Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Feeling lousy/Feel cruddy; Stay red, hot, and swollen for a full week; Stay red, hot, and swollen for a full week; Stay red, hot, and swollen for a full week; Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling lousy/Feel cruddy), ERYTHEMA (Stay red, hot, and swollen for a full week), FEELING HOT (Stay red, hot, and swollen for a full week), SWELLING (Stay red, hot, and swollen for a full week) and MYALGIA (Body aches) in a 78-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 patient's past medical history included Anaphylactic shock, COVID-19, Thyroid tumor, Diarrhea (bad diarrhea), Clostridium difficile infection, Fall in 2023, Hives (The patient had massive hives after she was placed with Flagyl again), Knee replacement (left knee) in 2004, Shoulder arthroplasty (The patient other shoulder had surgery two years ago due to a really painful fall in 2023 leading to shredded biceps. The part of her bicep had to be cut off and reattached, with rotator cuff straps that was not attached, and the other one is torn - she had a torn rotator cuff on the left arm. Apparently, the patient worn them out. I did not know what to say. The patient asked the doctor; do we just have a certain amount of time that we get to have good muscles and then they start deteriorating.) in 2023, Gallbladder removal (gall bladder was removed 5 years ago before COVID) in 2020, Hysterectomy, Thyroidectomy partial (quarter of her thyroid was taken out 30 years ago) in 1990 and Knee replacement (right knee) in 2012. Previously administered products included for Clostridium difficile infection: FLAGYL [METRONIDAZOLE] (It was reported that arthritis which felt like every bone in her hands and her feet was shattering again making it incredibly painful and then reiterated that this happened very, very fast due to a reaction with Flagyl making her hesitant to put anything into her body and added it was double whammy from then. The patient had massive hives after she was placed with Flagyl again), FLAGYL [METRONIDAZOLE] (It was reported that arthritis which felt like every bone in her hands and her feet was shattering again making it incredibly painful and then reiterated that this happened very and very fast due to a reaction with Flagyl making her hesitant to put anything into her body and added it was double whammy from then. The patient had massive hives after she was placed with Flagyl again). Past adverse reactions to the above products included Hives with FLAGYL [METRONIDAZOLE]; and Rheumatoid arthritis with FLAGYL [METRONIDAZOLE]. Concurrent medical conditions included Rheumatoid arthritis (The patient was more a little sensitive when she got her arthritis that was so intense which has been a lifelong battle stating it was extremely painful. She described her arthritis which felt like every bone in her hands and her feet was shattering over and over making it incredibly painful and then reiterated that this happened very, very fast due to a reaction with Flagyl making her hesitant to put anything into her body and added it was double whammy from then.) and Hypothyroidism (The patient "low thyroid" due to a benign tumor on her thyroid. She added that a quarter of her thyroid was taken out 30 years ago and it happened in 1990 when she had the said surgery in the thyroid but couldn't really remember. She takes thyroid supplement because her thyroid test did not come as high as it should.). Concomitant products included INFLUENZA VACCINE for an unknown indication. On 18-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced MALAISE (Feeling lousy/Feel cruddy), ERYTHEMA (Stay red, hot, and swollen for a full week), FEELING HOT (Stay red, hot, and swollen for a full week), SWELLING (Stay red, hot, and swollen for a full week), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). In 2025, MALAISE (Feeling lousy/Feel cruddy), ERYTHEMA (Stay red, hot, and swollen for a full week), FEELING HOT (Stay red, hot, and swollen for a full week), SWELLING (Stay red, hot, and swollen for a full week), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Clostridium test: (Positive) Clostridium difficile test. Patient was on thyroid supplement. It was reported that the patient was consistently received Moderna vaccines. It was reported that post vaccination symptom of caused her to stay red, hot, and swollen for a full week. She had a headache and body aches as well as other reactions. It was reported that the symptoms were listed as normal. The patient did not vomit but had chills and just feeling lousy. It was also reported that the patient wonders if the dose was doubled up or something referred as to why she experienced reactions which lasted for a week and which also made her feel cruddy. No treatment medications provided by the reporter. This case was linked to MOD-2025-790871 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2025: Live non-significant follow-up received in which new reference number was added. On 03-Nov-2025: Live non-significant follow-up received in which case narrative was updated and new reference number was added.
Hypothyroidism (The patient "low thyroid" due to a benign tumor on her thyroid. She added that a quarter of her thyroid was taken out 30 years ago and it happened in 1990 when she had the said surgery in the thyroid but couldn't really remember. She takes thyroid supplement because her thyroid test did not come as high as it should.); Rheumatoid arthritis (The patient was more a little sensitive when she got her arthritis that was so intense which has been a lifelong battle stating it was extremely painful. She described her arthritis which felt like every bone in her hands and her feet was shattering over and over making it incredibly painful and then reiterated that this happened very, very fast due to a reaction with Flagyl making her hesitant to put anything into her body and added it was double whammy from then.)
Medical History/Concurrent Conditions: Anaphylactic shock; Clostridium difficile infection; COVID-19; Diarrhea (bad diarrhea); Fall; Gallbladder removal (gall bladder was removed 5 years ago before COVID); Hives (The patient had massive hives after she was placed with Flagyl again); Hysterectomy; Knee replacement (right knee); Knee replacement (left knee); Shoulder arthroplasty (The patient other shoulder had surgery two years ago due to a really painful fall in 2023 leading to shredded biceps. The part of her bicep had to be cut off and reattached, with rotator cuff straps that was not attached, and the other one is torn - she had a torn rotator cuff on the left arm. Apparently, the patient worn them out. I did not know what to say. The patient asked the doctor; do we just have a certain amount of time that we get to have good muscles and then they start deteriorating.); Thyroid tumor; Thyroidectomy partial (quarter of her thyroid was taken out 30 years ago)
INFLUENZA VACCINE
Test Name: Clostridium difficile test; Test Result: Positive