GLT-11427-10696 · OpenVSafe

Timeline

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

2021-11-17
Dose 1 — Pfizer-BioNTech
2021-11-19
Registered in v-safe
2021-11-19
Survey response — days 1–6 daily, dose 1, dependent
MedDRA: Injection site pain, Pain, Self-medication — Feeling: Good · Site: Pain, Redness

Free text: On 11.17.21 no pain. On 11.18.21 0700 pain at dite when moving arm. By 1800 pain when moving was more severe than the morning and I took acetaminophen..

MedDRA releases: 2024-11 · check-in free text available
2021-11-20
Health check-in — days 1–6 daily, dose 1, dependent
Feeling: Good · Site: Pain · None

Adult check-in
2021-11-21
Health check-in — days 1–6 daily, dose 1, dependent
Feeling: Good · None

Adult check-in
2021-11-28
Health check-in — day 7, dose 1, dependent
Feeling: Good · None

Adult check-in
2021-12-01
Health check-in — day 14, dose 1, dependent
Feeling: Good

Adult check-in
2021-12-08
Health check-in — day 21, dose 1, dependent
Feeling: Good

Adult check-in
2021-12-09
Dose 2 — Pfizer-BioNTech
2021-12-10
Survey response — days 1–6 daily, dose 2, dependent
MedDRA: Injection site pain — Feeling: Good · Site: Pain, Redness, Swelling · Fatigue or tiredness

Free text: Moderate pain when touching site of injection.

MedDRA releases: 2024-11 · check-in free text available
2021-12-12
Health check-in — days 1–6 daily, dose 2, dependent
Feeling: Good · Site: Pain, Redness · None

Adult check-in
2021-12-13
Health check-in — days 1–6 daily, dose 2, dependent
Feeling: Good · Site: Pain, Redness · None

Adult check-in
2021-12-15
Survey response — days 1–6 daily, dose 2, dependent
MedDRA: Myalgia, Pain, Pulmonary embolism — Feeling: Good · Muscle or body aches

Free text: Aches probably due to PE performance test resulting in sore muscles.

MedDRA releases: 2024-11 · check-in free text available
2021-12-18
Health check-in — day 7, dose 2, dependent
Feeling: Good · None

Adult check-in
2021-12-25
Health check-in — day 14, dose 2, dependent
Feeling: Good

Adult check-in
2022-01-01
Health check-in — day 21, dose 2, dependent
Feeling: Good

Adult check-in
2022-01-06
Health check-in — day 28, dose 2, dependent
Feeling: Good

Adult check-in
2022-01-15
Health check-in — day 35, dose 2, dependent
Feeling: Good

Adult check-in
2022-01-22
Health check-in — day 42, dose 2, dependent
Feeling: Good

Adult check-in
2022-03-12
Survey response — 3 months, dose 2, dependent
MedDRA: Oropharyngeal pain — Feeling: Good

Free text: Sore throat

MedDRA releases: 2024-11 · check-in free text available
2022-06-09
Survey response — 6 months, dose 2, dependent
MedDRA: Influenza, Influenza virus test, Nasopharyngitis, SARS-CoV-2 test, SARS-CoV-2 test negative — Feeling: Good · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: Influenza A in April. A cold in end of May (negative for Covid with home test). · Healthcare visit (other): Pediatrician visit and testing to rule out covid and confirm flu diagnosis.

MedDRA releases: 2024-11 · check-in free text available
2022-06-09
Report sent to call center — 6 months, dose 2, dependent
Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

1 call case(s)
2022-06-10
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-11-17	Pfizer-BioNTech	No
2	2021-12-09	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2022-06-09	Successful 2022-06-10	Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill

Free text

Release 10 — days 1–6 daily, dose 1, dependent

2021-11-19

Systemic reaction (other): On 11.17.21 no pain. On 11.18.21 0700 pain at dite when moving arm. By 1800 pain when moving was more severe than the morning and I took acetaminophen..

Release 10 — days 1–6 daily, dose 2, dependent

2021-12-10

Systemic reaction (other): Moderate pain when touching site of injection.

2021-12-15

Systemic reaction (other): Aches probably due to PE performance test resulting in sore muscles.

Release 11 — 3 months, dose 2, dependent

2022-03-12

Symptoms: Sore throat

Release 12 — 6 months, dose 2, dependent

2022-06-09

Symptoms: Influenza A in April. A cold in end of May (negative for Covid with home test).

Healthcare visit (other): Pediatrician visit and testing to rule out covid and confirm flu diagnosis.

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	Influenza virus test	·	·	✓
HCVO	SARS-CoV-2 test	·	·	✓
SD	Influenza	·	·	✓
SD	Nasopharyngitis	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SRO	Injection site pain	·	·	✓
SRO	Myalgia	·	·	✓
SRO	Pain	·	·	✓
SRO	Pulmonary embolism	·	·	✓
SRO	Self-medication	·	·	✓

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