Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product dose omission issue, Skin burning sensation, Tinnitus
Clinical narrative: heat sensation on her scalp; She did not get her second dose; headache that would not go away and continued to get worse; something pushing out of her brain; 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; it has a stinging sensation all over her head; 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 FEELING HOT (heat sensation on her scalp) and PRODUCT DOSE OMISSION ISSUE (She did not get her second dose). 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), PAIN (it has a stinging sensation all over her head), FEELING HOT (heat sensation on her scalp), FEELING ABNORMAL (something pushing out of her brain) and HEADACHE (headache that would not go away and continued to get worse) had not resolved and PRODUCT DOSE OMISSION ISSUE (She did not get her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported. Patient wanted to know if the side effects were going to go away or if she would get better. Patient was referred to HCP but she said that she already contacted her HCP and was not able to get a concrete answer.  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.  Company comment: This is a spontaneous case concerning a 32-year-old female with no medical history reported, who experienced the serious (medically significant) and unexpected event of neuropathy peripheral along with other non-serious events. The events occurred the same day after a first dose of mRNA-1273 vaccine was administered. She received medication but did not worked. The benefit -risk relationship of mRNA -1273 vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2022: Follow-up received included, Reporter contact information added. Outcome of events (neuropathy peripheral, tinnitus, skin burning sensation, abnormal sensation in eye, pain, feeling hot and feeling abnormal) updated from unknown to not recovered. I-narrative updated.; Sender's Comments: This is a spontaneous case concerning a 32-year-old female with no medical history reported, who experienced the serious (medically significant) and unexpected event of neuropathy peripheral along with other non-serious events. The events occurred the same day after a first dose of mRNA-1273 vaccine was administered. She received medication but did not worked. The benefit -risk relationship of mRNA -1273 vaccine) is not affected by this report.