Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Rash, Rash macular, Skin burning sensation
Clinical narrative: Fiber length dependant peripheral neuropathy; Generalized itchiness/Itchiness more like prickliness; mouth/tongue/lip tingling; sensation of not getting enough air / Shortness of breath; intermittent flushing; paresthesia  / Tingling sensation/tingling in hand ,neck,face,arm; Delay in fine motor skills /function infingers/hands/ loss of motor skill; generalized hives/rash; New sensation of temperature sensitivity in skin (burning/cold) mainly arms/neck/face; Strange after taste which afffected ability to taste food (did not lose sense of taste, but less sharp); Slightly discoloration of nose; Hands/arms slight fleeting numbness; Tongue felt thick; Cheeks blotchy; Freckly; generalized hives/rash; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Fiber length dependant peripheral neuropathy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 18821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure (less than 6 T/C seizures between 2007-2009, likely related to antidepressant medication) from 2007 to 2009. Concurrent medical conditions included Drug allergy (Allergy to polysorbate-80 : positive intradermal reaction), Penicillin allergy (Reaction: Hives), Drug allergy (Allergy to Dilantin, Reaction: Hives, Start date : Oct-2021), Drug allergy (Allergy to Lamictal, Reaction: Hives, Start date : Oct-2021), Herpes simplex (noticed darkening/discoloration of herpes lesion within 1 week after injection) since 1974, Drug allergy (Allergy to Demerol), Drug allergy (Allergy to prochlorperazine), Drug allergy (Allergy to quinolones) and Drug allergy (Allergy to PCN). Concomitant products included MULTIVITAMIN [VITAMINS NOS] from an unknown date to 07-Apr-2021 for an unknown indication.    On 27-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Fiber length dependant peripheral neuropathy) (seriousness criterion medically significant), PRURITUS (Generalized itchiness/Itchiness more like prickliness), PARAESTHESIA (paresthesia  / Tingling sensation/tingling in hand ,neck,face,arm), MOTOR DYSFUNCTION (Delay in fine motor skills /function infingers/hands/ loss of motor skill), URTICARIA (generalized hives/rash) and RASH (generalized hives/rash). 27-Mar-2021, the patient experienced PARAESTHESIA ORAL (mouth/tongue/lip tingling) and TONGUE DISORDER (Tongue felt thick). 27-Mar-2021, the patient experienced DYSPNOEA (sensation of not getting enough air / Shortness of breath), FLUSHING (intermittent flushing) and TASTE DISORDER (Strange after taste which afffected ability to taste food (did not lose sense of taste, but less sharp)). 27-Mar-2021, the patient experienced SKIN BURNING SENSATION (New sensation of temperature sensitivity in skin (burning/cold) mainly arms/neck/face) and HYPOAESTHESIA (Hands/arms slight fleeting numbness). 27-Mar-2021, the patient experienced SKIN DISCOLOURATION (Slightly discoloration of nose), RASH MACULAR (Cheeks blotchy) and EPHELIDES (Freckly). At the time of the report, NEUROPATHY PERIPHERAL (Fiber length dependant peripheral neuropathy), PRURITUS (Generalized itchiness/Itchiness more like prickliness), PARAESTHESIA ORAL (mouth/tongue/lip tingling), DYSPNOEA (sensation of not getting enough air / Shortness of breath), FLUSHING (intermittent flushing), PARAESTHESIA (paresthesia  / Tingling sensation/tingling in hand ,neck,face,arm), MOTOR DYSFUNCTION (Delay in fine motor skills /function infingers/hands/ loss of motor skill), URTICARIA (generalized hives/rash), SKIN BURNING SENSATION (New sensation of temperature sensitivity in skin (burning/cold) mainly arms/neck/face), TASTE DISORDER (Strange after taste which afffected ability to taste food (did not lose sense of taste, but less sharp)), SKIN DISCOLOURATION (Slightly discoloration of nose), HYPOAESTHESIA (Hands/arms slight fleeting numbness), TONGUE DISORDER (Tongue felt thick), RASH MACULAR (Cheeks blotchy), EPHELIDES (Freckly) and RASH (generalized hives/rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: normal (normal) Normal : mid 80s to mid 90s and lowest upon walking (60s). In April 2021, Skin test: abnormal (abnormal) Indicated intradermal reactions to Moderna vaccine and Pfizer (lot EM9810) vaccines and polysorbate-80. On 29-Apr-2021, Blood immunoglobulin E: 16.03 (High) Reference range : less than 1, SARS Cov 2 (IgG) Semi QN. In 2021, Heart rate: high (High) Heart rate increased : greater than 100 beats per minute. On 09-Jul-2021, Echocardiogram: abnormal (abnormal) Filamentous strands detected on aortic cusp per.. On 16-Jul-2021, Blood immunoglobulin E: more than 20 (High) Reference range : less than 1, SARS Cov 2 (IgG) Semi QN.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had loss of motor skills and grip strength, had bilateral weakness, decreased sensitivity in upper and lower extremities and felt intermittent joint pain and discomfort in heart and lumbar spine. The filamentous strand that was detected was unusual for the patient's age group and indicative of systemic inflammation, hypercoagulable state and degenerative disease. The patient was recommended to follow up with a neurologist and cardiologist.  The patient saw an allergies mid-April and confirmed positive intradermal reactions to left over Moderna and Pfizer vaccines as well as Polysorbate-80. Intradermal testing completed for PEG early June and recommended to have oral challenge testing to confirm whether or not allergy is indicated.   No treatment medication was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.     Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up received : updated patient demographics (height, weight, ethnicity and ethnic group), updated medical history, updated case seriousness, added laboratory data and concomitant medication and outcome of events updated from unknown  to not recovered for all events and added new events: Neuropathy peripheral, urticaria, hypoesthesia, feeling hot, taste disorder, neuralgia, skin discoloration, burning sensation, dysgeusia, ephelides, rash macular and arthralgia.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.