XVM-23182-46204 · OpenVSafe

Timeline

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

2021-01-04
Registered in v-safe
2021-01-04
Dose 1 — Pfizer-BioNTech
2021-01-04
Health check-in — 0 day, dose 1
Feeling: Good · Site: Pain, Swelling · Diarrhea

Adult check-in
2021-01-06
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Site: Pain, Swelling · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-07
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-08
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Headache, Joint pains, Muscle or body aches

Adult check-in
2021-01-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-10
Survey response — days 1–6 daily, dose 1
MedDRA: Muscle spasms, Pain in extremity — Feeling: Good · Muscle or body aches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-11
Health check-in — 7 day, dose 1
Feeling: Good · Diarrhea

Adult check-in
2021-01-18
Survey response — 14 day, dose 1
MedDRA: Headache — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-25
Dose 2 — Pfizer-BioNTech
2021-01-25
Health check-in — 0 day, dose 2
Feeling: Fair · Site: Pain · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-26
Survey response — days 1–6 daily, dose 2
MedDRA: Sinus pain — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to work, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-27
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fever · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2021-01-28
Survey response — days 1–6 daily, dose 2
MedDRA: Dizziness — Feeling: Fair · Fever · Headache, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-01-29
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-30
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-01
Survey response — 7 day, dose 2
MedDRA: Adverse reaction, Asthma, Hypersensitivity, Increased upper airway secretion, Productive cough — Feeling: Fair

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-08
Health check-in — 14 day, dose 2
Feeling: Good

Adult check-in
2021-02-15
Survey response — 21 day, dose 2
MedDRA: Increased viscosity of upper respiratory secretion — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-22
Survey response — 28 day, dose 2
MedDRA: Abdominal distension, Chest discomfort, Medical counselling, Pre-existing disease, Respiratory tract congestion — Feeling: Fair · Get care from a doctor or other healthcare professional

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-02-22
Report sent to call center — 28 day, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-01
Health check-in — 35 day, dose 2
Feeling: Good

Adult check-in
2021-03-08
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2021-04-26
Survey response — 3 month, dose 2
MedDRA: Ear discomfort, Ear pain — Feeling: Good

MedDRA releases: 2021-09,2023-04,2024-11 · check-in answers available
2021-07-26
Health check-in — 6 month, dose 2
Feeling: Good

Adult check-in
2021-08-16
Call 1 — Could Not Reach Participant
2021-08-19
Call 2 — Left Voicemail
2022-01-25
Health check-in — 12 month, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-04	Pfizer-BioNTech
2	2021-01-25	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-02-22	Unsuccessful

Free text

Release 1

Systemic reaction (other): Pain/cramping like a charlie horse in my left poster leg in atea of my calf and behind knee and up my leg a little. This has been going on x2 days ...feels like a charlie horse. Its pretty relentless.

Release 2

Symptoms: Headache

Systemic reaction (other): Sinus pain

Release 3

Systemic reaction (other): Dizziness

Systemic reaction (other): Allergy-type symptoms, lots of mucus in my throat and mild asthma symptoms

Release 4

Symptoms: A lot of thick mucus in the back of my throat.

Symptoms: Chest congestion and tightness, bloating.

Healthcare visit (other): Email correspondence with healthcare provider to request medication as I have underlying asthma and an inflammatory process/disease.

Release 8

Symptoms: Bilateral ear aches, fullness.

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
HCVO	Medical counselling	✓	✓	✓
HCVO	Pre-existing disease	✓	✓	✓
SD	Abdominal distension	✓	✓	✓
SD	Chest discomfort	✓	✓	✓
SD	Ear discomfort	✓	✓	✓
SD	Ear pain	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Increased viscosity of upper respiratory secretion	✓	✓	✓
SD	Respiratory tract congestion	✓	✓	✓
SRO	Adverse reaction	·	·	✓
SRO	Asthma	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Hypersensitivity	✓	✓	○
SRO	Increased upper airway secretion	·	·	✓
SRO	Muscle spasms	✓	✓	✓
SRO	Pain in extremity	✓	✓	✓
SRO	Productive cough	✓	✓	○
SRO	Sinus pain	✓	✓	✓

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