Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
her one leg is paralyzed; bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine; ears ringing; she is in extreme pain everyday; hair has fallen out, not all of it - most of it; she has lost teeth; barely able to walk anymore; It has just gotten worse and worse over the years; Neurological disorders; patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head; This spontaneous case was reported by an other health care professional and describes the occurrence of MONOPLEGIA (her one leg is paralyzed) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced MONOPLEGIA (her one leg is paralyzed) (seriousness criterion medically significant), BEDRIDDEN (bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine), TINNITUS (ears ringing), PAIN (she is in extreme pain everyday), ALOPECIA (hair has fallen out, not all of it - most of it), TOOTH LOSS (she has lost teeth), GAIT DISTURBANCE (barely able to walk anymore), CONDITION AGGRAVATED (It has just gotten worse and worse over the years), NERVOUS SYSTEM DISORDER (Neurological disorders) and HEADACHE (patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head). At the time of the report, MONOPLEGIA (her one leg is paralyzed), BEDRIDDEN (bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine), TINNITUS (ears ringing), PAIN (she is in extreme pain everyday), ALOPECIA (hair has fallen out, not all of it - most of it), TOOTH LOSS (she has lost teeth), GAIT DISTURBANCE (barely able to walk anymore), CONDITION AGGRAVATED (It has just gotten worse and worse over the years), NERVOUS SYSTEM DISORDER (Neurological disorders) and HEADACHE (patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter considered MONOPLEGIA (her one leg is paralyzed), BEDRIDDEN (bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine), TINNITUS (ears ringing), PAIN (she is in extreme pain everyday), ALOPECIA (hair has fallen out, not all of it - most of it), TOOTH LOSS (she has lost teeth), GAIT DISTURBANCE (barely able to walk anymore), CONDITION AGGRAVATED (It has just gotten worse and worse over the years), NERVOUS SYSTEM DISORDER (Neurological disorders) and HEADACHE (patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head) to be related. Concomitant medication was not reported. Patient's year of birth was reported as 1956. Patient was severely injured by vaccine. Patient started having side effects 4 years ago. Patient was bedridden and was in critical condition as a result of the Moderna COVID-19 vaccine. Patient has been seen by probably 100 physicians over the last 4 years, and they thought there was some hope for recovery when it was on the news that there was a new drug out to reverse this vaccine. Caller stated patient has stabs in her head, feels like somebody is biting her, she has lost most of her hair, her teeth have fallen out, she can't walk, she has a lot of neurological issues as a result of the vaccine. Caller added the patient's side effects started first day headache, then it went to her ears ringing, then it went to her head feeling like there was cement in her head. Eventually over the last 4 years, her hair has fallen out, not all of it - most of it, she has lost teeth, she was in extreme pain every day, excruciating as she describes it, barely able to walk anymore, her one leg was paralyzed. It had just gotten worse and worse over the years, and she had seen so many physicians, and no one had an answer on how to stop what was happening to her. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.