5ML-33642-42191

3 vaccinations 12 coded responses 33 check-ins 12 free-text entries 4 call cases

Sex: Female
Age at first dose: 36-40
ZIP prefix: 117 / NY
Registered: 2021-03-08

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

Timeline

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

2021-03-08
Registered in v-safe
2021-03-08
Dose 1 — Pfizer-BioNTech
2021-03-08
Health check-in — day 0, dose 1
Feeling: Good · None

Adult check-in
2021-03-09
Survey response — days 1–6 daily, dose 1
MedDRA: Cough — Feeling: Poor · Site: Swelling · Fever · Headache, Fatigue or tiredness

Free text: A very mild cough off & on

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-10
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Fever · None

Adult check-in
2021-03-11
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Fever · Fatigue or tiredness

Adult check-in
2021-03-13
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-14
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-15
Survey response — day 7, dose 1
MedDRA: Neck pain — Feeling: Poor · Headache

Free text: Neck pain. Started late yesterday

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-22
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-03-29
Dose 2 — Pfizer-BioNTech
2021-03-29
Health check-in — day 0, dose 2
Feeling: Good · None

Adult check-in
2021-03-30
Survey response — days 1–6 daily, dose 2
MedDRA: Electric shock sensation, Pre-existing disease — Feeling: Good · Site: Pain, Swelling

Free text: While asleep 2 times her body jumped like an electric shock hit her. (Has Down Syndrome & mom is filling this out)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-04-01
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-02
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-03
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

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

Adult check-in
2021-04-05
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-12
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-19
Survey response — day 21, dose 2
MedDRA: Headache — Feeling: Fair

Free text: Headache

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-27
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-03
Survey response — day 35, dose 2
MedDRA: Headache, Sinus disorder — Feeling: Good

Free text: Having more headaches & sinus problems then usual

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-10
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-06-28
Survey response — 3 months, dose 2
MedDRA: Injection site swelling, Pain in extremity — Feeling: Good

Free text: Arm started hurting again off and on. Still a little swollen at injection site. Nothing much.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-09-27
Survey response — 6 months, dose 2
MedDRA: Arthralgia, Asthenia, Headache, Office visit, Pre-existing disease — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Not sure if this is related. (b)(6) has Down Syndrome. I am her mom answering for her. She seems to be not as energetic & complaining a little more about joint pain, and mild headaches. Doctors are following her. She has many medical issues.

MedDRA releases: 2024-11 · check-in free text available
2021-09-27
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-09-29
Dose 3 — Pfizer-BioNTech
2021-09-29
Call 1 — Left Voicemail
2021-10-04
Survey response — days 1–6 daily, dose 3
MedDRA: Dyspnoea, Fatigue — Feeling: Good · Fatigue or tiredness

Free text: Very tired, breathing a little harder while sleeping

MedDRA releases: 2024-11 · check-in free text available
2021-10-06
Health check-in — day 7, dose 3
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-10-13
Survey response — day 14, dose 3
MedDRA: Headache, Respiratory tract congestion, Sinusitis — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Severe headache, congestion, and sinus infection.

MedDRA releases: 2024-11 · check-in free text available
2021-10-13
Report sent to call center — day 14, dose 3
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-10-18
Call 1 — Left Voicemail
2021-10-19
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-10-20
Survey response — day 21, dose 3
MedDRA: SARS-CoV-2 test negative, Sinus congestion, Sinusitis — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Still getting over bad sinus infection & congestion. Took Antibiotics & steroids. Follow up with doctor tomorrow. Covid test was neg.

MedDRA releases: 2024-11 · check-in free text available
2021-10-20
Report sent to call center — day 21, dose 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-10-22
Call 1 — Left Voicemail
2021-10-27
Health check-in — day 28, dose 3
Feeling: Fair

Adult check-in
2021-10-27
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2021-11-03
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-11-11
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2021-12-29
Survey response — 3 months, dose 3
MedDRA: Fatigue — Feeling: Fair

Free text: Very tired

MedDRA releases: 2024-11 · check-in free text available
2022-03-31
Survey response — 6 months, dose 3
MedDRA: Emergency care, Pain in extremity — Feeling: Fair · Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Severe pain in calf of leg about 2 months ago. Went to hospital and all test were negative. The pain is much less, but still there. Waiting to see a rheumatologist in the end of April.

MedDRA releases: 2024-11 · check-in free text available
2022-03-31
Report sent to call center — 6 months, dose 3
Get care from a doctor or other healthcare professional

Emergency room or emergency department visit · 1 call case(s)
2022-04-04
Call successful
Participant prefers to complete VAERS report online
2022-09-29
Health check-in — 12 months, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-08	Pfizer-BioNTech
2	2021-03-29	Pfizer-BioNTech
3	2021-09-29	Pfizer-BioNTech	No

Call center

4 call center cases

4 successful

See the call center timeline

Free text

Release 5 — days 1–6 daily, dose 1

2021-03-09

Systemic reaction (other): A very mild cough off & on

Release 5 — day 7, dose 1

2021-03-15

Systemic reaction (other): Neck pain. Started late yesterday

Release 6 — days 1–6 daily, dose 2

2021-03-30

Systemic reaction (other): While asleep 2 times her body jumped like an electric shock hit her. (Has Down Syndrome & mom is filling this out)

Release 7 — day 21, dose 2

2021-04-19

Symptoms: Headache

Release 8 — day 35, dose 2

2021-05-03

Symptoms: Having more headaches & sinus problems then usual

Release 9 — 3 months, dose 2

2021-06-28

Symptoms: Arm started hurting again off and on. Still a little swollen at injection site. Nothing much.

Release 9 — 6 months, dose 2

2021-09-27

Symptoms: Not sure if this is related. (b)(6) has Down Syndrome. I am her mom answering for her. She seems to be not as energetic & complaining a little more about joint pain, and mild headaches. Doctors are following her. She has many medical issues.

redacted (b)(6)

Release 10 — days 1–6 daily, dose 3

2021-10-04

Systemic reaction (other): Very tired, breathing a little harder while sleeping

Release 10 — day 14, dose 3

2021-10-13

Symptoms: Severe headache, congestion, and sinus infection.

Release 10 — day 21, dose 3

2021-10-20

Symptoms: Still getting over bad sinus infection & congestion. Took Antibiotics & steroids. Follow up with doctor tomorrow. Covid test was neg.

Release 10 — 3 months, dose 3

2021-12-29

Symptoms: Very tired

Release 11 — 6 months, dose 3

2022-03-31

Symptoms: Severe pain in calf of leg about 2 months ago. Went to hospital and all test were negative. The pain is much less, but still there. Waiting to see a rheumatologist in the end of April.

Each entry is dated by the survey it was written in (the CDC re-sent the releases with survey dates in 2025); click a date to see that 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	Arthralgia	·	·	✓
SD	Asthenia	·	·	✓
SD	Emergency care	·	·	✓
SD	Fatigue	·	·	✓
SD	Headache	✓	✓	✓
SD	Injection site swelling	✓	✓	✓
SD	Office visit	·	·	✓
SD	Pain in extremity	✓	✓	✓
SD	Pre-existing disease	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Sinus congestion	·	·	✓
SD	Sinus disorder	✓	✓	✓
SD	Sinusitis	·	·	✓
SRO	Cough	✓	✓	✓
SRO	Dyspnoea	·	·	✓
SRO	Electric shock sensation	✓	✓	✓
SRO	Fatigue	·	·	✓
SRO	Neck pain	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓

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