Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vulvovaginal dryness
Clinical narrative: Vaginal Dryness; severe nausea; increased urination; usual arm pain redness and swelling; usual arm pain redness and swelling; usual arm pain redness and swelling; Fever; Fatigue; headache; cloudy feeling; Diarrhea; sore throat; Joint and muscle pain; Joint and muscle pain; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reaction(s). Information was processed together.  This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW0176), intramuscularly administered in arm left on 06Jul2021 12:00 as dose 1, single for covid-19 immunization. Medical history included developmental hip dysplasia from 2013 and ongoing (2014 plus 2016 right labral tear repair); herniated disc from 2017 and ongoing; hip bursitis bilateral from 2016 and ongoing; hip bone nerve saphenous from 2016 and ongoing; shoulder rotate injury from Jan2021 and ongoing; ongoing inflammation; ongoing nerve pain; and ongoing muscle spasm. The patient was not pregnant at the time of vaccination and time of events. Concomitant medications included gabapentin taken for neuralgia from 2016 and ongoing; naproxen sodium (ALEVE) taken for inflammation from an unspecified start date and ongoing; baclofen (BACLOFEN) taken for muscle spasms from an unspecified start date and ongoing; diclofenac (VOLTAREN) taken for inflammation from an unspecified start date and ongoing; and an unspecified oral daily vitamin taken for an unspecified indication, from an unspecified start date and ongoing. The patient previously received azithromycin (Z-PAK) for allergy. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Started with usual arm pain redness and swelling on 06Jul2021 12:30. Joint and muscle pain (seriousness criteria: persistent/significant disability/incapacity) by evening on 06Jul2021 with onset time reported as "aprox. 06:0PM" and as treatment, the patient took Aleve, gabapentin, and baclofen as well as ice. Fever by evening on 06Jul2021. Fatigue by evening with headache and cloudy feeling - all on 06Jul2021. Diarrhea on 06Jul2021. Now sore throat on 06Jul2021. Next day, 07Jul2021 12:30, severe nausea (seriousness criteria: persistent/significant disability/incapacity), almost vomit. Increased urination (assessed as non-serious) on 07Jul2021 which healed with unspecified treatment. Second day, 08Jul2021, took Zofran 4mg BID to help with nausea so she can eat bland food. All other symptoms present. By Friday evening on 09Jul2021 fever gone, arm symptoms gone and; muscle/joint pain lessened. All others still present. Vaginal dryness on 09Jul2021, treated with Lubeplus A plus D ointments, and healed. The outcome of events joint and muscle pain was recovering. The outcome of events arm pain redness and swelling, and fever was recovered on 09Jul2021. The outcome of events increased urination and vaginal dryness was recovered on an unspecified date in 2021. The outcome of the other remaining events was not recovered. Since the vaccination, the patient has not been tested for covid-19.  Follow-up (13Aug2021): Follow-up attempts are completed. No further information is expected.