Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site hypersensitivity, Vaccination site pain, Vaccination site swelling, Walking aid user, Weight decreased
Clinical narrative: Pseudo infection; Dystonic tremors; Knee arthropathy; Central Tremors; Infected toe; No appetite; Lost 14 pounds; Weakness; Incapacitated so had to use walker; Shingles; Nasal ulcer; Sick from Moderna COVID vaccination; Knee pain; Allergic reaction with pain and swelling to gel injection in knee; Allergic reaction with pain and swelling to gel injection in knee; Allergic reaction with pain and swelling to gel injection in knee; COVID-19; Foggy feeling in head; This spontaneous case was reported by a consumer and describes the occurrence of PSEUDOMONAS INFECTION (Pseudo infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   On 01-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate free. In February 2022, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced FEELING ABNORMAL (Foggy feeling in head). On an unknown date, the patient experienced PSEUDOMONAS INFECTION (Pseudo infection) (seriousness criterion medically significant), DYSTONIC TREMOR (Dystonic tremors), ARTHROPATHY (Knee arthropathy), TREMOR (Central Tremors), LOCALISED INFECTION (Infected toe), DECREASED APPETITE (No appetite), WEIGHT DECREASED (Lost 14 pounds), ASTHENIA (Weakness), WALKING AID USER (Incapacitated so had to use walker), HERPES ZOSTER (Shingles), NASAL ULCER (Nasal ulcer), ILLNESS (Sick from Moderna COVID vaccination), ARTHRALGIA (Knee pain), VACCINATION SITE HYPERSENSITIVITY (Allergic reaction with pain and swelling to gel injection in knee), VACCINATION SITE PAIN (Allergic reaction with pain and swelling to gel injection in knee) and VACCINATION SITE SWELLING (Allergic reaction with pain and swelling to gel injection in knee). At the time of the report, PSEUDOMONAS INFECTION (Pseudo infection), HERPES ZOSTER (Shingles), NASAL ULCER (Nasal ulcer), ILLNESS (Sick from Moderna COVID vaccination), VACCINATION SITE HYPERSENSITIVITY (Allergic reaction with pain and swelling to gel injection in knee), VACCINATION SITE PAIN (Allergic reaction with pain and swelling to gel injection in knee) and VACCINATION SITE SWELLING (Allergic reaction with pain and swelling to gel injection in knee) had resolved, DYSTONIC TREMOR (Dystonic tremors), ARTHROPATHY (Knee arthropathy), TREMOR (Central Tremors), LOCALISED INFECTION (Infected toe) and ARTHRALGIA (Knee pain) had not resolved, DECREASED APPETITE (No appetite), WEIGHT DECREASED (Lost 14 pounds), ASTHENIA (Weakness) and WALKING AID USER (Incapacitated so had to use walker) outcome was unknown and FEELING ABNORMAL (Foggy feeling in head) and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Pain assessment: 9 out of 10.         Treatment information mentioned antibiotics NOS and knee surgery. Patient had dystonic tremors and central tremors. In Feb 2022, she had covid and symptoms tiredness, sore throat, body aches, temperature, no appetite, nausea. She tested positive for covid. She was nauseas for a month. She had brain fog. She had knee pain and also took antibiotics for toe infection. She also got Infection what looked like a cold sore or shingles inside and outside of her nostril. Physician called it some kind of infection. It happened after she came back. She had a gel injection in knee and had an allergic reaction with severe pain. She lost 14 pounds and had to use the walker cause she was incapacitated. Had to have the gel sucked out two times in Jul 2022. Physician said it was a pseudo infection and wanted to wait till after swelling went down to do the surgery, but did not do it and it went away. On 13-Jul-2022, she had surgery on right knee. Physician had to peel away cartilage and what he called fish egg looking things. She had right knee surgery twice but had troubles as of 26 Aug 2022.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.Reporters causality of events with Humira was reasonable possibility.  Company comment: This spontaneous case concerns a 68-year-old female patient, with no relevant medical history, who experienced the unexpected serious (medical significant) event of pseudomonas infection and unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive approximately 7 months after third dose of mRNA-1273 vaccine, patient had covid related symptoms tiredness, sore throat, body aches, temperature, patient had knee pain also took antibiotics for toe infection, patient also had shingles inside and outside of her nostril, patient took gel injection in knee and had allergic with severe pain, according to physician it is pseudo infection and wanted to wait to do surgery until selling went down, but it did not do the surgery and finally went away, later patient had right knee surgery. Patient received two doses of TOZINAMERAN 6 months prior to the third dose of mRNA-1273 vaccine. Current ongoing pandemia is confounding for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient, with no relevant medical history, who experienced the unexpected serious (medical significant) event of pseudomonas infection and unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive approximately 7 months after third dose of mRNA-1273 vaccine, patient had covid related symptoms tiredness, sore throat, body aches, temperature, patient had knee pain also took antibiotics for toe infection, patient also had shingles inside and outside of her nostril, patient took gel injection in knee and had allergic with severe pain, according to physician it is pseudo infection and wanted to wait to do surgery until selling went down, but it did not do the surgery and finally went away, later patient had right knee surgery. Patient received two doses of TOZINAMERAN 6 months prior to the third dose of mRNA-1273 vaccine. Current ongoing pandemia is confounding for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.