FPM-19387-03872

Timeline

1. 2021-05-01
   Dose 1 — Pfizer-BioNTech
2. 2021-05-18
   Registered in v-safe
3. 2021-05-18
   Health check-in — day 14, dose 1

   Feeling: Fair

   Adult check-in
4. 2021-05-31
   Dose 2 — Pfizer-BioNTech
5. 2021-05-31
   Survey response — day 0, dose 2

   MedDRA: Medical counselling, Menstruation delayed — Feeling: Poor · Site: Pain, Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness, Nausea · Be unable to do your normal daily activities

   Free text: My last period was on Easter Sunday April 4th 2021. I seen my Docter because I missed a whole menstral period. I have copper T for birthcontrol. I give me a normal period. After 12 years on this birth control I have never missed a period. Im 43 and not on a single medication. This is not normal at all and the public should be made aware of this. Today is May 31 and I I have no signs of any period. Dr checked with 2 tests and he said Im not pregnant.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
6. 2021-06-01
   Survey response — days 1–6 daily, dose 2

   MedDRA: Menstruation delayed, Unevaluable event — Feeling: Poor · Site: Itching · Joint pains, Muscle or body aches · Be unable to do your normal daily activities

   Free text: Still havent hand my period is once April 4th.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
7. 2021-06-02
   Survey response — days 1–6 daily, dose 2

   MedDRA: Amenorrhoea — Feeling: Poor · Site: Itching · Headache, Joint pains, Muscle or body aches, Fatigue or tiredness · Be unable to do your normal daily activities

   Free text: Since April 4th I have skipped 2 periods. Im 42 and in perfect health. Birth control is copper T

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
8. 2021-06-04
   Survey response — days 1–6 daily, dose 2

   MedDRA: Menstruation delayed, Menstruation irregular — Feeling: Poor · Site: Itching · Headache · Be unable to do your normal daily activities

   Free text: My period has not come since April 4th.I am on no meds.Healthy, I have missed two cycles.I am on copper T birth control with no hormones.

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
9. 2021-06-14
   Survey response — day 14, dose 2

   MedDRA: Heavy menstrual bleeding, Menstruation irregular — Feeling: Fair · Be unable to do your normal daily activities

   Free text: After 2 months and 2 weeks I finally got my period. Its been 7 days of this cycle and its longer and heavier than usual

   MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
10. 2021-06-21
    Survey response — day 21, dose 2

    MedDRA: Heavy menstrual bleeding, Menstrual clots, Office visit — Feeling: Fair · Be unable to work or attend school, Be unable to do your normal daily activities, Get care from a doctor or other healthcare professional

    Free text: Symptoms: Ive now had my period for 13 days. So heavy, clots every time I sit on the toilet. Everytime I sat and or sit the mentral feels like urine. Every hour I over flow my tampon and pad. I have been messing my clothes because thats how much blood is · Healthcare visit (other): My regular gynatologist

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
11. 2021-06-21
    Report sent to call center — day 21, 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

    1 call case(s)
12. 2021-06-28
    Survey response — day 28, dose 2

    MedDRA: Anaemia, Heavy menstrual bleeding, Menometrorrhagia, Menstrual clots, Office visit — 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

    Free text: Symptoms: I became anemic after 17 days of skipping my period and then haveing a period that is 17 days heavy every 1 hour and clots and blood spelling like urine. · Healthcare visit (other): I went in and got blood test done with my gynecologist. It concluded I became anemic.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
13. 2021-06-28
    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

    1 call case(s)
14. 2021-06-28
    Call 1 — Left Voicemail
15. 2021-07-02
    Call 1 — Left Voicemail
16. 2021-07-12
    Survey response — day 42, dose 2

    MedDRA: Anaemia — 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, Outpatient clinic or urgent care clinic visit

    Free text: I have become anemic after 17 day of of and then a 11 day break then 8 days of period.

    MedDRA releases: 2021-09,2023-04,2024-11 · check-in free text available
17. 2021-07-12
    Report sent to call center — day 42, 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

    1 call case(s)
18. 2021-07-20
    Call 1 — Left Voicemail
19. 2021-08-30
    Survey response — 3 months, dose 2

    MedDRA: Dyspnoea — 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

    Free text: Shortness of breath

    MedDRA releases: 2021-09,2024-11 · check-in free text available
20. 2021-08-30
    Report sent to call center — 3 months, dose 2

    Get care from a doctor or other healthcare professional

    1 call case(s)
21. 2021-08-31
    Call 1 — Left Voicemail