Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8837DA | OT / LA |
lack of sleep; When she woke up, she felt very tired; chills/teeth-chattering; nausea; feeling light-headed; fever; sick; weak muscles; unable to get up from the sofa; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 75 years old female patient who experienced sick, weak muscles, unable to get up from the sofa, lack of sleep, chills/teeth-chattering, nausea, feeling light-headed and fever after receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] and while treated with Lidocaine. The patient's past medical history included Appendicitis perforated. The patient's past medical treatment(s) and family history were not provided. The patient past vaccination involves Shingles shot before and she felt sick too. On 23-Sep-2025 at 11:00 am, the patient started taking Lidocaine 2 DF (dosage form) (unknown strength, indication, form and expiry) On 23-Sep-2025 at 12:30 PM, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe once (lot U8837DA, with unknown expiry) (Strength: High Dose) via intramuscular route in the left arm as influenza. On 23-Sep-2025 at 6:15 PM, her sever side effects kicked in. She experienced chills that lasted for almost 5 hours, teeth-chattering (chills), nausea, feeling light-headed (dizziness), sick (illness), weak muscles (muscular weakness), and her fever hit 102.9F (pyrexia). She was unable to get up from the sofa (movement disorder) (Latency: 5 hrs 45 min) from Influenza Usp Trival A-B High Dose Subvirion Vaccine and (Latency: 7 hrs 15 min) from lidocaine. She added that she had medical issues before wherein her appendix burst and she experienced close to what she experienced now. Patient said that around 1:30 AM the next day, she started to calm down and she got her sleep. When she woke up, she felt very tired (fatigue) and she said that it may be due to lack of sleep (sleep deficit) (Latency: 1 day) from both suspects. She added that she had a shingles shot before and she felt sick too, but it's no big deal. She's been having this flu shot for years and she never had this issue until her most recent one.Patient came from her dentist that day and she had two lidocaine shots in her gums an hour and a half before having the FLUZONE HD. She asked if there's interaction between the two which is why she experienced all of these side effects. Reportedly, Patient said that she's okay now. Relevant laboratory test results included: Body temperature - On 23-Sep-2025: 102.9 F Action taken with Lidocaine was unknown. Action taken with INFLUENZA VACCINE TRIVALENT was not applicable. The patient was treated with Paracetamol (Tylenol) for Chills, Nausea, Dizziness, Illness, Muscular weakness and Pyrexia. At time of reporting, the outcome was Recovered / Resolved on 23-Sep-2025 for the event chills/teeth-chattering, was Recovered / Resolved on an unknown date in Sep-2025 for all events.
Medical History/Concurrent Conditions: Ruptured appendix
Lidocaine
Test Date: 20250923; Test Name: Fever; Test Result: 102.9 {DF}