Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | — | IM |
got pain; immediately had the palpitations that night/ the palpitations got worse/racing heart/ really racing heart at night and palpitations during the day/ heart palpitations on any exc; I did have a reaction; heart pain; feel like my heart is inflammed; something happened with my metabolic; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart pain) and CARDITIS (feel like my heart is inflammed) in a 71-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The non-company product included Influenza vaccine inact sAg 3v (Fluad) for an unknown indication. The patient's past medical history included Back injury (hurt back in 2022) in 2022 and Inflammation (Patient got inflammation when patient hurt the back years ago). Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Patient though it was in Mar-2021 (unsure if Feb or Mar and whether 2020 or 2021). Patient had a racing heart at night and and it went away.); for COVID-19 prophylaxis: SPIKEVAX NOS. Past adverse reactions to the above products included Heart racing with PFIZER BIONTECH COVID-19 VACCINE; and No adverse effect with SPIKEVAX NOS. Family history included Prediabetes (Patient husband had prediabetes) since an unknown date and Blood pressure (mother had blood pressure) since an unknown date. Concurrent medical conditions included Hypertension (taking Losartan). Concomitant products included Losartan for Hypertension. On 12-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) .2 milliliter and dose of Influenza vaccine inact sAg 3v (Fluad) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 12-Nov-2025, the patient experienced PALPITATIONS (immediately had the palpitations that night/ the palpitations got worse/racing heart/ really racing heart at night and palpitations during the day/ heart palpitations on any exc). On 13-Nov-2025, the patient experienced PAIN (got pain). In November 2025, the patient experienced ANGINA PECTORIS (heart pain) (seriousness criterion medically significant), CARDITIS (feel like my heart is inflammed) (seriousness criterion medically significant), IMMUNISATION REACTION (I did have a reaction) and METABOLIC DISORDER (something happened with my metabolic). At the time of the report, ANGINA PECTORIS (heart pain), CARDITIS (feel like my heart is inflammed), IMMUNISATION REACTION (I did have a reaction), PAIN (got pain) and METABOLIC DISORDER (something happened with my metabolic) outcome was unknown and PALPITATIONS (immediately had the palpitations that night/ the palpitations got worse/racing heart/ really racing heart at night and palpitations during the day/ heart palpitations on any exc) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2025, Blood pressure measurement: blood pressure spiked/ my blood pressure spiked to 180. In November 2025, Blood pressure measurement: 110 and stable. In November 2025, C-reactive protein: high. In November 2025, Electrocardiogram: fine and it did show something. In November 2025, Full blood count: low. In November 2025, Metabolic function test: high glucose. In November 2025, Weight: lost 20 pounds. On 12-Nov-2025 Wednesday at around 3:30 p.m., patient got both mNEXSPIKE and Fluad 65+ flu shot. Patient did have a reaction; patient wanted some advice on how long this could go on. Patient had been getting Moderna for the very first COVID-19 shot ever since the first one, which was Pfizer, which patient had a racing heart at night, and it went away, but never had any problems with Moderna, so always requested Moderna, and never had another problem. Patient got vaccine at least once a year and got boosters at the beginning and all that so up to date. Patients got really scared about getting COVID, so she was careful, and she never had COVID. First time she had the racing heart was Pfizer, but it went away, but then 5 years later, she was 5 years older and just got this. Patient also got it at the same time, she got the flu shot, which never did before, and, but her flu symptoms, did not have anything, but she immediately had the palpitations that night on 12-Nov-2025 and the next day, the following day. The palpitations got worse, and she got pain and went to the ER 24 hours later, and her blood pressure spiked. Patient's blood pressure spiked to 180. Patient visited primary care physician the week prior and monitored her blood pressure and it was 110 there so she did not have, and patient took 25 mg of losartan which was really, low. She lost 20 pounds and went to the ER, and they did an ECG. They did a bunch of blood work. She had all the tests. She had stairs in her home. Walking up the stairs, she felt it, and had a racing heart, a really racing heart at night and palpitations during the day. The patient had heart pain. More heart pain when the patient went to the hospital because she didn't realize what to do. She was worried about myocarditis or pericarditis because the day before she did 30 minutes on her exercise bike. Her heart was fine and the test results. They did a chest X-ray. This was also unusual for her. Her C-reactive protein was high. Her EKG, they said they compared it, it did show something, but they weren't worried about it. Patient's CBC was low, patient had that before, but basically was the inflammation, she believed heart was inflamed and something happened with her metabolic. Patient's husband had the exact same vaccines was prediabetic and he never had any reaction. The patient followed up on 14-Nov-2025 and on 17-Nov-2025 and blood pressure was stable. When blood pressure shoots up, she increases her blood pressure medicine. She was originally taking 50 mg but was down to 25 mg for the last couple of months, but then took like 25 mg more and then took more when patient got home, monitored it and took it accordingly and took probably 50 mg for a couple days and again down to normal 25 mg. When the patient lost 20 pounds and her blood pressure got too low, blood pressure medicine was lowered in. Referring to the heart palpitations on any exertion, she could not do anything. She was basically lying there and basically lying all day and taking warm baths for her circulation. She uses a heating mat. She had it for years and could not take anti-inflammatory medication and got this for inflammation when she hurt her back years ago. It was just heated crystals, and it brought down inflammation. The patient never had any reaction except that one time, so this was sort of a surprise. There were no heart damage and patients didn't have a heart attack. This case was linked to US-MODERNATX, INC.-MOD-2025-791945, US-MODERNATX, INC.-MOD-2025-791944 (E2B Linked Report). This case was linked to MOD-2025-791943 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-791945:lot of people case US-MODERNATX, INC.-MOD-2025-791944:Husband's case
Blood pressure (mother had blood pressure); Hypertension (taking Losartan); Prediabetes (Patient husband had prediabetes)
Medical History/Concurrent Conditions: Back injury (hurt back in 2022); Inflammation (Patient got inflammation when patient hurt the back years ago)
Losartan
Test Date: 20251113; Test Name: blood pressure; Result Unstructured Data: blood pressure spiked/ my blood pressure spiked to 180; Test Date: 202511; Test Name: blood pressure; Result Unstructured Data: 110; Test Date: 202511; Test Name: blood pressure; Result Unstructured Data: stable; Test Date: 202511; Test Name: C-reactive protein; Result Unstructured Data: high; Test Date: 202511; Test Name: ECG; Result Unstructured Data: fine; Test Date: 202511; Test Name: EKG; Result Unstructured Data: it did show something; Test Date: 202511; Test Name: CBC; Result Unstructured Data: low; Test Date: 202511; Test Name: metabolic panel; Result Unstructured Data: high glucose; Test Date: 202511; Test Name: body weight; Result Unstructured Data: lost 20 pounds