Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 6 hours later her hand was paralyzed /fingers were paralyzed for 24 hours; still cannot feel her feet right /her legs feel like concrete; much pain; severe muscle weakness; feels like she has the flu.; severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (6 hours later her hand was paralyzed /fingers were paralyzed for 24 hours) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 047A21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Drug toxicity (Patient states that the booster shot made her react the same as when she took a fluoroquinolone.11 years ago patient had Medication induced QIPP from Fluoroquinolone toxicity, patient ended going from being a healthy individual to a cripple patient. It took her 3 years to walk again. patient ended up having to get IVIG treatments for 8 years since then. Patient also states that when this happened to her it felt like a bomb went off in her body.), Penicillin allergy (polio vaccine got deadly sick with and that was due to the penicillin in it) and Vaccination adverse reaction (As a child patient had issues with vaccines). Previously administered products included for Product used for unknown indication: polio vaccine (polio vaccine got deadly sick with and that was due to the penicillin in it), Levaquin (Patient states that the booster shot made her react the same as when she took a  Levaquin.) and ciprofloxacin (Patient states that the booster shot made her react the same as when she took a ciprofloxacin.). Past adverse reactions to the above products included Adverse event with Levaquin and ciprofloxacin; and Illness with polio vaccine. Concomitant products included MULTIVITAMIN [VITAMINS NOS], BORON, TAURINE and PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced MONOPLEGIA (6 hours later her hand was paralyzed /fingers were paralyzed for 24 hours) (seriousness criterion medically significant), LIMB DISCOMFORT (still cannot feel her feet right /her legs feel like concrete), PAIN (much pain), MUSCULAR WEAKNESS (severe muscle weakness), INFLUENZA LIKE ILLNESS (feels like she has the flu.) and ARTHRALGIA (severe joint pain). At the time of the report, MONOPLEGIA (6 hours later her hand was paralyzed /fingers were paralyzed for 24 hours) and LIMB DISCOMFORT (still cannot feel her feet right /her legs feel like concrete) had resolved and PAIN (much pain), MUSCULAR WEAKNESS (severe muscle weakness), INFLUENZA LIKE ILLNESS (feels like she has the flu.) and ARTHRALGIA (severe joint pain) outcome was unknown.            Patient's weight was reported as 120. The patient's concomitant medication include Multivitamin without iron, IVIG treatments, Tamerind, Boron Supplements, Taurine Supplements every once in a while. She used to get IVIG treatments every 6 weeks and now it is IVIG treatments every 3 weeks for 2 days straight for 6 hours.  Patient also states that her mom said she always had trouble with live vaccines.  Company Comment: This spontaneous case concerns a 57-year-old, female patient with relevant medical history of Fluoroquinolone toxicity, reaction to penicillin and vaccines, who experienced serious (Medically significant) unexpected events of Monoplegia on the same day of receiving third booster dose of mRNA-1273. Patient reports that 6 hours after the booster, her hand was paralyzed, she could not lift her elbows or wrists, her fingers were paralyzed for 24 hours, she still cannot feel her feet right. She has gained the mobility back but she still feels like her blood is boiling in her body, she is in much pain, severe muscle weakness, severe joint pain, her legs feel like concrete and she feels like she has the flu. She states that the booster relapsed her Medication induced QIPP from Fluoroquinolone toxicity and the booster shot made her react the same as when she took a fluoroquinolone, ciprofloxacin, or Levaquin. The patient was treated with IVIG. Medical history of fluoroquinolone toxicity, reaction to penicillin and vaccines could be confounder for the events. At the time of report, outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-501300 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old, female patient with relevant medical history of Fluoroquinolone toxicity, reaction to penicillin and vaccines, who experienced serious (Medically significant) unexpected events of Monoplegia on the same day of receiving third booster dose of mRNA-1273. Patient reports that 6 hours after the booster, her hand was paralyzed, she could not lift her elbows or wrists, her fingers were paralyzed for 24 hours, she still cannot feel her feet right. She has gained the mobility back but she still feels like her blood is boiling in her body, she is in much pain, severe muscle weakness, severe joint pain, her legs feel like concrete and she feels like she has the flu. She states that the booster relapsed her Medication induced QIPP from Fluoroquinolone toxicity and the booster shot made her react the same as when she took a fluoroquinolone, ciprofloxacin, or Levaquin. The patient was treated with IVIG. Medical history of fluoroquinolone toxicity, reaction to penicillin and vaccines could be confounder for the events. At the time of report, outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report