4GV-21730-69309 · OpenVSafe

Timeline

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

2021-01-16
Dose 1 — Pfizer-BioNTech
2021-01-25
Registered in v-safe
2021-01-25
Survey response — day 7, dose 1
MedDRA: Injection site nodule — Feeling: Good · Site: Pain, Redness, Swelling, Itching

Free text: I have a raised, red and hot bump at the injection site that is about 3 inches across. Is this something I should be concerned about?

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-01
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-02-06
Dose 2 — Pfizer-BioNTech
2021-02-08
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-02-09
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-10
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-11
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-02-12
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Headache · Be unable to do your normal daily activities

Adult check-in
2021-02-13
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-02-28
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-03-06
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-03-14
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-21
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-05-09
Survey response — 3 months, dose 2
MedDRA: Injection site pain, Injection site swelling — Feeling: Good

Free text: So strange but I have had recurring tenderness and swelling in the injection site.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-08-07
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2021-09-27
Dose 3 — Pfizer-BioNTech
Co-administered: Flu
2021-09-28
Survey response — days 1–6 daily, dose 3
MedDRA: Arthralgia, Back pain, Insomnia, Pain in extremity — Feeling: Fair · Site: Pain, Redness, Swelling · Fever · Chills, Headache, Joint pains · Be unable to do your normal daily activities

Free text: I have full arm and wrist pain in the injection arm. I also gave back pain on that side. Difficult to sleep.

MedDRA releases: 2024-11 · check-in free text available
2021-09-29
Health check-in — days 1–6 daily, dose 3
Feeling: Fair · Site: Pain, Redness, Swelling · Chills, Joint pains · Be unable to do your normal daily activities

Adult check-in
2021-09-30
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain, Redness, Swelling · Headache, Joint pains, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-10-01
Survey response — days 1–6 daily, dose 3
MedDRA: Arthralgia — Feeling: Fair · Site: Pain, Redness, Swelling · Joint pains, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: A lot of very bad wrist pain in injection arm.

MedDRA releases: 2024-11 · check-in free text available
2021-10-02
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain, Redness, Swelling · Joint pains · Be unable to do your normal daily activities

Adult check-in
2021-10-03
Health check-in — days 1–6 daily, dose 3
Feeling: Good · Site: Pain, Redness, Swelling · Headache, Joint pains

Adult check-in
2021-10-04
Health check-in — day 7, dose 3
Feeling: Good · Site: Pain, Redness, Swelling · None

Adult check-in
2021-10-11
Survey response — day 14, dose 3
MedDRA: Constipation, Flatulence, Insomnia — Feeling: Fair · Be unable to do your normal daily activities

Free text: Terrible gas pains and constipation. I don't normally have this problem. Could not sleep, In bathroom all night.

MedDRA releases: 2024-11 · check-in free text available
2021-10-18
Health check-in — day 21, dose 3
Feeling: Good

Adult check-in
2021-10-26
Health check-in — day 28, dose 3
Feeling: Good

Adult check-in
2021-11-01
Health check-in — day 35, dose 3
Feeling: Good

Adult check-in
2021-11-09
Health check-in — day 42, dose 3
Feeling: Good

Adult check-in
2021-12-29
Health check-in — 3 months, dose 3
Feeling: Good

Adult check-in
2022-03-28
Health check-in — 6 months, dose 3
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-01-16	Pfizer-BioNTech
2	2021-02-06	Pfizer-BioNTech
3	2021-09-27	Pfizer-BioNTech	Flu

Free text

Release 2 — day 7, dose 1

2021-01-25

Systemic reaction (other): I have a raised, red and hot bump at the injection site that is about 3 inches across. Is this something I should be concerned about?

Release 8 — 3 months, dose 2

2021-05-09

Symptoms: So strange but I have had recurring tenderness and swelling in the injection site.

Release 9 — days 1–6 daily, dose 3

2021-09-28

Systemic reaction (other): I have full arm and wrist pain in the injection arm. I also gave back pain on that side. Difficult to sleep.

2021-10-01

Systemic reaction (other): A lot of very bad wrist pain in injection arm.

Release 10 — day 14, dose 3

2021-10-11

Symptoms: Terrible gas pains and constipation. I don't normally have this problem. Could not sleep, In bathroom all night.

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	Constipation	·	·	✓
SD	Flatulence	·	·	✓
SD	Injection site pain	✓	✓	✓
SD	Injection site swelling	✓	✓	✓
SD	Insomnia	·	·	✓
SRO	Arthralgia	·	·	✓
SRO	Back pain	·	·	✓
SRO	Injection site nodule	✓	✓	✓
SRO	Insomnia	·	·	✓
SRO	Pain in extremity	·	·	✓

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