XWE-55364-49096 · OpenVSafe

Timeline

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

2021-03-08
Registered in v-safe
2021-03-08
Dose 1 — Pfizer-BioNTech
2021-03-08
Survey response — 0 day, dose 1
MedDRA: Immediate post-injection reaction, Lip swelling, Nausea, Paraesthesia oral, Swollen tongue — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-09
Survey response — days 1–6 daily, dose 1
MedDRA: Diarrhoea — Feeling: Good · Site: Pain

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-10
Survey response — days 1–6 daily, dose 1
MedDRA: Fatigue, Pain — Feeling: Good · Muscle or body aches, Fatigue or tiredness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-12
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-13
Survey response — days 1–6 daily, dose 1
MedDRA: Gingival pain — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-14
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-03-15
Health check-in — 7 day, dose 1
Feeling: Good · None

Adult check-in
2021-03-25
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-03-29
Dose 2 — Pfizer-BioNTech
2021-03-29
Survey response — 0 day, dose 2
MedDRA: Paraesthesia oral, Vertigo — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-30
Survey response — days 1–6 daily, dose 2
MedDRA: Nausea, Pain in extremity — Feeling: Good · Nausea · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-03-31
Survey response — days 1–6 daily, dose 2
MedDRA: Lip pain, Oral discomfort — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-02
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-03
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-04
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-05
Health check-in — 7 day, dose 2
Feeling: Good · None

Adult check-in
2021-04-12
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-04-19
Survey response — 21 day, dose 2
MedDRA: Cough, Paranasal sinus discomfort, SARS-CoV-2 test negative — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-04-26
Survey response — 28 day, dose 2
MedDRA: Faeces soft, Nausea — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-05-03
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-05-10
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-06-28
Health check-in — 3 month, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-08	Pfizer-BioNTech
2	2021-03-29	Pfizer-BioNTech

Free text

Release 5

Systemic reaction (other): tingling of lips and tip of tongue for 5 min right after injection... no tingling after that... lips and tongue feel a tiny bit swollen on and off... it comes and goes... very slight nausea for 2 to 3 hrs after shot.... very slight... no breathing problems at all

Systemic reaction (other): loose stools... not bad but there

Systemic reaction (other): very very veey mild on both fatigue and aches...

Systemic reaction (other): gums are sensitive

Release 6

Systemic reaction (other): about 3 seconds of vertigo every 20 to 30 min since 2nd shot... lips feel a tiny bit sensitive... per dr i did take 1 benadryl about 30 min before vaccine due to tingling tip of tongue and lips after covid first shot

Systemic reaction (other): arm sore last nite, better today... minor nausea this morning, gone now

Systemic reaction (other): no symptoms today .. note... forgot to report that had lip sensitivity and burning day of shot and day after... it's gone now

Release 7

Symptoms: prob allergies... cough and sinus pressure... gpt better and then came back... no fever... covid test done 4/16/2021- negative

Release 8

Symptoms: soft stools last 2 mornings... gets better by afternoon... slight nausea after walking today- just did half of my normal 6.2 miles due to slight nausea

Free-text releases are not linked to a specific 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	Cough	✓	✓	✓
SD	Faeces soft	✓	✓	✓
SD	Nausea	✓	✓	✓
SD	Paranasal sinus discomfort	✓	✓	✓
SD	SARS-CoV-2 test negative	✓	✓	✓
SRO	Diarrhoea	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Gingival pain	✓	✓	✓
SRO	Immediate post-injection reaction	✓	✓	✓
SRO	Lip pain	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Nausea	✓	✓	✓
SRO	Oral discomfort	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pain in extremity	✓	✓	✓
SRO	Paraesthesia oral	✓	✓	✓
SRO	Swollen tongue	✓	✓	✓
SRO	Vertigo	✓	✓	✓

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