Sex: U
Vaccine: COVID19
Symptoms: Dry skin, Hypoaesthesia oral, Immunisation, Interchange of vaccine products, Lip swelling
Clinical narrative: swelling of the lip; numbness/ lips swollen numbness (twice); lymph nodes swelled/ Lymph nodes swollen in arm of covid shot; Dry cracked and peeling skin; Dry cracked and peeling skin; Dry cracked and peeling skin; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from contactable reporters (consumer and other health care professional (HCP)) for a Pfizer sponsored program. The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Nov2021 12:00 (Lot number: FH8020) as dose 2 (booster), single for COVID-19 immunisation. Relevant medical history included: "Complete Hysterectomy", start date: 2003 (unspecified if ongoing), notes: Surgery 2003; "Anxiety" (unspecified if ongoing). Concomitant medications included: BUPROPION XL taken for anxiety (ongoing); INDOL 3 CARBINOL taken for hormone therapy (ongoing); 3,3'-DIINDOLYLMETHANE taken for hormone therapy (ongoing), Min-Chex supplement taken for focus/calming (ongoing), start date: 05Apr2021; hormones pellets taken for hormone therapy (ongoing), start date Jun2020. Vaccination history included: Janssen-covid shot (Dose: 1st Janssen-Covid shot, Single Dose injection, Time (24hr): 11:30 Am, Anatomical site of injection: Left Arm, Batch/Lot number: 1805031), administration date: 04Aug2021, for COVID-19 immunization. The patient did not receive any vaccine within four weeks. The following information was reported: OFF LABEL USE (non-serious) with onset 01Nov2021 12:00, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 01Nov2021 12:00, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 01Nov2021 12:00, outcome "unknown", described as "Booster"; LIP SWELLING (non-serious) with onset 08Nov2021 and also on 22Nov2021, outcome "recovered with sequelae" (15Nov2021 also on 29Nov2021), described as "swelling of the lip"; HYPOAESTHESIA ORAL (non-serious) with onset 08Nov2021 and also on 22Nov2021, outcome "recovered with sequelae" (15Nov2021 also on 29Nov2021), described as "numbness/ lips swollen numbness (twice)"; LYMPHADENOPATHY (non-serious) with onset 03Nov2021, outcome "recovered" (07Nov2021), described as " lymph nodes swelled/ Lymph nodes swollen in arm of covid shot"; DRY SKIN (non-serious), SKIN FISSURES (non-serious), SKIN EXFOLIATION (non-serious) all with onset 03Nov2021, outcome "recovered" (07Nov2021) and all described as "Dry cracked and peeling skin". The events "swelling of the lip" and "numbness/ lips swollen numbness (twice)" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lip swelling, hypoaesthesia oral, dry skin, skin fissures, skin exfoliation, and included ice compress and over the counter (OTC) diphenhydramine (BENADRYL)/ AQUAPHOR plus lysine lip ointment, warm compress. Therapeutic measures were not taken as a result of lymphadenopathy. No specific relevant test for thromboembolic events with thrombocytopenia was reported.  Additional information: after receiving the Pfizer booster shot lymph nodes swelled which patient understand as normal. What concerned patient was a swelling of the lips and numbness. One week had passed and side effects appear to be getting worse. Lips swollen with numbness plus sensitive to touch. Followed by dry cracked and peeling skin. This had occurred 2-times. Both times lasting 7-days.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.