Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal oedema, Stevens-Johnson syndrome, Urticaria
Clinical narrative: Stevens-Johnson syndrome; upper lip started to swell/lips were swollen/both lips swollen bad/top and bottom lips were very, very swollen/swollen lips; swollen lips and throat; hives on chin, shoulders and back/ had itchy hives all over/bad hives/hives on are the rest of the body/hives all over torso; This is a spontaneous report from a contactable consumer (patient) and other HCP (nurse). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in Arm Right on 06Mar2021 18:15 (Lot Number: EN6199) (at the age of 28 years old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included bipolar disorder and depression, both from an unknown date. Concomitant medications included lithium; venlafaxine; hydroxyzine embonate (VISTARIL [HYDROXYZINE EMBONATE]); lithium carbonate; propranolol; venlafaxine hydrochloride (EFFEXOR); all were taken for an unspecified indication, start and stop date were not reported. The patient previously took lamictal and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 (Sunday), that day after Pfizer COVID vaccine, patient had bad hives, woke up with hives on chin, shoulders and back. The hives continued on Monday (08Mar2021) to get worse, hives continued to get worse and then on Tuesday, woke up and lips were swollen. It was reported that 2 days after vaccine, her upper lip started to swell. Then 3 days after (on Wednesday), woke up and both of her lips were swollen, top and bottom lips were very, very swollen, both lips swollen bad. Stated that it was getting worse. And had itchy hives all over her body, hives on are the rest of the body, the hives have continued over the rest of her body. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Also reported by the other HCP that the adverse events: hives all over torso, swollen lips and throat started on 06Mar2021, which resulted in Emergency room/department or urgent care, the reported treatment received for the adverse event were Benadryl, steroids. When probed if the product was prescribed by any healthcare professional. Further stated, that she also had hives on her abdomen and on her legs. She tried taking Advil allergy and now she was taking a different allergy medication. Patient stated that one of the things her doctor was worried about was Stevens-Johnson syndrome. With the current symptoms that the patient had that were getting worse not better. She was wondering if she needed to go to a hospital for any assistance. The outcome of the event Stevens-Johnson syndrome was unknown while for the other events was recovering.  Follow-up attempts are needed. Additional information is requested.; Sender's Comments: A possible causal relationship between BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the reported events, including swollen lips and throat and suspected Stevens-Johnson syndrome cannot be excluded, considering temporal relationship.  The case will be reassessed should additional information become available.  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.