Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: coronavirus disease 2019 (COVID-19) infection; coronavirus disease 2019 (COVID-19) infection; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 22-0004-05367 (Technical Resources International, Inc.).  A 76-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose number unknown, single (Batch/Lot number: unknown), on 10Jan2021 as dose number unknown, single (Batch/Lot number: unknown), on 16Sep2021 as dose number unknown, single (Batch/Lot number: unknown) and on 13May2022 as dose number unknown, 15 ug single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "asthma", start date: 15Jun1984 (unspecified if ongoing); "mixed hypercholesterolemia", start date: 15Jun1990 (unspecified if ongoing), notes: low density lipoprotein [LDL] of 75 on atorvastatin; "type 2 diabetes mellitus (T2DM)", start date: 15Jun2017 (unspecified if ongoing), notes: without complication; without long-term current use of insulin; "obstructive sleep apnea (OSA)", start date: 30Jun2017 (unspecified if ongoing), notes: not on continuous positive airway pressure (CPAP); "internal hernia", start date: 2017 (unspecified if ongoing); "incisional hernia repair", start date: 2020 (unspecified if ongoing); "cancer of appendix", start date: 15Jun2019 (unspecified if ongoing); "pulmonary embolism", start date: 30Jun2019 (unspecified if ongoing); "cecal cancer" (unspecified if ongoing); "detrusor areflexia" (unspecified if ongoing); "neurogenic bladder" (unspecified if ongoing), notes: treated with self-catherization BID; "hyperlipidemia" (unspecified if ongoing); "neck mass" (unspecified if ongoing); "senile nuclear sclerosis (Cataract nuclear)" (unspecified if ongoing); "left anterior fascicular block (Bundle branch block left)" (unspecified if ongoing); "vitamin D deficiency" (unspecified if ongoing); "tonsillectomy and adenoidectomy" (unspecified if ongoing), notes: (as a toddler); "bilateral robotic inguinal hernia repair", start date: 10Jul2017 (unspecified if ongoing); "right eye extracapsular cataract removal and intraocular lens (IOL) insertion", start date: 02Dec2018 (unspecified if ongoing), notes: on 02Dec2018, 08Nov2021; "right laparoscopic hemicolectomy and ileocolostomy", start date: 08Aug2019 (unspecified if ongoing); "flexible cystoscopy", start date: 30Sep2019 (unspecified if ongoing); "transurethral resection of bladder tumor (TURBT)", start date: 15Oct2019 (unspecified if ongoing); "appendectomy", start date: 15Nov2019 (unspecified if ongoing); "trunk myocutaneous flap" (unspecified if ongoing), notes: robotic XI herniorrhaphy ventral rectus myocutaneous flap on 17Feb20, 10Aug20, 22Feb21, 14Feb22; "oxycodone allergy" (unspecified if ongoing), notes: Drug allergy; "seasonal allergy", start date: 15Jun1950 (unspecified if ongoing); "prostate cancer" (unspecified if ongoing), notes: brother; "history of occasionally alcohol use (wine" (unspecified if ongoing), notes: denied history of tobacco and drug use.; "bladder cancer", start date: 15Aug2019 (unspecified if ongoing); "bifascicular block on ECG" (unspecified if ongoing); "Flexible sigmoidoscopy", start date: 22Jul2020 (unspecified if ongoing); "Herniorrhaphy (Hernia repair)", start date: 10Aug2020 (unspecified if ongoing). The patient's family history included: "heart attack" (unspecified if ongoing); "diabetes mellitus (DM)" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: mother, father and brother; "stroke" (unspecified if ongoing), notes: Father; "atrial fibrillation" (unspecified if ongoing), notes: Father; "coronary artery diseases (CAD)" (unspecified if ongoing), notes: Father. The patient's concomitant medications were not reported. Vaccination history included: pneumococcal 13-valent conjugate vaccine, administration date: 02Sep2015; inactivated zoster vaccine 0.5 ml, administration date: 17May2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "coronavirus disease 2019 (COVID-19) infection". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: In Jun2022, the subject had a coronavirus disease 2019 (COVID-19) infection and symptoms included fever and fatigue. He was quarantined at home. The subject took Paxlovid (nirmatrelvir/ritonavir) 300/150 mg QD (once a day) PO (per oral) from 22Jun2022 to 26Jun2022 for COVID-19. On 07Oct2022, the subject received a booster dose of Pfizer Bivalent COVID-19 vaccine 0.3 mL IM as COVID-19 prevention.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded.