first dose of the Moderna Covid-19 to a 17 year old patient.; Dizziness; A spontaneous report was received from a healthcare provider (HCP) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness and inappropriate age at vaccine administration.  The patient's medical history was not provided.  Concomitant medications were not provided.  On 21 JAN 2021, the patient received her first of two doses of mRNA-1273 (lot number 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The HCP reported that in order to not waste any doses, the facility calls on family and friends to get the vaccine for no shows.  The HCP reported that the patient experienced dizziness a few minutes after the injection.  The patient hadn't eaten for 16 hours prior to taking the shot.  The patient was monitored, and it resolved within the hour.    Treatment for this event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, dizziness and inappropriate age at vaccine administration was recovered.; Reporter's Comments: This case report concerns a 17-year-old female patient who was administered mRNA-1273 vaccine Lot# 042L20A (inappropriate age at vaccine administration) and experienced dizziness. The event of dizziness is temporarily associated with the product use and a causal association cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.
230	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1045800-1	Itching and rash to the injection site, left deltoid. Down left arm shoulder and chest. After a few minutes patient was stable and sent home after monitoring patient. Benadryl was administered at 12:17pm. Patient advised to take Benadryl prior to 2nd dose.
231	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1045996-1	17 year old received their first dose of the Moderna vaccine; Aches; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273)/ product administered to patient of inappropriate age and developed aches/myalgia.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) between 11 Jan 2021 and 21 Jan 2021 (date not specified) intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.  The patient was scheduled to receive the second dose in Feb 2021. Action taken with mRNA-1273 in response to the events was not provided.  The event, 17-year-old received their first dose of the Moderna vaccine, was considered resolved on the same day of vaccine administration (date not specified). The outcome of the event, aches, was not reported.; Reporter's Comments: This case report concerns a 17-year-old female patient who was administered mRNA-1273 vaccine Lot# 011L20A (inappropriate age at vaccine administration) and experienced aches. The event of aches is temporarily associated with the product use and a causal association cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011594:
232	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1046159-1	PATIENT HAD NO ADVERSE EVENT. THIS REPORT IS BECAUSE THE PATIENT IS BELOW THE RECOMMENDED AGE. THE PATIENT'S PHYSICIAN AUTHORIZED THE IMMUNIZATION
233	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1046980-1	No adverse reactions reported. Client did not meet the age 18 criteria per Moderna's manufacture guidance.
234	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1047426-1	Vaccine given to 17 year old patient
235	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1047454-1	17 YO M, received Moderna Covid-19 vaccine (1st dose) on 01/19/21. Pt falls under the unauthorized age group for Moderna vaccine administration. On 02/22/21, pt returned to vaccination site for 2nd dose, 2nd dose was not administered d/t age requirements. Nurse Manager spoke to pt and father regarding deviation of vaccine administration. Pt nor father reported any adverse s/s after pt received 1st dose of Moderna on 01/19/21.
236	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1048964-1	16-year-old received the first dose of Moderna Covid-19 by accident; A spontaneous report was received from a consumer concerning a 16-year-old, male patient who received the first dose of Moderna COVID-19 vaccine (mRNA-1273) by accident/MedDRA PT: Product administered to patient of inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient received first dose of Moderna COVID-19 vaccine by accident.   Action taken mRNA-1273 in response to the event was unknown. However, it was reported the patient was taken to receive the second dose of Moderna COVID-19 vaccine but was denied to him because he was a minor  The event, 16-year-old received the first dose of Moderna Covid-19 by accident, was resolved on 13 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot # 013L20A) with no associated AEs.
237	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1048965-1	dose to a 16 year old; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, male consumer who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, a 16-year-old patient was administered the first dose of the Moderna vaccine.  No other information was received. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.  The event, vaccine given to a patient less than 18-years-old, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.
238	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1048966-1	underage son received Covid vaccine; A spontaneous report was received from the mother of a 17 year old male patient.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 02 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient was 17 tears old (underage). No treatment information was provided.   Action taken with the mRNA-1273 was not reported.  The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 02 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
239	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1048971-1	First moderna shot on 1/12 and due for his second shot, turned away due to being 17 years; A spontaneous report was received from a consumer (patient's mother), regarding a 17 years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), which resulted in, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years (product administered to patient of inappropriate age).  The patient's medical history was not reported. No concomitant medications were reported.  On 12 JAN 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  The consumer reported that the patient was given his first Moderna shot on 12 JAN 2021. On 10 FEB 2021, the patient was due for his second shot and turned away due to patient being 17 years. The consumer contacted their primary care physician and trying to find out a way to get the patient his second shot, so the first one does not go waste. The consumer would like to enroll the patient in the trial for the second shot. No treatment medication information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, first Moderna shot on 1/12 and due for his second shot, turned away due to being 17 years, was recovered on 12 JAN 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
240	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1048972-1	<18 years old received the 1st dose of the moderna covid-19 vaccine; A spontaneous report was received from a healthcare professional concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the reporter stated that after a vaccination drive thru they had a surplus vaccine of the vaccination site so they called in people to vaccinate. A family (mother, father and son) were vaccinated but the son was below 18 years of age and this wasn't confirmed before vaccination so he received the 1st dose of the Moderna covid-19 vaccine on 09 Jan 2021. No adverse events reported and no treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The event, <18 years old received the 1st dose of the moderna covid-19 vaccine, was considered resolved on 09 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received fist dose of mRNA-1273 (Lot number: 025J20-20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age.
241	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1049199-1	N/A
242	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1049248-1	N/A
243	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1049287-1	Patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age; A spontaneous report was received from a healthcare professional concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Jan 2021, the patient received her first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The Director of Medical Operations called in stating that it was reveled on 12 Jan 2021 that a patient in his clinic received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age. The administration was made in error.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
244	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1049871-1	Reporting a vaccine administration error: unauthorized age group. Vaccinated while not yet 18 years of age. No adverse event.
245	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1050300-1	Patient was under the age that the Emergency Use Authorization order allowed to be administered. Patient did not have any other adverse events.
246	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1056178-1	feeling cold; achy; feverish; they gave vaccine to my 16 year old daughter; A spontaneous report was received from a consumer concerning her daughter, a 16-year-old female patient that received the vaccine/product delivered to a patient of inappropriate age and experienced feeling cold, feverish/pyrexia and achy/pain.  The patient's medical history was not provided. Concomitant medications were not provided.   On 09 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unreported) in the left arm for the prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient experienced feeling cold, feverish and achy. Treatment for these events was not provided. Caregiver inquiring as to what to do about second dose.  Caregiver REFUSED permission to contact and DOES NOT want the Centers for Disease Control notified.  Action taken with mRNA-1273 was not reported.   The outcome of the event,  received the vaccine/product delivered to a patient of inappropriate age was considered resolved. The events, experienced feeling cold, feverish/pyrexia and achy/pain, was unknown.; Reporter's Comments: This report refers to a case of Product administration error √ Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with  associated  events of feeling cold, Pain ,Pyrexia .Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
247	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1056468-1	Received the COVID vaccine at age 16; Injecstion site pain; A spontaneous report was received from a physician regarding his daughter who is a 17-year-old female, unknown race and ethnicity, who was administered Moderna Covid-19 vaccine and experienced pain at injection site.  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 22-Jan-2021, prior to the onset of events, patient received her first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot#011J20A). The physician who is patient's father would like to give her the second dose. Also, he wanted to consider her for pediatric trials.  Action taken with vaccine is physician showed willingness to give his daughter a second dose.  The outcome of the events, inappropriate age at vaccination and pain at injection site is unknown at the time of report.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (Lot # 011J20A) with pain at injection site reported. Based on the current available information and temporal  association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
248	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1056520-1	Headache; 16 years old received vaccine; A spontaneous report was received from a patient concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and 16 years old received vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21-Jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23-Jan-2021, the patient experienced headache for a couple of days. Treatment for the event included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, headache and 16 years old received vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error √ Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with event of headache.Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
249	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1061912-1	accidental vaccination of a 16 year old; A spontaneous report  was received from a consumer concerning a 16 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. The route of administration was unknown. The patient got the first dose of the Moderna vaccine on 14Jan2021.  On 11 FEB 2021, the patient was turned away for their second dose because of their age.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event experiencing accidental vaccination was resolved; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
250	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1061930-1	Inappropriate age at vaccine administration; A spontaneous report was received from a Dentist (healthcare professional)  concerning a 16 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-jan-2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  No Treatment information has been provided.   Action taken with mRNA-1273 in response to the events was unknown/ not reported.   The outcome, vaccine administered to a 16-year old male, was considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administered for mRNA-1273 with no associated AEs.
251	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1061934-1	Patient of 17YO received the vaccine; A spontaneous report was received from a health care professional concerning a 17 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event patient of 17YO received the vaccine was resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot #unknown)  with no associated AEs reported.
252	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1062430-1	daughter who is under 18 received the vaccine; A spontaneous report received from a Consumer concerning, 17-year-old, female patient who received dose of Moderna COVID-19 vaccine.    The patient's medical history was not included. Patient's concomitant was not included.   On 19JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient father stated that his daughter who was under 18 received her 1st dost of the Moderna COVID-19 vaccine. Father stated when he took her back for the 2nd dose of the Moderna COVID-19 vaccine the facility denied her.   Treatment information was not included/ unknown.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 025L20A) with no associated AEs reported.
253	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1065389-1	17 year old mistakenly received the first dose of the vaccine; A spontaneous report was received from a nurse concerning a 17 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25 Jan 2021, the first dose of vaccine was administered to 17 year old female  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was recovered.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 with no associated AEs.
254	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1065391-1	Mistakenly received the first dose of the vaccine; A spontaneous report was received from a nurse concerning a 17 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On Date 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) at unknown route and anatomical location for prophylaxis of COVID-19 infection.   The patient experienced the event medication error- 17 years old individual mistakenly received the first dose of the vaccine.   Treatment details if provided or No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event 17 years old individuals mistakenly received the first dose of the vaccine unknown.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (lot/batch: unknown)  with no associated AEs.; Sender's Comments:  MOD-2021-015769:Same reporter
255	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1068589-1	17 year old received the first injection of the Moderna vaccine; A spontaneous report was received from a consumer concerning a 17-year-old, female patient who received Moderna's COVID-19 (m-RNA-1273) vaccine.  The patient medical history was not provided. No relevant concomitant medication was provided.  The patient received their first of two planned doses of mRNA-1273 (batch number not provide) on 13JAN2021 intramuscularly for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced product administered to patient of inappropriate age.  She went back to receive the 2nd dose and was sent home due to being under 18 yo.  Treatment taken was not reported. Action taken was not reported.  The outcome of event was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
256	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1068752-1	Bruised arm; Itchy; Accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old; A spontaneous report ( was received from a pharmacist concerning a 15-year-old, female patient to who accidently received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental administration of the Moderna COVID-19 vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, itchy/pruritus and bruised arm/contusion.  The patient's medical history was not provided. No concomitant product use was reported.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L29A) in the right arm intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021, a 15-year-old female patient received an accidental dose of the Moderna COVID-19 vaccine and experienced an itchy arm.   On 28 Jan 2021, the reporter noted the patient had a bruised arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, accidental administration of the Moderna COVID-19 Vaccine to a patient who is 15 years old/product administered to patient of inappropriate age, was considered resolved on 25 Jan 2021.  The outcome of the events, itchy and bruised arm, were considered unknown.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 12L29A, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
257	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1076730-1	Fatigue; Headache; Fever; Dizziness; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient (not pregnant) received the second dose bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 29Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her first dose of bnt162b2 on 08Jan2021 in the left arm. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 17:00, the patient had deadache, fever, dizziness and fatigue. No treatment was reported. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
258	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1080138-1	16-Year-Old Vaccinated; A spontaneous report (United States) was received from health care professional(nurse) concerning 16 years-old, male patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake;    The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date in Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 [Batch Number: Unknown] intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, a 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake was considered recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
259	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1080155-1	Patient under 18 years of age had vaccine administered; A spontaneous report  was received from other healthcare professional (Nurse) concerning a 17-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 043L20A), unknown route for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the Moderna vaccine was administered to patient under 18 years of age.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event Moderna vaccine was administered to patient under 18 years of age was considered recovered.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 043L20A  with no associated AEs.
260	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1080666-1	Patients under the age of 18 Inadvertently given their series of Moderna vaccine; A spontaneous report was received from a nurse concerning a 17-years-old female patient who received Moderna's (mRNA-1273) COVID-19 Vaccine.  The patient's medical history was not provided. No concomitant medications were provided.  The patient received her first of two planned doses of mRNA-1273 (Lot/batch number: 012L20A) on 15 Jan 2021. On 15 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: 010M20A) for prophylaxis of COVID-19 infection.  The patient under the age of 18 Inadvertently was given her series of Moderna vaccine (inappropriate age at vaccine administration).  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event the patient under the age of 18 Inadvertently given their series of Moderna vaccine was considered recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 012L20A for her first dose and lot number 010M20A for her second dose) with no associated AEs reported.
261	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1083767-1	Under age of 18 were inadvertently given their series of Moderna vaccine; A spontaneous report was received from a nurse concerning a 16-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) under the age of 18 (inappropriate age at vaccine administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012L20A) for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 010M20A) for prophylaxis of COVID-19 infection.  The patient under the age of 18 (16  years female) Inadvertently received both doses of Moderna vaccine (inappropriate age at vaccine administration). No adverse reactions were reported.  Treatment details if provided or No treatment information was provided.   Action taken is not applicable  The outcome of the event, patient under the age of 18 was inadvertently given their series of Moderna vaccine was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for  mRNA-1273, who received both doses (batch number: 012L20A and 010M20A) with no associated AEs.  Causality for this medication error is not applicable.
262	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1101149-1	Received Moderna Vaccine- under age requirement; A spontaneous report was received from a consumer concerning a 17-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The consumer received the first of the two planned doses of mRNA-1273 on 15 Jan 2021 (Batch# 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event was resolved.  The assessment was not provided for the event.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 039K20A) with no associated AEs reported.
263	COVID19 VACCINE	0 days	6-17 years	Jan., 2021	1107176-1	17 year old received the vaccine; A spontaneous report was received from a consumer concerning a 17, year old female patient who received mRNA-1273 for prophylaxis of COVID-19 infection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 15- Jan- 2021 for prophylaxis of COVID-19 infection.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, drug administered to patient of inappropriate age, was reported.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
264	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1011059-1	No adverse effects.  Pt was vaccinated 3 days prior to turning 18 years of age, which is the recommended age for administration.
265	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1045539-1	Hot flashes; Tired; 17-year old inadvertently given the first dose of the vaccine; A spontaneous report was received from a parent whose 17-year-old, female daughter received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in hot flashes, and tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Feb 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient's father reported his daughter was given the Moderna vaccine in error as she is only 17. The patient experienced hot flashes and was tired after receiving the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, vaccine given to a 17-year old, was considered resolved on 06 Feb 2021. The outcomes for events, hot flashes and tired, were not reported.; Reporter's Comments: This report refers to a 17-year old female patient who received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection with reported events of hot flashes and was tired. Based temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
266	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1046086-1	Vaccine administration error - patient is a 17 year old and vaccine received EUA for 18 years of age and older.
267	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1046521-1	given at less than the approved age
268	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1046539-1	dose given at less than the approved age
269	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1046917-1	MEDICATION ERROR.  PATIENT AGE 16, UNDER AGE FOR EUA.
270	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1046942-1	MEDICATION ERROR, VACCINE GIVEN TO PATIENT UNDER THE AGE OF THE EUA,
271	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1047288-1	Patient was vaccinated at age of 16 and 11 months.
272	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1047312-1	Received vaccine at the age of 16 and 11 months.
273	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1047322-1	Pt 17 yrs old. Clinic required 18+ , no other adverse reactions.
274	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1047344-1	Pt Age is 17, Clinic age requirement 18.
275	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1047431-1	Client was 17 years old at the time of administration.
276	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1047477-1	Client was 17 yrs old at time of administration.
277	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1047492-1	First shot of Moderna given accidentally on 1/23/21, without realizing patient was under 18; therefore, second shot was need on 2/20/21.  Corporate and Moderna approved patient getting second shot on 2/20/21.  Consent form was signed by gaurdian and authorized by pharmacy corporate and Moderna, since patient had already recieved first dose.  No known adverse effects.
278	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049015-1	Patient underage for vaccine.
279	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049050-1	Client present for second dose, and nurse discovered that she was only 16 years old. Client had received first does of Moderna 4 weeks prior, and therefore was due for her second Moderna- despite the fact that she was underage for that manufacturer. Moderna is currently approved for those 18 and up. Our Medical Director was contacted, and he informed us that we should continue with Moderna instead of switching to Pfizer for the second dose. While the client was underage for the Moderna vaccine- there is no research done to choose to switch manufacturers between dose one and dose two. Mom was informed of what happened, and stated she was OK with continuing with the Moderna shot.
280	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049062-1	No side effects: 17 year old given moderna vaccine
281	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049071-1	Patient is 17 yrs 2 months and the Moderna Vaccine has not gotten official approval for those under 18 at this time.   Pt did not report any physical symptoms at time of vaccination and none reported back to this writer at this time.
282	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049139-1	Dad says 5-10 minutes after vaccine patient started having symptoms.  Patient said it felt like she couldn't breathe, like her throat was closing off.  Patient walked with staff member to EMS ambulance ~50 feet away.
283	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049290-1	Gave vaccine to 17 year old; A spontaneous report was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.
284	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049300-1	16 years of age, received the first dose; A spontaneous report  was received from a Pharmacist concerning a 16-year-old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273), resulting in the event, 16 years of age, received the first dose/product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021, the patient received their first of two planned of mRNA-1273 (Lot number: 011M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection  Pharmacist called in 09-FEB-2021 to report giving first dose of mRNA-1273 to a female patient 16 years of age. The pharmacist inquired if the dose regimen should be discontinued or completed with the second dose when due. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, 16 years of age, received the first dose, was considered resolved on 09 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 011M20A with no associated AEs.
285	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049591-1	Error: Patient Too Young for Vaccine Administered
286	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049830-1	"Pfizer-Bio-Tech COVID-19 Vaccine EUA"" : Individual received the Pfizer Covid-19 vaccine. She began to feel dizzy and flushed at 1:00 pm. Her vitals were 82/46, 22, 68, 98% RA at1:00 pm. We applied ice to back of neck. B/P 72/42,20, 76 P, 98 % RA. 1:20 pm. Individual report that he had not drink any fluids and only had a few bites to eat. Patient swallowing intact. She was given bottle of water. 1:46 pm vitals were 82/54, 100% SATS, 81, 14. Individual stated she felt better and was not longer dizzy. 1:55 pm vitals 79/54. 14, 78, 98% RA. Individual went home with family with no noted distress.""
287	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049896-1	Patient did not qualify for vaccine. She is 16 and she is a lifeguard.
288	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049902-1	Patient is 17yo here for COVID 19  Pfizer Vaccine; Within 15 minutes of the shot, she developed unresponsiveness.   She has snoring, seizure disorders, OSA, hypertension, developmental delay, elective mutism. Her mother called us to the room Per mother , She was unresponsive, her lips were blue and she was pale She has had no recent seizure; compliant with Keppra She was very anxious prior to the vaccine. She was at baseline this am per mom prior to the shot.
289	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1049907-1	female here with mom mom multiple siblings for Covid vaccine.  Within 30 minutes of the Covid vaccine patient had a vomiting episode.  Pulse ox was 99.  There is no labored respirations.  She did not respond to commands but according to his sibling she does not always respond to commands.  However when I took her hand to get her to squeeze my hand and gave it back to her she purposefully put it back on a CD which she was holding to her chest.  Blood pressure was stable heart rate was approximately 130.  The home care aide was not able to tell me whether or not this was her baseline.  Her brother said that she does not does not answer questions depending on the day.  However I am not sure he is the appropriate historian.  She has a history of multiple medical issues including autism, quadriplegia, asthma, and food allergies.  As such she was kept here for a full 30 minutes.  At no time was there any color change.  No labored breathing or wheezing on exam.  There is a little bit of nystagmus and appeared to focus when questioned about how she was doing but without a verbal response.  She will be transferred to the emergency room in stable condition emergency room has been notified.
290	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1051596-1	Error: Patient Too Young for Vaccine Administered
291	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1051740-1	Patient was mistakenly given Moderna vaccine and was under the age of 18.  At the time of his monitoring pt had no adverse effect of the vaccine.
292	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1051818-1	Patient received the 1st dose of Moderna on 1/22/2021; on 2/22/2021, the patient arrived for his 2nd dose and was admisitered the Pfizer vaccine.
293	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1056179-1	Gave a 17 year old the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, a health care professional gave a 17-year-old the Moderna COVID-19 vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, gave a 17-year-old the vaccine/product administrated to patient of inappropriate age, was considered resolved on 10 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number not provided) with no associated AEs reported.
294	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1056454-1	17-year-old patient received the first dose of Moderna Covid-19 vaccine; A spontaneous report received from a pharmacist concerning, 17-year-old female patient who has received the first dose of Moderna COVID-19 vaccine    The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    On 01-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Reporter stated that a 17 year-old patient received the vaccine. No further information was provided. Treatment information was not provided/ unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.    The outcome of the event was considered resolved on 01 Feb 2021.; Reporter's Comments: This is a case of 17-year-old female patient who was administered mRNA-1273 (product administered to patient of inappropriate age) (Batch #: unknown). There was no associated adverse event reported  for the event of product administered to patient of inappropriate age.
295	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1056472-1	16 year old received 1th shot of Moderna vaccine; A spontaneous report was received from a healthcare provider concerning a 16-year-old patient of unknown gender who received the vaccine.  The patient's medical history included Sickle Cell Disease. Concomitant product use was not provided by the reporter.     On 10FEB2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    HCP reporting 16-year-old patient with Sickle Cell Disease has received 1st shot of Moderna vaccine on 10Feb2021. HCP is asking if the patient should receive 2nd Moderna shot.   The event, vaccine at inappropriate age (16 years old), was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
296	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1056493-1	Injection site pain and tenderness; 16 year old patient administered the vaccine; A spontaneous report was received from a health care provider regarding a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) inappropriately at the age of 16 and experienced injection site pain and tenderness/vaccination site pain.  The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3 and ethinylestradiol, ferrous fumarate, norethisterone.  On 12 Feb 2021, prior to the onset of the events, the patient inappropriately received the first of two doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.    On 13 Feb 2021, the day after the vaccine was given the patient experienced injection site pain and tenderness.  Treatment information was not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, vaccine being given inappropriately to a 16-year-old, was considered resolved on 12 Feb 2021.  The event, vaccine site pain and tenderness, was unknown.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 031M20A), reporting Product administered to patient of inappropriate age with associated adverse event of vaccination site pain. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
297	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1056514-1	17 year-old received the Moderna COVID-19 vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, male who received Moderna's COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12-Feb-2021, prior to the onset of the event, the patient received their first of two planned does of mRNA-1273 (Lot number: 012M20A) for prophylaxis of COVID-19 infection.  On 12-Feb-2021, the patient was administered mRNA-1273 vaccine.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, 17-year-old received the Moderna COVID-19 vaccine, was considered resolved on 12 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
298	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1062428-1	17 year old patient received Moderna vaccine; A spontaneous report was received from a nurse concerning a 17 years-old patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant product use was not provided by reporter.    On 16 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot #: 013M20A) (site of administration not specified), intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the 17 years-old patient was administered Moderna vaccine. The nurse was inquiring what to do next. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  On 16 Feb 2021, the event 17 year old patient received Moderna vaccine was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who received for mRNA-1273, lot # 013M20A (Inappropriate age at vaccine administration) . There were no reported AEs associated with this case of Inappropriate age at vaccine administration.
299	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1062853-1	Per MD's note on patient's chart on 2/26/21: Spoke with both the patient's mother and father today. Patient is 16 and received Moderna vaccine. Both state's current guidance and my correspondence with CDC indicate that she should receive 2nd dose of Moderna and not change to Pfizer. Patient does have a history of Rett Syndrome (rare neurologic genetic defect). Parents report 1 week after receiving Moderna vaccination, she experience her first seizure and was transported and treated at Hospital. Seizures can be a feature of this disorder but the patient had not experienced one in the past. Her parents report that her Neurologist does not believe the seizure to be related to vaccination. I informed parents I would search the VAERS system for similar reports. They were not enrolled in V-Safe, but I encouraged them to do so and gave them a link to the CDC site for registration. Correspondence with CDC (via email): ""If the Moderna vaccine is inadvertently administered to patients 16 or 17 years old instead of Pfizer-BioNTech as the first dose, CDC currently recommends that the Moderna vaccine may be administered as the second dose (as off-label use). The second dose should be administered as close to the recommended interval as possible, 28 days for the Moderna vaccine. Additional information regarding administration errors and deviations can be found in CDC?s current interim clinical considerations regarding mRNA COVID-19 vaccines.""
300	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1065912-1	Gave vaccine to 17 year old; A spontaneous report  was received from a nurse concerning a 17-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event, gave vaccine to a 17-year-old/inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, gave vaccine to a 17-year-old, was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 013M20A with no associated AEs.
301	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1065948-1	17-year-old patient was given the first dose; A spontaneous report was received from a pharmacist (PharmD) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patients' medical history was not provided. Concomitant product use was not provided.  On 17 FEB 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.   The reporter was made aware of a 17-year-old that was given the first dose of the vaccine at his clinic.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, 17-year-old patient was given the first dose, was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 023M20A) with no associated AEs reported.; Sender's Comments:  MOD-2021-015022:different patient, different reporter (from same institution) US-MODERNATX, INC.-MOD-2021-015022:different patient, same reporter
302	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1066235-1	17 year old received moderna vaccine; A spontaneous report was received from a pharmacist regarding a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) with inappropriate age at vaccination administration.  The patient's medical history was not included. Concomitant medications were not provided.   On 16 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 16 Feb 2021, it was noticed after the vaccine was given that the patient was not the correct age to receive the vaccine. Her age is reported as 17.  No side effects were reported and treatment was not given.  Action taken with mRNA-1273 was not reported.  The outcome of the event, receiving the vaccine at an inappropriate age, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
303	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1073476-1	16 YEAR OLD WAS ACCIDENTLY VACCINATED; A spontaneous report was received from other healthcare professional (Pharmacist) concerning a 16-years-old patient, received who Moderna's COVID-19 vaccine (mRNA-1273) accidentally.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, the patient received their dose of mRNA-1273 (Batch Number: Unknown), intramuscularly in the shoulder for prophylaxis of COVID-19 infection.  On 18 Feb 2021, 16 -years-old patient was accidentally vaccinated with the Moderna Covid-19 vaccine  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event 16 -years-old patient was accidentally vaccinated with the Moderna Covid-19 vaccine was considered recovered.; Reporter's Comments: This report refers to a case of a 16-year-old patient with Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated adverse events.   Event considered resolved.
304	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1074305-1	Vaccine was administered to a 16 year old; A spontaneous report was received from a pharmacist concerning a 16 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (PT: Product administered to patient of inappropriate age) with no associated adverse events.  The patient's medical history was not provided. No concomitant medications was reported.  On 17-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 016M20A) via unknown route for prophylaxis of COVID-19 infection.  Treatment information was not applicable.  Action taken with mRNA-1273 was not provided..  The outcome of the event, vaccine was administered to a 16 year old, was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age 16 year old for mRNA-1273 (Lot number: 016M20A) with no associated AEs reported.
305	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1074387-1	Pediatric patient received the first dose of the Moderna COVID19 vaccine; A spontaneous report, was received from a nurse, concerning a 17 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in pediatric patient received the first dose of the Moderna COVID19 vaccine (product administered to patient of inappropriate age).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), for the prophylaxis of COVID-19 infection.   The nurse who was the supervisor for outpatient monitoring reports an adverse event that a pediatric patient received the first dose of the Moderna COVID19 vaccine on 19 Feb 2021. The patient was a 17 years and 2 months old and declines to be contacted further for any further information. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, pediatric patient received the first dose of the Moderna COVID19 vaccine, was recovered on 19 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, with no associated AEs.
306	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1080143-1	16 year old vaccinated; A spontaneous reportwas received from a Pharmacist regarding 16-year-old individual, unknown race, and ethnicity, who was administered first dose of Moderna Covid-19 vaccine on 19-FEB-2021 (Inappropriate age at vaccine administration).  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 19-FEB-2021, individual received first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot : 029L20A).   It was not known whether the individual experienced any adverse event after vaccination.   Action taken with 2nd dose of vaccine was not reported.  The outcome of the event inappropriate age at vaccination was recovered.; Reporter's Comments: This report refers to a case of 'Inappropriate age at vaccine administration'  for mRNA-1273, Lot : 029L20A with no associated AEs. Causality for the medication error is not applicable.
307	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1080332-1	16 year old received moderna vaccine; A spontaneous report was received from other healthcare professional (Pharmacist) concerning a 16-years-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273), on 20Feb2021.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Feb 2021, the patient received their dose of mRNA-1273 (Batch Number Unknown), unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, 16 years old patient received moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event 16 years old patient received moderna vaccine was considered resolved.; Reporter's Comments: This is a case of 16-year-old patient who was administered mRNA-1273 (Inappropriate age at vaccine administration) (Batch #: unknown). There was no associated adverse event reported for the event of Inappropriate age at vaccine administration.
308	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1080450-1	Patient got the first dose at the age of 16; A spontaneous report was received from a pharmacist concerning a 16-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got the first dose at the age of 16.   The patient's medical history was not provided. Concomitant product use was not provided by the pharmacist.  On 06 Feb 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) for prophylaxis of COVID-19 infection.   On 06 Feb 2021, the patient got the first dose at the age of 16 (Inappropriate age at vaccine administration). The patient was fine and no symptoms at all. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event patient got the first dose at the age of 16 was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration  for mRNA-1273, lot # 010M20Awith no associated AEs.
309	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1093320-1	17 year old recevied vaccine; A spontaneous report as received from a pharmacist concerning a 17-year-old, male patient, who received Moderna COVID-19 vaccine and considered as product administered to patient of inappropriate age .   The patient's had no known past medical history of drug addiction or an adverse reactions to vaccines. Concomitant medications were not provided.   On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:010M20A) through intramuscular route in the right deltoid for prophylaxis of COVID-19 infection.   No treatment information was provided.   Lab details were not provided.  Action taken with mRNA-1273 in response to the event was not applicable  The outcome of inappropriate age at vaccination administration was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
310	COVID19 VACCINE	0 days	6-17 years	Feb., 2021	1100219-1	17 year old patient received the vaccine; A spontaneous report was received from a healthcare professional concerning a 17 year old patient of unknown gender who was administered the mRNA-1273 vaccine at an inappropriate age.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 22-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    The patient was 17 years old and not the appropriate age of 18 to receive the vaccine.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, product administered to patient of inappropriate age, was considered recovered.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
311	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1076823-1	The patient has had no problems with the vaccine. We were finishing vials of both Janssen and Pfizer at the same time at the end of the evening. He received a dose of Janssen when he should have received Pfizer since he will not be 18 years old for 4 months.
312	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1081618-1	No adverse events reported, was instructed to complete VAERS form due to age 16 at time of vaccination.
313	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1085612-1	16 year old patient was inadvertently given Janssen Covid 19 vaccine by PA. This was discovered by Regional Director, who has not been able to reach the patient or guardian, but is awaiting a call back.
314	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1086165-1	The patient is 16, and should have received the Pfizer shot, which is approved for 16 and up.  The patient received a Janssen vaccine, which is only approved for 18 and up.
315	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1088042-1	Patient is 17 years of age
316	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1089766-1	Janssen covid vaccination given to individual younger than approved age. Unknown is any ADE's manifested.
317	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1091995-1	Administered to 17 years old person whereas the recommended age group was >18- administrative error
318	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1094660-1	Patient is 17 years old and 9 months, vaccine is currently approved for 18 and over. No adverse events were experienced. We spoke with both the doctor and patient's parents
319	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1094746-1	Pt. 17 years old, no adverse events,
320	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1095954-1	Pt received vaccine that is recommended for 18 years and older and is only 16 years at time of injection
321	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1095961-1	Pt given vaccine at 17 years old and vaccine recommended for 18 years and older.
322	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1096061-1	Patient is under 18 years old. No adverse events during covid clinic.
323	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1096457-1	no adverse event. Patient is under the age that is approved for the vaccine. He is 15.
324	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1097033-1	Vaccine given to a patient outside of age range. Patient was 14 years old
325	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1097034-1	Vaccine was administered to patient under the age indicated of 18 years and up. Patient was 17 years old and reports no symptoms at this time or any adverse side effects.
326	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1097500-1	Administered out of approved age range. Vaccine approved for 18 years and older. Patient was 17 years old at the time of vaccination.
327	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1097675-1	This was a clinic for Covid-19.  Janssen vaccine was used. Patient is 17 years old. RpH reviewed the information gave the vaccine to him. The vaccine is for 18 and over.  I spoke to mom who check and patient has no side effects thus far is doing fine. Employee at our store translated for mom. The information was given to this store for processing only.
328	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1097704-1	Patient under the age of 18 at time of administration
329	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1097758-1	16 y/o was given a Janssen COVID19  vaccine shot, the product was only studied/approved for 18+ y/o
330	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1098078-1	This patient was given the vaccine at an off-site clinic event and received the Janssen vaccine which in indicated for patients 18yr and older however patient is 17 years old. Advised father and patient of incident, no reported side effects or adverse events as of time of communication with patient.
331	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1098825-1	No adverse event occurred. Vaccine was given to 17 year old, approved for 18 and older.
332	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1099291-1	Patient is out of the FDA range for receiving the vaccine. No side effects have been reported
333	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1101570-1	Janssen covi-19 vaccine was administered for under age patient
334	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1102745-1	17 year old was given the vaccine despite 18 years and older being the approved age. Patient's aunt on 3/15/21 reports that patient did not have any side effects from the vaccine. Voice message was left for patient's doctor.
335	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1104046-1	client was given Janssen vaccine by mistake. He is only 16 years old
336	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1104144-1	None  Patient was underage when recieved the vaccine. Janssen J&J only approved for adults 18 years and older. Mother notified and informed to reached out to her primary health care doctor. Mother was also encouraged to sign up for the v-safe mobile sheet.
337	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1105090-1	One of the vaccinators (a Medical Student) at an off-site mass vaccination event, administered the J & J Janssen COVID-19 vaccine to a teenager under the age of 18 years. The teen remained on site for 30 minutes after receiving the vaccine and experienced no ill effects.  An incident report was completed and signed by the medical student preceptor and the parent of the teen.  This report is being generated due to the vaccine being given off-label of manufacturers recommendations.
338	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1105615-1	No treatment needed, given outside FDA approved range
339	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1106548-1	Vaccination of a minor (17 yrs) - Protocol violation and internal investigation ongoing.
340	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1108135-1	Patient was seen in vaccine clinic, received Janssen vaccine at the age of 16, minimum age for dose per Manufacturer is 18 years of age, no adverse event has happened.
341	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1108932-1	pt under the age of 18 received COVID 19 vaccine
342	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1109911-1	On 3-15-2021, Pharmacist administered Janssen COIVD-19 vaccine to patient (16 yrs) who is under the approved age of 18. No symptoms or ADE for patient and gaurdian signed off
343	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1110334-1	8 yo female arrived to COVID vaccine clinic with her mother.  The mother filled out a consent form for her daughter to be vaccinated and was told by a National Guard member that her daughter could not be vaccinated.  Mother continued through process for her own vaccine and after receiving her COVID 19 vaccine, she presented her child's form to the National Guard member/vaccinator and had her child sit in the chair for vaccination.  The National Guard member/vaccinator did not verify the age of the child  and proceeded to vaccinate her.
344	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1110375-1	The patient was signed up for the Pfizer vaccine which we ran out of doses. The patient said they were fine with Janssen and it was switched at the out window to that vaccine. The patient was 2 months shy of his 18th birthday which Janssen is not indicated for. The patient had no adverse reactions to this point but we wanted it documented.
345	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1115268-1	seizure like symptoms; Dizziness; lethargy; fatigue; This is a spontaneous report from a contactable pharmacist.  A 16-year-old male patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was EN6205. Medical history and concomitant medications were unknown. On 02Mar2021 at 12:00, the patient experienced Dizziness, seizure like symptoms, lethargy, fatigue. It was unknown if the patient was treated due to the events. The patient recovered from the events in Mar2021. It was unknown if the patient had COVID prior vaccination; it was unknown if the patient was tested for COVID post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizure cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
346	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1115897-1	Pt under age at the time of vaccination
347	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1115968-1	17 year old patient given single dose Janssen COVID-19 vaccination. Underage, but incarcerated as an adult.
348	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1116375-1	Vaccine given to inappropriate age recipient.
349	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1116376-1	Vaccine given to incorrect age recipient
350	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1116404-1	Vaccine given to age inappropriate recipient.
351	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1116840-1	Clinic nurse administered the Janssen vaccine to a 17 year old female in an offsite clinic. Administration error was not caught until the client left the building after waiting 15 minutes post vaccination. No complications/reactions noted at the time.
352	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1117604-1	none
353	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1117613-1	none.
354	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1120367-1	unknown
355	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1122598-1	Client was inadvertently vaccinated before 18 years of age. Mother was present and brought son to mass vaccination event.
356	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1123250-1	This is a 17 year old male that received the Janssen vaccine, which is approved for 18 years and older.  VAERS being completed to document an administration error (wrong age).  In this case, a Home Health nurse was administering the Janssen vaccine to a homebound patient per our program to vaccinate those high-risk seniors that are home-bound, as well as their in-home caregivers.  During a visit to vaccinate the homebound senior, this 17 year old was also vaccinated without detected the wrong-age error.  Following administration, the vaccine information was being input into ALERT and the age error was detected and reported.  No adverse effects noted for the patient.
357	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1123282-1	Administration error: Pt. was younger than the age authorized for Janssen vaccine. Pt. had no adverse reaction to the vaccine.
358	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1123819-1	Patient received the vaccine outside of the recommended age group of 18 years or age or older.
359	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1127380-1	Administered under minimum age
360	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1127412-1	Patient received a vaccine not indicated for 16 years of age. Patient felt a little tired on 3/22 and then this morning she was ok, per mom.
361	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1129749-1	Patient received vaccine at a clinic sponsored by clinic. Patient is under 18 years of age and was not eligible for vaccine.
362	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1130563-1	Janssen vaccine given to a 16 year old.
363	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1131480-1	Patient reported fever.  Also this shot was given to a patient outside of the approved use.  Patient was only 16 years old, this vaccine was approved use for 18+.
364	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1131496-1	Vaccine was not approved in this age group, not 18+
365	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1131532-1	Pt isn't eligible on date of administration
366	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1133980-1	no adverse reactions but patient was outside the age range
367	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1136052-1	Person receiving vaccine was 16 at time of vaccination.  Vaccine is currently only approved for use in ages over 18.
368	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1137365-1	Patient presented himself as 18 and confirmed to staff that he was 18.  Staff realized pt. 17 after vaccine completed during documentation.
369	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1138113-1	Janssen product was administered to 16 year and 11 month old female.
370	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1138377-1	PATIENT REPORTED:  IMMEDIATELY AFTER VACCINATION SHE FELT WOOZY.  AROUND MIDNIGHT PATIENT REPORTS FEVER AND CHILLS THAT LASTED UNTIL 1-2AM (3/16/21).  PATIENT ALSO REPORTS HEADACHES FOR THE NEXT 2 DAYS.
371	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1138609-1	Administration error - patient was 17 at the time of receiving this vaccine.
372	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1138637-1	VACCINE IS  INDICATED FOR AGES 18 AND OLDER AND P T IS 17
373	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1138647-1	PT AGE IS 15 YEARS OLD  AND  VACCINE IS RECOMMENDED FOR PTS OLDER THAN 18
374	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1142350-1	blisters on the tongue, followed by itching, and anaphylactic shock from 11:30pm to 12:30am. benadryl and 2 epi pens were used and then at the hospital steroids and IV benadryl were utilized. Benadryl was used for the next 24 hours and then steroids were prescribed outpatient
375	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1144282-1	Patient is 17 years old. EUA is for 18 and older.
376	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1144319-1	Patient wrote on his consent form that he was 18 years of age, when he was technically 17y and 8m. Therefore, vaccine was administered off label. He has not contacted us to report adverse events. We have attempted to contact him but he has not returned our calls at the time of this report.
377	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1145089-1	Vaccine given to patient under 18 years of age
378	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1146159-1	Underage person received vaccine - no adverse event
379	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1147275-1	Participant is 17years of age and should not have been administered the Moderna vaccine according to the manufactuer's guidelines.  The participant sat in post op for 15 minutes with no adverse reaction. Mother was present the entire time.
380	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1148509-1	Scheduling error occurred and patient was given vaccine outside of recommended age group. No adverse reactions observed on 3/30/21 at clinic, patient's parents notified and will continue to monitor.
381	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1148936-1	JANSSEN COVID-19 VACCINE GIVEN TO 17 YEAR OLD MALE
382	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1149156-1	nausea, headache, shakes, high fever 103+, 104+ for Thursday - Saturday,   Health Department dispatched the nurse to inject the vaccine at the facility.  My daughter?s COVID-19 vaccine card clearly states her birthday / age.  Why did the nurse administer the unapproved COVID-19 vaccine, Janssen, to a minor?  According to CDC, only Phfizer vaccine is approved to be administered to someone of age of 17?
383	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1152092-1	No adverse side effects/outcomes, the patient was administered the vaccine off label at age 16
384	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1152106-1	No adverse side effects/outcomes, the patient was administered the vaccine off label at age 17
385	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1152115-1	No adverse side effects/outcomes, the patient was administered the vaccine off label at age 17
386	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1152135-1	No adverse side effects/outcomes, the patient was administered the vaccine off label at age 17
387	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1152151-1	No adverse side effects/outcomes, the patient was administered the vaccine off label at age 16
388	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1152339-1	unauthorized age group
389	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1152815-1	Patient was asked screening questions and asked birthdate.  Patient stated that he was 18 years of age.  His birthdate indicates that he is only 17 and this was caught after the vaccination was already given.
390	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1153335-1	PATIENT WAS FOUND TO BE 17 YEARS OF AGE POST VACCINATION.  VACCINE IS INDICATED FOR 18 YRS AND OLDER.
391	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1154400-1	Realized she was only 17 at time of shot,  have to be 18 with EUA.
392	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1155230-1	Pt was age 17 at vaccination. Vaccine is not currently approved for use in persons under the age of 18.
393	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1155527-1	They made initial contact with young lady when she entered the holding area (as they do with every car).   Their second contact came when the mother showed up on scene.   At that time the patient reported that at one point her vision began to get dark on the peripherals and she may have passed out.  She stated she turned on her hazard lights (four-way flashers) at that point.  Our personnel never noticed a vehicle not progressing forward at any point.   Our personnel then removed her from the line for evaluation: She no longer had any complaints, vitals: BP 106/57  P-64 and regular  SPO2-99% and did not want transport to the hospital.   The patient and mother were given instruction of things to watch for and what warranted calling 911.   They report the mother and patient had no concerns upon their departure.    Further, there were 4-6 personnel in the 15-minute holding area yesterday.  They are constantly on foot moving between all the cars.
394	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1156777-1	Healthcare staff attended vaccine administration provided by Public Health Nursing Nurse Manager from  facility was sent JANSSEN EUA prior to the day of vaccine administration and asked by PHN review and  give EUA to eligible staff and residents for review prior to administration date. Staff to receive the vaccine was selected by their facilities Nurse Manager. Staff presented with completed consent form and received JANSSEN vaccine despite being 17 years old
395	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1156853-1	Patient is 17 years of age and vaccine inadvertently administered. The error was noted on entry of the vaccination later at the clinic. Follow up on 4/1/21 with the father reports that although did not feel well in the AM of 3/31/21, is not having any complaints at this time.
396	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1156982-1	Client given Johnson & Johnson despite age-related ineligibility
397	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1157768-1	During a vaccine clinic, a 16 year old patient was inadvertently given the Janssen Covid-19 vaccine which is approved for 18 years and older.  The patient was observed for the required 15 minutes post vaccination; no adverse events observed.
398	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1157872-1	During a vaccine clinic, a 17 year old patient was inadvertently given the Janssen Covid-19 vaccine which is approved for 18 years and older.  The patient was observed for the required 15 minutes post vaccination; no adverse events observed.
399	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1159660-1	Janssen Vaccine not indicated for age of patient
400	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1160714-1	Patient was 17 years old at time of vaccination the approved age for Johnson & Johnson is 18. No events occurred.
401	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1168275-1	Client was only 17 years old when she received single dose Janssen. Client and parent notified. No adverse sided affects noted per parent.
402	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1168436-1	Client received vaccine approved for ages 18 and up. Client was 17 at the time of the injection.
403	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1169773-1	Under the age of 18
404	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1171459-1	Reporting to VAERS due to patient under 18 years of age.  Patient had fever the night of administration, felt weak (""similar to flu-like symptoms"") the next day and all symptoms resolved within 24 hours.""
405	COVID19 VACCINE	0 days	6-17 years	Mar., 2021	1173014-1	No adverse event reported. Patient was under 18 when administered.
406	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1155443-1	Vaccine administered to a 17 year old. Only approved for an 18 year old.
407	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1155505-1	Administered outside EUA approved age limit
408	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1156213-1	Patient was 17 years old at time of vaccination
409	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1158034-1	Patient was below the recommended age of 18years for this vaccination by 4 months.
410	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1158983-1	PT CAME TO VACCINATION CLINIC WITH HIS FATHER WHO SIGNED PREVACCINATION CHECK SHEET.  THE CLINIC WAS HELD AT WHERE THE PATIENT WORKS.  PATIENT IS 16 AND RECEIVED JOHNSON AND JOHNSON VACCINE IN ERROR DUE TO THE FACT HE IS NOT 18.  WE HAVE CHECKED IN WITH PATIENT AND HIS FATHER 4/1/2021 BOTH HAD BODY ACHES, HEADACHE AND CHILLS. I CHECKED IN WITH BOTH THIS AM 4/2/2021 NEITHER ONE HAS ANY SYMPTOMS TODAY.
411	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1160283-1	Patient was not the required age of 18 years old at time of vaccination
412	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1160846-1	Give vaccine at too young of age during a vaccine fair
413	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1160870-1	Given vaccine at vaccine event an under 18.  No side effecgts
414	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1160933-1	Given vaccine under age 18
415	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1164174-1	Patient is a 16-year-old, male with no known medical history. At 2:48 pm, the patient received a dose of the Janssen vaccine, (lot number 1808980, expires on 06/20/2021) on left deltoid, given by RN. RN confirmed the name and date of birth of patient, but reportedly forgot to check the patient's age. Patient left to EMT waiting area while his mother stayed with RN to edit her vaccination card. At 2:49 pm, the patient's mother reportedly stated ""I'm so glad he just turned 16 so he can get the vaccine!"" RN l immediately notified RN of situation. RN asked the patient how he was feeling at 2:51, to which his response was ""fine"". Patient presented via hand off from RN to EMT at 2:55 pm. Nurse report stated that patient was 16 years old and given the Janssen vaccine. At 3:00 pm, EMT, began to monitor the patient's vitals, which are as follows: HR 75 BPM, 118 systolic BP, 3 second capillary refill. Patient presented GCS 15, no symptoms of allergic reaction. Skin was pink and dry. Patient was sitting upright and breathing adequately with no difficulty. Patient reports feeling ""fine"" at 3:00 pm. At 3:05 pm the patient's vitals were: 128 systolic BP. At 3:10 pm the patient's BP was 128/100. At 3:15 pm the patient's  systolic BP was 122. At 3:20 pm the patient's systolic BP was 124. At 3:25 pm the patient's BP was 122/82 with a HR of 58 BPM. Throughout the 30 minute observation period, the patient and his mother were provided with education on the contraindication of Janssen vaccine and children under the age of 16. The patient's mother verbalized understanding of teaching and stated she would follow up with patient's PCP. The patient and his mother left the facility at 3:33 pm. The patient's gait was steady and balanced. The patient was driven home by his mother shortly after leaving the facility.""
416	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1164209-1	No adverse event. Pt was 17 at time of event, 8 days away from 18th birthday.
417	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1165217-1	unauthorized age group-turning 18 years old next month
418	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1167381-1	Underage person received vaccine - no adverse event
419	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1169449-1	Vaccine was given outside of recommended age group (patient was 17 years old at time of vaccination). Patient had symptoms in line with clinical trials (body aches, fatigue, flu) for 1.5 days after which they were feeling
420	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1171216-1	none. The patient attested that she was 18 years of age.
421	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1171443-1	Patient administered vaccine, not the appropriate age. Patient 17 years old at time of vaccination.
422	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1171819-1	none - gave to 17.5 yo
423	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1172372-1	Patient is 17 years old. He will turn 18 on April 28, 2021.
424	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1172492-1	patient is 16 years old. Johnson and Johnson COVID vaccine  approved for people over 18 years of age
425	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1172538-1	Patient was inadvertently vaccinated at age 17. No adverse effects during monitoring.
426	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1172642-1	Minor client received the Janssen vaccine.
427	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1172673-1	Minor client received the Janssen vaccine.
428	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1173122-1	Patient was inadvertently given the Janssen covid vaccine at age 17.
429	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1173818-1	No symptoms but patient not yet 18 for Janssen vaccine.
430	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1173926-1	no event, minor
431	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1173940-1	no event, minor in age
432	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1173947-1	no event. minor in age
433	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1173953-1	no event, minor in age
434	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1175969-1	Given COVID19 vaccine out of approved age range; patient is only 16 and approved age is 18 and above.
435	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1175997-1	Given COVID19 vaccine out of age range; patient is 17, and vaccine approved for 18 and above.
436	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1176082-1	Fever 103.4 Body aches Shivering Flu-like symptoms
437	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1176885-1	Father and Son came in together about 45 min earlier than their appointment.  They were in a rush  when checking in for the appointment.   They came to the check-in table and we went over the consent form and made sure we saw that the patients date of birth was in the year of 2003.  However, after the vaccination was given at the point of data entry we realized that the patient is not actually 18 years old till a month later.  We called and were sent directly to voicemail and we left a message to call us back.  And no call back has been received.
438	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1177142-1	No adverse reaction, reporting that child got vaccine when not of the approved age of 18.  Patient only 17 at the time of vaccination
439	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1177511-1	Patient was underage - 5 days away from 18th birthday.  Shot was administered by nursing students.
440	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1177523-1	No adverse event.  This individual is a minor. They had created an appointment for the Janssen COVID vaccination, arrived with legal guardian, and received the vaccination.
441	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1177545-1	No adverse event.  This individual is a minor. They had created an appointment for the Janssen COVID vaccination, arrived with legal guardian, and received the vaccination.
442	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1177560-1	No adverse event.  This individual is a minor. They had created an appointment for the Janssen COVID vaccination, arrived with legal guardian, and received the vaccination.
443	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1177576-1	No adverse event.  This individual is a minor. They had created an appointment for the Janssen COVID vaccination, arrived with legal guardian, and received the vaccination.
444	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1177690-1	Patient was only 17, 5 days away from 18th birthday.  Vaccination was administered by student.  Patient had no side effects after 15 minutes.  sister also had vaccine at same time.  VAERS created for her as well.
445	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1178651-1	PATIENT WAS UNDER AGE TO RECEIVE THE VACCINE, RN ADMITS THEY MADE A MATH ERROR CALCULATING THE AGE OF THE PATIENT. PT DID NOT HAVE ANY SIGNS OR SYMPTOMS OF ALLERGIC REACTION.
446	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1178677-1	Pt vaccinated was under the age of 18 and received the Janssen vaccine which is not approved for those under 18
447	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1179619-1	Vaccine accidentally given to 16 year old.
448	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1180113-1	PHARMACIST WHO PERFORMS CLINIC IN STORE, ADMINISTER JANSSEN SHOT TO 16 YEARS OLD.  NO ADVERSE REACTION HAS BEEN REPORTED YET
449	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1180123-1	PHARMACIST WHO PERFORMS CLINIC IN STORE, ADMINISTER JANSSEN SHOT TO 16 YEARS OLD.  NO ADVERSE REACTION HAS BEEN REPORTED YET.
450	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1180133-1	PHARMACIST WHO PERFORMS CLINIC IN , ADMINISTER JANSSEN SHOT TO 16 YEARS OLD.  NO ADVERSE REACTION HAS BEEN REPORTED YET.
451	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1180543-1	Patient was 17 at the time of vaccination
452	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1180568-1	Patient underage for vaccine
453	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1180613-1	Patient was administered a dose of Janssen vaccine at the age of 16yo- only indicated in adults 18yo and older
454	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1181561-1	Patient was given the vaccine and his age is 17. We were under the impression 16 and older can get the vaccine. We followed the advice of the medical director to administer the vaccine. Patient had no side effects or adverse reactions reported at this time.
455	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1181940-1	No apparent injury of adverse effect.  Vaccine was inadvertently administered to patient below approved age for EUA.
456	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1182591-1	Patient was immunized at 17 years old and 8 months.
457	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1183338-1	Patient said he was of age to receive the vaccine but after clinic was over, it was verified that he was actually 17 and under the approved age to receive the Janssen covid vaccine. no side effects were reported from the vaccine.
458	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1183412-1	17 year 10 month old male given IM injection of Johnson & Johnson vaccine in right deltoid at 1 pm on 04/8/2021. Pt was observed for 30 minutes after receiving vaccine without  reaction observed . Mother was notified that child was younger than 18 years old. Mother verbalized that she thought he would be fine.  Mother was provided with Janssen fact sheet.
459	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1183612-1	Patient was injected with the Janssen COVID-19 Vaccine EUA however it is outside of the age guidelines. Patient is 16 years old
460	COVID19 VACCINE	0 days	6-17 years	Apr., 2021	1184593-1	Was a 17 year old who was given Janssen COVID vaccination by Dr. approximately 2:20 pm on 4/8/2021. No adverse effects noted. Client was advised Janssen is not approved for people under 18 years of age. Host parents were contacted by phone and notified that client received vaccination.
461	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0929277-1	lump in arm pit of injection arm
462	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0930353-1	Patient in clinic for chief complaint of possible side effect of the covid vaccine which she received yesterday.  She states that she woke up at 0200 with chest tightness, achyness and headache.  She rates the discomfort 7/10 last night and improved now to 5/10.  She denies any worsening with any type of exertion and states that she can do simple things like take a shower, walk across the room, down the street or even stairs without any worsening.  She denies any SOB or chest pain--just feels tight.  Doesn't feel like she can't get a full breath or get the air out of her lungs either.  She received her first of two doses of the Pfizer vaccine yesterday (4:23pm) and had no difficulty with the injection itself and then 9.5 hours later woke up from sleep with this chest tightness as well as achyness and headache.   ßShe states that she had the exact same symptoms when she had positive covid test back in August of this year with the addition of fatigue which lasted for 5 days.  At that time it was not felt necessary to do any further testing nor treat with steroids according to cardiology.  She does have history of LV non-compaction cardiomyopathy and her last visit with cardiology was about 2 years ago and she had a normal EKG and echo only showed ""mild LV non compaction at the apex"" at that time. He did not need to see her again until she is 18 unless she has problems.  She states that she generally does very well and other than this tightness she does not have any other significant symptoms.""
463	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0942502-1	Patient described rapid onset sweating and flushing. Said he felt light headed as well. Gave Benadryl 25 mg with continued observation for 30 minutes and he said he felt mostly better, but still tired and weak. Followed up next day and his mother said he was doing better.
464	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0945646-1	Vaccination occurred on 1/12 at 13:00. A few hours after the vaccination, I experienced muscle pain in the vaccinated arm.  1/13: I had trouble sleeping; left arm was in immense pain.  07:00: experiencing arm soreness, muscle pain, nausea, hot flashes; temperature = 99.5 08:20: experiencing arm soreness, muscle pain, hot flashes, chills, sensitivity to light; temperature = 100.6. Took 650mg acetaminophen. 09:00: experiencing arm soreness, muscle pain, sensitivity to light; temperature = 100.8 10:30: experiencing arm soreness, muscle pain; temperature = 99.2 11:15: experiencing arm soreness, muscle pain; temperature = 99.0 12:20: experiencing arm soreness, muscle pain; temperature = 98.0 Extremely fatigued; took nap (13:00-17:00) 17:00: experiencing arm soreness, muscle pain, headache; temperature = 99.3 18:00: experiencing arm soreness, muscle pain, headache; temperature = 99.2. Took 650mg acetaminophen. 19:00: experiencing arm soreness, muscle pain, headache; temperature = 100.8 20:00: experiencing arm soreness, muscle pain; temperature = 98.3 21:00: experiencing arm soreness, muscle pain; temperature = 100.6 21:30: experiencing arm soreness, muscle pain; temperature = 99.2 22:20: experiencing arm soreness, muscle pain; temperature = 100.1. Took 400mg Ibuprofen.  1/14: 07:00: woke up experiencing pain at the injection site, neck pain, headache. These events continued throughout the day. No temperature over 99.5. 18:30: Took 650mg acetaminophen for headache.
465	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0946517-1	(MODERNA COVID 19 VACCINE EUA)   Unknown, tried contacting patient back multiple times but was unsuccessful
466	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0957908-1	pt is a health care provider and desired the vaccine due to her job . 17 years old. When she was called she was told she needed to rtc for second dose after her 18 year birthday. She reported a fever fo 101, sore arm and body aches. Discussed comfort measures today.
467	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0970410-1	Nausea causing vomiting 15 hours after injection
468	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	0974439-1	DEVELOPED BODY ACHES, FEVER, HEADACHE, AND CHILLS
469	COVID19 VACCINE	1 day	6-17 years	Jan., 2021	1100277-1	Chills; body aches; This is a spontaneous report from a contactable consumer (patient parent). A 17-year-old (17-year-old age at vaccination) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 27Jan2021 01:00 PM at single dose in left arm for COVID-19 immunization at  clinic. Medical history was none. The patient was not pregnant at time of vaccination. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No Allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously took (at age 17-year-old) first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E1014D) on 06Jan2021 in left arm for COVID-19 immunization. The patient experienced chills, body aches on 28Jan2021 01:15 AM. No treatment received for the adverse events. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The outcome of events was recovering.  Information on the lot/batch number for 2nd dose has been requested.
470	COVID19 VACCINE	1 day	6-17 years	Feb., 2021	1040554-1	Went to sit down and passed out; felt dizzy; nausious/nausia; sweaty; sick feeling; as she was ghost white; bad headache.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) via intramuscular on left arm on 02Feb2021 03:45 PM, at age of 16 years old at single dose for Covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as allergies to medications, food, or other products was reported as none known. Prior to vaccination, patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included multivitamin and melatonin gummies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via intramuscular at left arm on 12Jan2021 03:45 PM for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported morning after vaccine 03Feb2021 08:00 patient was felt dizzy and nausious. Told her mom and her mom ran over as she was ghost white. Went to sit down and passed out. Patient experienced sweaty, nausia, sick feeling and bad headache. Patient went to the emergency room (ER), they gave fluids and blood work. No heart issues noted. Felt better around 3 hours after. Headache was bad and continued on 05Feb2021 (reported today). Also, still feel nausious and had to lay down. All events occurred on 03Feb2021 08:00 AM. Patient was recovering. It was reported the adverse event result in emergency room/department or urgent care. The seriousness criteria were reported as not serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was received treatment for the adverse event included fluids and heart monitoring. The patient underwent lab tests and procedures which included blood work in Feb2021. Since the vaccination, patient had not been tested for COVID-19. Outcome of events bad headache and nauseous was not recovered, for felt dizzy, as she was ghost white, passed out, sweaty, sick feeling was recovering.; Sender's Comments: Based on the information provided and plausible temporal association, a contributory of the suspect drug to the reported events cannot be completely excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
471	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1088976-1	3/10/21 am - developed low grade fever, dizzy, neck, shoulder, arm area soreness, fatigue
472	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1095402-1	Discovered that patient was 17 years and 9 months of age later in the day after vaccine was administered. No adverse reaction reported from patient, however when I reached out to mother on 3/12/21 (the next day) to discuss age guidelines the mother reported that patient did have a fever of 104F and a headache. The mother states she is/will give OTC fever reducers and monitor her for further adverse reaction.
473	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1096709-1	Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received  10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)
474	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1098741-1	Patient was under 18 when she received vaccine, she is not having any adverse events to the injection.
475	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1131437-1	Patient is 16 years of age and should have not received the vaccine.
476	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1131489-1	Shot was not approved for this age, only approved for 18+.
477	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1131491-1	Vaccine was not approved in this age group.  Only approved for 18+.
478	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1142788-1	There was not an unusual reaction other than temp around 101 and body ache. However, she was not 18 at the time of administration. Due to temp Patient consulted MD for note for a excuse from work leave
479	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1162680-1	Vaccine SHOULD NOT have been administered.  When I took patient I did not know that the Janssen HAS NOT been approved for under 18 year olds.   Nausea, tiredness, weakness, sweating, headache, shakes
480	COVID19 VACCINE	1 day	6-17 years	Mar., 2021	1169898-1	Mother of patient describes chills, fatigue, and kidney pain. Is being exclusively managed by PCP who has seen him multiple times.  Given Jannsen at mass vaccination clinic by student nurse under preceptor supervision. Error not brought to attention of until 4/2/2021.
481	COVID19 VACCINE	1 day	6-17 years	Apr., 2021	1169311-1	Fever, Chills, deltoid pain mild developed abruptly 20 hours after injection.
482	COVID19 VACCINE	1 day	6-17 years	Apr., 2021	1175429-1	I was notified by IRIS that the individual was 17 years of age and not the 18 years of age per vaccine guidelines. She did come in with a company. I did talk with client and notified her and parent. Client said she has a little fever and that is all today. Feelling well she reports.
483	COVID19 VACCINE	1 day	6-17 years	Apr., 2021	1181514-1	On 4/6/2021, Vaccination administered in error to an individual under the age of 18 (age 17 years and 5 months at time of administration).  Upon identification of error, both patient and parent notified.  Patient experienced injection site pain within 12 hours of administration.  At 24hrs post-administration she experienced headache, fatigue, decreased appetite and mild nausea, and body aches.  At 30 hours post vaccination her symptoms were improved.  Symptoms resolved at 48hrs post-vaccination.
484	COVID19 VACCINE	1 day	6-17 years	Apr., 2021	1184528-1	Patient was not 18 at the time of vaccination.  This vaccine is only eligible for 18+.
485	COVID19 VACCINE	2 days	6-17 years	Dec., 2020	0907181-1	Extreme arm pain alternating with numbness and tingling, joint pain in shoulder, elbow, and wrist, chills, low grade fever (100.5), fatigue
486	COVID19 VACCINE	2 days	6-17 years	Jan., 2021	0950793-1	Red round bump under his left armpit that is painful to the touch  Currently using Ibuprofen and ice packs to help
487	COVID19 VACCINE	2 days	6-17 years	Jan., 2021	1055003-1	1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day.
488	COVID19 VACCINE	2 days	6-17 years	Jan., 2021	1114461-1	Anaphylactoid reaction; PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS  This is a report from an interventional study source for sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject was in the open-label phase of the study when the event occurred. A 17-year-old female subject with a past medical history significant for multiple allergies with anaphylaxis received first dose of blinded therapy (BNT162;PLACEBO) on 20Nov2020 at 17:04 and second dose on 15Dec2020 at 15:16. Per protocol, the participant was unblinded and confirmed to have received placebo and subsequently received third dose of study vaccine (BNT162B2) on 25Jan2021 at 16:50, all via intramuscular route in left deltoid as single doses for COVID-19 immunization. Ongoing medical history included penicillin allergy from 2010, peanut allergy from 2004, legume allergy from 2012, chickpea allergy from 2012, chocolate allergy from 2012, flaxseed allergy from 2016, all with anaphylaxis; pollen allergy from 2007, and asthma and eczema both from 2003. Additional medical history included: tree nuts allergy from 2004 (anaphylaxis). Ongoing concomitant medications included salbutamol sulfate (PROAIR) from 2010 for asthma, epinephrine (AUVI Q) from 2005 for penicillin allergy, peanut allergy, tree nuts allergy, legume allergy, chickpea allergy, flaxseed allergy and chocolate allergy, cetirizine hydrochloride (ZYRTEC) from 2007 for pollen allergy, loratadine (CLARITIN) from 2007 for pollen allergy, and triamcinolone acetonide from 2007 for eczema. There were no concomitant vaccines administered on same date of study vaccine and no prior vaccinations (within 4 weeks prior to the first administration date of study drug).  The subject experienced hives left arm on 27Jan2021 at 10:30, shortness of breath 27Jan2021 at 11:00 and a diagnosis of anaphylactoid reaction on 27Jan2021 at 10:30, which were considered as life threatening (the event was considered life-threatening as subject with known anaphylaxis with tree nuts and subject reported similar symptoms). Clinical course was reported as follows: On 27Jan2021 at 10:30 (2 days after receiving BNT162B2 injection on her left arm) the subject started developing hives on her left arm and used her epinephrine pen at 10:54 and shortly after developed shortness of breath at 11:00. The subject did not touch or consume anything new prior to developing the hives on her left arm and the shortness of breath. The subject was not seen by a school nurse and self-administered her epi-pen. The hives resolved at 11:04 and the shortness of breath resolved at 11:24. The subject denied any other symptoms and did not seek further medical attention. There were no relevant tests done. The action taken in response to the events for study vaccine (BNT162B2) was permanently withdrawn (reported as not applicable as per investigator). The subject was not dosed vaccination 4 on 17Feb2021 (Visit 102). Outcome of the events was recovered on 27Jan2021.   The investigator reported that there was a reasonable possibility that the event anaphylactoid reaction was related to Dose 3 of the study vaccine (BNT162B2), but not related to dose 1 and dose 2 of blinded therapy (BNT162;PLACEBO), concomitant drugs or clinical trial procedure.  Follow-up (27Jan2021 and 03Feb2021):  Seriousness life-threatening justification, additional medical history (tree nuts allergy) and clinical course (did not touch or consume anything new before SAE).  Follow-up (18Feb2021): New information reported includes: action taken with the blinded study vaccine.  Follow-up (02Mar2021): New information reported includes: concomitant medication and action taken with the blinded study vaccine.  Follow-up (11Mar2021): New information reported includes:  SAE term updated to 'anaphylactoid reaction'.  This is a final report for initial notification of a life threatening event. .; Sender's Comments: The event 'anaphylactoid reaction' is unlisted in the protocol's Single Reference Safety Document (IB).  Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 28-FEB-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Anaphylactoid reaction.Review of the database for the PT Anaphylactoid reaction had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 29 non clinical trial cases.  The information available in this report is very limited. The Company considers that there is a reasonable possibility that 'anaphylactoid reaction' is related to the study product. There is a plausible, although belated, time relationship between vaccination with BNT162b2 and onset of the event in a subject with a medical history of allergic diathesis; it is worth noting that symptoms resolved rapidly upon self-medication. From the available information for the rationale that led to attribution of a life-threatening seriousness criterion, it may not be justifiable based on past-history of anaphylaxis alone  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
489	COVID19 VACCINE	2 days	6-17 years	Mar., 2021	1091649-1	patient was given the vaccine at age 16 when minimum age for vaccine is recommended to be age 18. she had no adverse effects
490	COVID19 VACCINE	2 days	6-17 years	Mar., 2021	1127200-1	one day of fever found to have elevated inflammatory markers, LV dysfunction (now resolved), elevated troponin and ST elevation in EKG concerning for myopericarditis. Admitted to hospital.  No documented fever in hospital, no rash, no GI symptoms, no other criteria met for MIS-C. Unclear etiology of myopericaraditis.
491	COVID19 VACCINE	2 days	6-17 years	Mar., 2021	1159441-1	Parent completed consent and questionnaire form for patient and checked that patient was 18 yrs and older. Nurse administered Janssen Vaccine. We were notified by the health department  and immunization center the next day that we administered the Janssen vaccine to a 16yr old.
492	COVID19 VACCINE	2 days	6-17 years	Apr., 2021	1181828-1	Patient was given vaccine at Community Outreach event on 04/2/21. Mother was contacted on 4/6/21 concerning incomplete name on her consent. She advised that her son received the covvid vaccine and had gone to the ER on 4/6/21 with a swollen tongue. She stated that he was treated with Tylenol and Benadryl and released to come home that day. Spoke with mom on 4/7/21 and she stated that the patient was stable and his entire tongue was not swollen just a small area. She denied any issues with his airway or breathing from time of vaccine to time of follow up call.
493	COVID19 VACCINE	3 days	6-17 years	Dec., 2020	0916466-1	Patient is below the minimum recommended age of 18. The patient is 17 years of age. The immunizing pharmacist neglected to catch that the patient was 17 before giving the vaccine. No adverse reactions have been reported - patient has been checked in and is fine with no symptoms or side effects. Simply reporting the dosing of an underage individual.
494	COVID19 VACCINE	3 days	6-17 years	Jan., 2021	0935956-1	Patient said she lost her hearing last Thursday (1/7/2021) around 6pm. She said she totally could not hear anything at all and she went to the ER at 11pm and stayed till 3am. Her hearing loss happened in her left ear and lasted for 5 days and started to hear sounds since Sunday and recovered. She described it as ""there was pressure inside the ear"" and she said she also went to her doctor and doctor said she had her hearing back 90% to 96%.""
495	COVID19 VACCINE	3 days	6-17 years	Jan., 2021	0943718-1	Patient is 16 years of age.  The vaccine is only authorized for patients 18 y/o and above.
496	COVID19 VACCINE	3 days	6-17 years	Feb., 2021	1071409-1	Since receiving his second dose of COVID-19 vaccine (Pfizer) on Sunday 2/21 he has had fever (tmax 103.0 F), headache, and stomach ache. His fever started on 2/21 and had persisted through 2/24.  He woke up from a nap on 2/24 in the afternoon at 1600 had onset of severe chest pain. Then reoccurring multiple times throughout the evening.  He was taken to a local hospital and the transferred to another hospital for higher level of care. Pediatric cardiology was consulted and treatment was started for suspected atypical pericarditis with colchicine 0.6mg BID and ibuprofen 600mg QID w/ famotidine 40mg QDay. His chest pain resolved the day of admission, even prior to starting treatment. Patient was discharged in clinically stable condition to follow up with pediatric cardiology in 2 weeks as outpatient.
497	COVID19 VACCINE	3 days	6-17 years	Feb., 2021	1183846-1	Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to my legs and stomach/very itchy and irritating; fatigue; This is a spontaneous report received from a contactable consumer (Reporting for herself). A 17-years-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: not reported) via an unspecified route of administration in Arm Left on 13Feb2021 12:45 (At the age of 17 years-old) as single dose for COVID-19 vaccination. The patient medical history was not reported and no known allergies. The historical vaccine included first dose of BNT162B2 received via an unspecified route of administration in Arm Left on 23Jan2021 12:30 for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. No COVID tested post vaccination. It was reported that patient had no symptoms after the 1st dose.   On 16Feb2021 she had fatigue (the first 1-2 days after getting the 2nd dose of Pfizer) that got better. Rash all over face and arms appeared 3 days later. It is now the 5th day and the rash has spread to legs and stomach. It was beginning to get very itchy and irritating. Patient was treated with hydrocortisone 3-4 times a day and it was not of much help. The outcome of the events was not recovered.
498	COVID19 VACCINE	3 days	6-17 years	Mar., 2021	1136072-1	nothing yet
499	COVID19 VACCINE	4 days	6-17 years	Jan., 2021	0933541-1	The vaccine is recommended for 18 and older
500	COVID19 VACCINE	6 days	6-17 years	Dec., 2020	0938297-1	C/O Tiredness, and Headache
501	COVID19 VACCINE	6 days	6-17 years	Mar., 2021	1102181-1	Due to language barrier this patient was given the Janssen Vaccine at age 16. this was not caught until data entry. the patient has not reported any adverse reactions or complications. County Health and State Health have been notified. this report in being submitted at their direction
502	COVID19 VACCINE	8 days	6-17 years	Dec., 2020	0926611-1	1/6 a rash developed at the injection site and by 1/7 it had spread to the belly and chest.
503	COVID19 VACCINE	8 days	6-17 years	Mar., 2021	1128089-1	patient was under 18 years old and pharmacist from a clinic gave a johnson and johnson vaccine to patient. not sure of any reactions but since patient is under age we were instructed to report to VAERS
504	COVID19 VACCINE	8 days	6-17 years	Apr., 2021	1199455-1	Patient reported difficulty breathing and chest pain; suffered cardiac arrest and death
505	COVID19 VACCINE	10-14 days	6-17 years	Jan., 2021	0950649-1	No adverse event. Reporting patient received vaccine at 15 yes 26 days old... under 16 year old guideline
506	COVID19 VACCINE	15-30 days	6-17 years	Dec., 2020	0950711-1	Last night I broke out into a bunch of itchy spots that resemble hives all over my body. The hives went away in the morning. Just now, 3:57pm today, I have puffy eyes and a swollen throat.
507	COVID19 VACCINE	15-30 days	6-17 years	Jan., 2021	0970806-1	No adverse event was reported by the patient.
508	COVID19 VACCINE	15-30 days	6-17 years	Jan., 2021	1047098-1	Vaccination age < EUA age .  Patient age 17 and EUA is >18.  No adverse effects noted.
509	COVID19 VACCINE	15-30 days	6-17 years	Jan., 2021	1051743-1	Vaccine given to age inappropriate patient.  Pt tolerated vaccine without any complications
510	COVID19 VACCINE	15-30 days	6-17 years	Mar., 2021	1169510-1	Too young to be vaccinated with Janssen.
511	COVID19 VACCINE	Unknown	6-17 years	Dec., 2020	0912401-1	Patient was under the age of 18 when Covid-19 vaccine was administered
512	COVID19 VACCINE	Unknown	6-17 years	Dec., 2020	0922582-1	Not an adverse reaction. Medication Error Vaccine for 18 and older given to 16 yr old.
513	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	0942370-1	Patient is 16 years old and was administered the vaccine by , pharmacist. Vaccine is approved for 18 years and older. Mother of patient stated no concern and patient was not experiencing any adverse effects other than sore arm.
514	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	0959217-1	No adverse events. The vaccine was administered in an error to the patient who is 16 year old.
515	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	0970280-1	Patient has not reported any adverse events from vaccination at the moment. She was administered a dose of the Moderna COVID-19 vaccine which is currently only approved for 18 yo and up. On day of inoculation, patient and her mother did not cite a reaction.
516	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	0977840-1	16 year old
517	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	0979455-1	Error: Too Young for Vaccine
518	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	0995255-1	He passed out; His blood sugar was 143; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3247) via an unspecified route of administration on the right arm on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included hypopituitarism. Concomitant medication included somatropin (NORDITROPIN) taken for hypopituitarism. He passed out (emergency room visit needed) on 17Jan2021, his blood sugar was 143 in Jan2021. Caller stated that her son received his first dose of the Pfizer COVID vaccine on 17Jan2021, stated he passed out. Caller stated they had to drive 3 hours away to get the vaccine and wanted to know that if because he experienced this after the first dose if it would be possible to find somewhere closer to home to get the second vaccine. Caller stated she is in the trial as an adult, that she reached out to her trial coordinator and they told her that they can only administer to persons in the trial. Son feels like maybe there is a drug interaction, caller stated she was not sure about this. Stated after her son passed out, they called an ambulance, states the Medic watched him for about 45 minutes, stated they ran some tests in Jan2021, he did go home that day. His blood sugar was 143 in Jan2021. Heart Rate monitor in Jan2021 she couldn't see so is unsure of the readings. The outcome of the event passed out was recovered on 17Jan2021, of other remain event was unknown.
519	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	1046357-1	Age under the requirement for EUA (<18 years of age).  No other adverse symptoms noted.
520	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	1046383-1	Vaccine administered to age < EUA (vaccine given to < 18 year old).  No other adverse effects noted.
521	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	1048844-1	Patient is less than 18 years of age when she received vaccine, however EUA is only for 18 years of age and older. No other adverse effects noted other than aches from vaccination.
522	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	1048904-1	Patient received vaccine at age 17 of age even though EUA is for 18 years of age and older.   No adverse effects noted.
523	COVID19 VACCINE	Unknown	6-17 years	Jan., 2021	1048921-1	Patient received vaccine at 16 years of age however EUA is indicated for 18 years of age and older.
524	COVID19 VACCINE	Unknown	6-17 years	Mar., 2021	1120389-1	unknown
525	COVID19 VACCINE	Unknown	6-17 years	Mar., 2021	1143587-1	There was no adverse event, patient was not eligible to receive the vaccine based on her age.  Patient guardian signed consent the patient was at least 18 years of age, however date of birth did not indicate that patient met the age requirements.
526	COVID19 VACCINE	Unknown	6-17 years	Apr., 2021	1183072-1	NO ADVERSE EVENTS REPORTED  Clinician sited the residence roughly 2 hours after vaccination to vaccinate another resident and patient was present and had no complaints.
527	COVID19 VACCINE	Unknown	6-17 years	Apr., 2021	1183122-1	NO ADVERSE EVENTS REPORTED  Clinician returned to residence to vaccinate another individual approximately 2 hours after patient was vaccinated and patient had no complaints following their vaccination.

[ransomnote]

Out of some 200+ vaccines in the CDC's VAERS database, 119 vaccines have received reports of strokes which were observed following vaccination. Note that research has not been conducted to determine if strokes were CAUSED by these vaccines or happened OCCUR at around the same time after vaccination.

Of the 119 vaccines with the word 'stroke' in the report's adverse event description, the J&J 'vaccine' is already #5 for the most reports published, after only 2 months of administration.

The CDC is far behind uploaded received reports - around April 6, the CDC had not enterred another 75% of the reports it had received for Covid-19 vaccines.

Also, Harvard research demonstrated that only about 1 to 2 percent of adverse events are ever reported to VAERS. Lastly, the CDC stopped or curtailed uploads to data; usually new records are added on Fridays and the data in VAERS was not updated on April 23 as expected.

Below is a post from another thread with links to data you can copy and paste in to MS Excel if you want to read specific reports to VAERS for the vaccines.

Spreading Data Past The Gatekeepers:

At the following two links: The suspect the CDC doesn't want you to have this information as they modified their program last night to make it othrewise inaccessible going forward. Therefore, share it loud, share it proud with everyone.

Here's the link to the VAERS data set of Covid-19 vaccine records which contain the word 'stroke' used for this discussion. I encourage people to copy and paste the data I exported from VAERS for 4/16/2021  into MS Excel to explore the records for themselves.

https://freerepublic.com/focus/chat/3920760/posts?page=2647#2647

Here's the link to the VAERS data set of Covid-19 vaccine records I posted to FR for 'anaphylaxis'. Again CDC has not updated VAERS since 4/16/2021 according to database exports as of last night.

https://freerepublic.com/focus/chat/3805345/posts?page=1570#1570

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Here are two graphics I created for posts elsewhere on FR

VAERS Covid 'vaccine' records with the word 'Stroke'
Sorted by Age

 

Here's the link to the original thread I posted: 

CDC VAERS and Covid-19 ‘Vaccines’: Under Reporting Adverse Events, Hiding Stroke Data? (freerepublic.com)

 

 

[2aProtectsTheRest]

"The report of an adverse event to VAERS is not documentation that a vaccine caused the event."

- Guide to Interpreting VAERS Data (https://vaers.hhs.gov/data/dataguide.html)

[boxlunch]

Horrifying that they are vaccinating children, who are almost entirely immune to this covidflu, with this experimental vaccine.

Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) for use in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID‑19.
The EUA for the Moderna COVID‑19 Vaccine is in effect for the duration of the COVID‑19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner https://www.modernatx.com/covid19vaccine-eua/

[maddog55]

Right up there with the Q BS.

[week 71]

Trying to think of a good term to call the “vaccines”. They do not prevent one from spreading the disease and do not prevent one from infection (but only reduce the severity). I am referring to them as Pre-therapeutics. First of its kind that I know of. Hard to believe they are giving them to young people who would do themselves and the rest of us well if they got Covid - beat it, as statistically 100% of them will, and help reach herd immunity.

[ransomnote]

I’ve been callin’ them the China vax because China provided the genome upon which the vaccines were developed.

See, I think this is the China Virus and they wouldn’t give us the accurate genome to it. Instead, I think the vax are part 2 of China’s biowarfare program.

[week 71]

Nothing pertaining to this virus and how it has been handled would surprise me. Nothing - everything is absurd.

[2aProtectsTheRest]

"They do not prevent one from spreading the disease and do not prevent one from infection (but only reduce the severity)."

That is false information. They prevent 94% of asymptomatic infection and 97% of symptomatic infection.

Find a new talking point. This one has expired.

[2aProtectsTheRest]

Sure it isn’t the aliens? I think the lizard people made it up to help Bill Gates steal our planet’s water.

[ransomnote]

“They do not prevent one from spreading the disease and do not prevent one from infection (but only reduce the severity).”
That is false information. They prevent 94% of asymptomatic infection and 97% of symptomatic infection.

Find a new talking point. This one has expired.

~~~~~~~~~~~~~

week 71 is correct. They do not prevent the spread or infection. Sadly, Israel is in the grip of the Chinese, who have established a port in Haifa and will determine if and when US ships are permitted into the harbor from this point foward.

One day Israelis were told they could not attend school or function in society without being vaccinated. China’s ‘process’ for controlling the public, enacting vaccinations, has been rolled out. Little of what comes out of Israel now will be valid information.

Prayers up for Israel and all fighting the biowarfare attacks of China, which is receiving the cooperation of domestic terrorists in their own country.

[2aProtectsTheRest]

That’s some truly ridiculous nonsense. Israel is run by the Chinese?

The best part of this nonsense is the implicit claim that the Chinese would be talking up how well the American Pfizer vaccine (which is the one almost exclusively deployed in Israel) is working. Except that’s the opposite of reality. The Chinese have been launching an information warfare campaign to discredit American vaccines because they compete with their own.

Wait, you wouldn’t know anything about that, would you?

https://www.pbs.org/wgbh/frontline/article/chinese-spam-network-aims-to-discredit-u-s-covid-vaccine-and-response-report-finds/
https://www.politico.com/newsletters/global-pulse/2021/01/28/what-chinas-vax-trolling-adds-up-to-491548
https://apnews.com/article/china-coronavirus-origin-65c6958bb2d8d22d811bb3d0c90f7418
https://www.reuters.com/world/china/russia-china-sow-disinformation-undermine-trust-western-vaccines-eu-report-says-2021-04-28/
https://www.bbc.com/news/56364952
https://www.usnews.com/news/world/articles/2021-04-28/russia-china-sow-disinformation-to-undermine-trust-in-western-vaccines-eu-report-says

[ransomnote]

The best part of this nonsense is the implicit claim that the Chinese would be talking up how well the American Pfizer vaccine (which is the one almost exclusively deployed in Israel) is working. Except that’s the opposite of reality. The Chinese have been launching an information warfare campaign to discredit American vaccines because they compete with their own.
~~~~~~~~~~~~~

Your comment is irrelevant. It doesn’t change the facts. Prayers up for Israel.

[2aProtectsTheRest]

Paranoid delusions about countries being “run by China” aren’t facts.

Israel is an American partner and ally. I stand with Israel. They are nobody’s puppet.

[grey_whiskers]

[PGalt]

posts bump