4FY-11620-04390 · OpenVSafe

Timeline

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

2021-01-05
Registered in v-safe
2021-01-05
Dose 1 — Pfizer-BioNTech
2021-01-06
Survey response — days 1–6 daily, dose 1
MedDRA: Dyspnoea, Emergency care, Fatigue, Hypersensitivity, Pharyngeal swelling — Feeling: Poor · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: I had swelling of the back of the throat with shortness of breath all starting around 0220 this morning. I want to the ED and was treated for al allergic reaction. I was given a lot of Benadryl and steroid via IV. I was discharged after a few hours when most of my symptoms improved. Today I just has slight swelling to the throat and fatigue with slight set of the hands.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-06
Report sent to call center — days 1–6 daily, dose 1
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-07
Survey response — days 1–6 daily, dose 1
MedDRA: Dysphagia, Dyspnoea exertional, Pharyngeal swelling, Self-medication — Feeling: Fair · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to work, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Emergency room or emergency department visit

Free text: Systemic reaction (other): Shortness of breath with just mild exertion. Mild swelling in throat still, still difficult to swallow solid foods but manageable. · Healthcare visit (other): Given RX of prednisone and OTC Benadryl 50mg q4h prn

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-07
Report sent to call center — days 1–6 daily, dose 1
Be unable to work · Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-08
Survey response — days 1–6 daily, dose 1
MedDRA: Dyspnoea, Dyspnoea exertional — Feeling: Fair · Joint pains, Muscle or body aches, Fatigue or tiredness

Free text: Shortness of breath, more on exertion

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-10
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Muscle or body aches, Fatigue or tiredness, Nausea

Adult check-in
2021-01-11
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-01-19
Health check-in — day 14, dose 1
Feeling: Fair

Adult check-in
2021-01-26
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-02-10
Call successful
Reported to VAERS voluntarily prior to GDIT contact
2021-02-16
Health check-in — day 42, dose 1
Feeling: Good

Adult check-in
2021-04-06
Health check-in — 3 months, dose 1
Feeling: Good

Adult check-in
2021-07-09
Health check-in — 6 months, dose 1
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-05	Pfizer-BioNTech

Call center

2 call center cases

2 successful

VAERS report filed, before or during a call: 2

See the call center timeline

Free text

Release 1 — days 1–6 daily, dose 1

2021-01-06

Systemic reaction (other): I had swelling of the back of the throat with shortness of breath all starting around 0220 this morning. I want to the ED and was treated for al allergic reaction. I was given a lot of Benadryl and steroid via IV. I was discharged after a few hours when most of my symptoms improved. Today I just has slight swelling to the throat and fatigue with slight set of the hands.

2021-01-07

Systemic reaction (other): Shortness of breath with just mild exertion. Mild swelling in throat still, still difficult to swallow solid foods but manageable.

Healthcare visit (other): Given RX of prednisone and OTC Benadryl 50mg q4h prn

2021-01-08

Systemic reaction (other): Shortness of breath, more on exertion

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
HCVO	Self-medication	✓	✓	✓
HCVO	Unevaluable event	○	○	○
SRO	Dysphagia	✓	✓	✓
SRO	Dyspnoea	✓	✓	✓
SRO	Dyspnoea exertional	✓	✓	✓
SRO	Emergency care	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Hypersensitivity	✓	✓	✓
SRO	Pharyngeal swelling	✓	✓	✓

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