RLT-19117-94990

4 vaccinations 18 coded responses 40 check-ins 18 free-text entries 4 call cases

Sex: Female
Age at first dose: 36-40
ZIP prefix: 100 / NY
Registered: 2020-12-29

Relationship: Self
Race: White
Ethnicity: Hispanic or Latino

Timeline

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

2020-12-28
Dose 1 — Moderna
2020-12-29
Registered in v-safe
2020-12-29
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain, Redness, Swelling · None

Adult check-in
2020-12-30
Survey response — days 1–6 daily, dose 1
MedDRA: Cheilitis, Oral herpes — Feeling: Good · Site: Pain, Redness, Swelling, Itching

Free text: Started getting some fever blister like sores on my lips. They are moderate

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2020-12-31
Survey response — days 1–6 daily, dose 1
MedDRA: Oral herpes, Self-medication — Feeling: Good · Site: Pain, Redness, Swelling

Free text: Still have 3 fever blister spots on my lips, they are mild & so far not full blown. Am using topical cream to help manage but no antiviral meds

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-01
Survey response — days 1–6 daily, dose 1
MedDRA: Lip disorder, Oral herpes — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Mild fever blisters on my lips (about 3) which I have never had so many at once. I also have some small bumps on my lips like allergies/rash

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-02
Survey response — days 1–6 daily, dose 1
MedDRA: Oral herpes — Feeling: Good

Free text: Moderate fever blisters on my lips, I have multiple ones on top & bottom lips which has never happened to me before

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-03
Survey response — days 1–6 daily, dose 1
MedDRA: Cheilitis, Oral herpes — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Rash on lips, sores on both corners of lips & still have multiple fever blisters on both lips.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-04
Survey response — day 7, dose 1
MedDRA: Cheilitis, Dyskinesia, Oral discomfort, Oral herpes — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Rash & chelitis on lips. Fever blisters have diminished but my lips feel like they are sunburnt & I can't easily open my mouth to talk, smile or eat

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-11
Survey response — day 14, dose 1
MedDRA: Cheilitis, Dermatitis, Oral herpes, Telemedicine — Feeling: Good

Free text: Worsening of fever blisters & cheilitis. Saw MD via telehealth appt & she diagnosed me when herpes viral vesicular dermatitis. It has made eating difficult, smiling hard & also it is painful to wear a mask.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-18
Survey response — day 21, dose 1
MedDRA: Cheilitis — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

Free text: The lip rash is contact dermatitis, not herpes simplex. But the dermatologist isnt sure what caused it, but it seems to be linked to when I got the first dose of the vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-18
Report sent to call center — day 21, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-25
Dose 2 — Moderna
2021-01-25
Survey response — day 0, dose 2
MedDRA: Dermatitis contact, Oral candidiasis, Pre-existing disease — Feeling: Good · Site: Pain · Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

Free text: Still dealing with contact dermatitis & Candida overgrowth around my mouth, but this started after the 1st vaccine. Will monitor changes

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-25
Report sent to call center — day 0, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-26
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Fair · Site: Pain, Redness, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: Still have contact dermatitis from after the first vaccine but it hasnt flared with 2nd dose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-27
Survey response — days 1–6 daily, dose 2
MedDRA: Dermatitis — Feeling: Good · Site: Pain, Redness, Swelling · Rash, not including the immediate area around the injection site

Free text: Still have mild contact dermatitis around my lips. Using nystatin & 2.5% hydrocortisone ointments to help

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-28
Survey response — days 1–6 daily, dose 2
MedDRA: Dermatitis contact, Reaction to previous exposure to any vaccine — Feeling: Good · Site: Pain, Redness · Rash, not including the immediate area around the injection site

Free text: Still have some contact dermatitis around my lips from after the first dose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-29
Survey response — days 1–6 daily, dose 2
MedDRA: Dermatitis contact — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Still have some contact dermatitis around my lips that is resolvong

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-30
Survey response — days 1–6 daily, dose 2
MedDRA: Dermatitis contact — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Still have some of the contact dermatitis around my mouth from after the 1st dose but its getting better

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-31
Survey response — days 1–6 daily, dose 2
MedDRA: Dermatitis — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Still have contact dermatitis a bit around my lips after the first vaccine.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-01
Survey response — day 7, dose 2
MedDRA: Dermatitis contact — Feeling: Good · Rash, not including the immediate area around the injection site

Free text: Still have contact dermatitis around lips from after 1st dose

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-08
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-15
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-22
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-01
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-08
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-03-22
Call 1 — Left Voicemail
2021-03-22
Call 1 — Left Voicemail
2021-03-30
Call 2 — Requested Callback
2021-03-30
Callback requested for
4:45P EST
2021-04-07
Call 2 — Left Voicemail
2021-04-07
Call 3 — Left Voicemail
2021-04-23
Call successful
Participant prefers to complete VAERS report online
2021-04-23
Call successful
Participant prefers to complete VAERS report online
2021-04-26
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-07-27
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-12-22
Dose 3 — Pfizer-BioNTech
2022-01-25
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in
2022-09-18
Dose 4 — Pfizer-BioNTech
2022-09-18
Health check-in — day 0, dose 4
Feeling: Good · Site: Pain · None

Adult check-in
2022-09-19
Health check-in — days 1–6 daily, dose 4
Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities

Adult check-in
2022-09-20
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Fatigue or tiredness

Adult check-in
2022-09-21
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-09-22
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-09-23
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-09-24
Health check-in — days 1–6 daily, dose 4
Feeling: Good · None

Adult check-in
2022-09-25
Survey response — day 7, dose 4
MedDRA: Emergency care, Uterine contractions during pregnancy — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Systemic reaction (other): Had mild contractions last night & had to go to labor & delivery to get monitored. I am 25 weeks pregnant. No sign of preterm labor per what was seen throughout monitoring. · Healthcare visit (other): Went to labor & deliver triage last night

MedDRA releases: 2024-11 · check-in free text available
2022-09-25
Report sent to call center — day 7, dose 4
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Emergency room or emergency department visit · 1 call case(s)
2022-09-27
Call successful
Participant prefers to complete VAERS report online
2022-10-04
Health check-in — day 14, dose 4
Feeling: Good

Adult check-in
2022-10-09
Health check-in — day 21, dose 4
Feeling: Fair

Adult check-in
2022-10-16
Health check-in — day 28, dose 4
Feeling: Fair

Adult check-in
2022-10-23
Health check-in — day 35, dose 4
Feeling: Good

Adult check-in
2022-10-30
Health check-in — day 42, dose 4
Feeling: Good

Adult check-in
2022-12-18
Survey response — 3 months, dose 4
MedDRA: Delivery, Gestational hypertension, Pre-eclampsia — Feeling: Good · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Hospitalization

Free text: Got gestational hypertension & then preeclampsia during labor

MedDRA releases: 2024-11 · check-in free text available
2022-12-18
Report sent to call center — 3 months, dose 4
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

Hospitalization · 1 call case(s)
2022-12-19
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2023-03-19
Health check-in — 6 months, dose 4
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-28	Moderna
2	2021-01-25	Moderna
3	2021-12-22	Pfizer-BioNTech	No
4	2022-09-18	Pfizer-BioNTech	No

Call center

4 call center cases

4 successful

See the call center timeline

Free text

Release 1 — days 1–6 daily, dose 1

2020-12-30

Systemic reaction (other): Started getting some fever blister like sores on my lips. They are moderate

2020-12-31

Systemic reaction (other): Still have 3 fever blister spots on my lips, they are mild & so far not full blown. Am using topical cream to help manage but no antiviral meds

2021-01-01

Systemic reaction (other): Mild fever blisters on my lips (about 3) which I have never had so many at once. I also have some small bumps on my lips like allergies/rash

2021-01-02

Systemic reaction (other): Moderate fever blisters on my lips, I have multiple ones on top & bottom lips which has never happened to me before

2021-01-03

Systemic reaction (other): Rash on lips, sores on both corners of lips & still have multiple fever blisters on both lips.

Release 1 — day 7, dose 1

2021-01-04

Systemic reaction (other): Rash & chelitis on lips. Fever blisters have diminished but my lips feel like they are sunburnt & I can't easily open my mouth to talk, smile or eat

Release 1 — day 14, dose 1

2021-01-11

Symptoms: Worsening of fever blisters & cheilitis. Saw MD via telehealth appt & she diagnosed me when herpes viral vesicular dermatitis. It has made eating difficult, smiling hard & also it is painful to wear a mask.

Release 2 — day 21, dose 1

2021-01-18

Symptoms: The lip rash is contact dermatitis, not herpes simplex. But the dermatologist isnt sure what caused it, but it seems to be linked to when I got the first dose of the vaccine

Release 2 — day 0, dose 2

2021-01-25

Systemic reaction (other): Still dealing with contact dermatitis & Candida overgrowth around my mouth, but this started after the 1st vaccine. Will monitor changes

Release 2 — days 1–6 daily, dose 2

2021-01-26

Systemic reaction (other): Still have contact dermatitis from after the first vaccine but it hasnt flared with 2nd dose

2021-01-27

Systemic reaction (other): Still have mild contact dermatitis around my lips. Using nystatin & 2.5% hydrocortisone ointments to help

Release 3 — days 1–6 daily, dose 2

2021-01-28

Systemic reaction (other): Still have some contact dermatitis around my lips from after the first dose

2021-01-29

Systemic reaction (other): Still have some contact dermatitis around my lips that is resolvong

2021-01-30

Systemic reaction (other): Still have some of the contact dermatitis around my mouth from after the 1st dose but its getting better

2021-01-31

Systemic reaction (other): Still have contact dermatitis a bit around my lips after the first vaccine.

Release 3 — day 7, dose 2

2021-02-01

Systemic reaction (other): Still have contact dermatitis around lips from after 1st dose

Release 12 — day 7, dose 4

2022-09-25

Systemic reaction (other): Had mild contractions last night & had to go to labor & delivery to get monitored. I am 25 weeks pregnant. No sign of preterm labor per what was seen throughout monitoring.

Healthcare visit (other): Went to labor & deliver triage last night

Release 12 — 3 months, dose 4

2022-12-18

Symptoms: Got gestational hypertension & then preeclampsia during labor

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	Emergency care	·	·	✓
SD	Cellulitis	○	○	○
SD	Cheilitis	✓	✓	✓
SD	Delivery	·	·	✓
SD	Dermatitis	✓	✓	✓
SD	Gestational hypertension	·	·	✓
SD	Oral herpes	✓	✓	✓
SD	Pre-eclampsia	·	·	✓
SD	Telemedicine	✓	✓	✓
SRO	Cheilitis	✓	✓	✓
SRO	Dermatitis	✓	✓	✓
SRO	Dermatitis contact	✓	✓	✓
SRO	Dyskinesia	✓	✓	✓
SRO	Emergency care	·	·	✓
SRO	Lip disorder	✓	✓	✓
SRO	Oral candidiasis	✓	✓	✓
SRO	Oral discomfort	✓	✓	✓
SRO	Oral herpes	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Reaction to previous exposure to any vaccine	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓
SRO	Uterine contractions during pregnancy	·	·	✓

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