28U-16890-96946 · OpenVSafe

Timeline

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

2021-06-23
Dose 1 — Pfizer-BioNTech
2021-06-24
Registered in v-safe
2021-06-24
Survey response — days 1–6 daily, dose 1
MedDRA: Paraesthesia — Feeling: Fair · Site: Pain

Free text: Tingling, prickly sensation. Started on chest but has spread all over body. No visible rash.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-25
Survey response — days 1–6 daily, dose 1
MedDRA: Ear pruritus, Paraesthesia, Throat irritation — Feeling: Poor · Rash, not including the immediate area around the injection site · 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: Intense pins and needles, tingling all over body. Itching in ears and throat.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-25
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-26
Survey response — days 1–6 daily, dose 1
MedDRA: Ear discomfort, Erythema, Nasal discomfort, Paraesthesia, Pruritus, Rash, Rash erythematous, Throat irritation — Feeling: Fair · Headache, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

Free text: Tingling, like pins and needles over whole body. Spider web like red rash under the skin on arms, chest, stomach, and back. Red face that looks burnt. Itching and burning in ears, nose, and throat.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-26
Report sent to call center — days 1–6 daily, dose 1
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-27
Survey response — days 1–6 daily, dose 1
MedDRA: Ear discomfort, Ear pruritus, Paraesthesia, Throat irritation — Feeling: Fair · Headache, Rash, not including the immediate area around the injection site · Be unable to do your normal daily activities

Free text: Tingling, pins and needles feeling across body. Especially bad on chest, neck, face, scalp. Burning and itching sensation in ears and down throat.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-30
Call 1 — Could Not Reach Participant
2021-07-06
Call 2 — Could Not Reach Participant

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-06-23	Pfizer-BioNTech	No

Call center

2 call center cases

2 unsuccessful

See the call center timeline

Free text

Release 9 — days 1–6 daily, dose 1

2021-06-24

Systemic reaction (other): Tingling, prickly sensation. Started on chest but has spread all over body. No visible rash.

2021-06-25

Systemic reaction (other): Intense pins and needles, tingling all over body. Itching in ears and throat.

2021-06-26

Systemic reaction (other): Tingling, like pins and needles over whole body. Spider web like red rash under the skin on arms, chest, stomach, and back. Red face that looks burnt. Itching and burning in ears, nose, and throat.

2021-06-27

Systemic reaction (other): Tingling, pins and needles feeling across body. Especially bad on chest, neck, face, scalp. Burning and itching sensation in ears and down throat.

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
SRO	Ear discomfort	✓	✓	✓
SRO	Ear pruritus	✓	✓	✓
SRO	Erythema	✓	✓	✓
SRO	Nasal discomfort	✓	✓	✓
SRO	Paraesthesia	✓	✓	✓
SRO	Pruritus	✓	✓	✓
SRO	Rash	✓	✓	✓
SRO	Rash erythematous	✓	✓	✓
SRO	Throat irritation	✓	✓	✓

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