Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
developed did not feel well; I had the shakes/started getting the shakes at the left arm as well as right arm/both started shaking and couldn't stop; stomach was upset; high blood pressure; went to move my arm and it felt like somebody was stabbing me with a knife, it was extremely painful. And arm was still a little sore, but by Sunday i was perfectly fine; pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/ arm really hurt/pain was terrible; chills; fever/later a fever of 101.9 F/had fever of 101.6 F; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA290218 (Sanofi). Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from patient. This case involves an unknown age and unknown gender patient who had the shakes/ started getting the shakes at the left arm as well as right arm/both started shaking and could not stop, heart rate wasn't too bad, it was 92 something, stomach was upset, high blood pressure, went to move my arm and it felt like somebody was stabbing me with a knife. it was extremely painful&my arm was still a little sore, but by sunday i was perfectly fine, pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/arm really hurt/pain was terrible, did not feel well, chills and fever/later a fever of 101.9 F/had fever of 101.6 F after receiving Influenza USP trival A-B subvirion NO preservative vaccine [Fluzone] and covid-19 vaccine MRNA. The patient's past vaccination (s) included covid-19 vaccine on 29-JAN-2021, Pfizer BioNTech covid-19 vaccine on 17-FEB-2021, Pfizer BioNTech covid-19 vaccine on 25-SEP-2021, Pfizer BioNTech COVID-19 vaccine on 22-APR-2022, Pfizer BioNTech covid-19 vaccine on 09-SEP-2022, Spikevax XBB.1.5 on 04-OCT-2023, Spikevax XBB.1.5 on 22-MAR-2024, spikevax 2024-2025 (KP.2) on 30-AUG-2024 with Dose 8, and spikevax 2024-2025 (KP.2) on 02-MAR-2025. The patient's past medical history, medical treatments) and family history were not provided. At the time of the event, the patient had ongoing Hypertension in 2013, Arrhythmia in 2013 and Respiration abnormal in 2013. On 12-Sep-2025, the patient received 1 DF (Dosage form) of suspect Influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (Unknown strength, Lot and expiry date) via Intramuscular route in unknown administration site for Influenza and dose 10 of 1 DF of suspect covid-19 vaccine MRNA Injection (Unknown strength, lot and expiry date) not produced by Sanofi Pasteur via intramuscular route in unknown administration site for covid-19 Prophylaxis. Information on the batch number was requested corresponding to the one at time of event occurrence. On 12-SEP-2025, the patient had the shakes/started getting the shakes at the left arm as well as right arm/both started shaking and could not stop (tremor), stomach was upset (abdominal discomfort), high blood pressure (hypertension), went to move my arm and it felt like somebody was stabbing me with a knife, it was extremely painful. And arm was still a little sore, but by Sunday i was perfectly fine (pain in extremity), pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/arm really hurt/pain was terrible (vaccination site pain), chills and fever/later a fever of 101.9 F/ had fever of 101.6 F (pyrexia) (Latency same day) following the administration of Influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. On 13-Sep-2025, the patient developed did not feel well (malaise) (Latency 1 day) following the administration of influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. On an unknown date in SEP-2025, the patient developed heart rate was not too bad, it was 92 something (heart rate increased) (unknown latency) following the administration of Influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. Relevant laboratory test results included: Body temperature - On 12-Sep-2025: 101.6 F; on 13-Sep-2025: 97.9 F and Heart rate - In September 2025: 92 UNK [92]. Action taken was not applicable. The patient was treated with paracetamol (tylenol) for Vaccination site pain, Pain in extremity and Pyrexia and codeine for Pain in extremity and Vaccination site pain. At time of reporting, the outcome was Recovering / Resolving for the event Vaccination site pain, was Recovered / Resolved on an unknown date Sep-2025 for the event Pain in extremity and was Unknown for other the events.
Arrhythmia; Hypertension; Respiration abnormal
Test Date: 20250912; Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Date: 20250912; Test Name: Body temperature; Result Unstructured Data: Test Result:101.6 Fahrenheit; Test Date: 20250912; Test Name: Body temperature; Result Unstructured Data: Test Result:101.9 Fahrenheit; Test Date: 20250913; Test Name: Body temperature; Result Unstructured Data: Test Result:97.9 Fahrenheit; Test Date: 202509; Test Name: Heart rate; Result Unstructured Data: Test Result:92