Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | LM2216 | OT / LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 48429CA | OT |
Subclinical hyperthyroidism/abnormal thyroid labs; Angina/chest pain; subacute thyroiditis; elevated BP; thyroid nodules; had a low TSH; swelling in her neck; tachycardia/palpitations; Initial information received on 05-Nov-2025 regarding an unsolicited valid serious case received from a physician. This case involves a 67 years old female patient who had subclinical hyperthyroidism/abnormal thyroid labs, angina/chest pain, subacute thyroiditis, elevated bp, tachycardia/palpitations, had a low tsh, swelling in her neck and thyroid nodules while receiving vaccine INFLUENZA VACCINE and while treated with TOZINAMERAN [COMIRNATY]. The patient's past medical treatment included COVID-19 vaccine mRNA on 05-SEP-2021 with Batch: FC3183; Expiry date: 21-oct-2021, COVID-19 vaccine mRNA on 15-APR-2022 with Batch: FJ9943; Exp: 07may2022, COVID-19 vaccine mRNA on 13-OCT-2022 with Lot: Gj3277; Exp: 31jul2023 and COVID-19 vaccine mRNA on 12-OCT-2023 with Lot: GH4664: Exp: 31-dec-2023. The patient's past medical history, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rash. Concomitant medications included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]) for Hyperlipidaemia; and VALSARTAN (VALSARTAN) for Hypertension. On an unknown date, the patient started taking COMIRNATY (TOZINAMERAN) Unknown dosage unknown intramuscular for Immunisation. On 12-Sep-2024, the patient received a dose of 0.3 (units unspecified) of suspect Influenza Vaccine produced by unknown manufacturer (lot 48429CA and expiry date- 30-JUN-2025) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the patient developed a serious subclinical hyperthyroidism/abnormal thyroid labs (hyperthyroidism), angina/chest pain (angina pectoris), subacute thyroiditis (thyroiditis subacute), elevated bp (blood pressure increased), thyroid nodules (thyroid mass) (unknown latency). On 23-SEP-2024 the patient developed a tachycardia/palpitations (tachycardia) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake (LM2216 and expiry date on 10-Mar-2025) of TOZINAMERAN. On 19-NOV-2024 the patient developed had a low tsh (blood thyroid stimulating hormone decreased), swelling in her neck (swelling), (unknown latency). Relevant laboratory test results included: Blood thyroid stimulating hormone - On an unknown date: 0.09 UNK [o.09] Free thyroxine index - On an unknown date: 1.6 UNK [1.6] Action taken was not applicable. The patient was treated with AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for Blood pressure increased. At time of reporting, the outcome was Recovering / Resolving for the event subclinical hyperthyroidism/abnormal thyroid labs, was Recovering / Resolving for the event had a low tsh, was Unknown for the event swelling in her neck, was Not Recovered / Not Resolved for the event thyroid nodules, was Recovering / Resolving for the event elevated bp, was Recovering / Resolving for the event subacute thyroiditis, was Recovered / Resolved on an unknown date for the event angina/chest pain and was Recovering / Resolving for the event tachycardia/palpitations. Seriousness Criteria- The event of angina pectoris and Hyperthyroidism was considered as medically significant.; Sender's Comments: Sanofi company comment dated 18-NOV-2025: This case involves a 67 years old female patient who had subclinical hyperthyroidism/abnormal thyroid labs, angina/chest pain, subacute thyroiditis, elevated bp, tachycardia/palpitations, had a low tsh, swelling in her neck and thyroid nodules while receiving vaccine INFLUENZA VACCINE and while treated with TOZINAMERAN [COMIRNATY].. Further information regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Rash
ATORVASTATIN [ATORVASTATIN CALCIUM]; VALSARTAN
Test Name: TSH; Test Result: 0.09 {DF}; Result Unstructured Data: o.09; Test Name: FT4; Test Result: 1.6 {DF}; Result Unstructured Data: 1.6