Age: 75.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Neuropathy peripheral, Pain in extremity, Ultrasound scan
Clinical narrative: neuropathy/ numbness in her and feet along with pains in her legs; numbness in her feet along with pains in her legs; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy/ numbness in her and feet along with pains in her legs) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: Johnson and Johnson COVID-19 vaccine on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 vaccine.   On 01-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced NEUROPATHY PERIPHERAL (neuropathy/ numbness in her and feet along with pains in her legs) (seriousness criterion medically significant) and PAIN IN EXTREMITY (numbness in her feet along with pains in her legs). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy/ numbness in her and feet along with pains in her legs) and PAIN IN EXTREMITY (numbness in her feet along with pains in her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, Ultrasound scan: showed no blood clots.         Patient received Moderna vaccine at the same time as flu vaccine. Immediately after receiving the Moderna vaccine patient experienced numbness in feet along with pains in legs. Patient went to the hospital where they have done an ultrasound which showed no blood clots. Patient went to primary care doctor who gave hydrocodone acetaminophen for symptoms, which has a prescription for with her rheumatologist. After this was given, her rheumatologist cancelled the other prescription. No Concomitant medications were reported.  Company comment: This spontaneous case concerns a 75-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Neuropathy peripheral. The event occurred on the same day of administration of an unknown dose of mRNA-1273 BIVALENT .222. The patient was previously administered with an unknown dose of Johnson and Johnson vaccine approximately 19 months prior. It has been reported that the patient experienced numbness and pain on her lower extremities immediately after administration of unknown dose of mRNA-1273 BIVALENT .222, patient sought consult at an institution where ultrasound was done but no blood clots were detected. Patient sought consult to her primary care physician where she was given hydrocodone acetaminophen of unknown dosage and frequency as her medication. Details of concomitant medications and medical history were not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 BIVALENT .222 is not affected by this report. Events' seriousness retained as per Important Medical Event List.; Sender's Comments: This spontaneous case concerns a 75-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Neuropathy peripheral. The event occurred on the same day of administration of an unknown dose of mRNA-1273 BIVALENT .222. The patient was previously administered with an unknown dose of Johnson and Johnson vaccine approximately 19 months prior. It has been reported that the patient experienced numbness and pain on her lower extremities immediately after administration of unknown dose of mRNA-1273 BIVALENT .222, patient sought consult at an institution where ultrasound was done but no blood clots were detected. Patient sought consult to her primary care physician where she was given hydrocodone acetaminophen of unknown dosage and frequency as her medication. Details of concomitant medications and medical history were not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 BIVALENT .222 is not affected by this report. Events' seriousness retained as per Important Medical Event List.