Age: 55.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Anxiety, Burning sensation, COVID-19 immunisation, Disturbance in attention, Dizziness
Clinical narrative: states that something has been off regarding heat and cold sensitivity in his hands and feet/Cold water feels too cold and hot water feels too hot/sensitivity to temperature has enhanced a lot; cannot sleep due to this; cannot focus on anything; scared that something is going to happen/states that something has been off regarding heat and cold sensitivity in his hands and feet/Cold water feels too cold and hot water feels too hot/; feels lightheaded and like he is going to faint; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; it seems like some type of neuropathy is going on; anxious/gets uneasiness spells every now/scared that something is going to happen; having burning sensations in his hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (it seems like some type of neuropathy is going on) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Second dose) in March 2021, PFIZER BIONTECH COVID-19 VACCINE (First dose) in March 2021 and PFIZER BIONTECH COVID-19 VACCINE (1st booster) in April 2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 08-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced BURNING SENSATION (having burning sensations in his hands and feet). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (it seems like some type of neuropathy is going on) (seriousness criterion medically significant), ANXIETY (anxious/gets uneasiness spells every now/scared that something is going to happen), TEMPERATURE INTOLERANCE (states that something has been off regarding heat and cold sensitivity in his hands and feet/Cold water feels too cold and hot water feels too hot/sensitivity to temperature has enhanced a lot), INSOMNIA (cannot sleep due to this), DISTURBANCE IN ATTENTION (cannot focus on anything), FEELING ABNORMAL (scared that something is going to happen/states that something has been off regarding heat and cold sensitivity in his hands and feet/Cold water feels too cold and hot water feels too hot/), DIZZINESS (feels lightheaded and like he is going to faint), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, NEUROPATHY PERIPHERAL (it seems like some type of neuropathy is going on), TEMPERATURE INTOLERANCE (states that something has been off regarding heat and cold sensitivity in his hands and feet/Cold water feels too cold and hot water feels too hot/sensitivity to temperature has enhanced a lot), INSOMNIA (cannot sleep due to this), DISTURBANCE IN ATTENTION (cannot focus on anything), FEELING ABNORMAL (scared that something is going to happen/states that something has been off regarding heat and cold sensitivity in his hands and feet/Cold water feels too cold and hot water feels too hot/), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown and ANXIETY (anxious/gets uneasiness spells every now/scared that something is going to happen), BURNING SENSATION (having burning sensations in his hands and feet) and DIZZINESS (feels lightheaded and like he is going to faint) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Nerve conduction studies: Nerve conduction study: Normal, Sensory neuropathy test is pending. On an unknown date, Weight: lost about 40 lbs.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient  reported that even with normal cold water, he feels too cold.He reported that he gets uneasiness spells every now and then where he feels lightheaded and like he is going to faint, but that feeling eventually passes through. He is seeing a neurologist. He says he had been healthy all his life, but now he had been suffering for almost 4 months. No treatment medications were reported.  Company comment: This is a Spontaneous case concerns a 55 years old male patient, with no relevant medical history, who experienced unexpected serious (medically significant) event of neuropathy peripheral, which occurred in context with booster dose of mRNA-1273 vaccination BA.4/BA.5. About a week after vaccination patient experienced burning sensation and cold insensitivity in the hand and the feet, patient says some type of neuropathy is going on. Patent experienced some light lightheaded and like he is going to faint, anxious and insomnia. Last week he went to emergency, consulted neurologist nerve conduction study was normal. Lost 40 lbs after vaccination. Patient received three doses of TOZINAMERNAN prior to the mRNA-1273 bivalent BA.1 vaccination BA.4/BA.5 (Interchange of vaccine products). The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccination is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-712074 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2023: Significant live Follow-up  information received - Relevant Past Drug History, Events and Results of tests and procedures relevant to the investigation of the patient and Narrative has been updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712074:other people case