ZGX-17654-46295 · OpenVSafe

Timeline

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

2021-03-10
Dose 1 — Pfizer-BioNTech
2021-03-31
Registered in v-safe
2021-03-31
Survey response — day 21, dose 1
MedDRA: Anaphylactic reaction, Headache, Immediate post-injection reaction, Nausea, Self-medication — Feeling: Fair · Be unable to do your normal daily activities

Free text: I had an anaphylactic reaction 50 minutes after receiving the first shot Then again at 24 hours and at 48 hours. The 3rd day I experienced nausea and headache I took Benadryl. My PCP advised not to have the 2nd shot.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-02
Dose 2 — Pfizer-BioNTech
2021-04-02
Survey response — day 0, dose 2
MedDRA: Unevaluable event — Feeling: Good

Free text: I took 1 Benadryl pill 45minutes before receiving 2nd dose.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-03
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain, Swelling · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-04-04
Survey response — days 1–6 daily, dose 2
MedDRA: Feeling abnormal — Feeling: Fair · Site: Pain · Fever · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Like my head is in the clouds

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-05
Survey response — days 1–6 daily, dose 2
MedDRA: Fatigue — Feeling: Fair · Site: Pain, Swelling · Fever · Chills, Headache, Fatigue or tiredness, Nausea

Free text: Symptoms were not constant other than the fatigue.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-06
Survey response — days 1–6 daily, dose 2
MedDRA: Feeling cold, Hyperhidrosis, Nausea — Feeling: Fair · Fatigue or tiredness, Nausea

Free text: Nausea was for an hour this morning. Felt cold then started sweating.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-07
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Fatigue or tiredness, Nausea

Adult check-in
2021-04-08
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-04-09
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-16
Survey response — day 14, dose 2
MedDRA: Constipation, Flatulence — Feeling: Good

Free text: Constipation and severe intestinal gas for 3 days this week. Spent much time running to the toilet.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-23
Survey response — day 21, dose 2
MedDRA: Abdominal discomfort, Fatigue, Flatulence, Nausea — Feeling: Fair

Free text: Intestinal discomfort and gas, nausea, fatigue even with extra sleep the night before.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-30
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-07
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-05-14
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-07-02
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-10-03
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-04-02
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-10	Pfizer-BioNTech
2	2021-04-02	Pfizer-BioNTech

Free text

Release 6 — day 21, dose 1

2021-03-31

Symptoms: I had an anaphylactic reaction 50 minutes after receiving the first shot Then again at 24 hours and at 48 hours. The 3rd day I experienced nausea and headache I took Benadryl. My PCP advised not to have the 2nd shot.

Release 6 — day 0, dose 2

2021-04-02

Systemic reaction (other): I took 1 Benadryl pill 45minutes before receiving 2nd dose.

Release 6 — days 1–6 daily, dose 2

2021-04-04

Systemic reaction (other): Like my head is in the clouds

2021-04-05

Systemic reaction (other): Symptoms were not constant other than the fatigue.

Release 7 — days 1–6 daily, dose 2

2021-04-06

Systemic reaction (other): Nausea was for an hour this morning. Felt cold then started sweating.

Release 7 — day 14, dose 2

2021-04-16

Symptoms: Constipation and severe intestinal gas for 3 days this week. Spent much time running to the toilet.

Release 7 — day 21, dose 2

2021-04-23

Symptoms: Intestinal discomfort and gas, nausea, fatigue even with extra sleep the night before.

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	Abdominal discomfort	✓	✓	✓
SD	Anaphylactic reaction	✓	✓	✓
SD	Constipation	✓	✓	✓
SD	Fatigue	✓	✓	✓
SD	Flatulence	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Immediate post-injection reaction	✓	✓	✓
SD	Nausea	✓	✓	✓
SD	Self-medication	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Feeling abnormal	✓	✓	✓
SRO	Feeling cold	✓	✓	✓
SRO	Hyperhidrosis	✓	✓	✓
SRO	Nausea	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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