ZGF-16512-56118 · OpenVSafe

Timeline

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

2021-03-18
Dose 1 — Pfizer-BioNTech
2021-04-07
Registered in v-safe
2021-04-08
Dose 2 — Pfizer-BioNTech
2021-04-08
Survey response — day 0, dose 2
MedDRA: Swollen tongue — Feeling: Fair · Site: Pain, Swelling, Itching · Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Swelling of my tongue slightly

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-09
Survey response — days 1–6 daily, dose 2
MedDRA: Lymphadenopathy, Swollen tongue — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

Free text: Slightly swollen tongue again - swollen lymph nodes

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-10
Survey response — days 1–6 daily, dose 2
MedDRA: Lymphadenopathy, Swollen tongue — Feeling: Fair · Site: Itching · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Swollen tongue and slightly swollen lymph nodes

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-13
Survey response — days 1–6 daily, dose 2
MedDRA: Muscle twitching, Swollen tongue, Tinnitus — Feeling: Fair · Chills, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Swollen tongue - ringing in ears - nerve twitching in face

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-15
Survey response — day 7, dose 2
MedDRA: Pruritus, Swollen tongue — Feeling: Fair · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Itching on back of neck , swollen tongue - less,

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-22
Survey response — day 14, dose 2
MedDRA: Fatigue, Nausea, Pain, Somnolence — Feeling: Fair · Be unable to work, Be unable to do your normal daily activities

Free text: Nauseous and achy and tired Slight stinging emanation in my stomach area Sleeping a lot more than normal

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-29
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-05-06
Survey response — day 28, dose 2
MedDRA: Nausea — Feeling: Good · Be unable to do your normal daily activities

Free text: Nauseous

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-13
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-05-22
Survey response — day 42, dose 2
MedDRA: Nausea, Rash, Rash pruritic — Feeling: Good

Free text: Nausea frequently Strange rashes bumpy rash on shoulders and frequent itching of the trunk of the body

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-10
Survey response — 3 months, dose 2
MedDRA: Sinus congestion — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Congestion Sinus isdues

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-10
Report sent to call center — 3 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-16
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-18	Pfizer-BioNTech
2	2021-04-08	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-07-10	Unsuccessful

Free text

Release 7 — day 0, dose 2

2021-04-08

Systemic reaction (other): Swelling of my tongue slightly

Release 7 — days 1–6 daily, dose 2

2021-04-09

Systemic reaction (other): Slightly swollen tongue again - swollen lymph nodes

2021-04-10

Systemic reaction (other): Swollen tongue and slightly swollen lymph nodes

2021-04-13

Systemic reaction (other): Swollen tongue - ringing in ears - nerve twitching in face

Release 7 — day 7, dose 2

2021-04-15

Systemic reaction (other): Itching on back of neck , swollen tongue - less,

Release 7 — day 14, dose 2

2021-04-22

Symptoms: Nauseous and achy and tired Slight stinging emanation in my stomach area Sleeping a lot more than normal

Release 8 — day 28, dose 2

2021-05-06

Symptoms: Nauseous

Release 8 — day 42, dose 2

2021-05-22

Symptoms: Nausea frequently Strange rashes bumpy rash on shoulders and frequent itching of the trunk of the body

Release 9 — 3 months, dose 2

2021-07-10

Symptoms: Congestion Sinus isdues

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	Fatigue	✓	✓	✓
SD	Nausea	✓	✓	✓
SD	Pain	✓	✓	✓
SD	Rash	✓	✓	✓
SD	Rash pruritic	✓	✓	✓
SD	Sinus congestion	✓	✓	✓
SD	Somnolence	✓	✓	✓
SRO	Lymphadenopathy	✓	✓	✓
SRO	Muscle twitching	✓	✓	✓
SRO	Pruritus	✓	✓	✓
SRO	Swollen tongue	✓	✓	✓
SRO	Tinnitus	✓	✓	✓

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