Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | — | — |
vaccine on 11-MAR-2019 and 06-AUG-2019; This spontaneous report was received from a physician and refers to a 60-year-old female patient. The patient's concurrent conditions included essential hypertension (benign), hyperlipidemia, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA)/chronic hypercapnic respiratory failure on bilevel positive airway pressure (BipPA) therapy, non-small cell lung cancer (NSCLC) status post stereotactic body radiotherapy (SBRT), coronary artery disease (CAD), dysphagia, gastroesophageal reflux disease (GERD), and esophageal dysmotility. She was an ex-smoker with a history of passive smoking (mother, father, co-workers and husband were smokers). She was oxygen dependent. Her medical history included appendectomy. In 2016, she experienced right supraspinatus tendon tear. The patient's historical vaccinations included influenza vaccine (Quad) PF, influenza (standard dose) trivalent vaccine, influenza (trival) Im preservative free vaccine, pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13), pneumococcal vaccine polysacch 23v (PNEUMOVAX 23) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP). Concomitant vaccines included hepatitis B vaccine (manufacturer unknown). On 11-MAR-2019, the patient was vaccinated with 1st dose of hepatitis a vaccine, inactivated (manufacturer unknown), administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). On 06-AUG-2019, the patient was vaccinated with 2nd dose of hepatitis a vaccine, inactivated (manufacturer unknown), administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported) (Inappropriate schedule of product administration). This is one of two reports referring to the same patient. Lot# is being requested and will be submitted if received.
Bilevel positive airway pressure; Chronic respiratory failure; COPD; Coronary artery disease; Dependence on oxygen therapy; Dyskinesia of oesophagus; Dysphagia; Essential hypertension, benign; Ex-smoker; GERD; Hyperlipidemia; Non-small cell lung cancer; Obstructive sleep apnoea; Passive smoking; Tendon rupture
Medical History/Concurrent Conditions: Appendectomy; Stereotactic body radiotherapy
hepatitis B vaccine; hepatitis B vaccine; hepatitis B vaccine