ZNJ-38039-81055

2 vaccinations 5 coded responses 19 check-ins 5 free-text entries 2 call cases

Sex: Female
Age at first dose: 61-65
ZIP prefix: 221 / VA
Registered: 2021-05-09

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

2021-05-06
Dose 1 — Pfizer-BioNTech
2021-05-09
Registered in v-safe
2021-05-10
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · None

Adult check-in
2021-05-11
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-05-13
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-05-20
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-05-29
Survey response — day 21, dose 1
MedDRA: Abdominal pain, Abdominal pain upper, Asthenia, Condition aggravated, Malabsorption, Mastocytosis, Pre-existing disease — Feeling: Fair

Free text: I have mast cell disease and my malabsorption seems to have worsened - low energy. I also have stomach and abdominal pain that I ordinarily dont have. I had it last week too and didnt report it because it didnt occur to me that it may be r

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-06
Survey response — day 28, dose 1
MedDRA: Condition aggravated, Ear pruritus, Erythema, Pre-existing disease, Pruritus — Feeling: Fair · Be unable to do your normal daily activities

Free text: I have mast cell disease, and my symptoms have been worse since my first vaccine. Upper body itches terribly and skin is bright red. Generally have these symptoms but not this bad. Ear lobes have itched since vaccine, and this has never a problem.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-10
Dose 2 — Pfizer-BioNTech
2021-06-13
Survey response — days 1–6 daily, dose 2
MedDRA: Abdominal pain, Abdominal pain lower, Ligament disorder, Muscle disorder, Myalgia, Office visit, Pelvic pain — Feeling: Fair · Site: Pain · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · 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: Systemic reaction (other): Ill oak crest pain and low abdominal pain which feels muscular as it is not associated with digestive tract issued · Healthcare visit (other): Had in-person iliac crest visit before 2nd shot and doctor thinks pain is related to first vaccine. Have upcoming virtual appointment with gastroenterologist regarding abdominal pain which, again, I believe is muscular (or ligament) related.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-13
Report sent to call center — days 1–6 daily, dose 2
Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

1 call case(s)
2021-06-14
Survey response — days 1–6 daily, dose 2
MedDRA: Abdominal pain lower, Bone pain — Feeling: Good · Site: Pain · Muscle or body aches, Rash, not including the immediate area around the injection site

Free text: Iliac crest hurts as does lower abdomen on one side

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-06-15
Health check-in — days 1–6 daily, dose 2
Feeling: Fair · Muscle or body aches

Adult check-in
2021-06-16
Health check-in — days 1–6 daily, dose 2
Feeling: Poor · Fatigue or tiredness, Abdominal pain · Be unable to do your normal daily activities

Adult check-in
2021-06-17
Health check-in — day 7, dose 2
Feeling: Good · Site: Pain, Itching · Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain, Rash, not including the immediate area around the injection site

Adult check-in
2021-06-24
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-06-24
Call successful
Participant prefers to complete VAERS report online
2021-07-01
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-07-08
Health check-in — day 28, dose 2
Feeling: Fair

Adult check-in
2021-07-15
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-07-22
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-09-09
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-12-09
Survey response — 6 months, dose 2
MedDRA: Back pain, Office visit — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

Free text: Symptoms: Extreme back pain. · Healthcare visit (other): Two visits with orthopedic doctor / spine specialist. Soon will start PT.

MedDRA releases: 2024-11 · check-in free text available
2021-12-09
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

1 call case(s)
2021-12-10
Call successful
Does not wish to fill out VAERS report
2022-06-10
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-05-06	Pfizer-BioNTech
2	2021-06-10	Pfizer-BioNTech

Call center

Reported	Outcome	VAERS-related outcome
2021-06-13	Successful 2021-06-24	Participant prefers to complete VAERS report online
2021-12-09	Successful 2021-12-10	Does not wish to fill out VAERS report

Free text

Release 8 — day 21, dose 1

2021-05-29

Symptoms: I have mast cell disease and my malabsorption seems to have worsened - low energy. I also have stomach and abdominal pain that I ordinarily dont have. I had it last week too and didnt report it because it didnt occur to me that it may be r

Release 8 — day 28, dose 1

2021-06-06

Symptoms: I have mast cell disease, and my symptoms have been worse since my first vaccine. Upper body itches terribly and skin is bright red. Generally have these symptoms but not this bad. Ear lobes have itched since vaccine, and this has never a problem. cut off by CDC

Release 9 — days 1–6 daily, dose 2

2021-06-13

Systemic reaction (other): Ill oak crest pain and low abdominal pain which feels muscular as it is not associated with digestive tract issued

Healthcare visit (other): Had in-person iliac crest visit before 2nd shot and doctor thinks pain is related to first vaccine. Have upcoming virtual appointment with gastroenterologist regarding abdominal pain which, again, I believe is muscular (or ligament) related.

2021-06-14

Systemic reaction (other): Iliac crest hurts as does lower abdomen on one side

Release 10 — 6 months, dose 2

2021-12-09

Symptoms: Extreme back pain.

Healthcare visit (other): Two visits with orthopedic doctor / spine specialist. Soon will start PT.

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	Abdominal pain	✓	✓	✓
HCVO	Ligament disorder	·	·	✓
HCVO	Muscle disorder	·	·	✓
HCVO	Office visit	✓	✓	✓
SD	Abdominal pain	✓	✓	✓
SD	Abdominal pain upper	✓	✓	✓
SD	Asthenia	✓	✓	✓
SD	Back pain	·	·	✓
SD	Condition aggravated	✓	✓	✓
SD	Ear pruritus	✓	✓	✓
SD	Erythema	✓	✓	✓
SD	Malabsorption	○	✓	○
SD	Mastocytosis	○	✓	○
SD	Pre-existing disease	✓	✓	✓
SD	Pruritus	✓	✓	✓
SRO	Abdominal pain lower	✓	✓	✓
SRO	Bone pain	✓	·	✓
SRO	Myalgia	✓	✓	✓
SRO	Pelvic pain	·	·	✓

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