UAF-58009-57571

2 vaccinations 11 coded responses 18 check-ins 11 free-text entries 2 call cases

Sex: Female
Age at first dose: 51-55
ZIP prefix: 281 / NC
Registered: 2021-02-12

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

2021-02-10
Dose 1 — Pfizer-BioNTech
2021-02-12
Registered in v-safe
2021-02-12
Survey response — days 1–6 daily, dose 1
MedDRA: Abnormal faeces, Arthralgia, Breast pain, Flatulence, Neck pain, Pain, Pain in extremity, Paraesthesia oral, Paranasal sinus discomfort, Paranasal sinus hypersecretion, Pre-existing disease — Feeling: Fair · Site: Pain · Muscle or body aches, Fatigue or tiredness

Free text: Take coumadin PT/INR at 1.5 2/11 day after 1st dose received usually 2 to 2.5. sinus pressure left side, lower leg/calf pain left side, neck pain left side evening of shot 4 hours after shot lips tingling like after teeth filling shot wearing off, drainage into throat same day and minimum yesterday morning. Yesterday had pain in left breast reminded me of shingles pain had 8 years ago, pain in left shoulder better today noticed left forearm mild soreness today,. All other pain symptoms have subsided. Have noticed stools not diarrhea but not normal and excessive gas. Pain symptoms day of shot and yesterday moderate to severe and shoulder pain today mild to moderate

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-14
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Fever · Fatigue or tiredness

Adult check-in
2021-02-15
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Fever · Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-02-17
Survey response — day 7, dose 1
MedDRA: Headache — Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness

Free text: Had headaches yesterday more of a moderate level just forgot to enter data in time

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-02-24
Survey response — day 14, dose 1
MedDRA: Abdominal pain lower, Pain in extremity, Tenderness — Feeling: Fair

Free text: Severe pain right lower abdomen around to back, reminded me of appendicitis pain level started Monday eased off Tuesday just tenderness Tuesday, about 6 pm today Wednesday severe pain same right side with left calf pain if still in am will see doctor

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-03
Dose 2 — Pfizer-BioNTech
2021-03-03
Survey response — day 0, dose 2
MedDRA: Paraesthesia oral, Throat tightness — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Fatigue or tiredness

Free text: 1 or 1 hr 15 min max after shot tingling of tongue and throat tightness experienced

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-04
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fever · Muscle or body aches, Fatigue or tiredness, Nausea, Diarrhea

Adult check-in
2021-03-05
Survey response — days 1–6 daily, dose 2
MedDRA: Hot flush, Night sweats — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Fatigue or tiredness

Free text: Night sweats like hot flashes experienced 2x last night temp checked but no fever

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-06
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2021-03-09
Survey response — days 1–6 daily, dose 2
MedDRA: Hot flush, Pyrexia — Feeling: Good · Fever · Headache, Fatigue or tiredness

Free text: My feverish feeling still feels like hot flashes coming back check temperature each time and no fever noted

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-11
Survey response — day 7, dose 2
MedDRA: Hot flush, Menopausal symptoms — Feeling: Fair · Fever · Headache

Free text: Menopausal hot flashes started again after 2nd shot

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-19
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-03-24
Survey response — day 21, dose 2
MedDRA: Fatigue, Hot flush — Feeling: Fair

Free text: More tired than usual, hot flashes still occurring and have had 99.6 - 99.9 F temp recorded on 2 different occasions

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-31
Survey response — day 28, dose 2
MedDRA: Headache, Hot flush — Feeling: Fair

Free text: Headache, hot flashes still back

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-07
Health check-in — day 35, dose 2
Feeling: Fair

Adult check-in
2021-04-16
Health check-in — day 42, dose 2
Feeling: Fair

Adult check-in
2021-06-02
Survey response — 3 months, dose 2
MedDRA: Hot flush, Irritability, Menopausal symptoms, Postmenopausal haemorrhage, Unevaluable event — Feeling: Fair · Be unable to work, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

Free text: Symptoms: Menstrual cycle occurred last week of April- I am 3 years post menopausal - hot flashes have returned(started day after 2nd shot, occurred 2-3 weeks, went away & came back with period), very irritable at times, have racked up $1000s of medical bill · Healthcare visit (other): Still working on diagnosis with many doctors to rule out cancer or determine if vaccine issue

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-02
Report sent to call center — 3 months, dose 2
Be unable to work · Get care from a doctor or other healthcare professional

1 call case(s)
2021-09-03
Survey response — 6 months, dose 2
MedDRA: Anovulatory cycle, Exposure to SARS-CoV-2, Hot flush, Menstruation irregular, Postmenopause, Uterine dilation and curettage — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit

Free text: 2-3 years post meno-hot flashes started day of 2nd shot & ovulated once with 1 week period in April-multiple tests & surgery (D&C) to rule out uterine cancer all tests negative thankfully-no additional menstrual cycles-husband has body aches & covid+

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-09-03
Report sent to call center — 6 months, dose 2
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)
2021-09-08
Call 1 — Could Not Reach Participant
2021-09-13
Call 2 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-02-10	Pfizer-BioNTech
2	2021-03-03	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-06-02	Unsuccessful
2021-09-03	Unsuccessful

Free text

Release 4 — days 1–6 daily, dose 1

2021-02-12

Systemic reaction (other): Take coumadin PT/INR at 1.5 2/11 day after 1st dose received usually 2 to 2.5. sinus pressure left side, lower leg/calf pain left side, neck pain left side evening of shot 4 hours after shot lips tingling like after teeth filling shot wearing off, drainage into throat same day and minimum yesterday morning. Yesterday had pain in left breast reminded me of shingles pain had 8 years ago, pain in left shoulder better today noticed left forearm mild soreness today,. All other pain symptoms have subsided. Have noticed stools not diarrhea but not normal and excessive gas. Pain symptoms day of shot and yesterday moderate to severe and shoulder pain today mild to moderate

Release 4 — day 7, dose 1

2021-02-17

Systemic reaction (other): Had headaches yesterday more of a moderate level just forgot to enter data in time

Release 4 — day 14, dose 1

2021-02-24

Symptoms: Severe pain right lower abdomen around to back, reminded me of appendicitis pain level started Monday eased off Tuesday just tenderness Tuesday, about 6 pm today Wednesday severe pain same right side with left calf pain if still in am will see doctor cut off by CDC

Release 5 — day 0, dose 2

2021-03-03

Systemic reaction (other): 1 or 1 hr 15 min max after shot tingling of tongue and throat tightness experienced

Release 5 — days 1–6 daily, dose 2

2021-03-05

Systemic reaction (other): Night sweats like hot flashes experienced 2x last night temp checked but no fever

2021-03-09

Systemic reaction (other): My feverish feeling still feels like hot flashes coming back check temperature each time and no fever noted

Release 5 — day 7, dose 2

2021-03-11

Systemic reaction (other): Menopausal hot flashes started again after 2nd shot

Release 6 — day 21, dose 2

2021-03-24

Symptoms: More tired than usual, hot flashes still occurring and have had 99.6 - 99.9 F temp recorded on 2 different occasions

Release 6 — day 28, dose 2

2021-03-31

Symptoms: Headache, hot flashes still back

Release 8 — 3 months, dose 2

2021-06-02

Symptoms: Menstrual cycle occurred last week of April- I am 3 years post menopausal - hot flashes have returned(started day after 2nd shot, occurred 2-3 weeks, went away & came back with period), very irritable at times, have racked up $1000s of medical bill cut off by CDC

Healthcare visit (other): Still working on diagnosis with many doctors to rule out cancer or determine if vaccine issue

Release 9 — 6 months, dose 2

2021-09-03

Symptoms: 2-3 years post meno-hot flashes started day of 2nd shot & ovulated once with 1 week period in April-multiple tests & surgery (D&C) to rule out uterine cancer all tests negative thankfully-no additional menstrual cycles-husband has body aches & covid+ cut off by CDC

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	Unevaluable event	✓	✓	✓
SD	Abdominal pain lower	✓	✓	✓
SD	Anovulatory cycle	✓	·	✓
SD	Exposure to SARS-CoV-2	✓	·	✓
SD	Fatigue	✓	✓	✓
SD	Headache	✓	✓	✓
SD	Hot flush	✓	✓	✓
SD	Irritability	✓	✓	✓
SD	Menopausal symptoms	○	✓	○
SD	Menstruation irregular	✓	·	✓
SD	Pain in extremity	✓	✓	✓
SD	Postmenopausal haemorrhage	✓	·	✓
SD	Postmenopause	✓	·	✓
SD	Tenderness	✓	✓	✓
SD	Uterine dilation and curettage	✓	·	✓
SRO	Abnormal faeces	✓	✓	✓
SRO	Arthralgia	✓	✓	✓
SRO	Breast pain	✓	✓	✓
SRO	Flatulence	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Hot flush	✓	✓	✓
SRO	Menopausal symptoms	✓	✓	✓
SRO	Neck pain	✓	✓	✓
SRO	Night sweats	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Pain in extremity	✓	✓	✓
SRO	Paraesthesia oral	✓	✓	✓
SRO	Paranasal sinus discomfort	✓	✓	✓
SRO	Paranasal sinus hypersecretion	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Pyrexia	✓	✓	✓
SRO	Throat tightness	✓	✓	✓

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