Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Pulmonary embolism
Clinical narrative: agloss of taste; may have acquired COVID-19 infection; lumbar pain; infection; mouth become very swollen/Tongue swollen/mouth being swollen as, tongue swollen, gums and inner lips; In 2021, developed blood clots, shortly after he had Moderna vaccine. Clots became pulmonary embolism; deep vein thrombosis; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (In 2021, developed blood clots, shortly after he had Moderna vaccine. Clots became pulmonary embolism) and DEEP VEIN THROMBOSIS (deep vein thrombosis) in a 78-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Sleep disorder NOS and Acid reflux (oesophageal). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (oesophageal), ROSUVASTATIN for Cholesterol, TEMAZEPAM for Hypersomnia, ALFUZOSIN for Muscle relaxation, VITAMIN D3 for Supplementation therapy, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Feb-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jul-2024, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) 1 dosage form. In July 2021, the patient experienced PULMONARY EMBOLISM (In 2021, developed blood clots, shortly after he had Moderna vaccine. Clots became pulmonary embolism) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (deep vein thrombosis) (seriousness criterion medically significant). In July 2024, the patient experienced INJECTION SITE INFECTION (infection), MOUTH SWELLING (mouth become very swollen/Tongue swollen/mouth being swollen as, tongue swollen, gums and inner lips) and BACK PAIN (lumbar pain). On an unknown date, the patient experienced AGEUSIA (agloss of taste) and COVID-19 (may have acquired COVID-19 infection). The patient was treated with APIXABAN (ELIQUIS) in 2021 for Clot blood, at a dose of 5 milligram twice a day and Manual therapy (Epidural) for Back pain. At the time of the report, PULMONARY EMBOLISM (In 2021, developed blood clots, shortly after he had Moderna vaccine. Clots became pulmonary embolism), DEEP VEIN THROMBOSIS (deep vein thrombosis), AGEUSIA (agloss of taste) and COVID-19 (may have acquired COVID-19 infection) outcome was unknown, INJECTION SITE INFECTION (infection) had resolved and MOUTH SWELLING (mouth become very swollen/Tongue swollen/mouth being swollen as, tongue swollen, gums and inner lips) and BACK PAIN (lumbar pain) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient had received Moderna vaccine (first one) on 06-Feb-2021 then, every 6 or 8 months for booster. The patient was a very healthy fellow, hiked every few weeks. In July 2021, developed blood clots, shortly after he had Moderna vaccine and experienced "DVT" (Deep Vein Thrombosis), in which "clot travelled through his lungs", which lead to a "PE" (pulmonary embolism), had tremendous amounts blood work done over the past 3 years. Stopped taking Moderna, started taking Pfizer, now 2 or 3 boosters, would not be taking Moderna. He was prescribed with Eliquis, for blood clots.   On 30-Sep-2023, he received the Pfizer COVID-19 vaccine and that he didn't have a reaction back then. The patient theorized that adverse events might be associated to batch of Pfizer COVID-19 vaccine, but was unsure, also mentioned that it was currently "heavy allergy season", so that might have triggered "symptoms" or adverse events. He had experienced "loss of taste", also considered that he might have acquired COVID-19 infection.  It was reported that, the patient had received Pfizer Covid Vaccine booster on 06-Jul-2024 and Had reaction, well, not a reaction, but infection, used antibiotic, was a little under the weather the next day. it was approximately 6 weeks. Infection at site of injection: Infection stopped, it oozed for probably 3 or 4 weeks. Went to store about 2 weeks ago, they said to use antibiotic and bandage. The oozing has stopped. There is still inflammation and scab around the site. With the antibiotic, it is healing and itchy. It was mentioned that, patient 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. Does have other symptoms, with the mouth.  Company Comment- This spontaneous case concerns a 78  year  old male patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI deep vein thrombosis and pulmonary embolism approximately 5 months after receiving the Spikevax vaccine (mRNA  1273). He also presented the non-serious AESI ageusia on an unknown date. The report stated that the patient experienced deep vein thrombosis, which lead to a pulmonary embolism. The outcome of the events was unknown. No further clinical details were provided for medical reviewing. At the time of the report the patient was under treatment with rosuvastatin, acetylsalicylic acid, and apixaban. The patient also received a booster dose the co  suspect Tozinameran COVID  19 vaccines approximately 3 years after the mRNA  1273 vaccine. In context of vaccination with Tozinameran (approximately 6 weeks) he experienced Injection site infection, Mouth swelling, back pain, ageusia, and he suspected that he might have acquired COVID-19 infection. These events were assessed as not related to mRNA  1273 due to lack of temporal relationship. Patient´s age could be a confounding factor for deep vein thrombosis. The benefit-risk relationship of Spikevax vaccine (mRNA  1273) is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2024: Live follow-up received included start date of the suspect product and event was updated and narrative updated.