Received Apr 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | — | — |
unintentional weight loss; muscle wasting; bad reaction; heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in an 82-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Influenza vaccine inact sAg 3v (Fluad) for an unknown indication and Influenza vaccine inact split 3v (Fluzone high dose) for an unknown indication. The patient's past medical history included Tachycardia. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of Influenza vaccine inact sAg 3v (Fluad) (unknown route) 1 dosage form and dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. In January 2025, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced ABNORMAL LOSS OF WEIGHT (unintentional weight loss), MUSCLE ATROPHY (muscle wasting) and IMMUNISATION REACTION (bad reaction). The patient was treated with Rehabilitation therapy for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (heart attack), ABNORMAL LOSS OF WEIGHT (unintentional weight loss), MUSCLE ATROPHY (muscle wasting) and IMMUNISATION REACTION (bad reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Unintentional weight loss. No concomitant medications were reported. It was reported that the patient had been getting the Moderna COVID-19 vaccine yearly, since 2021 but she had unintentional weight loss where she was trying to figure out with her doctor when exactly it started. The patient received Moderna vaccines in March 2021 and April 2021. It was reported that the patient received Fluad (Flu shot) only once due to a bad reaction (due to it being adjunct/ increased for her age making it stronger). Due to that, she then decided to go back to receiving the High Zone moving forward. The patient received High Zone (Flu shot) yearly; usually, patient waited a month before receiving the said flu shot following Moderna COVID-19 vaccine administration. The reporter was asking about the connection between Moderna COVID-19 shots and unintentional weight loss, ingredients, reason behind changing in formulation, and when would the new formulation come out. One of reporter's friends suggested to look into the COVID-19 shots as per the said friend, it had so many issues. It was reported that the patient started her weight gain several years ago, before the first Spikevax so she was trying to see if there was any connection to the said product with her unintentional weight loss probably going back 2-3 years ago but also said that it might not have anything to do with the COVID-19 shots. Additionally, the patient was confined due to the possibility of a minor heart attack at the beginning of January of 2025. She was then sent to rehab from having a heart attack. She had muscular dystrophy or muscle wasting, which was also described as a big issue, so she had to work into it too. The reporter then confirmed that the patient did fine with 2025 after learning that there had been no changes to the inactive ingredients of the 2025-2026 Formula compared to previous Moderna COVID-19 vaccines. The patient did not experience any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Patient's advanced age was assessed as confounding factor for all reported event. IMMUNISATION REACTION was assessed as not related, as the event occurred after flu vaccine. ABNORMAL LOSS OF WEIGHT and MUSCLE ATROPHY were assessed as not related due to nature of reported events. The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Tachycardia
Test Name: Weight; Result Unstructured Data: Unintentional weight loss