XXR-10721-26307

4 vaccinations 11 coded responses 36 check-ins 11 free-text entries 3 call cases

Sex: Female
Age at first dose: 36-40
ZIP prefix: 370 / TN
Registered: 2021-03-16

Relationship: Self
Race: Asian
Ethnicity: Not Hispanic or Latino

Timeline

Registration Vaccinations Survey responses Call reports Cases without a report Call attempts Call successful Pregnancy survey

2021-03-15
Dose 1 — Pfizer-BioNTech
2021-03-16
Registered in v-safe
2021-03-16
Survey response — days 1–6 daily, dose 1
MedDRA: Dizziness, Hyperhidrosis, Immediate post-injection reaction — Feeling: Good · Site: Pain · Muscle or body aches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-17
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-18
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-19
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-20
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Muscle or body aches

Adult check-in
2021-03-21
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-22
Health check-in — 7 day, dose 1
Feeling: Good · None

Adult check-in
2021-03-29
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-04-05
Health check-in — 21 day, dose 1
Feeling: Fair

Adult check-in
2021-04-09
Dose 2 — Pfizer-BioNTech
2021-04-09
Survey response — 0 day, dose 2
MedDRA: Device connection issue, Medical counselling — Feeling: Fair · Site: Pain · Muscle or body aches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-10
Survey response — days 1–6 daily, dose 2
MedDRA: Flank pain, Self-medication, Thirst — Feeling: Poor · Site: Pain · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-11
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Joint pains, Muscle or body aches

Adult check-in
2021-04-12
Survey response — days 1–6 daily, dose 2
MedDRA: Injection site bruising — Feeling: Fair · Site: Pain · Rash, not including the immediate area around the injection site

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-13
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-14
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2021-04-15
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-16
Health check-in — 7 day, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-25
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-04-30
Health check-in — 21 day, dose 2
Feeling: Good

Adult check-in
2021-05-09
Health check-in — 28 day, dose 2
Feeling: Fair

Adult check-in
2021-05-14
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-05-21
Survey response — 42 day, dose 2
MedDRA: Gastroenteritis viral — Feeling: Good · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-07-10
Survey response — 3 month, dose 2
MedDRA: Biliary colic, Cholelithiasis — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit, Hospitalization

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-07-10
Report sent to call center — 3 month, dose 2
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

1 call case(s)
2021-07-16
Call 1 — Left Voicemail
2021-10-08
Survey response — 6 month, dose 2
MedDRA: Biliary colic, Cholecystectomy, Cholelithiasis, Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, Taste disorder — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit, Hospitalization

MedDRA releases: 2024-11 · check-in answers available
2021-10-08
Report sent to call center — 6 month, dose 2
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Outpatient clinic or urgent care clinic visit · Emergency room or emergency department visit · Hospitalization · 1 call case(s)
2021-10-11
Call 1 — Could Not Reach Participant
2021-10-15
Call 2 — Could Not Reach Participant
2021-11-19
Dose 3 — Pfizer-BioNTech
2022-04-11
Survey response — 12 month, dose 2
MedDRA: Food allergy, Skin discolouration — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2022-04-11
Report sent to call center — 12 month, dose 2
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-04-13
Call 1 — Left Voicemail
2022-04-13
Call successful
Participant prefers to complete VAERS report online
2022-11-11
Dose 4 — Pfizer-BioNTech
2022-11-12
Survey response — days 1–6 daily, dose 4
MedDRA: Hot flush, Urticaria — Feeling: Fair · Site: Pain · Rash, not including the immediate area around the injection site

MedDRA releases: 2024-11 · check-in answers available
2022-11-13
Survey response — days 1–6 daily, dose 4
MedDRA: Oropharyngeal pain — Feeling: Good · Site: Pain

MedDRA releases: 2024-11 · check-in answers available
2022-11-14
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-11-15
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-11-16
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-11-18
Health check-in — 7 day, dose 4
Feeling: Good · None

Adult check-in
2022-11-25
Health check-in — 14 day, dose 4
Feeling: Good

Adult check-in
2022-12-02
Survey response — 21 day, dose 4
MedDRA: Cough, Fatigue, Oropharyngeal pain, Productive cough, Respiratory tract congestion — Feeling: Poor · Be unable to work or attend school, Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2022-12-09
Health check-in — 28 day, dose 4
Feeling: Fair

Adult check-in
2022-12-23
Health check-in — 42 day, dose 4
Feeling: Good

Adult check-in
2023-02-10
Health check-in — 3 month, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-15	Pfizer-BioNTech
2	2021-04-09	Pfizer-BioNTech
3	2021-11-19	Pfizer-BioNTech	No
4	2022-11-11	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-07-10	Successful	Participant prefers to complete VAERS report online
2021-10-08	Successful	Participant prefers to complete VAERS report online
2022-04-11	Successful 2022-04-13	Participant prefers to complete VAERS report online

Free text

Release 5

Systemic reaction (other): Light-headed and sweaty and dizzy within 15 mins of my injection

Release 7

Systemic reaction (other): I am NOT pleased with my experience of getting the 2nd shot! I dont believe I got the full medicine pushed in my arm. The lady at (b)(6) vaccination site in (b)(6), TN today did not perform the dosing properly. I felt the needle in my right arm, and when she attempted to remove the syringe, it fell into my car. I believe she did not give the dose to me from the syringe, only stuck my arm. It all happened to fast because that site is drive-thru application. I truly dont believe I was fully given the 2nd dose properly because I didnt experience the same side effects I experienced within the first 15 minimum of the 1st dose back on 3-15-2021. I would like to speak to someone from CDC about this please. Thank you.

redacted (b)(6)

Systemic reaction (other): I was so thirsty last night and this mornings. Had middle back pain where kidneys are all early morning. Plus, started monthly period this morning. Had my usual PMS cramps and lower back ache. Took one Midol and slept with heating pad for several hours this afternoon. Feeling better by 4:00pm CST but not fully 100%.

Systemic reaction (other): Bruising noticed at and around injection site

Release 8

Symptoms: I had an unrelated stomach virus that lasted the 24 hours on 5/17/2021.

Release 9

Symptoms: Severe gallbladder pain and gallbladder stones. Gallbladder removal surgery scheduled for next week.

Release 10

Symptoms: Had gallbladder removed in July due to stones and severe pain. Just this week on 10/4, started having signs of some covid symptoms, fever, sore throat, head congestion, stuffy and runny nose, some taste changes. 10/7 rapid covid test was negative. cut off by CDC

Release 11

Symptoms: New food allergies discovered. Dark spot near right armpit (side I got my Covid shots)

Release 12

Systemic reaction (other): Hot flashes and hives on tops of hands

Systemic reaction (other): Sore throat

Symptoms: Sore throat, phlegm, tiredness, some congestion and cough.

Free-text releases are not linked to a specific survey response. The CDC cut some text off at about 250 characters: symptoms in every release, and the other two fields in releases 9-12. Those entries are marked "cut off by CDC".

MedDRA terms by release

Field	Preferred term	2021-09	2023-04	2024-11
SD	Biliary colic	✓	✓	✓
SD	Cholecystectomy	·	·	✓
SD	Cholelithiasis	✓	✓	✓
SD	Cough	·	·	✓
SD	Fatigue	·	·	✓
SD	Food allergy	·	·	✓
SD	Gastroenteritis viral	✓	✓	✓
SD	Nasal congestion	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Productive cough	·	·	✓
SD	Pyrexia	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Skin discolouration	·	·	✓
SD	Taste disorder	·	·	✓
SRO	Device connection issue	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Flank pain	✓	✓	✓
SRO	Hot flush	·	·	✓
SRO	Hyperhidrosis	✓	✓	✓
SRO	Immediate post-injection reaction	✓	✓	✓
SRO	Injection site bruising	✓	✓	✓
SRO	Medical counselling	✓	✓	✓
SRO	Oropharyngeal pain	·	·	✓
SRO	Self-medication	✓	✓	✓
SRO	Thirst	✓	✓	✓
SRO	Urticaria	·	·	✓

✓ active code · ○ coded but marked inactive · blank = not in that release