2XM-75648-31930

2 vaccinations 9 coded responses 19 check-ins 9 free-text entries 3 call cases

Sex: Female
Age at first dose: 51-55
ZIP prefix: 319 / GA
Registered: 2021-01-09

Relationship: Self
Race: Black or African American
Ethnicity: Not Hispanic or Latino

Timeline

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

2021-01-08
Dose 1 — Pfizer-BioNTech
2021-01-09
Registered in v-safe
2021-01-09
Survey response — days 1–6 daily, dose 1
MedDRA: Injection site rash, Pruritus, Rash, Self-medication — Feeling: Poor · Site: Pain, Swelling · Headache, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

Free text: Rash is around injection site I broke out in a rash on my face and back of head (I have no hair) and my body was itchy started last night.... I did take Tylenol as instructed by provider after taking the shot which was a couple of hours afterwards, also I did take Zyrtec over an hour ago.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-09
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-10
Survey response — days 1–6 daily, dose 1
MedDRA: Rash, Swelling face — Feeling: Fair · Site: Swelling · Nausea, Abdominal pain · Be unable to do your normal daily activities

Free text: Still have rash on head and swelling in face as well as yesterday 01-09-21....

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-10
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities

1 call case(s)
2021-01-12
Survey response — days 1–6 daily, dose 1
MedDRA: Rash, Swelling face — Feeling: Fair · Rash, not including the immediate area around the injection site

Free text: Still have rash on head somewhat spreading and face still slightly swollen, rash is starting to go away somewhat on face....

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-13
Survey response — days 1–6 daily, dose 1
MedDRA: Feeling abnormal, Office visit, Pruritus, Rash, Swelling — Feeling: Poor · Headache, Fatigue or tiredness, Abdominal pain, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Slight rash on face and head, itchy and feel swollen.... · Healthcare visit (other): Occupational Health Clinic at workplace....Didn't feel as bad when seen was just keeping them aware and if I needed to get the second dose. Right now not feeling my best....

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-13
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-14
Survey response — days 1–6 daily, dose 1
MedDRA: Generalised oedema, Pruritus, Rash, Swelling face — Feeling: Fair · Fatigue or tiredness, Nausea, Abdominal pain

Free text: Body and face still feels swollen, itchy, slight rash still on head- getting better.... I feel worse at night

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-15
Survey response — day 7, dose 1
MedDRA: Oedema peripheral, Rash, Swelling face — Feeling: Fair · Fatigue or tiredness

Free text: Rash is getting better on head and look like its starting to get better on face.... still look and feel swollen face, hands, and body.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-22
Health check-in — day 14, dose 1
Feeling: Fair

Adult check-in
2021-02-01
Dose 2 — Pfizer-BioNTech
2021-02-05
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Swelling · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-02-06
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-02-07
Survey response — days 1–6 daily, dose 2
MedDRA: Pruritus, Rash — Feeling: Poor · Site: Pain · Joint pains, Muscle or body aches, Rash, not including the immediate area around the injection site

Free text: Itchy and rash on body

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-08
Survey response — day 7, dose 2
MedDRA: Rash — Feeling: Fair · Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: Rash on face and body l

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-15
Health check-in — day 14, dose 2
Feeling: Fair

Adult check-in
2021-02-22
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-01
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-01
Call successful
Participant prefers to complete VAERS report online
2021-03-08
Health check-in — day 35, dose 2
Feeling: Fair

Adult check-in
2021-03-15
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-05-05
Survey response — 3 months, dose 2
MedDRA: Rash, Swelling — Feeling: Fair · Be unable to do your normal daily activities

Free text: Breaking out with off and on rashes, still feeling like Im swollen and more problems with my arms and hands hurting and swollen Have not been to doctor but will have to go because arms and hands are getting worse.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-08-03
Health check-in — 6 months, dose 2
Feeling: Fair

Adult check-in
2022-02-06
Health check-in — 12 months, dose 2
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-08	Pfizer-BioNTech
2	2021-02-01	Pfizer-BioNTech

Call center

3 call center cases

3 successful

See the call center timeline

Free text

Release 1 — days 1–6 daily, dose 1

2021-01-09

Systemic reaction (other): Rash is around injection site I broke out in a rash on my face and back of head (I have no hair) and my body was itchy started last night.... I did take Tylenol as instructed by provider after taking the shot which was a couple of hours afterwards, also I did take Zyrtec over an hour ago.

2021-01-10

Systemic reaction (other): Still have rash on head and swelling in face as well as yesterday 01-09-21....

2021-01-12

Systemic reaction (other): Still have rash on head somewhat spreading and face still slightly swollen, rash is starting to go away somewhat on face....

2021-01-13

Systemic reaction (other): Slight rash on face and head, itchy and feel swollen....

Healthcare visit (other): Occupational Health Clinic at workplace....Didn't feel as bad when seen was just keeping them aware and if I needed to get the second dose. Right now not feeling my best....

Release 2 — days 1–6 daily, dose 1

2021-01-14

Systemic reaction (other): Body and face still feels swollen, itchy, slight rash still on head- getting better.... I feel worse at night

Release 2 — day 7, dose 1

2021-01-15

Systemic reaction (other): Rash is getting better on head and look like its starting to get better on face.... still look and feel swollen face, hands, and body.

Release 3 — days 1–6 daily, dose 2

2021-02-07

Systemic reaction (other): Itchy and rash on body

Release 3 — day 7, dose 2

2021-02-08

Systemic reaction (other): Rash on face and body l

Release 8 — 3 months, dose 2

2021-05-05

Symptoms: Breaking out with off and on rashes, still feeling like Im swollen and more problems with my arms and hands hurting and swollen Have not been to doctor but will have to go because arms and hands are getting worse.

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	Feeling abnormal	✓	✓	✓
HCVO	Office visit	✓	✓	✓
SD	Rash	✓	✓	✓
SD	Swelling	✓	✓	✓
SRO	Exfoliative rash	○	○	○
SRO	Generalised oedema	✓	✓	✓
SRO	Injection site rash	✓	✓	✓
SRO	Oedema peripheral	✓	✓	✓
SRO	Pruritus	✓	✓	✓
SRO	Rash	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Swelling	✓	✓	✓
SRO	Swelling face	✓	✓	✓

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