Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | 5 | — | IM |
feel so bad and oftentimes, practically every night; but it appears like it's internal, not like the room is spinning around , but it feels, feels like it's inside [the] head from [the] eyes; dizziness; tired; Pressure on the eyes; pain in the back of the neck; Hearing also goes in and out patient wears a hearing aid; recently developed Humming in the head; got a bad flu coming on or a real bad high fever; have no energy; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Pressure on the eyes), NECK PAIN (pain in the back of the neck), HYPOACUSIS (Hearing also goes in and out patient wears a hearing aid), TINNITUS (recently developed Humming in the head) and INFLUENZA (got a bad flu coming on or a real bad high fever) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in 2020. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Dose 1) on 21-Jan-2021, Moderna Covid-19 vaccine (Dose 2) on 18-Feb-2021, Moderna Covid-19 vaccine (Dose 3) on 22-Oct-2021 and Moderna Covid-19 vaccine (Dose 4) on 14-Apr-2022. Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine. On 01-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In 2023, the patient experienced DIARRHOEA (diarrhea). On 20-Jan-2024, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced OCULAR DISCOMFORT (Pressure on the eyes), NECK PAIN (pain in the back of the neck), HYPOACUSIS (Hearing also goes in and out patient wears a hearing aid), TINNITUS (recently developed Humming in the head), INFLUENZA (got a bad flu coming on or a real bad high fever), ASTHENIA (have no energy), VERTIGO (but it appears like it's internal, not like the room is spinning around , but it feels, feels like it's inside [the] head from [the] eyes), DIZZINESS (dizziness) and FATIGUE (tired). On an unknown date, the patient experienced FEELING ABNORMAL (feel so bad and oftentimes, practically every night). In December 2023, DIARRHOEA (diarrhea) had resolved. At the time of the report, OCULAR DISCOMFORT (Pressure on the eyes), NECK PAIN (pain in the back of the neck), HYPOACUSIS (Hearing also goes in and out patient wears a hearing aid), TINNITUS (recently developed Humming in the head), INFLUENZA (got a bad flu coming on or a real bad high fever), ASTHENIA (have no energy), DIZZINESS (dizziness) and FATIGUE (tired) had not resolved and FEELING ABNORMAL (feel so bad and oftentimes, practically every night) and VERTIGO (but it appears like it's internal, not like the room is spinning around , but it feels, feels like it's inside [the] head from [the] eyes) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had no symptoms until Oct-2023 when she developed diarrhea that lasted until Dec-2023. She was good. There wasn't a thing wrong with until waking up on 20-Jan-2024 with the following symptoms which persisted. She had pressure on the eyes and dizziness, but it appears like it's internal, not like the room was spinning around her, but it felt, like it's inside the head from the eyes her head, the spinning would sometimes usually so bad that she had to, kept from walking into a wall. Also, every once in a while, she got a bad, pain in the back of the neck. She had also gone to a chiropractor and a psychologist and a psychiatrist, trying to figure out if it's mental and she had been to a psychologist for 18 months. Hearing also went in and out (patient wore a hearing aid but reported they were fine). She had recently developed humming in the head. The doctor who was for 48 years, could not figure it out. All tests came back good, which was a blessing. but she didn't have a life anymore because she couldn't do anything. Because the patient felt so bad and oftentimes, practically every night, usually in the evening, patient felt like a bad flu coming on or a real bad high fever, although patient didn't have a fever. Patient was tired, had no energy, it's constant, it never stopped from the time from patient opening her eyes, till going to sleep. Patient had seen 14 doctors of all different disciplines, she had numerous tests done; MRI, VMG, had been to ENTs, neurologist, cardiologists. Patient tried to figure out what's causing these symptoms. Patient had been told by several doctors to look into Covid/long covid/lingering covid. The physician told her that there's been a lot of feedback out there in the medical community about the COVID shots. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2025: Live significant follow-up received: Suspect product updated, medical history added, new events added. Also, secondary reporter added, and reference number added.
Medical History/Concurrent Conditions: COVID-19