Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | IM / RA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 7+ | — | IM / LA |
he didn't feel well; high blood pressure; chills; I 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.; fever/later a fever of 101.9/he had fever of 101.6'F; pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible; I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop; His stomach was upset; His heart rate wasn't too bad, it was 92 something; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible), TREMOR (I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop), HEART RATE INCREASED (His heart rate wasn't too bad, it was 92 something), ABDOMINAL DISCOMFORT (His stomach was upset) and MALAISE (he didn't feel well) in an 80-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine (Fluzone) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 1) on 29-Jan-2021, Pfizer COVID-19 vaccine (Dose 2) on 17-Feb-2021, Pfizer COVID-19 vaccine (Dose 3) on 25-Sep-2021, Pfizer COVID-19 vaccine (Dose 4) on 22-Apr-2022 and Pfizer COVID-19 vaccine (Dose 5) on 09-Sep-2022; for COVID-19 prophylaxis: Spikevax XBB.1.5 (Dose 6) on 04-Oct-2023, Spikevax XBB.1.5 (Dose 7) on 22-Mar-2024, SPIKEVAX 2024-2025 (KP.2) (SPIKEVAX 2024-2025 (KP.2) Dose 8) on 30-Aug-2024 and SPIKEVAX 2024-2025 (KP.2) (SPIKEVAX 2024-2025 (KP.2) Dose 9) on 02-Mar-2025. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine, Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine, SPIKEVAX 2024-2025 (KP.2), SPIKEVAX 2024-2025 (KP.2), Spikevax XBB.1.5 and Spikevax XBB.1.5. Concurrent medical conditions included Blood pressure high since 2013, Arrhythmia since 2013 and Abnormal breathing since 2013. On 12-Sep-2025, the patient received dose of Influenza vaccine (Fluzone) (Intramuscular use) 1 dosage form. On 12-Sep-2025 at 1:00 PM, the patient received tenth dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 12-Sep-2025, the patient experienced VACCINATION SITE PAIN (pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible), TREMOR (I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop), ABDOMINAL DISCOMFORT (His stomach was upset), HYPERTENSION (high blood pressure), CHILLS (chills), PAIN IN EXTREMITY (I 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.) and PYREXIA (fever/later a fever of 101.9/he had fever of 101.6'F). On 13-Sep-2025, the patient experienced MALAISE (he didn't feel well). In September 2025, the patient experienced HEART RATE INCREASED (His heart rate wasn't too bad, it was 92 something). The patient was treated with Paracetamol (Tylenol) on 12-Sep-2025 at an unspecified dose and frequency and Codeine phosphate (Codeine) on 12-Sep-2025 at an unspecified dose and frequency. On 14-Sep-2025, PAIN IN EXTREMITY (I 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.) had resolved. At the time of the report, VACCINATION SITE PAIN (pain and fever/extreme pain at the injection site/sore arm/went to move his arm and it felt like somebody was stabbing him with a knife/extremely painful/his arm really hurt/pain was terrible) was resolving, TREMOR (I had the shakes/he started getting the shakes at the left arm as well as his right arm/both started shaking and he couldn't stop), HEART RATE INCREASED (His heart rate wasn't too bad, it was 92 something), ABDOMINAL DISCOMFORT (His stomach was upset), CHILLS (chills) and PYREXIA (fever/later a fever of 101.9/he had fever of 101.6'F) had resolved and MALAISE (he didn't feel well) and HYPERTENSION (high blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2025, Body temperature: 101.6'F. On 13-Sep-2025, Body temperature: 97.9'F. In September 2025, Heart rate: 92. Concomitant medications were not reported. It was reported that patient never had a problem. It was reported that patient had sore arm for an hour up to the next day and described it as terrible. It was reported that by 9 o'clock, he had fever of 101.6'F. He took 2 Tylenol probably, at 8:30pm It was reported that patient called the doctor and got the nurse service, explained everything to a registered nurse and was advised to take Tylenol which he confirmed to the nurse that he already did. Patient was then advised by the nurse that patient should visit into the emergency room immediately because of the health history. Patient refused the advice of the nurse and stated that If it got worse will get an ambulance. At 10 PM and then another (both meds) on Saturday 4 AM. On the second take, the pain was stopped enough for patient to go to sleep for a few minutes or an hour or so. And then when he woke up, he took another one - Tylenol and Codeine. MOP then managed to sleep through the night off and on. Patient's his arm, even on Saturday, his arm really hurt. By sunday it was pretty much ok, and patient was better. But, all day Saturday, patient didn't feel well. The patient did not experience any additional symptoms/events. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2025: Live follow-up received is significant. DOB was added, gender was added, suspect product was updated, new events were added, reference number was added. On 17-Sep-2025: Live follow up received is non-significant. Reference number was added.
Abnormal breathing; Arrhythmia; Blood pressure high
Test Date: 20250912; Test Name: Body temperature; Result Unstructured Data: 101.6'F; Test Date: 20250913; Test Name: Body temperature; Result Unstructured Data: 97.9'F; Test Date: 202509; Test Name: Heart rate; Result Unstructured Data: 92