Sex: M
Vaccine: COVID19
Symptoms: Malaise, Mouth swelling, Swollen tongue, Vaccination site discharge, Vaccination site infection
Clinical narrative: lumbar pain; Infection at site of injection; site of injection oozed; inflammation and scab around the site; inflammation and scab around the site; vaccination site itchy; mouth swollen; a little under the weather; Tongue swollen; loss of taste; Clarified mouth being swollen as, tongue swollen, gums and inner lips.; Clarified mouth being swollen as, tongue swollen, gums and inner lips.; lip cracked a littler bit; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "acid reflux" (unspecified if ongoing); "stomach ulcer" (unspecified if ongoing); "sensitive gut" (unspecified if ongoing); "Blood cholesterol increased" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for thrombosis, start date: 2021 (ongoing); ALFUZOSIN taken for prophylaxis, start date: Feb2023 (ongoing); TEMAZEPAM taken for insomnia, start date: 2014 (ongoing); ROSUVASTATIN taken for blood cholesterol increased, start date: 2022 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for anticoagulant therapy, start date: 2022 (ongoing); VITAMIN D3 taken for supplementation therapy; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE] taken for gastrooesophageal reflux disease, gastric ulcer, gastrointestinal disorder, start date: 2021. Vaccination history included: Moderna vaccine (dose 1), administration date: 2021, for COVID-19 immunisation, reaction(s): "pulmonary embolism", "blood clots". Patient is a very healthy fellow, hikes every few weeks. In 2021, developed blood clots, shortly after he had Moderna vaccine. Clots became pulmonary embolism, has had tremendous amounts blood work done over the past 3 years. Nobody could figure out why. Stopped taking Moderna, started taking Pfizer, now 2 or 3 boosters, will not be taking Moderna.  The following information was reported: BACK PAIN (medically significant), outcome "unknown", described as "lumbar pain"; VACCINATION SITE INFECTION (non-serious), 1 week after the suspect product(s) administration, outcome "recovered", described as "Infection at site of injection"; VACCINATION SITE DISCHARGE (non-serious), outcome "recovered", described as "site of injection oozed"; VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE SCAB (non-serious), outcome "recovering" and all described as "inflammation and scab around the site"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "vaccination site itchy"; MOUTH SWELLING (non-serious), outcome "not recovered", described as "mouth swollen"; MALAISE (non-serious), outcome "unknown", described as "a little under the weather"; SWOLLEN TONGUE (non-serious), outcome "not recovered", described as "Tongue swollen"; AGEUSIA (non-serious), outcome "unknown", described as "loss of taste"; GINGIVAL SWELLING (non-serious), LIP SWELLING (non-serious), outcome "not recovered" and all described as "Clarified mouth being swollen as, tongue swollen, gums and inner lips."; CHAPPED LIPS (non-serious), outcome "not recovered", described as "lip cracked a littler bit". Therapeutic measures were taken as a result of back pain, vaccination site infection, vaccination site discharge, vaccination site inflammation, vaccination site scab. Therapeutic measures were not taken as a result of vaccination site pruritus, mouth swelling, malaise, swollen tongue, ageusia, gingival swelling, lip swelling, chapped lips. Clinical course: Clinical course: Patient had infection at site of injection a week after the injection and used antibiotic, was a little under the weather the next day. It has been 6 weeks now and patient still has infection at site of injection. Infection stopped. It oozed for probably 3 or 4 weeks. About 2 weeks ago, patient used antibiotic and bandage. The oozing has stopped. There is still inflammation and scab around the site. With the antibiotic, it is healing and itchy. Patient was wondering if that was related to the vaccine. The patient  was not sure if this is related but, at about the same time, patient's mouth become very swollen, tongue swollen, and considerable loss of taste. It was further clarified mouth being swollen as, tongue swollen, gums and inner lips. It started about 4 to 5 weeks ago. Patient was still experiencing these and is still pronounced. Just noticed this morning, patient's lip cracked a little bit and swelling has stayed about the same. Patient is going to stop into the dentist because, he feels, anything with mouth, should be addressed with dentist. Always think they are first line defense. Additionally, almost about the same time, could say, probably 6 weeks ago, maybe less, maybe even 4 weeks ago, had series of epidurals in the back, of steroids, for lumbar pain. May have been a week overlap. Not quite clear, when this all started. Maybe it is from the steroids. The same with the steroid injection, that was 29Jul2024, 4 weeks ago, the epidurals. Patient was going to call the provider who did epidural, to see if mouth thing is symptom of epidurals, or will go back to Covid vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.