4U2-25248-36551

4 vaccinations 12 coded responses 23 check-ins 12 free-text entries 2 call cases

Sex: Female
Age at first dose: 66+
ZIP prefix: 980 / WA
Registered: 2021-03-07

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

Timeline

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

2021-03-07
Registered in v-safe
2021-03-07
Dose 1 — Pfizer-BioNTech
2021-03-07
Survey response — day 0, dose 1
MedDRA: Chest pain, Dizziness, Pre-existing disease — Feeling: Good · Site: Pain · Headache, Muscle or body aches, Nausea · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Systemic reaction (other): Mild dizziness, mild chest pain same side as injection, EKG normal · Healthcare visit (other): EKG to rule out heart issue. Took 40mg loratadine, 40mg, famotidine, 16mg Methylprednisolone 24, 12, 1 hour before shot ordered by allergy Dr pre med for vaccine due to history of drug/chemical sensitivities.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-07
Report sent to call center — day 0, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-03-08
Survey response — days 1–6 daily, dose 1
MedDRA: Flushing, Hot flush, Sensitisation — Feeling: Fair · Site: Pain, Redness · Headache, Muscle or body aches, Fatigue or tiredness

Free text: Hot red flush on nose & face. I am amine sensitive, maybe vaccine contains amines?

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-10
Survey response — days 1–6 daily, dose 1
MedDRA: No adverse event — Feeling: Good · Site: Pain

Free text: No

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-11
Survey response — days 1–6 daily, dose 1
MedDRA: No adverse event — Feeling: Good

Free text: No

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-12
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-03-14
Survey response — day 7, dose 1
MedDRA: Injection site pain — Feeling: Good

Free text: Injection site is no longer tender

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-27
Dose 2 — Pfizer-BioNTech
2021-03-27
Survey response — day 0, dose 2
MedDRA: No adverse event — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain · Be unable to do your normal daily activities

Free text: No

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-28
Survey response — days 1–6 daily, dose 2
MedDRA: Unevaluable event — Feeling: Fair · Site: Pain · Chills, Headache, Muscle or body aches, Fatigue or tiredness

Free text: Pre med(40mgs ea loratadine&famotidine, 24mg Medrol) 24, 12, & 1 hour prior to shot plus 12 & 24 hours post shot advised by allergy doc

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-29
Survey response — days 1–6 daily, dose 2
MedDRA: Fatigue, Headache — Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness

Free text: Feeling better, fatigue & headache better than yesterday

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-01
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-02
Survey response — days 1–6 daily, dose 2
MedDRA: Condition aggravated, Pain, Pre-existing disease — Feeling: Good · Abdominal pain

Free text: An pain likely food related. Have food intolerances

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-03
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-04-10
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-04-24
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-05-01
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-05-08
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-06-26
Survey response — 3 months, dose 2
MedDRA: Food intolerance — Feeling: Good

Free text: Developed 2 new food intolerances.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-09-25
Survey response — 6 months, dose 2
MedDRA: Chest pain, Cough, Ear pain, Eye pain, Fatigue, Headache, Oropharyngeal pain, SARS-CoV-2 test negative — Feeling: Poor · Be unable to do your normal daily activities

Free text: Since 9/20 Headache & pain behind eyes fatigue sore throat mild chest pain occasional dry cough. Ear/ throat ache Husband has same symptoms Neg Covid test yesterday both if us

MedDRA releases: 2024-11 · check-in free text available
2021-10-20
Dose 3 — Pfizer-BioNTech
2021-11-13
Call 1 — Could Not Reach Participant
2021-11-18
Call 2 — Left Voicemail
2022-03-27
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in
2022-05-12
Dose 4 — Pfizer-BioNTech
2022-05-12
Health check-in — day 0, dose 4
Feeling: Fair · Site: Pain · Fever · Chills, Headache, Fatigue or tiredness

Adult check-in
2022-05-13
Survey response — days 1–6 daily, dose 4
MedDRA: Hypersensitivity, Inflammation — Feeling: Fair · Site: Pain · Fever · Headache, Fatigue or tiredness, Nausea, Diarrhea, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

Free text: Taking H1 & H2 Blockers & steroid to minimize allergy response to vaccine. Some nice symptoms may be from those meds. Also have moderate Inflamation on face, arms, chest, back but no pain or itching

MedDRA releases: 2024-11 · check-in free text available
2022-05-13
Report sent to call center — days 1–6 daily, dose 4
Get care from a doctor or other healthcare professional

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2022-05-16
Health check-in — days 1–6 daily, dose 4
Feeling: Good · Site: Pain · Fatigue or tiredness

Adult check-in
2022-05-17
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-07	Pfizer-BioNTech
2	2021-03-27	Pfizer-BioNTech
3	2021-10-20	Pfizer-BioNTech	No
4	2022-05-12	Pfizer-BioNTech	No

Call center

2 call center cases

2 unsuccessful

1 wait over 3 months for a first call

See the call center timeline

Free text

Release 5 — day 0, dose 1

2021-03-07

Systemic reaction (other): Mild dizziness, mild chest pain same side as injection, EKG normal

Healthcare visit (other): EKG to rule out heart issue. Took 40mg loratadine, 40mg, famotidine, 16mg Methylprednisolone 24, 12, 1 hour before shot ordered by allergy Dr pre med for vaccine due to history of drug/chemical sensitivities.

Release 5 — days 1–6 daily, dose 1

2021-03-08

Systemic reaction (other): Hot red flush on nose & face. I am amine sensitive, maybe vaccine contains amines?

2021-03-10

Systemic reaction (other): No

2021-03-11

Systemic reaction (other): No

Release 5 — day 7, dose 1

2021-03-14

Systemic reaction (other): Injection site is no longer tender

Release 6 — day 0, dose 2

2021-03-27

Systemic reaction (other): No

Release 6 — days 1–6 daily, dose 2

2021-03-28

Systemic reaction (other): Pre med(40mgs ea loratadine&famotidine, 24mg Medrol) 24, 12, & 1 hour prior to shot plus 12 & 24 hours post shot advised by allergy doc

2021-03-29

Systemic reaction (other): Feeling better, fatigue & headache better than yesterday

2021-04-02

Systemic reaction (other): An pain likely food related. Have food intolerances

Release 9 — 3 months, dose 2

2021-06-26

Symptoms: Developed 2 new food intolerances.

Release 9 — 6 months, dose 2

2021-09-25

Symptoms: Since 9/20 Headache & pain behind eyes fatigue sore throat mild chest pain occasional dry cough. Ear/ throat ache Husband has same symptoms Neg Covid test yesterday both if us

Release 11 — days 1–6 daily, dose 4

2022-05-13

Systemic reaction (other): Taking H1 & H2 Blockers & steroid to minimize allergy response to vaccine. Some nice symptoms may be from those meds. Also have moderate Inflamation on face, arms, chest, back but no pain or itching

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	Pre-existing disease	✓	✓	✓
SD	Chest pain	·	·	✓
SD	Cough	·	·	✓
SD	Ear pain	·	·	✓
SD	Eye pain	·	·	✓
SD	Fatigue	·	·	✓
SD	Food intolerance	✓	✓	✓
SD	Headache	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SRO	Chest pain	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Dizziness	✓	✓	✓
SRO	Fatigue	✓	✓	✓
SRO	Flushing	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Hot flush	✓	✓	✓
SRO	Hypersensitivity	·	·	✓
SRO	Inflammation	·	·	✓
SRO	Injection site pain	✓	✓	✓
SRO	No adverse event	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Sensitisation	✓	✓	✓
SRO	Unevaluable event	✓	✓	✓

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