Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck; condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications; condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications; ear deformities, fluid movement, and pressure; ear deformities, fluid movement, and pressure; This spontaneous case was reported by a patient and describes the occurrence of FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), EAR DEFORMITY ACQUIRED (ear deformities, fluid movement, and pressure) and EAR DISCOMFORT (ear deformities, fluid movement, and pressure) in a 37-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Ear injury and Nematodiasis (Suspected parasitic infection (possible nematode)/prior nematode infection). In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck) (seriousness criterion medically significant), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications) (seriousness criterion medically significant), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications) (seriousness criterion medically significant), EAR DEFORMITY ACQUIRED (ear deformities, fluid movement, and pressure) (seriousness criterion medically significant) and EAR DISCOMFORT (ear deformities, fluid movement, and pressure) (seriousness criterion medically significant). At the time of the report, FORMICATION (spiral" or "coil"-like structure under the skin from temple to neck/"odd spiraling thing with balls connected to it"/condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck), SINUS DISORDER (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), OTORRHOEA (condition causes movements under her skin like a "boa constrictor" from her temple to the base of her neck. It affected her ear, pulling it downward, and caused weeping from the eardrum and sinus complications), EAR DEFORMITY ACQUIRED (ear deformities, fluid movement, and pressure) and EAR DISCOMFORT (ear deformities, fluid movement, and pressure) had not resolved. No concomitant medications were reported. It was reported that patient suggested that the symptoms might be related to a prior nematode infection from the time in Costa Rica or potentially linked to a cheap headphone that initially injured ear hence "injured ear" and suspected parasitic infection (possible nematode)/prior nematode infection. Patient reported experiencing severe physical symptoms as odd spiraling thing with balls connected to it that had been affecting for over a year. She said the condition caused movements under skin like a "boa constrictor" from temple to the base of the neck. It affected ear, pulling it downward, and caused weeping from the eardrum and sinus complications. Patient mentioned that she had medical scans, biopsy results, doctor orders, and videos/images documenting the issue, although none of the tests picked up what she was experiencing. Patient suggested that the symptoms might be related to a prior nematode infection or potentially linked to a cheap headphone that initially injured ear. Patient stated that only a QPCR test would be able to identify what's happening. Patient was concerned it could be some unidentified issue involving spike protein particles "the size of a pea" and said "it moved in the hair follicles. Patient mentioned that what she was suffering, was inhumane, and she was in hell." Patient noted a loosening of the tightness in the ear after the vaccination and described it as "something was working," though she emphasized it was still not fully resolved. Patient compared the sensation to "rubber bands" loosening and described visible spiral-like objects matching online images of spike proteins. Patient believed that the vaccine may be impacting or unraveling the condition. It was unknown if the patient experienced any additional symptoms/events. Patient indicated that undergone multiple biopsies and scans and having seen various doctors. No treatment medications were reported. This case was linked to MOD-2025-786062, MOD-2025-786039 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-May-2025: Live significant follow-up received: Additional reporter, medical history, suspect product, additional events Formication, Sinus disorder, Otorrhoea, Ear disorder, Ear discomfort, narrative and reference numbers were added.; Reporter's Comments: Medical history of prior nematode infection and ear injury secondary to a cheap phone could be confounding factors for the case. The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Ear injury; Nematodiasis (Suspected parasitic infection (possible nematode)/prior nematode infection)