Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 1 | — | OT / RA |
chest felt heavy on 14Jul2025; rash all over stomach; 102 degree fever; vomiting; rash on the vaccine injection site; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 28Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 11Jul2025 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years, in right arm for immunisation; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 11Jul2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "vasovagal syncope" (unspecified if ongoing), notes: related to the low iron, hasn't had episode of that in a year, still takes iron so doesn't come to that anymore since patient was passing out all of the time; "low iron" (unspecified if ongoing); "Allergic to mangos" (unspecified if ongoing); "Birth control" (unspecified if ongoing); "allergies" (unspecified if ongoing); "passing out all of the time" (unspecified if ongoing); "heavy periods" (unspecified if ongoing); "little bit of a fever" (unspecified if ongoing). Concomitant medication(s) included: JUNEL oral taken for contraception, heavy menstrual bleeding (ongoing); XYZAL oral taken for hypersensitivity, start date: 2024 (ongoing); FERROUS SULFATE oral taken for blood iron decreased, start date: 2023 (ongoing). The following information was reported: VACCINATION SITE RASH (non-serious) with onset 12Jul2025, outcome "unknown", described as "rash on the vaccine injection site"; PYREXIA (medically significant) with onset 13Jul2025, outcome "not recovered", described as "102 degree fever"; RASH (non-serious) with onset 13Jul2025, outcome "unknown", described as "rash all over stomach"; VOMITING (medically significant) with onset 13Jul2025, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset 14Jul2025, outcome "unknown", described as "chest felt heavy on 14Jul2025". The event "chest felt heavy on 14jul2025" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results, notes: everything else seemed to be okay; Body temperature: (13Jul2025) 102 degree; Electrocardiogram: (unspecified date) normal. Therapeutic measures were taken as a result of pyrexia, vomiting. Clinical course: Th next morning patient had rash on the vaccine injection site. They thought it was a little reaction. Then the patient woke up at 3AM the next morning with 102 degree fever, fever continued, and vomiting. Did fluids, making sure patient was resting, gave Tylenol and Ibuprofen alternating those. Called the doctor's office to let know, and the doctor's office said to keep an eye on it. Later that day, the patient had rash all over stomach. The patient was in bed a couple of days and then went to the doctor and the ER because patient said chest felt heavy on 14Jul2025. Clarified and confirmed patient was not admitted into hospital, was seen in ER. Did EKG, which had abnormalities. Did a bunch of bloodwork and something else, cannot remember what. The reporter (mother) works for a cardiologist, so had a cardiologist look at the EKG, cardiologist said was normal for a 16-year-old to have some of those things. Patient swims and does track, heart is healthy. Not sure what the heaviness was. After the patient was speaking to friends, they said they had this before, no additional information provided, and no product names provided by caller. Caller wanted to report it. On 15Jul2025 patient saw HCP # to let know what had happened, and HCP is not going to give the next shot to patient next year, said not to worry about It. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient required ER visit for heaviness in chest and went to regular doctor to follow up on everything the day after. The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Allergy; Birth control; Fever; Fruit allergy; Heavy periods; Iron low; Passed out; Vasovagal symptoms (related to the low iron, hasn't had episode of that in a year, still takes iron so doesn't come to that anymore since patient was passing out all of the time)
JUNEL; XYZAL; FERROUS SULFATE
Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Comments: everything else seemed to be okay; Test Date: 20250713; Test Name: body temperature; Result Unstructured Data: Test Result:102 degree; Test Name: EKG; Result Unstructured Data: Test Result:normal