Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Rhinorrhoea, Secretion discharge, Sneezing
Clinical narrative: cough; sneezing; mucous and runny nose; mucous and runny nose; sore throat; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA070709 (Sanofi).  A 66-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), on 17Feb2024 as 600 mg 1 x followed by 300 mg qow (every other week)) and in 2024 as 600 mg 1 x followed by 300 mg qow (every other week)), all subcutaneous for asthma. The patient's relevant medical history included: "Covid", start date: Aug2024 (unspecified if ongoing), notes: diagnosed with covid last week (week of 01Aug2024, exact date unknown)  and had a runny nose.; "had a runny nose", start date: Aug2024 (unspecified if ongoing), notes: diagnosed with covid last week (week of 01Aug2024, exact date unknown)  and had a runny nose.; "headache", start date: 2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 16Nov2024, outcome "not recovered"; SECRETION DISCHARGE (non-serious), RHINORRHOEA (non-serious) all with onset 16Nov2024, outcome "not recovered" and all described as "mucous and runny nose"; SNEEZING (non-serious) with onset 16Nov2024, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 16Nov2024, outcome "not recovered", described as "sore throat". The action taken for dupilumab was dosage reduced. Therapeutic measures were taken as a result of cough, sneezing, secretion discharge, rhinorrhoea, oropharyngeal pain.  Additional information: Initial information was received on 27Feb2024 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Health Care Professional). This case involves a 65-year-old female patient who had headache, diagnosed with covid last week and had a runny nose, cough, sneezing, mucous and runny nose and sore throat while being treated with DUPILUMAB [DUPIXENT] delivered via dupixent single dose prefilled pen and CO VID-19 VACCINE. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On 17Feb2024, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection strength: 300 mg/2ml at a dose of 600 mg 1 X followed by 300 mg QOW (Every other week) on an unknown date in 2024 subcutaneously delivered via Dupixent single dose prefilled pen for Asthma. In Aug2024 the patient developed a non-serious event "diagnosed with covid last week and had a runny nose" (covid-19) (rhinorrhoea) (latency: approximately 6 months) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. On an unknown dale in 2024 the patient developed a non-serious event "headache" (unknown latency) (unknown batch number and expiry date) following the first dose intake of DUPILUMAB. On 13Nov2024, the patient received COVID-19 VACCINE, 1x (once) for booster (3rd) (unknown formulation, strength, and route). On 16Nov2024 the patient developed a non-serious event "cough" (latency: 9 months) following the first dose intake of DUPILUMAB and (latency) 3 days following the first dose intake of COVID-19 VACCINE (unknown batch number and expiry date of both drugs). On 16Nov2024 the patient developed a non-serious event "sneezing" (latency: 9 months) following the first dose intake of DUPILUMAB and (latency) 3 days following the first dose intake of COVID-19 VACCINE (unknown batch number and expiry date of both drugs). On 16Nov2024 the patient developed a non-serious event "mucous and runny nose' (rhinorrhoea) (latency: 9 months) following the first dose intake of D UPIL UM AB and (latency) 3 days following the first dose intake of COVID-19 VACCI NE (unknown batch number and expiry date of both drugs). On 16Nov2024 the patient developed a non-serious event "sore throat" (oropharyngeal pain) (latency: 9 months) following the first dose intake of DUPILUMAB and (latency) 3 days following the first dose intake of COVID-19 VACCINE (unknown batch number and expiry date of both drugs). Information regarding batch number and expiration date corresponding to the one al Ii me of event occurrence was requested. It was reported "patient stated she had a headache, stated nothing new since starling dupixent, but unknown when started. Reported she wanted to end call because she had headache, unable to get more information.  Unsure MD (Doctor of medicine) aware. Patient reports last Dupixent dose was 5 days late due to shipping issues. Patient states she was diagnosed with covid last week (week of 01Aug2024, exact date unknown)  and had a runny nose (MD aware, unknown if covid or runny nose is ongoing). Patient states she spent 1 night in the emergency and was not admitted to the hospital. Patient reports she received a covid shot (3rd booster shot) last Wednesday (13Nov2024) then on Saturday (16Nov2024) she developed cough, sneezing, sore throat, mucous and runny nose ( symptoms ongoing). Patient's pulmonary doctor prescribed antibiotics and steroids and she started both today (21Nov2024, ongoing). It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available'.  Action taken: no action taken for all events with Dupilumab and not applicable with Covid-19 vaccine. Corrective treatment: Not reported for headache and Covid-19; and was prescribed unknown antibiotics and steroids for rest of the events. Outcome: Unknown for headache and Covid-19; and not recovered for rest of the events. Additional information was received on 12Jun2024 from patient: no new significant information was added, text amended accordingly. Additional information was received on 21Aug2024 from patient. Age was added. Event: (covid-19) with symptom of (rhinorrhoea) was added. Text amended accordingly. Additional information was received on 21Nov2024 from patient: Co-suspect was added, Event of cough, sneezing, rhinorrhoea and oropharyngeal pain was added, clinical course was updated and text was amended accordingly.