5GZ-17588-49275 · OpenVSafe

Timeline

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

2021-03-11
Dose 1 — Pfizer-BioNTech
2021-04-04
Dose 2 — Pfizer-BioNTech
2021-04-20
Registered in v-safe
2021-04-20
Survey response — day 14, dose 2
MedDRA: Chapped lips, Dry mouth, Hypoaesthesia oral, Lip swelling — Feeling: Fair

Free text: Numbness of gums, swollen and cracked lips, and dry mouth. Onset of dry cracked lips and dry mouth around day 18 after first vaccine. Symptoms worsened about a week after second vaccine to include numbing of gums and swollen lips. Symptoms persist.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-27
Health check-in — day 21, dose 2
Feeling: Fair

Adult check-in
2021-05-04
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-11
Survey response — day 35, dose 2
MedDRA: Dry mouth, Lip dry, Mouth swelling, Oral mucosal erythema — Feeling: Poor

Free text: Swelling, redness, and dryness around mouth and on lips. Symptoms temporarily disappeared while on corticosteroid, but 4 days after last dose of treatment (Methylprednisolone 4mg) the symptoms returned.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-19
Survey response — day 42, dose 2
MedDRA: Lip dry, Lip swelling, Swelling face — Feeling: Fair · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Facial swelling around mouth, lip swelling, lip dryness.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-19
Report sent to call center — day 42, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-04
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2022-05-11
Call 1 — Could Not Reach Participant
2022-05-16
Call 2 — Could Not Reach Participant

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-11	Pfizer-BioNTech
2	2021-04-04	Pfizer-BioNTech

Call center

1 call center case

1 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 7 — day 14, dose 2

2021-04-20

Symptoms: Numbness of gums, swollen and cracked lips, and dry mouth. Onset of dry cracked lips and dry mouth around day 18 after first vaccine. Symptoms worsened about a week after second vaccine to include numbing of gums and swollen lips. Symptoms persist. cut off by CDC

Release 8 — day 35, dose 2

2021-05-11

Symptoms: Swelling, redness, and dryness around mouth and on lips. Symptoms temporarily disappeared while on corticosteroid, but 4 days after last dose of treatment (Methylprednisolone 4mg) the symptoms returned.

Release 8 — day 42, dose 2

2021-05-19

Symptoms: Facial swelling around mouth, lip swelling, lip dryness.

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	Chapped lips	✓	✓	✓
SD	Dry mouth	✓	✓	✓
SD	Hypoaesthesia oral	✓	✓	✓
SD	Lip dry	✓	✓	✓
SD	Lip swelling	✓	✓	✓
SD	Mouth swelling	✓	✓	✓
SD	Oral mucosal erythema	✓	✓	✓
SD	Swelling face	✓	✓	✓

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