ZQR-33244-54363 · OpenVSafe

Timeline

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

2020-12-24
Registered in v-safe
2020-12-24
Dose 1 — Moderna
2020-12-24
Survey response — day 0, dose 1
MedDRA: Hypoaesthesia oral, Immediate post-injection reaction, Lip swelling, Paraesthesia oral, Self-medication — Feeling: Fair · Fatigue or tiredness · Be unable to do your normal daily activities

Free text: About 40 minutes after getting the moderna covid vaccine I experienced a swollen lower lip and numbness/tingling to the lower lip. I was given 25 mg po Benadryl and had relief of symptoms. This was similar to what I experience with my shellfish allergy. My fatigue is basically from the benadryl that I took.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2020-12-24
Report sent to call center — day 0, dose 1
Be unable to do your normal daily activities

1 call case(s)
2020-12-25
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Pain · None

Adult check-in
2020-12-26
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Site: Itching · Muscle or body aches

Adult check-in
2020-12-27
Health check-in — days 1–6 daily, dose 1
Feeling: Good · Muscle or body aches

Adult check-in
2020-12-28
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2020-12-29
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2020-12-30
Health check-in — days 1–6 daily, dose 1
Feeling: Good · None

Adult check-in
2020-12-31
Survey response — day 7, dose 1
MedDRA: Lip swelling, Paraesthesia oral — Feeling: Good

Free text: Since I had the reaction with swollen and tingly lips how do you recommend proceeding with my second dose? Premedicate with benadryl??

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-07
Health check-in — day 14, dose 1
Feeling: Good

Adult check-in
2021-01-14
Health check-in — day 21, dose 1
Feeling: Good

Adult check-in
2021-01-21
Dose 2 — Moderna
2021-01-21
Survey response — day 0, dose 2
MedDRA: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Pre-existing disease, Self-medication — Feeling: Fair · Site: Pain · Chills, Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

Free text: Had a reaction similar to my shellfish allergy again. Numb and tingly lips and swollen. Had to take benadryl.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-22
Survey response — days 1–6 daily, dose 2
MedDRA: Abdominal distension, Flatulence, Pain — Feeling: Poor · Site: Pain · Chills, Joint pains, Muscle or body aches, Fatigue or tiredness, Abdominal pain · Be unable to do your normal daily activities

Free text: More bloating and gassy than abdominal pain. But pain from feeling so bloated.

MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
2021-01-23
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Pain, Itching · None

Adult check-in
2021-01-24
Health check-in — days 1–6 daily, dose 2
Feeling: Good · Site: Itching · None

Adult check-in
2021-01-25
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-01-26
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-01-27
Health check-in — days 1–6 daily, dose 2
Feeling: Good · None

Adult check-in
2021-01-28
Health check-in — day 7, dose 2
Feeling: Good · None

Adult check-in
2021-02-04
Health check-in — day 14, dose 2
Feeling: Good

Adult check-in
2021-02-11
Health check-in — day 21, dose 2
Feeling: Good

Adult check-in
2021-02-18
Health check-in — day 28, dose 2
Feeling: Good

Adult check-in
2021-02-25
Health check-in — day 35, dose 2
Feeling: Good

Adult check-in
2021-03-04
Health check-in — day 42, dose 2
Feeling: Good

Adult check-in
2021-04-22
Health check-in — 3 months, dose 2
Feeling: Good

Adult check-in
2021-07-22
Health check-in — 6 months, dose 2
Feeling: Good

Adult check-in
2022-01-23
Health check-in — 12 months, dose 2
Feeling: Good

Adult check-in

Vaccinations

Dose	Date	Manufacturer	Co-administered
1	2020-12-24	Moderna
2	2021-01-21	Moderna

Call center

Reported	Outcome	VAERS-related outcome
2020-12-24	priority 2/3

Free text

Release 1 — day 0, dose 1

2020-12-24

Systemic reaction (other): About 40 minutes after getting the moderna covid vaccine I experienced a swollen lower lip and numbness/tingling to the lower lip. I was given 25 mg po Benadryl and had relief of symptoms. This was similar to what I experience with my shellfish allergy. My fatigue is basically from the benadryl that I took.

Release 1 — day 7, dose 1

2020-12-31

Systemic reaction (other): Since I had the reaction with swollen and tingly lips how do you recommend proceeding with my second dose? Premedicate with benadryl??

Release 2 — day 0, dose 2

2021-01-21

Systemic reaction (other): Had a reaction similar to my shellfish allergy again. Numb and tingly lips and swollen. Had to take benadryl.

Release 2 — days 1–6 daily, dose 2

2021-01-22

Systemic reaction (other): More bloating and gassy than abdominal pain. But pain from feeling so bloated.

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
SRO	Abdominal distension	✓	✓	✓
SRO	Flatulence	✓	✓	✓
SRO	Hypoaesthesia oral	✓	✓	✓
SRO	Immediate post-injection reaction	✓	✓	✓
SRO	Lip swelling	✓	✓	✓
SRO	Pain	✓	✓	✓
SRO	Paraesthesia oral	✓	✓	✓
SRO	Pre-existing disease	✓	✓	✓
SRO	Self-medication	✓	✓	✓

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