Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product dose omission issue, Skin burning sensation, Tinnitus
Clinical narrative: She did not get her second dose; heat sensation on her scalp; something pushing out of her brain; headache that would not go away and continued to get worse; it has a stinging sensation all over her head; She has nerve issues; ringing in her ears from intense headache; burning sensation on her scalp on the second day/heat sensation; feels like there is something pushing out of her eyes; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (She has nerve issues) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NORTRIPTYLINE and TOPIRAMATE (TOPAMAX) for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced NEUROPATHY PERIPHERAL (She has nerve issues) (seriousness criterion medically significant), TINNITUS (ringing in her ears from intense headache), SKIN BURNING SENSATION (burning sensation on her scalp on the second day/heat sensation), ABNORMAL SENSATION IN EYE (feels like there is something pushing out of her eyes), PAIN (it has a stinging sensation all over her head), FEELING ABNORMAL (something pushing out of her brain) and HEADACHE (headache that would not go away and continued to get worse). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not get her second dose) and FEELING HOT (heat sensation on her scalp). At the time of the report, NEUROPATHY PERIPHERAL (She has nerve issues), TINNITUS (ringing in her ears from intense headache), SKIN BURNING SENSATION (burning sensation on her scalp on the second day/heat sensation), ABNORMAL SENSATION IN EYE (feels like there is something pushing out of her eyes), PRODUCT DOSE OMISSION ISSUE (She did not get her second dose), PAIN (it has a stinging sensation all over her head), FEELING HOT (heat sensation on her scalp) and FEELING ABNORMAL (something pushing out of her brain) outcome was unknown and HEADACHE (headache that would not go away and continued to get worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment: This spontaneous case concerns a 32 year old female with no medical history reported, who experienced , Serious ( medically significant ) , unexpected event of neuropathy peripheral  and other non-serious , unexpected events of tinnitus, skin burning sensation , abnormal sensation in eye, pain , feeling abnormal and headache which occurred on the same day post vaccination  with the 1st dose of mRNA-1273 vaccine , On an unknown date non-serious , unexpected event of Product dose omission occurred after vaccination with the 1st dose of mRNA-1273 vaccine. The re-challenge for this case is not applicable since the patient did not take the 2nd dose. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 32 year old female with no medical history reported, who experienced , Serious ( medically significant ) , unexpected event of neuropathy peripheral  and other non-serious , unexpected events of tinnitus, skin burning sensation , abnormal sensation in eye, pain , feeling abnormal and headache which occurred on the same day post vaccination  with the 1st dose of mRNA-1273 vaccine , On an unknown date non-serious , unexpected event of Product dose omission occurred after vaccination with the 1st dose of mRNA-1273 vaccine. The re-challenge for this case is not applicable since the patient did not take the 2nd dose. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.