ZWZ-14572-74934 · OpenVSafe

Timeline

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

2021-04-12
Dose 1 — Janssen/Johnson & Johnson
2021-04-13
Registered in v-safe
2021-04-13
Health check-in — days 1–6 daily, dose 1
Feeling: Fair · Site: Pain · Fever · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to work, Be unable to do your normal daily activities

Adult check-in
2021-04-14
Survey response — days 1–6 daily, dose 1
MedDRA: Intermenstrual bleeding — Feeling: Good · Site: Pain

Free text: Unexpected Spotting - About 8-10 hours after my vaccine I started spotting which was unexpected because I had finished my period the week prior. The next day (the day after my vaccination) I spotted throughout the entire day and then today (two days after my vaccine) I slightly spotted. This is definitely abnormal for me.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-15
Survey response — days 1–6 daily, dose 1
MedDRA: Vaginal haemorrhage — Feeling: Good · Site: Pain

Free text: Continued and increased unexpected spotting

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-04-16
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2021-04-18
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2021-04-19
Health check-in — day 7, dose 1
Feeling: Good · None

Adult check-in
2021-04-26
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-05-03
Health check-in — day 21, single dose
Feeling: Good

Adult check-in
2021-05-10
Health check-in — day 28, single dose
Feeling: Good

Adult check-in
2021-05-17
Health check-in — day 35, single dose
Feeling: Good

Adult check-in
2021-05-24
Health check-in — day 42, single dose
Feeling: Good

Adult check-in
2021-07-12
Survey response — 3 months, dose 1
MedDRA: Nasopharyngitis — Feeling: Good · Be unable to work or attend school, Be unable to do your normal daily activities

Free text: Had a cold for a few days

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-10-12
Survey response — 6 months, dose 1
MedDRA: Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, Sneezing — Feeling: Good

Free text: I had a sore throat, congestion, runny nose, and sneezing. I got tested for COVID but it was negative so I assume it was just a regular old cold.

MedDRA releases: 2024-11 · check-in free text available
2021-12-28
Dose 2 — Pfizer-BioNTech
2021-12-31
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Redness, Swelling · Headache

Adult check-in
2022-01-03
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2022-01-05
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2022-01-11
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2022-01-18
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2022-01-25
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2022-02-01
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2022-02-08
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2022-06-28
Survey response — 6 months, dose 2
MedDRA: Kidney infection, Urinary tract infection — Feeling: Good · Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation, Outpatient clinic or urgent care clinic visit, Emergency room or emergency department visit

Free text: Two UTIs/kidney infections

MedDRA releases: 2024-11 · check-in free text available
2022-06-28
Report sent to call center — 6 months, dose 2
Get care from a doctor or other healthcare professional

Telehealth, virtual health, or email health consultation · Outpatient clinic or urgent care clinic visit · Emergency room or emergency department visit · 1 call case(s)
2022-06-29
Call 1 — Left Voicemail
2022-06-29
Call successful
Not applicable – Participant does not believe symptoms are related to vaccine and does not wish to fill
2022-12-28
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2021-04-12	Janssen/Johnson & Johnson
2	2021-12-28	Pfizer-BioNTech	No

Call center

1 call center case

1 successful

See the call center timeline

Free text

Release 7 — days 1–6 daily, dose 1

2021-04-14

Systemic reaction (other): Unexpected Spotting - About 8-10 hours after my vaccine I started spotting which was unexpected because I had finished my period the week prior. The next day (the day after my vaccination) I spotted throughout the entire day and then today (two days after my vaccine) I slightly spotted. This is definitely abnormal for me.

2021-04-15

Systemic reaction (other): Continued and increased unexpected spotting

Release 9 — 3 months, dose 1

2021-07-12

Symptoms: Had a cold for a few days

Release 10 — 6 months, dose 1

2021-10-12

Symptoms: I had a sore throat, congestion, runny nose, and sneezing. I got tested for COVID but it was negative so I assume it was just a regular old cold.

Release 12 — 6 months, dose 2

2022-06-28

Symptoms: Two UTIs/kidney infections

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
SD	Kidney infection	·	·	✓
SD	Nasopharyngitis	✓	✓	✓
SD	Oropharyngeal pain	·	·	✓
SD	Respiratory tract congestion	·	·	✓
SD	Rhinorrhoea	·	·	✓
SD	SARS-CoV-2 test negative	·	·	✓
SD	Sneezing	·	·	✓
SD	Urinary tract infection	·	·	✓
SRO	Intermenstrual bleeding	✓	✓	✓
SRO	Vaginal haemorrhage	✓	✓	✓

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