ZDK-15641-54626 · OpenVSafe

Timeline

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

2021-02-11
Dose 1 — Moderna
2021-02-14
Registered in v-safe
2021-02-14
Survey response — days 1–6 daily, dose 1
MedDRA: Lip swelling, Self-medication — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Saturday 2/13 I woke up with a very swollen lower lip. Took Benadryl and in a couple hours it subsided. I read that cosmetic procedures could cause that with Moderna, but Ive had No such procedures.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-14
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-02-15
Survey response — days 1–6 daily, dose 1
MedDRA: Lip swelling, Self-medication, Tongue discomfort — Feeling: Good

Free text: 2 days after shot my lower lip was significantly swollen and (not previously mentioned) my areas on my tongue burned. Benadryl Reduced lip swelling in a few hours. Tongue is took another day to resolve.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-16
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-02-17
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-02-18
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-02-25
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-03-04
Survey response — day 21, dose 1
MedDRA: Lip swelling, Medical counselling, Self-medication, Tongue discomfort — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: #1 Moderna vaccine 2/11. Lower lip swelled and tongue burned 2/13. On 3/1 happened again. Took Benadryl each time. 2/13 lip got better in few hours. 3/1 lip all better in 30 min. Tongue burning persists. Advised NOT to get #2 shot!

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-04
Report sent to call center — day 21, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-11
Health check-in — day 28, dose 1
Feeling: Good

Adult check-in
2021-08-02
Call 1 — Left Voicemail
2021-08-12
Survey response — 6 months, dose 1
MedDRA: Lip swelling — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Intermittent lip swelling that would last about 6 hours

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-12
Report sent to call center — 6 months, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-08-17
Call 1 — Left Voicemail
2021-08-17
Call successful
Reported to VAERS voluntarily prior to GDIT contact
2022-02-13
Survey response — 12 months, dose 1
MedDRA: Lip swelling, Office visit, Reaction to previous exposure to any vaccine, Swelling face, Telemedicine — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Symptoms: My lips and cheek swelled a couple days after the first and after the second vaccine. Also a couple days after flu shot! This never happened before Moderna #1. · Healthcare visit (other): Telemedicine and later an allergist

MedDRA releases: 2024-11 · check-in free text available
2022-02-13
Report sent to call center — 12 months, dose 1
Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2022-02-15
Call successful
Reported to VAERS voluntarily prior to GDIT contact

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-11	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2021-02-14	Successful	Reported to VAERS voluntarily prior to GDIT contact
2021-03-04	Successful	Reported to VAERS voluntarily prior to GDIT contact
2021-08-12	Successful 2021-08-17	Reported to VAERS voluntarily prior to GDIT contact
2022-02-13	Successful 2022-02-15	Reported to VAERS voluntarily prior to GDIT contact

Free text

Release 4 — days 1–6 daily, dose 1

2021-02-14

Systemic reaction (other): Saturday 2/13 I woke up with a very swollen lower lip. Took Benadryl and in a couple hours it subsided. I read that cosmetic procedures could cause that with Moderna, but Ive had No such procedures.

2021-02-15

Systemic reaction (other): 2 days after shot my lower lip was significantly swollen and (not previously mentioned) my areas on my tongue burned. Benadryl Reduced lip swelling in a few hours. Tongue is took another day to resolve.

Release 5 — day 21, dose 1

2021-03-04

Symptoms: #1 Moderna vaccine 2/11. Lower lip swelled and tongue burned 2/13. On 3/1 happened again. Took Benadryl each time. 2/13 lip got better in few hours. 3/1 lip all better in 30 min. Tongue burning persists. Advised NOT to get #2 shot!

Release 9 — 6 months, dose 1

2021-08-12

Symptoms: Intermittent lip swelling that would last about 6 hours

Release 11 — 12 months, dose 1

2022-02-13

Symptoms: My lips and cheek swelled a couple days after the first and after the second vaccine. Also a couple days after flu shot! This never happened before Moderna #1.

Healthcare visit (other): Telemedicine and later an allergist

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	Office visit	·	·	✓
HCVO	Telemedicine	·	·	✓
SD	Lip swelling	✓	✓	✓
SD	Medical counselling	✓	✓	✓
SD	Reaction to previous exposure to any vaccine	·	·	✓
SD	Self-medication	✓	✓	✓
SD	Swelling face	·	·	✓
SD	Tongue discomfort	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Tongue discomfort	✓	✓	✓

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