Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mean cell haemoglobin concentration decreased, Mouth injury, Oesophageal pain, Oral candidiasis, Oral discomfort
Clinical narrative: Booster; Coughing; Candida infection; Mouth pain; Swelling face/, swollen left side of the face; Facial pain/pain on left side of the face; Oral candida; Numbness lips/numbness in half of left lip; Numbness mouth; Numbness facial/numbness the middle of the left jaw; Mean cell hemoglobin concentration low; Hematocrit increased; Hemoglobin increased; Salivation/saliva coming out when eating; Oral mucosal erythema/redness inside the mouth; Discomfort in mouth; Sores mouth; Inflammation localised/inflammation between gum and cheek; White blood cell count increased/elevated white blood count; Red blood cell count low; Tooth infection; Shingles; Fungal vulvovaginitis/vaginal fungal infection/recurring vaginal fungal infection; Postoperative abscess; Wrong injection technique; Esophageal pain/gastroesophageal reflux type of pain; Vaginal itching; Vaginal discharge; Mouth injury/hole on mouth where the dental implant was removed; Fungal esophagitis/oesophageal fungal infection; Post procedural infection; Dental implantation; Oral surgery; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4049529-00, US-PFIZER INC-202101830094.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Feb2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single, intramuscular, administration date 28Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 14Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2017 (Batch/Lot number: unknown) to 14Aug2021 at (1 in 2 wk) and second regimen subcutaneous since 2021 (ongoing) (Batch/Lot number: unknown) at (1 in 2 wk) for colitis ulcerative. Relevant medical history included: "Tobacco user/five or six cigarettes a day, socially", start date: 1965 (unspecified if ongoing), notes: Tobacco user/five or six cigarettes a day, socially, "Alcohol user/occasional drinking", start date: 1972 (unspecified if ongoing), "Total hysterectomy" (unspecified if ongoing), "Rotator cuff surgery" (unspecified if ongoing), "PENICILLIN ALLERGY" (unspecified if ongoing), notes: PENICILLIN ALLERGY MANIFESTED BY COULD NOT BREATH, TONGUE AND FACE VERY SWOLLEN, LOT OF ITCHING ON FACE AND BODY, "Stomach disorder" (unspecified if ongoing), "CHOLESTEROL" (unspecified if ongoing), "HIGH BLOOD PRESSURE" (unspecified if ongoing), "PAIN" (unspecified if ongoing), "SUPPLEMENT" (unspecified if ongoing), "ACID REFLUX" (unspecified if ongoing), "Cough", start date: 2020 (unspecified if ongoing), "Fungal esophagitis", start date: 2020, stop date: 2020, notes: Recovered, "Vulvovaginal mycotic infection", stop date: 2020, notes: Recovered, "IODINE ALLERGY" (unspecified if ongoing), notes: IODINE ALLERGY; "Dental implantation" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE SODIUM taken for abdominal pain upper, ROSUVASTATIN CALCIUM taken for blood cholesterol, LOSARTAN POTASSIUM taken for hypertension, ADVIL [IBUPROFEN] taken for pain, VITAMIN D3 taken for product used for unknown indication, ZINC taken for supplementation therapy, ROSUVASTATIN taken for blood cholesterol, VITAMIN D NOS taken for supplementation therapy, PANTOPRAZOLE taken for gastrooesophageal reflux disease, VITAMIN C ACID. Past drug history included: Remicade for UNKNOWN INDICATION, reaction(s): "COULD NOT BREATH", notes: patient's past medications, MANIFESTED BY TWO OR THREE EPISODES OF NOT BREATHING, COULD NOT BREATH WAS PUT ON CORTISONE, Remicade for UNKNOWN INDICATION, reaction(s): "REMICADE ALLERGY", notes: patient's past medications, MANIFESTED BY TWO OR THREE EPISODES OF NOT BREATHING, COULD NOT BREATH WAS PUT ON CORTISONE, Iodine, notes: patient's past medications. The following information was reported: IMMUNISATION (hospitalization, medically significant), outcome "unknown", described as "Booster", CANDIDA INFECTION (hospitalization, medically significant) with onset 25Aug2021, outcome "not recovered", described as "Candida infection", ORAL PAIN (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Mouth pain", SWELLING FACE (hospitalization, medically significant) with onset Aug2021, outcome "recovering", described as "Swelling face/, swollen left side of the face", FACIAL PAIN (hospitalization, medically significant) with onset Aug2021, outcome "recovering", described as "Facial pain/pain on left side of the face ", ORAL CANDIDIASIS (hospitalization, medically significant) with onset Aug2021, outcome "recovered" (2021), described as "Oral candida", HYPOAESTHESIA ORAL (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Numbness lips/numbness in half of left lip", HYPOAESTHESIA ORAL (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Numbness mouth", HYPOAESTHESIA (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Numbness facial/numbness the middle of the left jaw", FUNGAL OESOPHAGITIS (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "Fungal esophagitis/oesophageal fungal infection", POST PROCEDURAL INFECTION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Post procedural infection"; DENTAL IMPLANTATION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Dental implantation"; ORAL SURGERY (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Oral surgery", TOOTH INFECTION (hospitalization, medically significant) with onset Feb2021, outcome "not recovered", described as "Tooth infection", MEAN CELL HAEMOGLOBIN CONCENTRATION DECREASED (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Mean cell hemoglobin concentration low", HAEMATOCRIT INCREASED (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Hematocrit increased"; HAEMOGLOBIN INCREASED (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Hemoglobin increased"; SALIVARY HYPERSECRETION (hospitalization, medically significant) with onset Aug2021, outcome "recovering", described as "Salivation/saliva coming out when eating"; ORAL MUCOSAL ERYTHEMA (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Oral mucosal erythema/redness inside the mouth"; VULVOVAGINAL PRURITUS (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Vaginal itching"; VAGINAL DISCHARGE (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "Vaginal discharge"; MOUTH INJURY (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Mouth injury/hole on mouth where the dental implant was removed"; STOMATITIS (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Sores mouth"; INFLAMMATION (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Inflammation localised/inflammation between gum and cheek"; WHITE BLOOD CELL COUNT INCREASED (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "White blood cell count increased/elevated white blood count"; POSTOPERATIVE ABSCESS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Postoperative abscess"; HERPES ZOSTER (hospitalization, medically significant) with onset Feb2021, outcome "recovered" (Mar2021), described as "Shingles"; RED BLOOD CELL COUNT DECREASED (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Red blood cell count low"; VULVOVAGINAL MYCOTIC INFECTION (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "Fungal vulvovaginitis/vaginal fungal infection/recurring vaginal fungal infection"; ORAL DISCOMFORT (hospitalization, medically significant) with onset Aug2021, outcome "not recovered", described as "Discomfort in mouth"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Wrong injection technique"; OESOPHAGEAL PAIN (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Esophageal pain/gastroesophageal reflux type of pain"; COUGH (hospitalization, medically significant), outcome "unknown", described as "Coughing".  The patient was hospitalized for oral pain, swelling face (start date: 21Aug2021). In Mar2021 she had three teeth removed as an outpatient and it was healed. On 10Aug2021 she had tooth implant done then two days later her face got swollen so she went back to her dentist and the antibiotic was shifted. On 21Aug2021 she got hospitalized due to swollen face and pain. She was referred to a special physician, but the antibiotic was shifted again to a new one then she was finally got discharged last 23Aug2021 afternoon. She had to go to the emergency room this past weekend in Aug2021 because of an infection she got in her mouth after a surgical procedure. The infection got worse in her mouth, and she needed to get antibiotic intravenous at the emergency room. Her mouth was inflamed and had pus at infection site. She still had the vaginal fungal infection from time to time which she treated by drinking lots of water. She also experienced coughing and gastroesophageal reflux type of pain due to her oesophageal fungal infection. She used her inhaler if she felt any coughing. She also stated that back in Aug2021 she was hospitalized for three days because of the fungal infection on her mouth. She was given an unknown antibiotic at the hospital and was prescribed with unknown mouthwash. Since there was still a whole on her mouth where the dental implant was removed, sometimes food got in the whole and she felt pain and discomfort. The patient underwent the following laboratory tests and procedures: colonoscopy: (2020) unknown result, notes: Esophageal fungal infection; computerised tomogram: (Aug2021) no abscess; computerised tomogram head: (Aug2021) no abscess; endoscopy: (2020) unknown result, notes: Esophageal fungal infection; full blood count: (Aug2021) unknown result; haematocrit: (Aug2021) elevated; haemoglobin: (Aug2021) elevated; mean cell haemoglobin concentration: (Aug2021) low; red blood cell count: (Aug2021) low; white blood cell count: (Aug2021) elevated; x-ray: (Aug2021) no abscess. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of candida infection, oral pain, swelling face, facial pain, oral candidiasis, hypoaesthesia oral, hypoaesthesia oral, hypoaesthesia, fungal oesophagitis, post procedural infection, dental implantation, oral surgery, tooth infection, mean cell haemoglobin concentration decreased, haematocrit increased, haemoglobin increased, salivary hypersecretion, oral mucosal erythema, vulvovaginal pruritus, vaginal discharge, mouth injury, stomatitis, inflammation, white blood cell count increased, postoperative abscess, herpes zoster, red blood cell count decreased, vulvovaginal mycotic infection, oral discomfort, oesophageal pain and included treatment with Nystatin, Ciprofloxacin, Clindamycin, Pulmicort Flexhaler, antibiotics and fluconazole.  The reporter's assessment of the causal relationship of the all the events with the bnt162b2 was not reported at the time of this report.  The reporter's causality for the events of oral surgery, oral candida, postoperative abscess was reported as no reasonable possibility to Humira 40mg/0.4ml (adalimumab) while not reported for the events dental implantation, wrong injection technique, mouth injury, sores mouth, esophageal pain, post procedural infection, discomfort in mouth and not assessable for remaining events.  The company (AbbVie) causality for the events of dental implantation, oral surgery, wrong injection technique, salivation, mouth injury was reported as no reasonable possibility to Humira 40mg/0.4ml (adalimumab) while reported as eeasonable possibility for the events swelling face, tooth infection, facial pain, oral candida, mean cell hemoglobin concentration low, hematocrit increased, hemoglobin increased, oral mucosal erythema, vaginal itching, vaginal discharge, sores mouth, cough, numbness lips, numbness facial, numbness mouth, inflammation localised, white blood cell count increased, esophageal pain, postoperative abscess, shingles, red blood cell count low, candida infection, post procedural infection, mouth pain, fungal esophagitis, vulvovaginal mycotic infection, discomfort in mouth.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.