29J-21613-89565

4 vaccinations 9 coded responses 27 check-ins 9 free-text entries 5 call cases

Sex: Female
Age at first dose: 66+
ZIP prefix: 334 / FL
Registered: 2021-01-24

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

2021-01-06
Dose 1 — Pfizer-BioNTech
2021-01-24
Registered in v-safe
2021-01-24
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-27
Survey response — day 21, dose 1
MedDRA: Fatigue, Insomnia — Feeling: Good

Free text: Seemingly more tired the last two weeks Was not sleeping well at nite...getting abt 4 hrs of sleep. Last nite I slept thru the nite (7 Â½ hrs!!)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-03
Dose 2 — Pfizer-BioNTech
2021-02-03
Survey response — day 0, dose 2
MedDRA: Pain in extremity — Feeling: Good

Free text: Just had the 2nd shot at 9 am this morning...so far, very minimal soreness (when moving arm)to report (4:15 pm)

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-04
Survey response — days 1–6 daily, dose 2
MedDRA: Hypersomnia, Self-medication — Feeling: Poor · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Though I felt feverish, my temp was normal but I experienced the above symptoms all day. Also took 2 extra strength tylenol last nite at 8 pm. Slept over 9 hrs!

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-05
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Good · Fatigue or tiredness

Free text: No other symptoms

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-06
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-07
Survey response — days 1–6 daily, dose 2
MedDRA: Ear pain — Feeling: Fair · Fever · Chills, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Off & on pain in right ear

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-08
Survey response — days 1–6 daily, dose 2
MedDRA: Ear pain, Specialist consultation, Telemedicine — Feeling: Fair · Fever · Chills, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Systemic reaction (other): Off & on pain in left ear · Healthcare visit (other): Phone call to primary cares office today- have a telemed appt tmr aft

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-08
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-09
Survey response — days 1–6 daily, dose 2
MedDRA: Hypotension, Telemedicine — Feeling: Poor · Fever · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Systemic reaction (other): Very low BP: 92/50 this am · Healthcare visit (other): Telemed Appt with nurse practitioner

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-09
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-10
Health check-in — day 7, dose 2
Feeling: Good · Fatigue or tiredness · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Adult check-in
2021-02-10
Report sent to call center — day 7, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-17
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-24
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-03
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-10
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-17
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-05
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-07-22
Call 1 — Left Voicemail
2021-08-04
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-08-19
Dose 3 — Pfizer-BioNTech
2021-10-04
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2021-11-18
Survey response — 3 months, dose 3
MedDRA: Helicobacter infection, Medical counselling, Office visit — Feeling: Good · Get care from a doctor or other healthcare professional

Free text: Symptoms: H-pylori infection post an endoscopy · Healthcare visit (other): Office visit then telemed call to discuss results of endoscopy

MedDRA releases: 2024-11 · check-in free text available
2021-11-18
Report sent to call center — 3 months, dose 3
Get care from a doctor or other healthcare professional

1 call case(s)
2021-11-22
Call successful
Not applicable - Accidental Reporting
2021-11-22
Call successful
Not applicable - Accidental Reporting
2021-11-22
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2021-11-22
Call successful
Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
2022-02-17
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in
2022-03-31
Dose 4 — Pfizer-BioNTech
2022-04-26
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-04-28
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-05-05
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-05-12
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-06-30
Health check-in — 3 months, dose 4
Feeling: Good

Adult check-in
2022-09-29
Survey response — 6 months, dose 4
MedDRA: Pneumonia, Sinusitis — 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

Free text: sinusitis ?pneumonia

MedDRA releases: 2024-11 · check-in free text available
2022-09-29
Report sent to call center — 6 months, dose 4
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)
2022-09-30
Call successful
Not applicable - Accidental Reporting
2023-03-31
Health check-in — 12 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-06	Pfizer-BioNTech
2	2021-02-03	Pfizer-BioNTech
3	2021-08-19	Pfizer-BioNTech	No
4	2022-03-31	Pfizer-BioNTech	No

Call center

5 call center cases

5 successful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 2 — day 21, dose 1

2021-01-27

Symptoms: Seemingly more tired the last two weeks Was not sleeping well at nite...getting abt 4 hrs of sleep. Last nite I slept thru the nite (7 Â½ hrs!!)

Release 3 — day 0, dose 2

2021-02-03

Systemic reaction (other): Just had the 2nd shot at 9 am this morning...so far, very minimal soreness (when moving arm)to report (4:15 pm)

Release 3 — days 1–6 daily, dose 2

2021-02-04

Systemic reaction (other): Though I felt feverish, my temp was normal but I experienced the above symptoms all day. Also took 2 extra strength tylenol last nite at 8 pm. Slept over 9 hrs!

2021-02-05

Systemic reaction (other): No other symptoms

2021-02-07

Systemic reaction (other): Off & on pain in right ear

2021-02-08

Systemic reaction (other): Off & on pain in left ear

Healthcare visit (other): Phone call to primary cares office today- have a telemed appt tmr aft

2021-02-09

Systemic reaction (other): Very low BP: 92/50 this am

Healthcare visit (other): Telemed Appt with nurse practitioner

Release 10 — 3 months, dose 3

2021-11-18

Symptoms: H-pylori infection post an endoscopy

Healthcare visit (other): Office visit then telemed call to discuss results of endoscopy

Release 12 — 6 months, dose 4

2022-09-29

Symptoms: sinusitis ?pneumonia

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
HCVO	Medical counselling	·	·	✓
HCVO	Office visit	·	·	✓
HCVO	Specialist consultation	✓	✓	✓
HCVO	Telemedicine	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Helicobacter infection	·	·	✓
SD	Insomnia	✓	✓	✓
SD	Pneumonia	·	·	✓
SD	Sinusitis	·	·	✓
SRO	Ear pain	✓	✓	✓
SRO	Hypersomnia	✓	✓	✓
SRO	Hypotension	✓	✓	✓
SRO	Pain in extremity	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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