SKK-46558-28868 · OpenVSafe

Timeline

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

2021-03-12
Dose 1 — Moderna
2021-03-19
Registered in v-safe
2021-03-20
Survey response — day 7, dose 1
MedDRA: Breast feeding, Breast pain, Capillary fragility, Eye swelling, Ocular hyperaemia, Pre-existing disease, Rash macular, Rash neonatal — Feeling: Fair · Fever · Fatigue or tiredness, Rash, not including the immediate area around the injection site

Free text: Breast feeding daughter with terrible diaper rash that started 5 days after vaccination- never had a diaper rash in 2 years. I have breast pain that started the day of vaccination. My inner lining of eyes started with extreme redness and blotchy broken capillaries yesterday- worse today. Eyes are swollen- I do not have allergies or had this happen before. I do have autoimmune dz

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-26
Survey response — day 14, dose 1
MedDRA: Oral discomfort, Tongue discomfort — Feeling: Fair

Free text: Lips and tongue burning but do not see anything concerning

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-09
Dose 2 — Moderna
2021-04-16
Survey response — day 7, dose 2
MedDRA: Cheilitis, Lip swelling — Feeling: Fair · Site: Pain, Swelling · Fever · Headache, Joint pains, Fatigue or tiredness, Nausea, Diarrhea, Abdominal pain

Free text: Swollen lips and irritation around lips

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-12	Moderna
2	2021-04-09	Moderna

Free text

Release 6 — day 7, dose 1

2021-03-20

Systemic reaction (other): Breast feeding daughter with terrible diaper rash that started 5 days after vaccination- never had a diaper rash in 2 years. I have breast pain that started the day of vaccination. My inner lining of eyes started with extreme redness and blotchy broken capillaries yesterday- worse today. Eyes are swollen- I do not have allergies or had this happen before. I do have autoimmune dz

Release 6 — day 14, dose 1

2021-03-26

Symptoms: Lips and tongue burning but do not see anything concerning

Release 7 — day 7, dose 2

2021-04-16

Systemic reaction (other): Swollen lips and irritation around lips

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	Oral discomfort	✓	✓	✓
SD	Tongue discomfort	✓	✓	✓
SRO	Breast feeding	✓	✓	✓
SRO	Breast pain	✓	✓	✓
SRO	Capillary fragility	✓	✓	✓
SRO	Cheilitis	✓	✓	✓
SRO	Eye swelling	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Ocular hyperaemia	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Rash macular	✓	✓	✓
SRO	Rash neonatal	○	✓	○

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