Received Jun 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UT8804BA | — |
her lungs were all swollen and inflamed; shaking; felt like there was an elephant in her chest; cold; Initial information received on 22-May-2026 regarding an unsolicited valid serious case received from a consumer. This case involves an 80-year-old female patient who experienced her lungs were all swollen and inflamed and shaking and felt like there was an elephant in her chest after receiving Influenza Trivalent Recombinant Vaccine [Flublok]. At the time of the event, the patient had ongoing condition(s) chronic obstructive pulmonary disease (COPD). The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 24-Dec-2025, the patient received a 1 dose of Influenza Trivalent Recombinant Vaccine [FLUBLOK TIV] (batch: UT8804BA, expiry date: unknown) (strength: unknown) via unknown route for Influenza immunisation. The patient received a flu shot on 24-Dec-2025 and a few hours later became very ill and experienced shaking (Tremor, onset date: unknown, latency: unknown) and felt cold (Nasopharyngitis, onset date: unknown, latency: unknown). The patient experienced that it felt like there was an elephant in her chest (Chest discomfort, onset date: unknown, latency: unknown) and decided to go to another doctor, and eventually felt fine. Last week before reporting, the patient became sick again and called the doctor to report that her chest had been bothering her again. The doctor ordered an X-ray and found that her lungs were all swollen and inflamed (Pneumonitis, onset date: unknown, latency: unknown). The patient was given a medicine and although she was not completely recovered, she started to feel better. Relevant laboratory test results included: X-ray - Result: lungs were swollen and inflamed. Action taken: Not applicable. Corrective treatment: Not reported. Event outcome: Unknown for tremor and nasopharyngitis, Chest discomfort and pneumonitis. Seriousness criteria: Pneumonitis was medically significant.; Sender's Comments: Sanofi company comment dated 02-Jun-2026: This case involves an 80 year old female patient who experienced pneumonitis following administration of influenza trivalent recombinant vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. The assessment is confounded by the presence of underlying chronic obstructive pulmonary disease (COPD), which is a known risk factor for respiratory symptoms including chest discomfort, inflammation and pulmonary complications. Additional confounding factors include lack of detailed medical history, absence of information on concomitant medications, and limited clinical evaluation. Further information regarding complete clinical assessment, prior vaccination history, and tolerance is required to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed in isolation.
COPD
Comments: NONE
Test Name: Xray; Result Unstructured Data: lungs were all swollen and inflamed