These are some select stories from the first month of Pediatric vaccinations in the US. There is a select group of syncope (fainting or 'loss of consciousness') in the little ones.
PRO TIP: Stay right by your kid before and after the vax. Vaccinate one kid at a time if possible. If they faint, don't let them fall and hit their head on the floor. Because then you have the child head injury on top of the child vaccine injury. The HCW who are administering the pediatric injections are having some trouble confusing adult with pediatric dosing. Many kids are getting adult doses and adult saline preparation doses, among other administration errors. This doesn't seem to result in too much (immediate) injury. I guess. Maybe.
Full spreadsheet here and code here and here. *Read the code first* if you don't understand my output or what I have done. All the paragraphs immediately below are separate AE ('Adverse Event') reports.
Stories (SYMPTOM_TEXT)
"Patient received her immunization and within 5 minutes collapsed and stopped breathing. When she began breathing again she was very pale and complained of abdominal pain and had dilated pupils. After a few more minutes of observation and drinking orange juice she began feeling fine again and had no abnormal chest or heart sounds."
"Jittery and ?head feels different/weird? on 11/13/2021 about 6 hours after vaccine. Woke up complaining of headaches next day. Pt started having uncontrolled head movements and jerks along with facial twitches. It started only when brain was at rest like watching TV or listening in class. Now, it?s happening constantly during conversations, eating, reading and writing. Continued daily and teachers noticed head bobbing and twitching. She also looks unfocused when looking at teachers."
"After the pediatric Pfizer vaccine was administered, the child had nausea and began to vomit. Her mother, then, took her to the rest room to clean her up. When the mother came out, she reported that the child was dizzy and almost fainted in the rest room. The child was placed on a chair. Her mother shook her. the child was able to speak, hear, and take commands. She knew her date of birth. I called the 911 squad. The manager of the store gave the child a cold bottle of water to drink. When the 911 squad arrived, the child was escorted outside to the ambulance. The mother elected not to have the child go to a hospital , but to take her home. She was planning to report the matter to the child's doctor. The emergency squad released the child to the mother. At 6:03 pm, one of the pharmacy personnel called the mother. The mother reported that the child was much better. At 9:12 pm, I called the mother. She reported that the child was fine."
"Between 10-20 seconds after patient received first Covid vaccine (Pfizer), this RN heard patient's father called for her name ""Patient, are you OK?"" RN went to patient's chair and found patient was on the floor with her head bending backward. Patient was lethargic, awake but slow to respond. Patient looked pale and was sweating. This RN carried patient to EMS Room. Ice pack was applied to patient back, head and neck. Patient drank water, she refused snack. Patient reported that she had lunch. Dad and brother were sitting next to the patient at Table 7 and told RN that ""Patient eyes was open but not moving when she was sliding off the chair."" 14:35 - BP = 88/55, P=80, O2Sat= 100% on RA, R=20. 15:00 - BP = 78/36, P=56, R=26, O2Sat 87-88%, patient was pale and reported difficulty breathing. RN/floor leader advised father to either call 911 or take patient to ER. Father preferred to take patient to the ER. Father was very pleasant. 1512: BP=84/50, P=74, R=18, O2Sat =100% on RA. Patient was smiling, skin was pink and said that ""I'm ok"". This RN escorted patient to the car with her father and brothers."
"Patient received dose 1 of the pediatric Pfizer COVID vaccine (lot FK5127) at approximately 1710. At 1713, the patient lost consciousness, slumped forward and fell on the ground, hitting her head. PHN and RN responded, assisting the patient supine. The patient was alert and oriented to person, place, and event. At 1715, vital signs: blood pressure 154/88, pulse 124, O2 98%, respirations 20. Patient reported she had felt lightheaded and had a headache before she fell. The patient's father reported that she had no medical conditions, took no medications, and had no allergies. The patient reported she ate prior to arrival. The father reported the patient had no prior history of syncope. RN provided ice pack for head, PHN noted no visible deformity, blood, or skin tear. PHN assessed neurologic function: pupils even and reactive to light accommodation, hand grip strength equal and strong bilaterally, foot strength equal and strong bilaterally. PHN offered to call EMS but patient's father declined. PHN offered Benadryl but patient's father declined. PHN educated on remaining for 30min monitoring from time of syncope, to follow up with provider, and when to call 911 for allergic reaction or concussion symptoms. At 1725, vital signs: blood pressure 146/82, pulse 104, O2 99%, respirations 16. Patient reported all symptoms had resolved but she felt anxious and her extremities are were Patient reported fear of needles. At 1730, patient sat up slowly, continuing to report no symptoms besides anxiety and cold extremities. At 1735, vital signs: blood pressure 142/82, pulse 96, O2 97%, respirations 16. Patient stood up, monitored closely by PHN and RN, and continued to report no symptoms besides anxiety. Patient was tearful. PHN completed concussion protocol and handed to father of patient after explaining. At 1744, vital signs: blood pressure 142/82, O2 100%, pulse 87, respirations 18. Patient reported she still felt anxious after the syncope. At 1745, patient left walking with steady gait, accompanied by father who would drive her home. "
"The patient passed out and fell to the floor about a minute after getting the vaccine. She was unresponsive for about 20 seconds. 911 was called. Ems took her to the hospital as a precaution. they stated normal blood sugar but a slow heart rate and patient was pale."
"Fainted 11 minutes after shot administered. Fell to floor and was alert again within a couple seconds. Pediatric staff provided ice for bumped head and sips of water, checked vital signs, and extended observation period. Released to go home approx. 20-30 minutes after incident."
"About 15 minutes after the vaccine was administered, one of the associates came to the pharmacy and informed us that the child has fainted and hit his head. The child was responsive, talkative, and awake when we approached him. His head was bleeding so we place a gauze on the child's head to keep the pressure and stop the bleeding. We called the ER and they arrived within 10 minutes. The medics wrapped his head with a bandage and took his blood pressure and informed the mother to take the child to the ER. The mother declined. I called the mother the next morning and she informed me that the child had staples placed in his head and that he was doing fine."
"Vaccine was administered at 9:35. at approximately 9:40 pt. reported "" I am dizzy and I see trails"", RN had pt. sit down. Pt became diaphoretic was unconscious for less than 30 seconds. Ice pack was applied to back of his neck and bottle of water was offered. Pt reported he felt better. Pt than became diaphoretic and reported feeling ""dizzy"" Nursing staffed called EMS at 9:42 and EMS arrived on scene at 9:45 EMS observed and evaluated patient. Pt's father was present and called patient's mother who declined allowing EMS to take patient to hospital. Patient was escorted to personal vehicle by father and EMS."
"She woke up immediately went to restroom to vomit. A couple hours later exp diarrhea felt weak and wanted to go to hospital . A year ago she had her appendix removed told me she felt like those symptoms. I checked her heart rate it was 145. I took her to the Urgent Care it took about hour to get there on the way she was fine. When we got there the doctor stated she was in Tachycardia. She was given Ondansetron for nausea and look dehydrated I was advised to get fluids in her."
Statistics
'All_symptoms' counts are similar (concatenated) SYMPTOM* text. As a percentage of all reported AE (Adverse Events), there are many of product, dose and administration errors for the first month of reported Pediatric injuries. The data.table 'Under12' has 2327 rows or unique AEs. Full spreadsheet here and code here and here. *Read the code first* if you don't understand my output or what I have done. In the spreadsheet, I removed the 'inappropriate age' AE ('Adverse Event') .
# Analysis
# Word counts
Under12[,.N,.(All_symptoms)][order(-N)][1:40]
All_symptoms N
1: Incorrect dose administered No adverse event 182
2: Incorrect dose administered 150
3: Product preparation issue 94
4: Product administered to patient of inappropriate age 67
5: Incorrect dose administered Product preparation issue 46
6: Syncope 41
7: Urticaria 38
8: Expired product administered 33
9: No adverse event Product administered to patient of inappropriate age 32
10: Incorrect product formulation administered 30
11: Vomiting 27
12: Product storage error 27
13: Underdose 24
14: Rash 20
15: Extra dose administered No adverse event 18
16: Dizziness 16
17: No adverse event 15
18: Product preparation issue Underdose 14
19: Expired product administered Product storage error 14
20: Extra dose administered 13
21: Unevaluable event 12
22: No adverse event Product preparation issue 12
23: Incorrect dose administered No adverse event Product preparation issue 10
24: Inappropriate schedule of product administration 10
25: Incorrect dose administered Pain in extremity 9
26: Loss of consciousness 8
27: Syringe issue 8
28: Nausea Vomiting 8
29: Pruritus Urticaria 8
30: Epistaxis 8
31: Rash Urticaria 7
32: Wrong product administered 7
33: Inappropriate schedule of product administration No adverse event 7
34: Headache Vomiting 6
35: Nausea Pallor 6
36: Syncope Unresponsive to stimuli 6
37: Loss of consciousness Syncope 6
38: Incorrect product formulation administered No adverse event 6
39: Headache 5
40: Dizziness Syncope 5
All_symptoms N
stack.symptoms(Under12)
stack.symptom.terms[,.N,.(terms)][order(-N)][1:40]
terms N
1: administered 758
2: product 571
3: incorrect 513
4: dose 503
5: event 333
6: pain 331
7: adverse 324
8: no 317
9: of 273
10: issue 230
11: preparation 210
12: site 206
13: injection 191
14: rash 169
15: syncope 166
16: to 166
17: dizziness 163
18: vomiting 160
19: inappropriate 152
20: headache 137
21: fatigue 133
22: patient 129
23: age 128
24: pyrexia 124
25: urticaria 119
26: test 115
27: nausea 112
28: swelling 107
29: blood 101
30: normal 96
31: pallor 90
32: loss 89
33: consciousness 88
34: error 83
35: abdominal 82
36: chest 81
37: pruritus 80
38: in 77
39: extremity 67
40: fall 65
terms N
# nchar > 10
stack.symptoms(Under12)
stack.symptom.terms[nchar(terms) > 10,.N,.(terms)][order(-N)][1:40]
terms N
1: administered 758
2: preparation 210
3: inappropriate 152
4: consciousness 88
5: administration 58
6: hyperhidrosis 53
7: formulation 44
8: electrocardiogram 36
9: oropharyngeal 35
10: unresponsive 30
11: post-injection 29
12: erythematous 21
13: hypoaesthesia 17
14: paraesthesia 16
15: disturbance 16
16: lymphadenopathy 15
17: respiratory 15
18: vaccination 14
19: immunisation 13
20: haemorrhage 13
21: computerised 13
22: hypersensitivity 13
23: unevaluable 12
24: hypotension 12
25: rhinorrhoea 11
26: confusional 10
27: temperature 10
28: electroencephalogram 8
29: examination 8
30: echocardiogram 8
31: aminotransferase 7
32: discolouration 7
33: lacrimation 6
34: circumstance 6
35: neurological 6
36: information 6
37: nervousness 5
38: henoch-schonlein 5
39: generalised 5
40: appendicitis 5
terms N
Death L_THREAT HOSPITAL HOSPITAL.DAYS
1: 1 9 42 88
# Demographic Tables
# Under 12, first month 11/2021 of pediatric dosing
x <- Under12;CritMarks()
Factor All.Reported.Covid.AE All.Reported.Covid.AE.Deaths
1: CovidAE.Reported.Total 2327 1
2: DIED 1 1
3: DISABLE 5 0
4: ER_ED_VISIT 199 0
5: HOSPITAL 42 0
6: HOSPITAL.DAYS 34 0
7: L_THREAT 9 0
8: Age.0.12 2327 1
9: Age.13.55 0 0
10: Age.56.120 0 0
11: SEX.Female 1176 1
12: SEX.Male 1142 0
13: SEX.UNK 9 0
# All Demographics COVID19 VAERS data to 12/03/2021
x <- all.data[VAX_TYPE == "COVID19" & !duplicated(VAERS_ID_enhanced),];CritMarks()
Factor All.Reported.Covid.AE All.Reported.Covid.AE.Deaths
1: CovidAE.Reported.Total 705574 10402
2: DIED 10402 10402
3: DISABLE 11742 105
4: ER_ED_VISIT 89723 2527
5: HOSPITAL 49256 3814
6: HOSPITAL.DAYS 32624 2765
7: L_THREAT 11442 410
8: Age.0.12 6437 6
9: Age.13.55 374849 1126
10: Age.56.120 258508 8346
11: SEX.Female 476000 4289
12: SEX.Male 205870 5641
13: SEX.UNK 23704 472
AGE F M U
1: 5 130 123 0
2: 6 126 123 2
3: 7 143 148 1
4: 8 166 160 0
5: 9 170 159 2
6: 10 172 168 1
7: 11 199 184 1
# I don't know why Moderna and Janssen are labeled as such in the Pediatric mix...
# Is it a possible curation error or just 'first pediatric month' administration mistakes? They had to know only PFIZER\\BIONTECH were approved for pediatric?
AGE JANSSEN MODERNA PFIZER\\BIONTECH UNKNOWN MANUFACTURER
1: 5 0 2 251 0
2: 6 0 1 250 0
3: 7 0 2 290 0
4: 8 0 3 323 0
5: 9 0 3 328 0
6: 10 2 0 339 0
7: 11 0 4 379 1
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