Sex: F
Vaccine: FLU4
Symptoms: Butterfly rash, Dry eye, Exploding head syndrome, Eye inflammation, Eye pain
Clinical narrative: immunodeficiency; Dry eyes aggravated; eye prosthesis insertion; eye pain; Plugs placed in eyes; mammogram abnormal; Head exploding; felt head exploding / headache was severe/ Headache aggravated; low grade fever; eye inflammation; Psoriasis flare-up/ hands Psoriasis / knee Psoriasis; stress; Psoriasis on nails; Butterfly rash; rosacea; This case was reported by a consumer via other manufacturer and described the occurrence of immunodeficiency in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis.   Co-suspect products included adalimumab (Humira) solution for injection in pre-filled pen for psoriatic arthritis and levothyroxine sodium (Synthroid) tablet for thyroidectomy.   The subject's past medical history included thyroid operation (had Thyroid surgery in 1986), eye dryness (had dry eyes), headache (had headache), heart rate increased (had Heart rate increased), hypertension (had hypertension), asthma (had asthma), knee replacement (had Knee replacement), fatty liver (had fatty liver diseases), c-section (had C section), liver enzyme abnormal (had unstable liver enzyme), pain in hip (had hip pain), pruritus, crawling sensation of skin (had ants crawling on skin due to codeine allergy), breathing difficult (had breathing issue due to sulpha allergy), rash (hexachlorophene allergy manifested by rash) and eye burns (inveltys allergy manifested by burned eyes). Previously administered products included codeine (had codeine), Loteprednol etabonate (received inveltys(Loteprednol etabonate)), HEXACHLOROPHENE (received hexachlorophene), BACTRIM (had bactrim), FLAGYL (received flagyl) and PLAQUENIL. Concurrent medical conditions included drug allergy (had allergy to codeine, hexachlorophine, Bactrim,  Flagyl and inveltys.) and sulfonamide allergy (had sulpha allergy). Concomitant products included salbutamol sulphate (Albuterol), fluticasone propionate (Flovent), carvedilol, amlodipine besilate (Norvasc), amlodipine, montelukast sodium (Singulair), piroxicam, caffeine + ergotamine tartrate (Cafergot), cefixime (Flexeril (Cefixime)) and hydrocodone bitartrate + paracetamol (Norco).   On an unknown date, the patient received Flu Seasonal QIV Dresden, Humira (subcutaneous) 40 mg at an unknown dose and frequency and Synthroid (oral) at an unknown dose and frequency. In December 2020, unknown after receiving Flu Seasonal QIV Dresden and an unknown time after starting Albuterol and Flovent, the patient experienced eye inflammation (serious criteria other: Other Medically Imp Condition), butterfly rash (serious criteria other: Other Medically Imp Condition), rosacea (serious criteria other: Other Medically Imp Condition), psoriasis flare-up (serious criteria other: Other Medically Imp Condition), stress (serious criteria other: Other Medically Imp Condition) and nail psoriasis (serious criteria other: Other Medically Imp Condition). On 28th December 2020, the patient experienced low grade fever (serious criteria other: Other Medically Imp Condition). On 31st December 2020, the patient experienced headache (serious criteria other: Other Medically Imp Condition) and exploding head syndrome. On an unknown date, the patient experienced immunodeficiency (serious criteria GSK medically significant and other: Other Medically Imp Condition), mammogram abnormal (serious criteria other: Other Medically Imp Condition), dry eyes aggravated (serious criteria other: Other Medically Imp Condition), eye prosthesis insertion (serious criteria other: Other Medically Imp Condition), eye pain and punctal plug insertion. The subject was treated with excedrin (nos) (Excedrin), ibuprofen (Advil), ibuprofen, paracetamol (Tylenol) and macrogol + propylene glycol (Systane). The action taken with Humira was unknown. The action taken with Synthroid was unknown. On an unknown date, the outcome of the eye inflammation, butterfly rash, rosacea, psoriasis flare-up, stress, nail psoriasis, low grade fever, headache, exploding head syndrome, immunodeficiency, mammogram abnormal, dry eyes aggravated and eye pain were recovered/resolved and the outcome of the eye prosthesis insertion and punctal plug insertion were unknown.   It was unknown if the reporter considered the immunodeficiency, eye inflammation, headache, low grade fever, mammogram abnormal, butterfly rash, rosacea, dry eyes aggravated, psoriasis flare-up, stress, nail psoriasis, eye prosthesis insertion, eye pain, punctal plug insertion and exploding head syndrome to be related to Flu Seasonal QIV Dresden.  Additional details were provided as follows: The patient had medical history of left quad rupture with repair, partial total knee repalcement and ACL repair. The age at vaccination was not reported. The patient performed mammogram in 2020 with breast tissue dense and something was found in the right breast around the nipple or areolar. on an unknown date, the patient experienced low immunity. in 2019, the patient experienced plugs palced in eyes and worsened dry eyes. in 2020, the patient experienced abnormal mammogram. in December 2020, the patient experienced eye inflammation, stress out, butterfly symptom or rosacea to face and psoriasis flare on right knee and both hands and nails. on 28th December 2020, the patient experienced low grade fever. on 31st December 2020,the patient experienced worsened headache/felt head explode. The reporter's causality for the event(s) of plugs palced in eyes was not provided. The reporter's causality for the event(s)of abnormal mammogram, eye inflammation, low immunity, stress out, butterfly symptom or rosacea to face onset in december 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache or felt head explode with humira 40mg/0.8ml(adalimumab) was no reasonable possibility.  The reporter stated that there was no reasonable possibility that the events of plugs palced in eyes, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in december 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode are related to humira 40mg/0.8ml(adalimumab). The reporter stated that the events of abnormal mammogram and eye inflammation were not assessable. The reporter stated that there was a reasonable possibility that the event of low immunity is related to humira 40mg/0.8ml(adalimumab). The reporter's causality for the event(s) of plugs palced in eyes, abnormal mammogram, low immunity, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode was not provided. The reporter's causality for the event(s) of eye inflammation with synthroid(levothyroxine) was no reasonable possibility. The reporter stated  that there was no reasonable possibility that the events of plugs palced in eyes, abnormal mammogram, eye inflammation, low immunity, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode were related to synthroid(levothyroxine).