Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dyspnoea, Pyrexia, Skin reaction
Clinical narrative: sputum discoloured / still coughing and some green stuff; skin reaction; Pyrexia / 99.8 degree fever; dyspnea / worsening shortness of breath; Cough / increased coughing and sputum; increased coughing and sputum; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from License Party. Other Case identifier(s): AE-016003 (BioNTech SE).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), in 2021 as dose number unknown, single) for immunisation; influenza vaccine (FLU VACCINE VII), on 20Oct2021 as dose number unknown, single) for immunisation; dupilumab (DUPIXENT), first regimen since 22Sep2021) at 300 mg (300 mg, once (as reported)), subcutaneous and second regimen since 03Nov2021) at 300 mg (300 mg, every other week) for asthma. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETYLCYSTEINE; TRELEGY; BUMETANIDE; NORVASC; ATORVASTATIN CALCIUM; ACCOLATE. Past drug history included: Metoprolol succinate, reaction(s): "Allergy"; Lisinopril 10 mg tablet, reaction(s): "Allergy"; Penicillin vk 250 mg tablet, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: COUGH (non-serious) with onset Oct2021, outcome "not recovered", described as "Cough / increased coughing and sputum"; DYSPNOEA (non-serious) with onset Oct2021, outcome "recovered", described as "dyspnea / worsening shortness of breath"; SPUTUM INCREASED (non-serious) with onset Oct2021, outcome "not recovered", described as "increased coughing and sputum"; PYREXIA (non-serious) with onset 21Oct2021, outcome "recovered" (22Oct2021), described as "Pyrexia / 99.8 degree fever"; SKIN REACTION (non-serious) with onset 29Jul2024, outcome "recovered" (2024); SPUTUM DISCOLOURED (non-serious), outcome "not recovered", described as "sputum discoloured / still coughing and some green stuff". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of pyrexia, dyspnoea, cough, sputum increased, skin reaction.  Additional information: Patient started loading dose of dupilumab on 22Sep2021. Then received the covid booster, flu vaccine, and shingles shot and was instructed by her medical doctor (md) to take 2-3 weeks off of the dupilumab and that is why she had a gap in therapy. Stated that she got flu shot on 20Oct2021 and then on 21Oct2021 had a 99.8 degree fever. Fever went away on 22Oct2021 but then had worsening shortness of breath, increased sputum and coughing. Patient was put on azithromycin course along with a 4-day steroid course. She got worse and was put on doxycycline and another steroid course, this time prednisone 40 mg x 4 days, 30 mg x 4 days, 20 mg x 4 days, then 10 mg x 4 days. Patient stated she then re-loaded with dupilumab on 03Nov2021 and was currently feeling 75 to 80% better and not as short of breath as she was 2 weeks before. Patient stated she had been still doing ipratropium bromide/albuterol twice daily and was using hypertonic saline as well. Finished doxycycline and prednisone course in the week of 15Nov2021. Stated she was still coughing up some green stuff on 15Nov2021. The patient was treated with azithromycin, doxycycline for events cough and sputum increased, prednisone for event dyspnoea, ipratropium bromide, salbutamol sulfate for events dyspnoea and cough, fexofenadine hydrochloride and cetirizine hydrochloride for event skin reaction.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.