Z5Y-42210-00440 · OpenVSafe

Timeline

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

2020-12-30
Registered in v-safe
2020-12-30
Dose 1 — Pfizer-BioNTech
2020-12-30
Health check-in — day 0, dose 1
Feeling: Fair · Site: Pain · Headache, Fatigue or tiredness

Adult check-in
2020-12-31
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Headache, Fatigue or tiredness

Adult check-in
2021-01-01
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Fatigue or tiredness

Adult check-in
2021-01-03
Survey response — days 1–6 daily, dose 1
MedDRA: Insomnia, Rash, Rash erythematous, Rash pruritic — Feeling: Fair · Fatigue or tiredness, Rash, not including the immediate area around the injection site · Get care from a doctor or other healthcare professional

Free text: Systemic reaction (other): Itchy red bumpy rash on ankles,elbows hands, feet and knees. Difficulty sleeping · Healthcare visit (other): I am making a appointment with a dermatologist for skin rash

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-03
Report sent to call center — days 1–6 daily, dose 1
Get care from a doctor or other healthcare professional

1 call case(s)
2021-01-04
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Fatigue or tiredness, Rash, not including the immediate area around the injection site

Adult check-in
2021-01-05
Survey response — days 1–6 daily, dose 1
MedDRA: Abnormal dreams, Condition aggravated, Insomnia, Pre-existing disease — Feeling: Fair · Fatigue or tiredness

Free text: I have had a very hard time sleeping since my first vaccination and forgot to mention it. I have been under treatment for insomnia for years but I have noticed that when I do fall asleep I am having having very vivid / distressing dreams.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-07
Health check-in — day 7, dose 1
Feeling: Fair · Fatigue or tiredness

Adult check-in
2021-01-20
Dose 2 — Pfizer-BioNTech
2021-01-29
Call 1 — Left Voicemail
2021-06-30
Health check-in — 6 months, dose 1
Feeling: Good

Adult check-in
2021-07-21
Survey response — 6 months, dose 2
MedDRA: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, Upper respiratory tract infection — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: On 7/7/2021 I had a sore throat , Low grade ,fever cough and congestion. & runny nose lasted 10 days.had 2 PCR COVID-19 test done,both negative and a rapid strep &strep cx both negative. Still have lingering cough. URI suspected

MedDRA releases: 2024-11 · check-in free text available
2022-01-20
Survey response — 12 months, dose 2
MedDRA: Cough, Oropharyngeal pain, SARS-CoV-2 test negative, Upper-airway cough syndrome — Feeling: Fair

Free text: Cough, sore throat ( covid test is negative x 2, probably postnasal drip)

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

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-30	Pfizer-BioNTech
2	2021-01-20	Pfizer-BioNTech	No

Call center

Reported	Outcome	VAERS-related outcome
2021-01-03	Unsuccessful

Free text

Release 1 — days 1–6 daily, dose 1

2021-01-03

Systemic reaction (other): Itchy red bumpy rash on ankles,elbows hands, feet and knees. Difficulty sleeping

Healthcare visit (other): I am making a appointment with a dermatologist for skin rash

2021-01-05

Systemic reaction (other): I have had a very hard time sleeping since my first vaccination and forgot to mention it. I have been under treatment for insomnia for years but I have noticed that when I do fall asleep I am having having very vivid / distressing dreams.

Release 9 — 6 months, dose 2

2021-07-21

Symptoms: On 7/7/2021 I had a sore throat , Low grade ,fever cough and congestion. & runny nose lasted 10 days.had 2 PCR COVID-19 test done,both negative and a rapid strep &strep cx both negative. Still have lingering cough. URI suspected

Release 10 — 12 months, dose 2

2022-01-20

Symptoms: Cough, sore throat ( covid test is negative x 2, probably postnasal drip)

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	Rash	✓	✓	✓
HCVO	Specialist consultation	○	○	○
SD	Cough	·	·	✓
SD	Oropharyngeal pain	·	·	✓
SD	Pyrexia	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Upper respiratory tract infection	·	·	✓
SD	Upper-airway cough syndrome	·	·	✓
SRO	Abnormal dreams	✓	✓	✓
SRO	Condition aggravated	✓	✓	✓
SRO	Insomnia	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Rash	✓	✓	✓
SRO	Rash erythematous	✓	✓	✓
SRO	Rash pruritic	✓	✓	✓

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