ZVV-25919-57238

2 vaccinations 8 coded responses 30 check-ins 8 free-text entries 3 call cases

Sex: Female
Age at first dose: 41-45
ZIP prefix: 041 / ME
Registered: 2021-04-25

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

2021-04-25
Registered in v-safe
2021-04-25
Dose 1 — Janssen/Johnson & Johnson
2021-04-25
Health check-in — day 0, dose 1
Feeling: Poor · Site: Pain · Fever · Headache, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

Adult check-in
2021-04-26
Health check-in — days 1–6 daily, dose 1
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-04-27
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
2021-04-28
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness

Adult check-in
2021-04-29
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-30
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-05-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-05-02
Survey response — day 7, dose 1
MedDRA: Abdominal pain, Dysmenorrhoea — Feeling: Fair · Be unable to do your normal daily activities

Free text: After 33 years of bad menstrual pain with my period, I had the absolute worst, most painful pelvic cramps Ive ever experienced. No way could I function through the pain.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-09
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-05-16
Health check-in — day 21, single dose
Feeling: Good

Adult check-in
2021-05-23
Health check-in — day 28, single dose
Feeling: Good

Adult check-in
2021-05-30
Health check-in — day 35, single dose
Feeling: Good

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

Adult check-in
2021-07-25
Health check-in — 3 months, dose 1
Feeling: Good

Adult check-in
2021-10-25
Survey response — 6 months, dose 1
MedDRA: Cough, Nasopharyngitis, SARS-CoV-2 test negative — Feeling: Fair · Be unable to work or attend school

Free text: I got a bad fall cold and cough but tested negative for Covid.

MedDRA releases: 2024-11 · check-in free text available
2021-11-08
Dose 2 — Pfizer-BioNTech
2021-11-08
Health check-in — day 0, dose 2
Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to work or attend school

Adult check-in
2021-11-09
Survey response — days 1–6 daily, dose 2
MedDRA: Nausea, Vomiting — Feeling: Fair · Site: Pain · Headache, Nausea, Vomiting

Free text: I vomited last night after completing the first check in and nausea started then

MedDRA releases: 2024-11 · check-in free text available
2021-11-11
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness, Nausea

Adult check-in
2021-11-12
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-11-13
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-11-14
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Headache

Adult check-in
2021-11-15
Survey response — day 7, dose 2
MedDRA: Ear pain, Unevaluable event — Feeling: Good

Free text: Sinus earache

MedDRA releases: 2024-11 · check-in free text available
2021-11-22
Survey response — day 14, dose 2
MedDRA: Ear pain, Office visit, Sinusitis, Toothache — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: Horrendous sinus infection with ear and tooth pain · Healthcare visit (other): Doctor visit in person

MedDRA releases: 2024-11 · check-in free text available
2021-11-22
Report sent to call center — day 14, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-11-23
Call 1 — Left Voicemail
2021-11-23
Call successful
Participant prefers to complete VAERS report online
2021-11-29
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-12-06
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-12-13
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-12-22
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2022-02-07
Survey response — 3 months, dose 2
MedDRA: Malaise, Mammogram abnormal, SARS-CoV-2 test negative, Unevaluable event — 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: I had a 25-36 hour bug with many Omicron symptoms but tested negative for COVID. In a possibly unrelated incident I have had to be seen for a mammogram and following up with an ultrasound to determine whether a lump is a cyst or a bigger issue. · Healthcare visit (other): Mammogram and ultrasound

MedDRA releases: 2024-11 · check-in free text available
2022-02-07
Report sent to call center — 3 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)
2022-02-09
Call 1 — Left Voicemail
2022-05-09
Survey response — 6 months, dose 2
MedDRA: Malaise, SARS-CoV-2 test negative — Feeling: Fair · Be unable to work or attend school

Free text: I've been sick. I tested negative for Covid but my son was positive. So I don't know why since I'm quite sure we had the same thing his just lasted longer.

MedDRA releases: 2024-11 · check-in free text available
2022-11-08
Survey response — 12 months, dose 2
MedDRA: COVID-19, Heavy menstrual bleeding, Menstrual disorder, Office visit, Polymenorrhoea — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: After having Covid in august, my menstrual cycle was extremely bizarre with multiple periods im a short time span, one that lasted 12 days, etc. A doctor visit suggested I wait a few months to see if it leveled out and it may be getting back to norm · Healthcare visit (other): Doctor's office visit

MedDRA releases: 2024-11 · check-in free text available
2022-11-08
Report sent to call center — 12 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2022-11-09
Call 2 — Left Voicemail
2022-11-09
Call 1 — Left Voicemail
2022-11-09
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-11-09
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	2021-04-25	Janssen/Johnson & Johnson
2	2021-11-08	Pfizer-BioNTech	No

Call center

3 call center cases

3 successful

See the call center timeline

Free text

Release 8 — day 7, dose 1

2021-05-02

Systemic reaction (other): After 33 years of bad menstrual pain with my period, I had the absolute worst, most painful pelvic cramps Ive ever experienced. No way could I function through the pain.

Release 10 — 6 months, dose 1

2021-10-25

Symptoms: I got a bad fall cold and cough but tested negative for Covid.

Release 10 — days 1–6 daily, dose 2

2021-11-09

Systemic reaction (other): I vomited last night after completing the first check in and nausea started then

Release 10 — day 7, dose 2

2021-11-15

Systemic reaction (other): Sinus earache

Release 10 — day 14, dose 2

2021-11-22

Symptoms: Horrendous sinus infection with ear and tooth pain

Healthcare visit (other): Doctor visit in person

Release 11 — 3 months, dose 2

2022-02-07

Symptoms: I had a 25-36 hour bug with many Omicron symptoms but tested negative for COVID. In a possibly unrelated incident I have had to be seen for a mammogram and following up with an ultrasound to determine whether a lump is a cyst or a bigger issue.

Healthcare visit (other): Mammogram and ultrasound

Release 11 — 6 months, dose 2

2022-05-09

Symptoms: I've been sick. I tested negative for Covid but my son was positive. So I don't know why since I'm quite sure we had the same thing his just lasted longer.

Release 12 — 12 months, dose 2

2022-11-08

Symptoms: After having Covid in august, my menstrual cycle was extremely bizarre with multiple periods im a short time span, one that lasted 12 days, etc. A doctor visit suggested I wait a few months to see if it leveled out and it may be getting back to norm cut off by CDC

Healthcare visit (other): Doctor's office visit

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	Office visit	·	·	✓
HCVO	Unevaluable event	·	·	✓
SD	Cough	·	·	✓
SD	COVID-19	·	·	✓
SD	Ear pain	·	·	✓
SD	Heavy menstrual bleeding	·	·	✓
SD	Malaise	·	·	✓
SD	Mammogram abnormal	·	·	✓
SD	Menstrual disorder	·	·	✓
SD	Nasopharyngitis	·	·	✓
SD	Office visit	·	·	✓
SD	Polymenorrhoea	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Sinusitis	·	·	✓
SD	Toothache	·	·	✓
SRO	Abdominal pain	✓	✓	✓
SRO	Dysmenorrhoea	✓	✓	✓
SRO	Ear pain	·	·	✓
SRO	Nausea	·	·	✓
SRO	Unevaluable event	·	·	✓
SRO	Vomiting	·	·	✓

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