5SK-17897-41987

2 vaccinations 6 coded responses 13 check-ins 6 free-text entries 2 call cases

Sex: Female
Age at first dose: 66+
ZIP prefix: 025 / MA
Registered: 2021-05-18

Relationship: Self
Race: Other
Ethnicity: N/A

Timeline

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

2021-05-06
Dose 1 — Pfizer-BioNTech
2021-05-18
Registered in v-safe
2021-05-18
Survey response — day 7, dose 1
MedDRA: Adverse reaction, Unevaluable event — Feeling: Good

Free text: Symptoms on May 12 & 13.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-05-20
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-05-27
Dose 2 — Pfizer-BioNTech
2021-05-28
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Site: Pain · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-05-29
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Site: Pain · Fever · Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Adult check-in
2021-05-30
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-05-31
Survey response — days 1–6 daily, dose 2
MedDRA: Headache — Feeling: Good · Site: Itching

Free text: Noticing that I have had random sharp pain in my head usually at night. Left of center, half way between left eye & ear

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-01
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Redness, Swelling · None

Adult check-in
2021-06-03
Health check-in — day 7, dose 2
Feeling: Good · Site: Redness · Headache

Adult check-in
2021-06-10
Survey response — day 14, dose 2
MedDRA: Lymphadenopathy, Peripheral swelling, Pruritus — Feeling: Good

Free text: Swelling in both hand, itching in hands, wrists and forearms. Enlarged axillary lymph node observed on CT scan 6/8/21. Contacted by Dr.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-19
Survey response — day 21, dose 2
MedDRA: Headache, Rash, Self-medication — Feeling: Good

Free text: I continue to get random rashes on my legs, ankle and wrist (small areas of pink dots mostly on the left side). Also having more frequent headaches. Taking aspirin and/or acetaminophen works; ... I dont usually have headaches

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-24
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-07-02
Survey response — day 35, dose 2
MedDRA: Lymphadenopathy, Unevaluable event — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Lymph nodes showed up on chest CT as enlarged & that could be an effect of vaccine... or not.I dont know when to get test repeat & still need other imaging as well. Ins.leaves $$copay even if false positive results. Any thoughts? Could use feedbac · Healthcare visit (other): Will need to see a doctor about false positives

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-07-02
Report sent to call center — day 35, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-07-07
Call 1 — Could Not Reach Participant
2021-07-09
Call 2 — Could Not Reach Participant
2021-08-26
Survey response — 3 months, dose 2
MedDRA: Discomfort, Office visit, Pruritus, Self-medication, Urticaria — Feeling: Fair · Get care from a doctor or other healthcare professional

Free text: Symptoms: Worsening problems with hive / welts with severe itching. It began after my 2 doses of the vaccine. Hive come on every night and I am treating by taking benadryl each night so that i can sleep. Very uncomfortable - may need to see allergist. · Healthcare visit (other): PCP

MedDRA releases: 2021-09,2024-11 · check-in free text available
2021-08-26
Report sent to call center — 3 months, dose 2
Get care from a doctor or other healthcare professional

1 call case(s)
2021-11-20
Call 1 — Could Not Reach Participant
2021-11-29
Call 2 — Left Voicemail

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-05-06	Pfizer-BioNTech
2	2021-05-27	Pfizer-BioNTech

Call center

2 call center cases

2 unsuccessful

See the call center timeline

Free text

Release 8 — day 7, dose 1

2021-05-18

Systemic reaction (other): Symptoms on May 12 & 13.

Release 8 — days 1–6 daily, dose 2

2021-05-31

Systemic reaction (other): Noticing that I have had random sharp pain in my head usually at night. Left of center, half way between left eye & ear

Release 9 — day 14, dose 2

2021-06-10

Symptoms: Swelling in both hand, itching in hands, wrists and forearms. Enlarged axillary lymph node observed on CT scan 6/8/21. Contacted by Dr.

Release 9 — day 21, dose 2

2021-06-19

Symptoms: I continue to get random rashes on my legs, ankle and wrist (small areas of pink dots mostly on the left side). Also having more frequent headaches. Taking aspirin and/or acetaminophen works; ... I dont usually have headaches

Release 9 — day 35, dose 2

2021-07-02

Symptoms: Lymph nodes showed up on chest CT as enlarged & that could be an effect of vaccine... or not.I dont know when to get test repeat & still need other imaging as well. Ins.leaves $$copay even if false positive results. Any thoughts? Could use feedbac

Healthcare visit (other): Will need to see a doctor about false positives

Release 9 — 3 months, dose 2

2021-08-26

Symptoms: Worsening problems with hive / welts with severe itching. It began after my 2 doses of the vaccine. Hive come on every night and I am treating by taking benadryl each night so that i can sleep. Very uncomfortable - may need to see allergist.

Healthcare visit (other): PCP

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	Discomfort	✓	·	✓
SD	Headache	✓	✓	✓
SD	Lymphadenopathy	✓	✓	✓
SD	Peripheral swelling	✓	✓	✓
SD	Pruritus	✓	✓	✓
SD	Rash	✓	✓	✓
SD	Self-medication	✓	✓	✓
SD	Urticaria	✓	·	✓
SRO	Adverse reaction	✓	✓	✓
SRO	Headache	✓	✓	✓
SRO	Unevaluable event	○	✓	○

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