Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Off label use, Pain, Pain in extremity, Palpitations
Clinical narrative: her face, neck, down her arm and chest  felt tingly,m pins and needles on feet and hands; heart started pounding; shortness of breath; left arm went numb and tingling,face numb and tingling; chest pain,sharp shooting pains in chest,really sever chest pain; she was diagnosed with POTS Postural Orthostatic Tachycardia Syndrome; her doctor recommended her not getting the second dose; tremors,constantly shaking; panic attacks; legs would give off; twitching; anxiety attacks,could not have the door shut due to her anxiety; ringing in ears; arm hurt,extremly painful; felt really bad,t did not feel like her body,felt like she was going to die,can't control her body,still feels like she is not going to wake up one day,bad brain fog; short term memory; could not multi task,has not been able to work since April,everything was so overwhelming, she could not even schedule a doctor's appointment,make a phone number and send a text message; swelling in the right side of her body; still has muscle spasm; horrible migraines; electric shock going all over her body; hair loss; hard time concentrating, black out in the middle of conversations; sensitivity to pain; nerves are overly sensitive; extrimly painful; affected her psychologically; chest tightness; has not been able to work; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain,sharp shooting pains in chest,really sever chest pain), PALPITATIONS (heart started pounding), DYSPNOEA (shortness of breath), HYPOAESTHESIA (left arm went numb and tingling,face numb and tingling), PARAESTHESIA (her face, neck, down her arm and chest  felt tingly,m pins and needles on feet and hands), TREMOR (tremors,constantly shaking), PANIC ATTACK (panic attacks), LIMB DISCOMFORT (legs would give off), MUSCLE TWITCHING (twitching), ANXIETY (anxiety attacks,could not have the door shut due to her anxiety), TINNITUS (ringing in ears), PAIN IN EXTREMITY (arm hurt,extremly painful), FEELING ABNORMAL (felt really bad,t did not feel like her body,felt like she was going to die,can't control her body,still feels like she is not going to wake up one day,bad brain fog), AMNESIA (short term memory), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not multi task,has not been able to work since April,everything was so overwhelming, she could not even schedule a doctor's appointment,make a phone number and send a text message), SWELLING (swelling in the right side of her body), MUSCLE SPASMS (still has muscle spasm), MIGRAINE (horrible migraines), ELECTRIC SHOCK SENSATION (electric shock going all over her body), ALOPECIA (hair loss), DISTURBANCE IN ATTENTION (hard time concentrating, black out in the middle of conversations), SENSITIVE SKIN (sensitivity to pain), NEURALGIA (nerves are overly sensitive), PAIN (extrimly painful), MENTAL STATUS CHANGES (affected her psychologically) and CHEST DISCOMFORT (chest tightness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced CHEST PAIN (chest pain,sharp shooting pains in chest,really sever chest pain) (seriousness criterion hospitalization). On 03-Apr-2021, the patient experienced PALPITATIONS (heart started pounding) (seriousness criterion hospitalization), DYSPNOEA (shortness of breath) (seriousness criterion hospitalization) and HYPOAESTHESIA (left arm went numb and tingling,face numb and tingling) (seriousness criterion hospitalization). In April 2021, the patient experienced IMPAIRED WORK ABILITY (has not been able to work). On an unknown date, the patient experienced PARAESTHESIA (her face, neck, down her arm and chest  felt tingly,m pins and needles on feet and hands) (seriousness criterion hospitalization), TREMOR (tremors,constantly shaking) (seriousness criterion medically significant), PANIC ATTACK (panic attacks) (seriousness criterion medically significant), LIMB DISCOMFORT (legs would give off) (seriousness criterion medically significant), MUSCLE TWITCHING (twitching) (seriousness criterion medically significant), ANXIETY (anxiety attacks,could not have the door shut due to her anxiety) (seriousness criterion medically significant), TINNITUS (ringing in ears) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm hurt,extremly painful) (seriousness criterion medically significant), FEELING ABNORMAL (felt really bad,t did not feel like her body,felt like she was going to die,can't control her body,still feels like she is not going to wake up one day,bad brain fog) (seriousness criterion medically significant), AMNESIA (short term memory) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not multi task,has not been able to work since April,everything was so overwhelming, she could not even schedule a doctor's appointment,make a phone number and send a text message) (seriousness criterion medically significant), SWELLING (swelling in the right side of her body) (seriousness criterion medically significant), MUSCLE SPASMS (still has muscle spasm) (seriousness criterion medically significant), MIGRAINE (horrible migraines) (seriousness criterion medically significant), ELECTRIC SHOCK SENSATION (electric shock going all over her body) (seriousness criterion medically significant), ALOPECIA (hair loss) (seriousness criterion medically significant), DISTURBANCE IN ATTENTION (hard time concentrating, black out in the middle of conversations) (seriousness criterion medically significant), SENSITIVE SKIN (sensitivity to pain) (seriousness criterion medically significant), NEURALGIA (nerves are overly sensitive) (seriousness criterion medically significant), PAIN (extrimly painful) (seriousness criterion medically significant), MENTAL STATUS CHANGES (affected her psychologically) (seriousness criterion medically significant), CHEST DISCOMFORT (chest tightness) (seriousness criterion medically significant), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (she was diagnosed with POTS Postural Orthostatic Tachycardia Syndrome) and OFF LABEL USE (her doctor recommended her not getting the second dose). The patient was hospitalized from 07-Apr-2021 to 10-Apr-2021 due to CHEST PAIN, DYSPNOEA, HYPOAESTHESIA, PALPITATIONS and PARAESTHESIA. The patient was treated with NORTRIPTYLINE for Adverse event, at an unspecified dose and frequency; GABAPENTIN for Adverse event, at an unspecified dose and frequency; ESCITALOPRAM OXALATE (LEXAPRO) for Adverse event, at an unspecified dose and frequency; DULOXETINE HYDROCHLORIDE (CYMBALTA) for Adverse event, at an unspecified dose and frequency and METOPROLOL for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain,sharp shooting pains in chest,really sever chest pain), PALPITATIONS (heart started pounding), DYSPNOEA (shortness of breath), HYPOAESTHESIA (left arm went numb and tingling,face numb and tingling), CHEST DISCOMFORT (chest tightness) and IMPAIRED WORK ABILITY (has not been able to work) had not resolved, PARAESTHESIA (her face, neck, down her arm and chest  felt tingly,m pins and needles on feet and hands), TREMOR (tremors,constantly shaking), PANIC ATTACK (panic attacks), LIMB DISCOMFORT (legs would give off), MUSCLE TWITCHING (twitching), ANXIETY (anxiety attacks,could not have the door shut due to her anxiety), TINNITUS (ringing in ears), PAIN IN EXTREMITY (arm hurt,extremly painful), FEELING ABNORMAL (felt really bad,t did not feel like her body,felt like she was going to die,can't control her body,still feels like she is not going to wake up one day,bad brain fog), AMNESIA (short term memory), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not multi task,has not been able to work since April,everything was so overwhelming, she could not even schedule a doctor's appointment,make a phone number and send a text message), SWELLING (swelling in the right side of her body), MUSCLE SPASMS (still has muscle spasm), MIGRAINE (horrible migraines), ELECTRIC SHOCK SENSATION (electric shock going all over her body), ALOPECIA (hair loss), DISTURBANCE IN ATTENTION (hard time concentrating, black out in the middle of conversations), SENSITIVE SKIN (sensitivity to pain), NEURALGIA (nerves are overly sensitive), PAIN (extrimly painful), MENTAL STATUS CHANGES (affected her psychologically) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (she was diagnosed with POTS Postural Orthostatic Tachycardia Syndrome) outcome was unknown and OFF LABEL USE (her doctor recommended her not getting the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Heart rate: high (High) 173, elevated. In April 2021, Echocardiogram: normal (normal) normal. In 2021, Blood test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data includes ECG, cardiac test, cardiac enzymes. The patient has gone to the ER 7 times since April. The patient stated that Nortriptyline, Gabapentin (after taking it, leg, face swelled up, and was in pain). The Patient saw a psychiatrist, they gave antidepressants and antianxiety pills, but stopped it. Concomitant medication not reported.  Company Comment: This case concerns a 35 year-old, female patient with no relevant medical history, who experienced the serious unexpected events of paraesthesia, tremor, limb discomfort, muscle twitching, panic attack, anxiety, tinnitus, pain in extremity, feeling abnormal, amnesia, loss of personal independence in daily activities, swelling, muscle spasms, migraine, electric shock sensation, alopecia, disturbance in attention, sensitive skin, neuralgia, pain, mental status changes, chest discomfort, palpitations, chest pain, dyspnoea and hypoaesthesia. The events occurred after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown since the events occurred after the first dose and no information has been provided regarding second dose. Off label use was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 35 year-old, female patient with no relevant medical history, who experienced the serious unexpected events of paraesthesia, tremor, limb discomfort, muscle twitching, panic attack, anxiety, tinnitus, pain in extremity, feeling abnormal, amnesia, loss of personal independence in daily activities, swelling, muscle spasms, migraine, electric shock sensation, alopecia, disturbance in attention, sensitive skin, neuralgia, pain, mental status changes, chest discomfort, palpitations, chest pain, dyspnoea and hypoaesthesia. The events occurred after the first dose of Moderna COVID-19 vaccine. The rechallenge was unknown since the events occurred after the first dose and no information has been provided regarding second dose. Off label use was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.