XVH-25134-35389

2 vaccinations 13 coded responses 29 check-ins 13 free-text entries 2 call cases

Sex: Female
Age at first dose: 46-50
ZIP prefix: 379 / TN
Registered: 2021-08-30

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

2021-08-30
Registered in v-safe
2021-08-30
Dose 1 — Pfizer-BioNTech
2021-08-30
Health check-in — 0 day, dose 1
Feeling: Good · None

Adult check-in
2021-08-31
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain, Redness · Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities

Adult check-in
2021-09-01
Survey response — days 1–6 daily, dose 1
MedDRA: Lymph node pain, Lymphadenopathy — Feeling: Fair · Site: Pain, Redness, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities

MedDRA releases: 2021-09,2024-11 · check-in answers available
2021-09-02
Survey response — days 1–6 daily, dose 1
MedDRA: Axillary mass, Lymphadenitis — Feeling: Fair · Site: Pain, Swelling · Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2021-09,2024-11 · check-in answers available
2021-09-02
Report sent to call center — days 1–6 daily, dose 1
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)
2021-09-03
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain, Swelling · Joint pains, Muscle or body aches, Diarrhea · Be unable to do your normal daily activities

Adult check-in
2021-09-04
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain, Swelling · Joint pains, Muscle or body aches, Diarrhea, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-09-05
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain, Swelling · Joint pains · Be unable to do your normal daily activities

Adult check-in
2021-09-06
Health check-in — 7 day, dose 1
Feeling: Fair · Site: Pain, Swelling · Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-09-06
Call 1 — Left Voicemail
2021-09-13
Health check-in — 14 day, dose 1
Feeling: Good

Adult check-in
2021-09-20
Health check-in — 21 day, dose 1
Feeling: Good

Adult check-in
2021-09-27
Health check-in — 28 day, dose 1
Feeling: Good

Adult check-in
2021-10-04
Health check-in — 35 day, dose 1
Feeling: Good

Adult check-in
2021-10-11
Survey response — 42 day, dose 1
MedDRA: Amenorrhoea, Plicated tongue, Tongue discomfort — Feeling: Poor

MedDRA releases: 2024-11 · check-in answers available
2021-11-01
Dose 2 — Pfizer-BioNTech
2021-11-01
Health check-in — 0 day, dose 2
Feeling: Fair · Site: Pain · Fatigue or tiredness, Abdominal pain

Adult check-in
2021-11-02
Survey response — days 1–6 daily, dose 2
MedDRA: Lymphadenopathy — Feeling: Poor · Site: Pain, Swelling · Fever · Muscle or body aches, Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

MedDRA releases: 2024-11 · check-in answers available
2021-11-02
Report sent to call center — days 1–6 daily, 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

Outpatient clinic or urgent care clinic visit · 1 call case(s)
2021-11-03
Survey response — days 1–6 daily, dose 2
MedDRA: Burning mouth syndrome, Lymphadenopathy — Feeling: Poor · Site: Pain, Swelling · Headache, Fatigue or tiredness · Be unable to work or attend school, Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-03
Call successful
Participant prefers to complete VAERS report online
2021-11-04
Survey response — days 1–6 daily, dose 2
MedDRA: Burning mouth syndrome, Lymphadenopathy — Feeling: Fair · Site: Pain, Swelling · Headache · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-05
Survey response — days 1–6 daily, dose 2
MedDRA: Burning mouth syndrome, Lymphadenopathy, Tongue discomfort — Feeling: Fair · Site: Pain, Swelling · Headache, Fatigue or tiredness · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-06
Survey response — days 1–6 daily, dose 2
MedDRA: Burning mouth syndrome, Lymphadenopathy — Feeling: Fair · Site: Pain, Redness, Swelling · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-07
Survey response — days 1–6 daily, dose 2
MedDRA: Axillary mass, Lymphadenopathy, Tongue discomfort — Feeling: Fair · Site: Pain, Swelling · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2021-11-08
Survey response — 7 day, dose 2
MedDRA: Burning mouth syndrome, Injection site bruising, Lymphadenopathy — Feeling: Fair

MedDRA releases: 2024-11 · check-in answers available
2021-11-19
Health check-in — 14 day, dose 2
Feeling: Fair

Adult check-in
2021-11-22
Survey response — 21 day, dose 2
MedDRA: Condition aggravated, Pre-existing disease — Feeling: Poor

MedDRA releases: 2024-11 · check-in answers available
2021-11-29
Health check-in — 28 day, dose 2
Feeling: Fair

Adult check-in
2021-12-07
Health check-in — 35 day, dose 2
Feeling: Fair

Adult check-in
2021-12-14
Health check-in — 42 day, dose 2
Feeling: Good

Adult check-in
2022-01-31
Survey response — 3 month, dose 2
MedDRA: COVID-19, Dysphonia, Fatigue, Nasal congestion, Pre-existing disease, Rhinorrhoea — Feeling: Fair · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2022-05-02
Survey response — 6 month, dose 2
MedDRA: COVID-19, Fatigue, Nasal congestion, Rhinorrhoea — Feeling: Good · Be unable to do your normal daily activities

MedDRA releases: 2024-11 · check-in answers available
2022-11-01
Health check-in — 12 month, dose 2
Feeling: Fair

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-08-30	Pfizer-BioNTech	No
2	2021-11-01	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-09-02	Unsuccessful
2021-11-02	Successful 2021-11-03	Participant prefers to complete VAERS report online

Free text

Release 9

Systemic reaction (other): Armpit lymph swollen tennis ball sized and painful

Systemic reaction (other): Tennis ball sized inflammation of under arm lymph nodes

Release 10

Symptoms: For last 5 days, Have tongue discomfort like I burned my tongue with ridges on side of tongue. Still no period, 8 weeks since last period.

Systemic reaction (other): Large inflammation of lymph nodes under arm

Systemic reaction (other): Swollen lymph nodes, burning mouth syndrome

Systemic reaction (other): Swollen lymph nodes under arm are golf ball sized now (from grapefruit sized on day 2), no improvement in burning tongue syndrome

Systemic reaction (other): Lymph nodes in armpit still swollen golf ball sized, burning mouth syndrome

Systemic reaction (other): Lymph nodes under arm still swollen with visible golf ball size lump, burning tongue syndrome

Systemic reaction (other): Lymph nodes still swollen, burning mouth syndrome, small bruise at injection site

Symptoms: Burning mouth syndrome got worse

Release 11

Symptoms: I got COVID. Symptoms included runny/stuffy nose, hoarseness and fatigue (same as the first time I contracted COVID in 2020).

Symptoms: Covid positive with runny/stuffy nose and fatigue

Free-text releases are not linked to a specific 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	Amenorrhoea	·	·	✓
SD	Condition aggravated	·	·	✓
SD	COVID-19	·	·	✓
SD	Dysphonia	·	·	✓
SD	Fatigue	·	·	✓
SD	Nasal congestion	·	·	✓
SD	Plicated tongue	·	·	✓
SD	Pre-existing disease	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	Tongue discomfort	·	·	✓
SRO	Axillary mass	✓	·	✓
SRO	Burning mouth syndrome	·	·	✓
SRO	Injection site bruising	·	·	✓
SRO	Lymph node pain	✓	·	✓
SRO	Lymphadenitis	✓	·	✓
SRO	Lymphadenopathy	✓	·	✓
SRO	Tongue discomfort	·	·	✓

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