2LM-59001-05350

Timeline

1. 2021-09-15
   Dose 1 — Pfizer-BioNTech
2. 2021-11-27
   Dose 2 — Pfizer-BioNTech
3. 2021-11-29
   Registered in v-safe
4. 2021-11-29
   Health check-in — days 1–6 daily, dose 2

   Feeling: Poor · Site: Pain, Swelling · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

   Adult check-in
5. 2021-11-30
   Survey response — days 1–6 daily, dose 2

   MedDRA: Axillary pain, Oedema peripheral, Pain, Pain in extremity, Paraesthesia — Feeling: Fair · Site: Pain · Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea, Abdominal pain

   Free text: Throbbing in my arm, tingling fingers, pain and swelling in my underarm.

   MedDRA releases: 2024-11 · check-in free text available
6. 2021-12-02
   Health check-in — days 1–6 daily, dose 2

   Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness, Nausea

   Adult check-in
7. 2021-12-03
   Health check-in — days 1–6 daily, dose 2

   Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

   Adult check-in
8. 2021-12-04
   Health check-in — day 7, dose 2

   Feeling: Fair · Site: Pain · Headache, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

   Adult check-in
9. 2021-12-30
   Survey response — day 28, dose 2

   MedDRA: COVID-19, Dysmenorrhoea, Influenza, Intermenstrual bleeding, Sinusitis — Feeling: Poor · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Telehealth, virtual health, or email health consultation

   Free text: Since my second Covid vaccine 30 days ago, I have had a sinus infection, Covid 19 and the flu. I have also experienced menstrual cramps and intermittent bleeding throughout the month.

   MedDRA releases: 2024-11 · check-in free text available
10. 2021-12-30
    Report sent to call center — day 28, dose 2

    Be unable to work or attend school · Be unable to do your normal daily activities · Get care from a doctor or other healthcare pr

    Telehealth, virtual health, or email health consultation · 1 call case(s)
11. 2022-01-05
    Call successful

    Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
12. 2022-01-08
    Survey response — day 42, dose 2

    MedDRA: Menstruation irregular, Polymenorrhoea, Unevaluable event — Feeling: Fair · Get care from a doctor or other healthcare professional

    Free text: Symptoms: I have had an irregular menstrual cycle with bleeding every week · Healthcare visit (other): Will see doctor next week

    MedDRA releases: 2024-11 · check-in free text available
13. 2022-01-08
    Report sent to call center — day 42, dose 2

    Get care from a doctor or other healthcare professional

    1 call case(s)
14. 2022-01-10
    Call successful

    Not applicable (accidental reporting or does not believe symptoms are related to vaccine)
15. 2022-02-28
    Survey response — 3 months, dose 2

    MedDRA: Dizziness, Fatigue, Menstruation irregular, Paranasal sinus inflammation, Pre-existing disease, Visual impairment — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

    Free text: Continues irregular menstrual bleeding, fatigue, dizziness, vision problems, chronic tonsil and sinus inflammation

    MedDRA releases: 2024-11 · check-in free text available
16. 2022-02-28
    Report sent to call center — 3 months, dose 2

    Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

    Outpatient clinic or urgent care clinic visit · 1 call case(s)
17. 2022-03-01
    Call 1 — Left Voicemail
18. 2022-05-28
    Survey response — 6 months, dose 2

    MedDRA: Asthma, Bacterial infection, Fatigue, General physical health deterioration, Menstruation irregular, Office visit, Palpitations, Pre-existing disease, Viral infection — Feeling: Poor · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

    Free text: Symptoms: My health has deteriorated since my first Covid vaccine and got significantly worse after the second. I have chronic fatigue, regular infections both viral and bacterial, asthma flair ups, heart palpitations and irregular menstrual bleeding. · Healthcare visit (other): In addition to seeing my PCP I have been referred to cardiology and immunology/allergy specialists

    MedDRA releases: 2024-11 · check-in free text available
19. 2022-05-28
    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

    Outpatient clinic or urgent care clinic visit · 1 call case(s)
20. 2022-06-01
    Call successful

    Participant prefers to complete VAERS report online
21. 2022-11-29
    Survey response — 12 months, dose 2

    MedDRA: Abnormal menstrual clots, Heavy menstrual bleeding — Feeling: Fair · Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional · Outpatient clinic or urgent care clinic visit

    Free text: Severe periods with excessive bleeding and clotting

    MedDRA releases: 2024-11 · check-in free text available
22. 2022-11-29
    Report sent to call center — 12 months, dose 2

    Be unable to do your normal daily activities · Get care from a doctor or other healthcare professional

    Outpatient clinic or urgent care clinic visit · 1 call case(s)
23. 2022-11-30
    Call 1 — Left Voicemail