Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival blister, Lip blister, Lip pruritus, Lip swelling, Oral discomfort
Clinical narrative: swollen, burning, itching lips with blisters and blisters on my gums; swollen, burning, itching lips with blisters and blisters on my gums; swollen, burning, itching lips with blisters and blisters on my gums; continue to have burning, itching, blistering and swelling of both lips; This is extremely painful; blister on her gums; This is a spontaneous report from a contactable consumer (Patient, self-reported) and a physician. A 57-year-old female non pregnant patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0161 and expiration date: Not reported), via an unknown route of administration, administered in arm left on 21Apr2021 14:45 at age of 57 years old as single dose for covid-19 immunisation. Medical history included chronic pain, stevens-johnson syndrome, Hep C, drug allergy to sofusbuvir. Concomitant medications included hydrocodone bitartrate/paracetamol (NORCO); valaciclovir; calcium and multivitamin. The patient historical vaccine include took First dose of BNT162B2, (lot number:ER8737), via intramuscular, in Arm Left on 31Mar2021 14:45 at age of 57 years old as single dose for covid-19 immunisation, Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient had not been tested for COVID-19, post vaccination. Reportedly, patient had a minor outbreak of SJS (Stevens-Johnson Syndrome) 14 days after the first vaccination but that cleared before the second vaccination. thirty-six hours after the second vaccination, Patient had swollen, burning, itching lips with blisters and blisters on her gums. This was a symptom of SJS, patient currently seeking medical treatment/assistance from dermatologist. Patient was waiting on her doctors office to call back. On 23Apr2021 03:00, the patient experienced swollen, burning, itching lips with blisters and blisters on gums, continue to have burning, itching, blistering and swelling of both lips and this was extremely painful. Patient visited physician office for adverse events. Therapeutic measures were taken (lidocaine, Clobetasol, getting a biopsy on 5/17, topical steroids) as a result of swollen, burning, itching lips with blisters and blisters on my gums, continue to have burning, itching, blistering and swelling of both lips, this was extremely painful. Outcome of event lip swelling, blisters was recovering. Outcome of other events was not recovered. The patient provided information to physician regarding the reported adverse events lip swelling, blisters with the use of the product, and physician considered vaccine had a casual effect to the adverse event.  No follow-up attempts are needed. No further information is expected.  Follow-up (24May2021): New information from a contactable physician in response to HCP letter includes: Medical history (add hep-c); Reaction data (outcome of event swelling, blisters was recovering).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between the events and suspect drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate