Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Headache, Hypoaesthesia, Inflammation, Insomnia
Clinical narrative: joints of his fingers hurt when pushing down to open the top of a medicine bottle; arms get so stiff, so that moving the mouse on computer is painful; inflammation with the body; his body starts shutting down about 4:30 pm every day with his having chills and getting really, really sore and stiff; Prickling/Tingling sensation; Red/itchy eyes; Sneezing/runny nose; Flushing; Numbness; Red /Itchy eye; joints were sore right above the knees, at his shoulder blades and shoulders, feet, and hips; muscles sore and straining if he sits on the commode and then stands up; the reactio continues sever pain in joints , muscels hand shoulders and feet; chills; Headache; hands would get sore from the knuckles to the wrist and swell a little; could not lay down because his nose was draining so much; was blowing his nose and trying to clear his throat; doctor told the patient that he thought the patient had a sinus infection; could not breath and his nose was stopped up; started getting a real severe sinus drainage with his eyes being really watery and his nose draining into his throat; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS HYPERSECRETION (started getting a real severe sinus drainage with his eyes being really watery and his nose draining into his throat), PERIPHERAL SWELLING (hands would get sore from the knuckles to the wrist and swell a little), INSOMNIA (could not lay down because his nose was draining so much), NASAL CONGESTION (was blowing his nose and trying to clear his throat) and SINUSITIS (doctor told the patient that he thought the patient had a sinus infection) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease on 05-Oct-1998. Concurrent medical conditions included Rheumatic arthritis acute and Hypersensitivity reaction since 28-Mar-2021. Concomitant products included VALSARTAN for Blood pressure, SIMVASTATIN for Cholesterol, DOXYCYCLINE for Rosacea, LOSARTAN for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PARANASAL SINUS HYPERSECRETION (started getting a real severe sinus drainage with his eyes being really watery and his nose draining into his throat), NASAL CONGESTION (was blowing his nose and trying to clear his throat), SINUSITIS (doctor told the patient that he thought the patient had a sinus infection) and DYSPNOEA (could not breath and his nose was stopped up). On an unknown date, the patient experienced PERIPHERAL SWELLING (hands would get sore from the knuckles to the wrist and swell a little), INSOMNIA (could not lay down because his nose was draining so much), PAIN IN EXTREMITY (joints of his fingers hurt when pushing down to open the top of a medicine bottle), JOINT STIFFNESS (arms get so stiff, so that moving the mouse on computer is painful), INFLAMMATION (inflammation with the body), FEELING ABNORMAL (his body starts shutting down about 4:30 pm every day with his having chills and getting really, really sore and stiff), PARAESTHESIA (Prickling/Tingling sensation), EYE PRURITUS (Red/itchy eyes), RHINORRHOEA (Sneezing/runny nose), FLUSHING (Flushing), HYPOAESTHESIA (Numbness), OCULAR HYPERAEMIA (Red /Itchy eye), ARTHRALGIA (joints were sore right above the knees, at his shoulder blades and shoulders, feet, and hips), MYALGIA (muscles sore and straining if he sits on the commode and then stands up), ARTHRALGIA (the reactio continues sever pain in joints , muscels hand shoulders and feet), CHILLS (chills) and HEADACHE (headache). The patient was treated with LEVOFLOXACIN (LEVAQUIN) on 01-Jun-2021 for Sinus infection, at an unspecified dose and frequency; GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) for Sinus infection, at an unspecified dose and frequency; PREDNISONE (oral) for Inflammation, at a dose of 18 pills total taper dose; MONTELUKAST SODIUM (SINGULAIR) for Sinus infection, at an unspecified dose and frequency; AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for Sinus infection, at an unspecified dose and frequency and HYDROXYCHLOROQUINE on 06-Feb-2021 at a dose of 100 milligram twice a day. At the time of the report, PARANASAL SINUS HYPERSECRETION (started getting a real severe sinus drainage with his eyes being really watery and his nose draining into his throat), PERIPHERAL SWELLING (hands would get sore from the knuckles to the wrist and swell a little), INSOMNIA (could not lay down because his nose was draining so much), NASAL CONGESTION (was blowing his nose and trying to clear his throat), SINUSITIS (doctor told the patient that he thought the patient had a sinus infection), DYSPNOEA (could not breath and his nose was stopped up), PAIN IN EXTREMITY (joints of his fingers hurt when pushing down to open the top of a medicine bottle), JOINT STIFFNESS (arms get so stiff, so that moving the mouse on computer is painful), INFLAMMATION (inflammation with the body), FEELING ABNORMAL (his body starts shutting down about 4:30 pm every day with his having chills and getting really, really sore and stiff), ARTHRALGIA (joints were sore right above the knees, at his shoulder blades and shoulders, feet, and hips), MYALGIA (muscles sore and straining if he sits on the commode and then stands up) and HEADACHE (headache) outcome was unknown and PARAESTHESIA (Prickling/Tingling sensation), EYE PRURITUS (Red/itchy eyes), RHINORRHOEA (Sneezing/runny nose), FLUSHING (Flushing), HYPOAESTHESIA (Numbness), OCULAR HYPERAEMIA (Red /Itchy eye), ARTHRALGIA (the reactio continues sever pain in joints , muscels hand shoulders and feet) and CHILLS (chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant medications included an unspecified statin. About 12 hours or so after the second dose, the patient started getting a real severe sinus drainage. The patient was prescribed nasal irrigator therapy and a ten day course of Levaquin therapy was added and the patient's sinuses are doing better. The blood test results indicated that a marker for inflammation is a little elevated, and that a unspecified rheumatoid arthritis marker was slightly increased compared to previous blood tests.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Updated medical history. Vaccine facility. Updated concomitant and treatment medications . Event info updated- the reaction continues sever pain in joints, muscle hand shoulders and feet.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.