68Q-13957-21302

3 vaccinations 13 coded responses 25 check-ins 12 free-text entries 4 call cases

Sex: Female
Age at first dose: 46-50
ZIP prefix: 923 / CA
Registered: 2021-06-04

Relationship: Self
Race: Native Hawaiian or other Pacific Islander
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-05-14
Dose 1 — Pfizer-BioNTech
2021-06-03
Dose 2 — Pfizer-BioNTech
2021-06-04
Registered in v-safe
2021-06-04
Survey response — days 1–6 daily, dose 2
MedDRA: Ear discomfort, Head discomfort — Feeling: Good · Site: Pain, Swelling, Itching · Fatigue or tiredness

Free text: Ears, slight head congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-05
Survey response — days 1–6 daily, dose 2
MedDRA: Axillary pain — Feeling: Good · Site: Pain, Swelling, Itching · Fever · Chills, Headache, Fatigue or tiredness, Abdominal pain

Free text: Left Underarm / Armpit Pain / Soreness (same side as injection site)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-06
Survey response — days 1–6 daily, dose 2
MedDRA: Axillary pain, Ear congestion — Feeling: Good · Site: Swelling, Itching · Headache, Fatigue or tiredness

Free text: Left armpit soreness and (left) ear congestion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-07
Survey response — days 1–6 daily, dose 2
MedDRA: Oropharyngeal pain, Respiratory tract congestion — Feeling: Good · Site: Itching · Headache, Muscle or body aches, Fatigue or tiredness

Free text: Sore throat, head congestion (ears)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-08
Survey response — days 1–6 daily, dose 2
MedDRA: Oropharyngeal pain — Feeling: Good · Site: Itching

Free text: Sore throat

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-10
Health check-in — day 7, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-06-19
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-06-24
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-07-01
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-07-08
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-07-16
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-09-02
Survey response — 3 months, dose 2
MedDRA: Headache, Respiratory disorder, Viral infection — Feeling: Fair · Be unable to do your normal daily activities

Free text: I had an upper respiratory problem and headaches last month. No testing done to confirm type of viral infection. One day of rest and symptoms were relieved with medication.

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-12-02
Survey response — 6 months, dose 2
MedDRA: Cough, Insomnia, Nasal congestion, Oropharyngeal pain — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Sore throat, cough, stuffy nose, difficulty sleeping

MedDRA releases: 2024-11 · check-in free text available
2021-12-02
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)
2021-12-03
Call 1 — Left Voicemail
2022-02-10
Dose 3 — Pfizer-BioNTech
2022-02-13
Survey response — days 1–6 daily, dose 3
MedDRA: Cough, Rhinorrhoea, Sinus congestion — Feeling: Fair · Site: Pain, Swelling · Fever · Chills, Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Sinus congestion, runny nose, and occasional cough

MedDRA releases: 2024-11 · check-in free text available
2022-02-14
Survey response — days 1–6 daily, dose 3
MedDRA: Paranasal sinus discomfort, Sinus congestion, Sinusitis — Feeling: Good · Site: Pain, Itching · Fatigue or tiredness

Free text: Sinusitis, sinus pressure/congestion

MedDRA releases: 2024-11 · check-in free text available
2022-02-16
Survey response — days 1–6 daily, dose 3
MedDRA: Rhinorrhoea — Feeling: Good · Fatigue or tiredness

Free text: Runny nose

MedDRA releases: 2024-11 · check-in free text available
2022-02-19
Health check-in — day 7, dose 3
Feeling: Good · None

Adult check-in
2022-02-24
Health check-in — day 14, dose 3
Feeling: Good

Adult check-in
2022-03-04
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2022-03-11
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2022-03-19
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2022-03-24
Survey response — day 42, dose 3
MedDRA: Fatigue, Myalgia, Sinus congestion, Sinus pain — Feeling: Fair · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Sinus congestion and sinus pain, tiredness, muscle aches

MedDRA releases: 2024-11 · check-in free text available
2022-03-24
Report sent to call center — day 42, dose 3
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-03-28
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-05-13
Survey response — 3 months, dose 3
MedDRA: Cough, Headache, Hyposmia, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, Sneezing, Thirst — Feeling: Fair · 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

Free text: Sore throat, increased thirst, cough, congestion, runny nose, sneezing, decreased sense of smell, headache

MedDRA releases: 2024-11 · check-in free text available
2022-05-13
Report sent to call center — 3 months, 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 · Emergency room or emergency department visit · 1 call case(s)
2022-05-13
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-05-13
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-08-13
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in
2023-02-12
Survey response — 12 months, dose 3
MedDRA: Cough, Dry throat, Headache, Malaise, Pain, Rhinorrhoea, Thirst — Feeling: Poor · 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

MedDRA releases: 2024-11
2023-02-12
Report sent to call center — 12 months, dose 3
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 · 1 call case(s)
2023-02-13
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-05-14	Pfizer-BioNTech
2	2021-06-03	Pfizer-BioNTech
3	2022-02-10	Pfizer-BioNTech	No

Call center

4 call center cases

4 successful

See the call center timeline

Free text

Release 8 — days 1–6 daily, dose 2

2021-06-04

Systemic reaction (other): Ears, slight head congestion

2021-06-05

Systemic reaction (other): Left Underarm / Armpit Pain / Soreness (same side as injection site)

2021-06-06

Systemic reaction (other): Left armpit soreness and (left) ear congestion

2021-06-07

Systemic reaction (other): Sore throat, head congestion (ears)

2021-06-08

Systemic reaction (other): Sore throat

Release 9 — 3 months, dose 2

2021-09-02

Symptoms: I had an upper respiratory problem and headaches last month. No testing done to confirm type of viral infection. One day of rest and symptoms were relieved with medication.

Release 10 — 6 months, dose 2

2021-12-02

Symptoms: Sore throat, cough, stuffy nose, difficulty sleeping

Release 11 — days 1–6 daily, dose 3

2022-02-13

Systemic reaction (other): Sinus congestion, runny nose, and occasional cough

2022-02-14

Systemic reaction (other): Sinusitis, sinus pressure/congestion

2022-02-16

Systemic reaction (other): Runny nose

Release 11 — day 42, dose 3

2022-03-24

Symptoms: Sinus congestion and sinus pain, tiredness, muscle aches

Release 11 — 3 months, dose 3

2022-05-13

Symptoms: Sore throat, increased thirst, cough, congestion, runny nose, sneezing, decreased sense of smell, headache

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	Cough	·	·	✓
SD	Dry throat	·	·	✓
SD	Fatigue	·	·	✓
SD	Headache	✓	·	✓
SD	Hyposmia	·	·	✓
SD	Insomnia	·	·	✓
SD	Malaise	·	·	✓
SD	Myalgia	·	·	✓
SD	Nasal congestion	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pain	·	·	✓
SD	Respiratory disorder	✓	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	Sinus congestion	·	·	✓
SD	Sinus pain	·	·	✓
SD	Sneezing	·	·	✓
SD	Thirst	·	·	✓
SD	Viral infection	✓	·	✓
SRO	Axillary pain	✓	✓	✓
SRO	Cough	·	·	✓
SRO	Ear congestion	✓	✓	✓
SRO	Ear discomfort	✓	✓	✓
SRO	Head discomfort	✓	✓	✓
SRO	Oropharyngeal pain	✓	✓	✓
SRO	Paranasal sinus discomfort	·	·	✓
SRO	Respiratory tract congestion	✓	✓	✓
SRO	Rhinorrhoea	·	·	✓
SRO	Sinus congestion	·	·	✓
SRO	Sinusitis	·	·	✓

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