Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis interstitial, Dysmenorrhoea, Gingival bleeding, Headache, Heavy menstrual bleeding
Clinical narrative: before vaccination she has not have her menstrual cycle for quite a while, and it then started yesterday.; her periods were "heavy, flooding" with "cramps"; her periods were "heavy, flooding" with "cramps"; gums that have been bleeding easier than normal; a weird pain in her upper legs, at the "top part", which started in her left leg and radiated to the right one, last night.; Interstitial Cystitis anyway,  flare it up; excessive, frequent and urgent urination; excessive, frequent and urgent urination; excessive, frequent and urgent urination; the arm where she was vaccinated was "cold to touch and sore; the arm where she was vaccinated was "cold to touch and sore; her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms.; her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms.; intermittent headaches; waves of nausea; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose for BNT162B2 at single dose at Arm Left on 28May2021 at 17:58 for COVID-19 immuniation (53-year-old at vaccination).   Relevant history included positive ANA, Interstitial Cystitis and Ocular Rosacea. Relevant concomitant drug included Doxycycline at 50 mg twice daily for ocular rosacea since 1 week before getting the vaccine to 27May2021. She noticed an increase in urination after starting it. Was told it was okay to get the vaccine while on it. Stopped it due to irritation in her stomach. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No family medical history relevant to AE(s). The patient explained she has experienced various side effects from the first dose. She reported having "excessive, frequent and urgent urination", which lasted for three hours the night she was vaccinated.  She mentioned the arm where she was vaccinated was "cold to touch and sore." Her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms. She then listed the following as additional symptoms: "intermittent headaches, waves of nausea, and gums that have been bleeding easier than normal". She then explained before vaccination she has not have her menstrual cycle for quite a while, and it then started since 09Jun2021 (reported as yesterday). She specified this morning, her periods were "heavy, flooding" with "cramps", which she had never experienced "at that level" before/ "more than typical". Lastly, she reported a weird pain in her upper legs since 07Jun2021, at the "top part", which started in her left leg and radiated to the right one, last night. She described this weird pain as "deep in" her legs, "not a muscular pain" but one that is either related to her "blood vessels or nerves". She said this pain is "not constant but shooting".  She asked if these symptoms are normal after getting the vaccine. The patient further specified that evening she had excessive, frequent and urgent urination; she was drinking more that day, but not that much more. That same night, her left arm was cold to the touch and sore. She also woke up during the night with numb and tingling fingers on both hands; it was her little finger and ring fingers on both hands; it would start in her hand and go up her arm. She had intermittent headaches and waves of slight nausea. States that she has not had a full menstrual cycle for some time, but yesterday she started her cycle and last night it got heavier, and today it's really heavy, like it's flooding. She also has really bad cramps. Her gums have been bleeding easier as well for the past couple days, but she did not see any blood today when she brushed her teeth. Also, she has leg pain; it started in her upper left leg on the 7th, deep in a vain, almost like a nerve pain, but last night it was in her right leg; it comes in waves. The pain is in the top inside part of her legs. It's either a nerve thing or a blood vessels thing. When she was experiencing the frequent urination, she started wondering if the vaccine was all leaving her body, so now she doesn't know if she has the protection from the vaccine. Is there a way to check that? She has Interstitial Cystitis anyway, and there are a lot of things that can flare it up, but this just lasted longer. States that it lasted about 3 hours, and now she is back to her normal. While it was occurring, it was excessive, she went to the bathroom about 8-10 times an hour and her pee was clear. States she was trying to drink more water to make sure she didn't get dehydrated, but as soon as she drank, she would have to go again.  She stated the intermittent headache and slight nausea, she expected to have after the vaccine. The cramping from her cycle is easing up, but the flow was really heavy earlier today, but in the last hour is has slowed a bit.  On the night of 08Jun2021, her gums were really bleeding when she was brushing her teeth, and last night they were bleeding, but this morning there was no bleeding at all, so hopefully it's stopped but she won't really know until she brushes her teeth tonight. The events did not result in Emergency Room or Physician Office visit.  No relevant tests performed.  The outcome of event pain in leg, gums have been bleeding was resolving. The outcome of other events was resolved. The patient was due to get her 2nd dose on 10Jun2021, but she was nervous to get it.  She has auto-immune concerns; she has a positive ANA. Her doctor told her that she definitely needs to get the vaccine.  She had her second dose scheduled on 18Jun2021.    Information on Lot/Batch number was available. Additional information has been requested