2V5-16312-63967

2 vaccinations 7 coded responses 25 check-ins 7 free-text entries 0 call cases

Sex: Female
Age at first dose: 51-55
ZIP prefix: 088 / NJ
Registered: 2021-04-07

Relationship: Self
Race: White
Ethnicity: Not Hispanic or Latino

Timeline Vaccinations Free text MedDRA terms

Timeline

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

2021-04-07
Registered in v-safe
2021-04-07
Dose 1 — Pfizer-BioNTech
2021-04-07
Health check-in — day 0, dose 1
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2021-04-08
Survey response — days 1–6 daily, dose 1
MedDRA: Blood pressure decreased, Body temperature decreased, Headache, Hypotension, Injection site pain, Self-medication — Feeling: Good · Site: Pain · Headache, Muscle or body aches

Free text: Last night, approx 12 hours after injection, severe headache with quick onset. I do experience para sympathetic response at times and that kicked in at that time. My body temp and blood pressure both went down. It did lessen overnight and I took Tylenol pm at onset. Mild headache at 4am still, over by 6am with just pain at the injection site today

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-09
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-10
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-12
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-13
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-14
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-04-21
Survey response — day 14, dose 1
MedDRA: Erythema, Pain in extremity, Pruritus, Rash papular — Feeling: Good

Free text: The morning of day 8, I had a small red area on my arm. By the afternoon, it was considerably larger, raised, swollen, itchy and painful - rash like and warm to touch.Gone after a few days

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-28
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-05-05
Dose 2 — Pfizer-BioNTech
2021-05-05
Survey response — day 0, dose 2
MedDRA: Body temperature increased, Hypertension — Feeling: Poor · Site: Pain · Headache, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Parasympathetic response kicked in less than 5 hours after shot, blood pressure and body temperature are down

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-06
Survey response — days 1–6 daily, dose 2
MedDRA: Blood pressure decreased, Body temperature decreased, Impaired driving ability, Impaired work ability, Pre-existing disease — Feeling: Fair · Site: Pain, Swelling · Headache, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Free text: Parasympathetic response is still occurring but at lesser intensity. Have not lost consciousness yet although blood pressure and body temp went down considerably last evening. Not comfortable driving or going to work today, need to be sure it all stabilizes first

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-07
Survey response — days 1–6 daily, dose 2
MedDRA: Autonomic neuropathy, Reduced parasympathetic activity — Feeling: Fair · Site: Pain, Swelling · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Parasympathetic response is milder, but still occurring

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-08
Survey response — days 1–6 daily, dose 2
MedDRA: Cholinergic syndrome, Therapeutic response unexpected — Feeling: Fair · Site: Pain · Headache

Free text: Parasympathetic response has abated at this point

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-09
Survey response — days 1–6 daily, dose 2
MedDRA: Dizziness — Feeling: Fair · Headache

Free text: Dizziness

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-10
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Headache

Adult check-in
2021-05-11
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Headache

Adult check-in
2021-05-12
Health check-in — day 7, dose 2
Feeling: Good · Headache

Adult check-in
2021-05-19
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-05-26
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-06-02
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-06-09
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-06-16
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-08-04
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-11-03
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-07	Pfizer-BioNTech
2	2021-05-05	Pfizer-BioNTech

Free text

Release 7 — days 1–6 daily, dose 1

2021-04-08

Systemic reaction (other): Last night, approx 12 hours after injection, severe headache with quick onset. I do experience para sympathetic response at times and that kicked in at that time. My body temp and blood pressure both went down. It did lessen overnight and I took Tylenol pm at onset. Mild headache at 4am still, over by 6am with just pain at the injection site today

Release 7 — day 14, dose 1

2021-04-21

Symptoms: The morning of day 8, I had a small red area on my arm. By the afternoon, it was considerably larger, raised, swollen, itchy and painful - rash like and warm to touch.Gone after a few days

Release 8 — day 0, dose 2

2021-05-05

Systemic reaction (other): Parasympathetic response kicked in less than 5 hours after shot, blood pressure and body temperature are down

Release 8 — days 1–6 daily, dose 2

2021-05-06

Systemic reaction (other): Parasympathetic response is still occurring but at lesser intensity. Have not lost consciousness yet although blood pressure and body temp went down considerably last evening. Not comfortable driving or going to work today, need to be sure it all stabilizes first

2021-05-07

Systemic reaction (other): Parasympathetic response is milder, but still occurring

2021-05-08

Systemic reaction (other): Parasympathetic response has abated at this point

2021-05-09

Systemic reaction (other): Dizziness

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	Erythema	✓	✓	✓
SD	Pain in extremity	✓	✓	✓
SD	Pruritus	✓	✓	✓
SD	Rash papular	✓	✓	✓
SRO	Autonomic neuropathy	○	✓	○
SRO	Blood pressure decreased	✓	✓	✓
SRO	Body temperature decreased	✓	✓	✓
SRO	Body temperature increased	✓	✓	✓
SRO	Cholinergic syndrome	○	✓	○
SRO	Dizziness	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Hypertension	✓	✓	✓
SRO	Hypotension	✓	✓	○
SRO	Impaired driving ability	✓	✓	✓
SRO	Impaired work ability	✓	✓	✓
SRO	Injection site pain	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Reduced parasympathetic activity	✓	·	✓
SRO	Self-medication	✓	✓	✓
SRO	Therapeutic response unexpected	✓	·	✓

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