Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Glycosylated haemoglobin, SARS-CoV-2 test, Therapeutic response unexpected, Urinary incontinence
Clinical narrative: does not have any symptoms of elevated BP and she has no signs of diabetes either/haven't had any symptoms of trigeminal neuralgia since having Covid-19 disease; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; couldn't hold pee to make it to the bathroom; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of three reports. A 62-year-old female patient received BNT162B2 (COMIRNATY), 1st dose on 16Mar2021 (lot number EN6208), 2nd dose on 06Apr2021 (lot number ER8737, expiration date 31Jul2021), both at single dose at left shoulder at 62-year-old via an unknown route for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). Medical history included high blood pressure/hypertension since 2010, diabetes since Aug2010, and trigeminal neuralgia.  Concomitant drug was not provided. Patient tested negative for Covid 19 disease four times before getting the Pfizer Covid vaccine 2 dose series. She had her first and second shots. Since then she tested positive for Covid after being vaccinated.  She did not know the test used the first time but she thought it was a false positive so she paid for an antigen test and that came back positive as well. She said that she had a negative Covid -19 test before family trip to (withheld) and also had a neg Covid-19 test before went to (withheld). On 22Aug2021. She had a Covid 19 test in (withheld) and it was positive, so she paid extra to have the antigen test and it came back positive on 23Aug2021 (also reported as 24Aug2021). She was then quarantined for 2 weeks in (withheld). She stated she felt fine for 2-3 days, but by the 5th-6th day she was "very cold, had a cold head, needed blankets and it felt like my head was open on top." (onset date 28Aug2021). She couldn't eat, had a funny taste like her tongue was coated and "all I could eat was yogurt 3x/day. " She was peeing in a garbage can because she couldn't make it to the bathroom. She was so weak. She just couldn't hold pee to make it to the bathroom. She was so weak couldn't even walk, they took her in a wheelchair to the airport and onto plane.  She had trigeminal neuralgia. Her upper teeth were hurting her and the pain was usually the effects of the nerve endings in lower jaw. But since having Covid, she no longer has that conditions. She felt that this was related to the vaccine and Pfizer saved her life. The medicine the neurologist prescribed made her "shaky and unstable" months before trip to (country). So she stopped taking it months ago. She had not had any symptoms of trigeminal neuralgia since having Covid-19 disease. It made it go away and they said she would probably have it the rest of her life. She also had not had any symptoms of elevated BP and she had no signs of diabetes either since her Covid 19 disease. Her A1C was 6.5 6 months ago 6.7 3 months ago (as of 15Sep2021). Outcome of the events was unknown.   Investigation result from Product Quality Complaints for lot number ER8737 included:  Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101216541 same reporter/vaccine, similar AE, different patient