Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Diagnostic aspiration, Ear, nose and throat examination, Papillary thyroid cancer, Ultrasound scan
Clinical narrative: Papillary thyroid cancer left lobe; A PHASE II TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A SARS-COV-2 MULTIVALENT RNA VACCINE IN HEALTHY SUBJECTS  This is a report from an interventional study source for Protocol BNT162-17 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. Other Case identifier(s): US-BNTAG-1649.  Initial information received on 12-JUL-2023 and additional information received on 13-JUL-2023: This is a serious case of Papillary thyroid cancer left lobe (MedDRA PT: Papillary thyroid cancer) from clinical trial BNT162-17. A 45 year-old male patient was diagnosed by the primary care physician with a malignant neoplasm of the thyroid gland in February 2023. The patient was treated with BNT162b2 on 11-JUL-2022. 150 days after start of treatment BNT162b2. The patient developed Papillary thyroid cancer left lobe (MedDRA PT: Papillary thyroid cancer) which was diagnosed on 08-DEC-2022. Last BNT162b2 administration before start of the event was on 11-JUL-2022 with a dose of 30mcg. This case is serious due to hospitalization. Relevant medical history includes was not reported. Relevant concomitant medication was not reported. In NOV-2022, the subject was seen by the local ENT practitioner for investigation of nasal congestion and laryngitis. The subject was prescribed Augmentin of unknown dose. The ENT palpated a left thyroid lobe nodule and an ultrasound was arranged for 08-DEC-2022. The ultrasound revealed in the left thyroid lobe, there was a dominant solid mid-to-upper-pole nodule measuring 3.0x1.9x2.2cm which was partially cystic and with calcification. There were also some prominent bilateral lymph nodes, mainly on the left side, with the largest measuring 1.7cm in level 2. A fine needle aspiration biopsy of the large left thyroid lobe nodule was performed on 23-DEC-2022. The sample was sent for sequencing. Thyroid function tests were normal, and the subject was referred for further evaluation and management of condition. On 09-JAN-2023, the subject was referred for evaluation of a left thyroid lobe nodule suspicious for papillary thyroid cancer. On 01-FEB-2023, a unilateral total thyroid lobectomy with isthmusectomy was performed on the left side. Intraoperative neurophysiologic monitoring and a biopsy of the cervical lymph node were completed, resulting in a final diagnosis of Papillary thyroid cancer left lobe (MedDRA PT: Papillary thyroid cancer) of severe intensity. At the time of reporting, the main event has recovered without sequelae. No further information is available at that time. Additional information has been requested.  The investigator and company (BIONTECH SE) considered there was not a reasonable possibility that the event "papillary thyroid cancer left lobe" was related to BNT162b2.  BioNTech SE Comment: Initial Medical Assessment: The reporting investigator considers the event Papillary thyroid cancer left lobe (MedDRA PT: Papillary thyroid cancer) to be serious due to hospitalization. The sponsor agrees to the investigator's assessment. In accordance with the sponsor's SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is not applicable. The reporting investigator assessed the event Papillary thyroid cancer left lobe (MedDRA PT: Papillary thyroid cancer) as not related to treatment with BNT162b2. The sponsor agrees to the investigator's assessment. The benefit-risk profile of BNT162b2 is still not affected by this event and no change in the reference safety information is required at this time.  BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: BioNTech SE Comment: Initial Medical Assessment: The reporting investigator considers the event Papillary thyroid cancer left lobe (MedDRA PT: Papillary thyroid cancer) to be serious due to hospitalization. The sponsor agrees to the investigator's assessment. In accordance with the sponsor's SOPs, only SARs will be assessed for expectedness. Hence, expectedness for this event is not applicable. The reporting investigator assessed the event Papillary thyroid cancer left lobe (MedDRA PT: Papillary thyroid cancer) as not related to treatment with BNT162b2. The sponsor agrees to the investigator's assessment. The benefit-risk profile of BNT162b2 is still not affected by this event and no change in the reference safety information is required at this time.