EML-15428-27124

2 vaccinations 11 coded responses 11 check-ins 11 free-text entries 4 call cases

Sex: Female
Age at first dose: 31-35
ZIP prefix: 201 / VA
Registered: 2021-03-13

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

2021-03-12
Dose 1 — Pfizer-BioNTech
2021-03-13
Registered in v-safe
2021-03-13
Survey response — days 1–6 daily, dose 1
MedDRA: Eye pruritus, Nasal pruritus, Oral pruritus, Paraesthesia oral, Pruritus, Swollen tongue, Throat irritation — Feeling: Poor · Site: Pain, Swelling, Itching · Headache, Muscle or body aches, Abdominal pain · Be unable to do your normal daily activities

Free text: Itching throat/mouth/nose/eyes, tingling lips, swollen tongue

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-14
Survey response — days 1–6 daily, dose 1
MedDRA: Headache, Nasal pruritus, Oral pruritus, Paraesthesia oral, Pyrexia, Self-medication, Swollen tongue, Throat irritation — Feeling: Poor · Site: Pain, Swelling, Itching · Fever · Headache, Fatigue or tiredness, Abdominal pain · Be unable to do your normal daily activities

Free text: Fever, headache, itchy throat/mouth/nose, tingling lips, swollen tongue... using Benadryl to help

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-15
Survey response — days 1–6 daily, dose 1
MedDRA: Abdominal pain upper, Headache, Lip swelling, Nasal pruritus, Oral pruritus, Paraesthesia oral, Throat irritation — Feeling: Fair · Site: Swelling, Itching · Fever · Chills, Headache, Fatigue or tiredness, Abdominal pain · Be unable to do your normal daily activities

Free text: Headache, stomachache, itchy throat/mouth/nose, tingling lips, swollen tongue

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-03-26
Survey response — day 14, dose 1
MedDRA: Diarrhoea — Feeling: Fair · Be unable to do your normal daily activities

Free text: Diarrhea

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-09
Dose 2 — Pfizer-BioNTech
2021-04-11
Survey response — days 1–6 daily, dose 2
MedDRA: Eye pruritus, Lacrimation increased, Pruritus, Rhinorrhoea, Swollen tongue, Throat irritation — Feeling: Poor · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness, Diarrhea, Abdominal pain · Be unable to do your normal daily activities

Free text: Itchy throat, swollen tongue, itchy face and eyes, running nose and eyes

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-12
Survey response — days 1–6 daily, dose 2
MedDRA: Pruritus, Throat irritation — Feeling: Fair · Site: Pain · Fever · Chills, Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Itchy throat and face

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-23
Survey response — day 14, dose 2
MedDRA: Menstrual disorder, Menstruation irregular — Feeling: Fair · Be unable to do your normal daily activities

Free text: Ive had two periods separated by only 12 days. This has never happened until this vaccine. The bleeding is bright red. There is no chance of pregnancy or miscarriage. The vaccine seems to be throwing off my cycle.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-16
Survey response — day 35, dose 2
MedDRA: Menstrual disorder, Office visit, Polymenorrhoea — Feeling: Fair · 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: Symptoms: Worsened and more frequently periods · Healthcare visit (other): Ive been seeing my PCP and getting bloodwork

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-16
Report sent to call center — day 35, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-05-21
Survey response — day 42, dose 2
MedDRA: Heavy menstrual bleeding, Polymenorrhoea — Feeling: Fair · 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: Worsened and frequent period bleeding. I am having a week long period every other week since I received the vaccine

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-21
Report sent to call center — day 42, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-09
Survey response — 3 months, dose 2
MedDRA: Laboratory test, Menstrual disorder — Feeling: Fair · 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: Symptoms: Gallstones and abnormal liver levels and continued frequent/heavy/abnormal menstruation · Healthcare visit (other): Lab work and ultrasounds

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-09
Report sent to call center — 3 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-15
Call 1 — Left Voicemail
2021-10-09
Survey response — 6 months, dose 2
MedDRA: Abnormal menstrual clots, Heavy menstrual bleeding, Menstruation irregular, Office visit — Feeling: Fair · 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: Symptoms: Worse menstrual bleeding heavier more frequently and big clots · Healthcare visit (other): Regular in person appointments and medication

MedDRA releases: 2024-11 · check-in free text available
2021-10-09
Report sent to call center — 6 months, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · 1 call case(s)
2021-10-13
Call 1 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-03-12	Pfizer-BioNTech
2	2021-04-09	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-05-16	Unsuccessful
2021-05-21	Unsuccessful
2021-07-09	Unsuccessful
2021-10-09	Unsuccessful

Free text

Release 5 — days 1–6 daily, dose 1

2021-03-13

Systemic reaction (other): Itching throat/mouth/nose/eyes, tingling lips, swollen tongue

2021-03-14

Systemic reaction (other): Fever, headache, itchy throat/mouth/nose, tingling lips, swollen tongue... using Benadryl to help

2021-03-15

Systemic reaction (other): Headache, stomachache, itchy throat/mouth/nose, tingling lips, swollen tongue

Release 6 — day 14, dose 1

2021-03-26

Symptoms: Diarrhea

Release 7 — days 1–6 daily, dose 2

2021-04-11

Systemic reaction (other): Itchy throat, swollen tongue, itchy face and eyes, running nose and eyes

2021-04-12

Systemic reaction (other): Itchy throat and face

Release 7 — day 14, dose 2

2021-04-23

Symptoms: Ive had two periods separated by only 12 days. This has never happened until this vaccine. The bleeding is bright red. There is no chance of pregnancy or miscarriage. The vaccine seems to be throwing off my cycle.

Release 8 — day 35, dose 2

2021-05-16

Symptoms: Worsened and more frequently periods

Healthcare visit (other): Ive been seeing my PCP and getting bloodwork

Release 8 — day 42, dose 2

2021-05-21

Symptoms: Worsened and frequent period bleeding. I am having a week long period every other week since I received the vaccine

Release 9 — 3 months, dose 2

2021-07-09

Symptoms: Gallstones and abnormal liver levels and continued frequent/heavy/abnormal menstruation

Healthcare visit (other): Lab work and ultrasounds

Release 10 — 6 months, dose 2

2021-10-09

Symptoms: Worse menstrual bleeding heavier more frequently and big clots

Healthcare visit (other): Regular in person appointments and medication

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	Laboratory test	✓	✓	✓
HCVO	Office visit	✓	✓	✓
SD	Abnormal menstrual clots	·	·	✓
SD	Diarrhoea	✓	✓	✓
SD	Heavy menstrual bleeding	✓	✓	✓
SD	Menstrual disorder	✓	✓	✓
SD	Menstruation irregular	✓	✓	✓
SD	Polymenorrhoea	✓	✓	✓
SRO	Abdominal pain upper	✓	✓	✓
SRO	Eye pruritus	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Lacrimation increased	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Nasal pruritus	✓	✓	✓
SRO	Oral pruritus	✓	✓	✓
SRO	Paraesthesia oral	✓	✓	✓
SRO	Pruritus	✓	✓	✓
SRO	Pyrexia	✓	✓	✓
SRO	Rhinorrhoea	✓	✓	✓
SRO	Self-medication	✓	✓	✓
SRO	Swollen tongue	✓	✓	✓
SRO	Throat irritation	✓	✓	✓

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