Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Migraine, Organising pneumonia, Pneumonitis, Pulmonary mass
Clinical narrative: cryptogenic organizing pneumonia; biopsy of lung nodules not malignant, presents as non-caseating granulomatous inflammation; Chest X-ray & CT scans show 11 pulmonary nodules; Cough; Wheezing; Migraines; severe bilateral ptosis w/ mild diploplia; severe bilateral ptosis w/ mild diplopia; This is a spontaneous report from a contactable physician. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0158), via intramuscular route, administered in right arm on 14Apr2021 at 18:30 (at the age of 64-year-old) as dose 2, single for COVID-19 immunization. Medical history included thyroid removed from 2002 to 2002, ongoing gastrooesophageal reflux disease (GERD). Concomitant medications included levothyroxine 125 ug tablet; pantoprazole 40 mg tablet; cyanocobalamin (VITAMIN B12 1000 ug capsule); magnesium citrate; carboxymethylcellulose 0.5% solution; ipratropium 0.06 % nasal spray; betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) and Sleep Aid OTC tablet. On an unknown date in Jun2021, the patient experienced cough, wheezing, migraines. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6207), via intramuscular route, administered in right arm on 12Mar2021 at 18:15 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient had no known allergies. The patient was not pregnant at the time of vaccination. On an unknown date in Jun2021, the patient had chest X-ray & CT (Computerized tomogram) scans which showed 11 pulmonary nodules of largest 4cm, had severe bilateral ptosis with mild diplopia (ptosis onset coincidental to onset of cough). In Jun2021, the patient had biopsy of lung nodules which resulted as not malignant, presented as non-caseating granulomatous inflammation which consistent with or possible cryptogenic organizing pneumonia (COP). The patient visited doctor or other healthcare professional office/clinic visit for the reported events. The patient underwent lab tests and procedures which included chest X-ray: 11 pulmonary nodules, largest 4cm in Jun2021, computerized tomogram thorax: 11 pulmonary nodules, largest 4cm in Jun2021, nasal swab was negative on 18Jun2021, nasal swab was negative on 01Aug2021, biopsy of lung nodules resulted as not malignant, presents as non-caseating granuloma in Jun2021 not malignant, presents as non-caseating granulomatous inflammation consistent with possible cryptogenic organizing pneumonia (COP). The patient was treated with azithromycin (ZITHROMAX Z-PAK) 250 MG; prednisone (DELTASONE) 10 mg; albuterol inhaler for the reported events. The outcome was not recovered for the reported events.; Sender's Comments: Based on the plausible temporal relation, the association between the events of organising pneumonia, pneumonitis and pulmonary mass and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.