ZV3-43535-72815

4 vaccinations 7 coded responses 31 check-ins 6 free-text entries 1 call case

Sex: Female
Age at first dose: 66+
ZIP prefix: 537 / WI
Registered: 2021-02-12

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

2021-01-29
Dose 1 — Pfizer-BioNTech
2021-02-12
Registered in v-safe
2021-02-12
Survey response — day 14, dose 1
MedDRA: Arthralgia, Fatigue, Insomnia, Joint stiffness, Limb discomfort, Mobility decreased, Muscle spasms, Muscle twitching, Pain in extremity, Pre-existing disease, Shoulder arthroplasty — Feeling: Good · Be unable to do your normal daily activities

Free text: Thus is my first check-in. With 1st shot, 48 hrs very painful arm, leaden, could hardly move it. 48-120 hrs post: my reverse shoulder replacement had joint pain, muscle spasms, twitching that kept me from sleeping. Fatigue 7 days. Next shot: thigh.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-19
Dose 2 — Pfizer-BioNTech
2021-02-19
Survey response — day 0, dose 2
MedDRA: Unevaluable event — Feeling: Fair · Headache, Joint pains

Free text: Not yet. Its only a couple of hours after my shot.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-20
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Joint pains, Muscle or body aches

Adult check-in
2021-02-21
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Redness · None

Adult check-in
2021-02-22
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Redness, Swelling, Itching · None

Adult check-in
2021-02-23
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-02-24
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · None

Adult check-in
2021-02-25
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-28
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-03-05
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-10-20
Dose 3 — Pfizer-BioNTech
2021-11-05
Survey response — day 14, dose 3
MedDRA: Burning sensation, Ear discomfort, Erythema, Feeling hot, Skin burning sensation, Skin warm — Feeling: Good

Free text: The third shot caused me to have a burning hot and bright red face, ears & neck for close to 45 mins around 3-4 hours after the shot. This recurred daily for 5-10 min periods over the next 7 days.

MedDRA releases: 2024-11 · check-in free text available
2021-11-11
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2021-11-17
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2021-11-24
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-12-01
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2022-01-19
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-04-20
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in
2022-04-25
Dose 4 — Pfizer-BioNTech
2022-04-25
Health check-in — day 0, dose 4
Feeling: Fair · Chills, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-04-26
Survey response — days 1–6 daily, dose 4
MedDRA: Headache, Poor quality sleep — Feeling: Good · Site: Pain · Headache, Muscle or body aches

Free text: Mostly a bad headache this morning, nearly gone by afternoon. My sleep last night was very fitful.

MedDRA releases: 2024-11 · check-in free text available
2022-04-27
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-04-28
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-04-29
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Diarrhea

Adult check-in
2022-04-30
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-05-01
Survey response — days 1–6 daily, dose 4
MedDRA: Back pain — Feeling: Fair · Muscle or body aches, Fatigue or tiredness

Free text: Lower back aches

MedDRA releases: 2024-11 · check-in free text available
2022-05-02
Health check-in — day 7, dose 4
Feeling: Fair · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2022-05-09
Survey response — day 14, dose 4
MedDRA: Diarrhoea, Faeces soft, Fatigue, Injection site pain, Injection site pruritus — Feeling: Fair

Free text: (1) Diarrhea/multiple very soft/explosive stools for approximately the past 10 days at least. (2) fatigue (needing more rest). (3) Realized around a week ago that I'm having mild itchy sensation and mild soreness at the thigh shot site.

MedDRA releases: 2024-11 · check-in free text available
2022-05-16
Health check-in — day 21, dose 4
Feeling: Good

Adult check-in
2022-05-23
Health check-in — day 28, dose 4
Feeling: Good

Adult check-in
2022-05-30
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-06-06
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2023-04-25
Survey response — 12 months, dose 4
MedDRA: Asthma, Pneumonia — Feeling: Good · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11
2023-04-25
Report sent to call center — 12 months, dose 4
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2023-04-26
Call 1 — Left Voicemail
2023-04-26
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	2021-01-29	Pfizer-BioNTech
2	2021-02-19	Pfizer-BioNTech
3	2021-10-20	Pfizer-BioNTech	No
4	2022-04-25	Pfizer-BioNTech	No

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 4 — day 14, dose 1

2021-02-12

Symptoms: Thus is my first check-in. With 1st shot, 48 hrs very painful arm, leaden, could hardly move it. 48-120 hrs post: my reverse shoulder replacement had joint pain, muscle spasms, twitching that kept me from sleeping. Fatigue 7 days. Next shot: thigh. cut off by CDC

Release 4 — day 0, dose 2

2021-02-19

Systemic reaction (other): Not yet. Its only a couple of hours after my shot.

Release 10 — day 14, dose 3

2021-11-05

Symptoms: The third shot caused me to have a burning hot and bright red face, ears & neck for close to 45 mins around 3-4 hours after the shot. This recurred daily for 5-10 min periods over the next 7 days.

Release 11 — days 1–6 daily, dose 4

2022-04-26

Systemic reaction (other): Mostly a bad headache this morning, nearly gone by afternoon. My sleep last night was very fitful.

2022-05-01

Systemic reaction (other): Lower back aches

Release 11 — day 14, dose 4

2022-05-09

Symptoms: (1) Diarrhea/multiple very soft/explosive stools for approximately the past 10 days at least. (2) fatigue (needing more rest). (3) Realized around a week ago that I'm having mild itchy sensation and mild soreness at the thigh shot site.

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	Asthma	·	·	✓
SD	Burning sensation	·	·	✓
SD	Diarrhoea	·	·	✓
SD	Ear discomfort	·	·	✓
SD	Erythema	·	·	✓
SD	Faeces soft	·	·	✓
SD	Fatigue	✓	✓	✓
SD	Feeling hot	·	·	✓
SD	Injection site pain	·	·	✓
SD	Injection site pruritus	·	·	✓
SD	Insomnia	✓	✓	✓
SD	Joint stiffness	○	✓	○
SD	Limb discomfort	✓	·	✓
SD	Mobility decreased	✓	·	✓
SD	Muscle spasms	✓	✓	✓
SD	Muscle twitching	✓	✓	✓
SD	Pain in extremity	✓	✓	✓
SD	Pneumonia	·	·	✓
SD	Pre-existing disease	✓	·	✓
SD	Shoulder arthroplasty	○	✓	○
SD	Skin burning sensation	·	·	✓
SD	Skin warm	·	·	✓
SRO	Back pain	·	·	✓
SRO	Headache	·	·	✓
SRO	Poor quality sleep	·	·	✓
SRO	Unevaluable event	✓	✓	✓

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