chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Photophobia, Pyrexia
Clinical narrative: BRIGHT LIGHTS HURT EYES; PAIN INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; FELT HOT; FELT COLD; ARM STILL HURTS/PAIN IN INJECTED ARM FROM SHOULDER TO WRIST; TINGLING SENSATION INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; NUMBNESS  INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; SHIVERS/CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and dye in ultrasound contrast, and other pre-existing medical conditions included: The patient was currently taking Vitamins. The patient experienced lump that has not gone in 30 years when treated with influenza vaccine for drug used for unknown indication, and drug allergy when treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and rosuvastatin calcium. On 28-AUG-2021, the patient experienced bright lights hurt eyes. On 28-AUG-2021, the patient experienced pain into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced felt hot. On 28-AUG-2021, the patient experienced felt cold. On 28-AUG-2021, the patient experienced arm still hurts/pain in injected arm from shoulder to wrist. On 28-AUG-2021, the patient experienced tingling sensation into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced numbness into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced shivers/chills. On 28-AUG-2021, the patient experienced headache. On 28-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain into armpits, left breast, chest, neck and jaw, felt hot, felt cold, tingling sensation into armpits, left breast, chest, neck and jaw, numbness into armpits, left breast, chest, neck and jaw, shivers/chills, and fever on AUG-2021, and had not recovered from headache, arm still hurts/pain in injected arm from shoulder to wrist, and bright lights hurt eyes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: STABBING PAIN IN THE RIGHT SIDE OF CHEST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the patient experienced stabbing pain in the right side of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stabbing pain in the right side of chest was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Erythema, Fatigue
Clinical narrative: Feeling hot; Redness; Rash; muscle ache; Chills; Nausea; Vomiting; persistent cough; persistent tightness in the chest; persistent sinus headache; blowing nose; phlegm; left arm was sore; poor sleep; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm) and COUGH (persistent cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), FATIGUE (extreme fatigue) and HEADACHE (headache). On 22-Apr-2021, the patient experienced RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), CHEST DISCOMFORT (persistent tightness in the chest) and SINUS HEADACHE (persistent sinus headache). On an unknown date, the patient experienced COUGH (persistent cough), FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), MYALGIA (muscle ache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), COUGH (persistent cough), CHEST DISCOMFORT (persistent tightness in the chest), SINUS HEADACHE (persistent sinus headache), FATIGUE (extreme fatigue), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown and FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027155 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: reporter contact information updated. On 12-Aug-2021: non-significant follow up On 12-Aug-2021: Significant follow-up appended. Patient demography updated. Concomitant medication updated Events updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027155:Case for dose 1
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Feeling hot; Redness; Rash; muscle ache; Chills; Nausea; Vomiting; persistent cough; persistent tightness in the chest; persistent sinus headache; blowing nose; phlegm; left arm was sore; poor sleep; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm) and COUGH (persistent cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), FATIGUE (extreme fatigue) and HEADACHE (headache). On 22-Apr-2021, the patient experienced RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), CHEST DISCOMFORT (persistent tightness in the chest) and SINUS HEADACHE (persistent sinus headache). On an unknown date, the patient experienced COUGH (persistent cough), FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), MYALGIA (muscle ache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), COUGH (persistent cough), CHEST DISCOMFORT (persistent tightness in the chest), SINUS HEADACHE (persistent sinus headache), FATIGUE (extreme fatigue), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown and FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027155 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: reporter contact information updated. On 12-Aug-2021: non-significant follow up On 12-Aug-2021: Significant follow-up appended. Patient demography updated. Concomitant medication updated Events updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027155:Case for dose 1
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Productive cough, Rash, Rhinorrhoea, Sinus headache
Clinical narrative: Feeling hot; Redness; Rash; muscle ache; Chills; Nausea; Vomiting; persistent cough; persistent tightness in the chest; persistent sinus headache; blowing nose; phlegm; left arm was sore; poor sleep; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm) and COUGH (persistent cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), FATIGUE (extreme fatigue) and HEADACHE (headache). On 22-Apr-2021, the patient experienced RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), CHEST DISCOMFORT (persistent tightness in the chest) and SINUS HEADACHE (persistent sinus headache). On an unknown date, the patient experienced COUGH (persistent cough), FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), MYALGIA (muscle ache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), COUGH (persistent cough), CHEST DISCOMFORT (persistent tightness in the chest), SINUS HEADACHE (persistent sinus headache), FATIGUE (extreme fatigue), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown and FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027155 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: reporter contact information updated. On 12-Aug-2021: non-significant follow up On 12-Aug-2021: Significant follow-up appended. Patient demography updated. Concomitant medication updated Events updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027155:Case for dose 1
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling hot; Redness; Rash; muscle ache; Chills; Nausea; Vomiting; persistent cough; persistent tightness in the chest; persistent sinus headache; blowing nose; phlegm; left arm was sore; poor sleep; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm) and COUGH (persistent cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), FATIGUE (extreme fatigue) and HEADACHE (headache). On 22-Apr-2021, the patient experienced RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), CHEST DISCOMFORT (persistent tightness in the chest) and SINUS HEADACHE (persistent sinus headache). On an unknown date, the patient experienced COUGH (persistent cough), FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), MYALGIA (muscle ache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), COUGH (persistent cough), CHEST DISCOMFORT (persistent tightness in the chest), SINUS HEADACHE (persistent sinus headache), FATIGUE (extreme fatigue), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown and FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027155 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: reporter contact information updated. On 12-Aug-2021: non-significant follow up On 12-Aug-2021: Significant follow-up appended. Patient demography updated. Concomitant medication updated Events updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027155:Case for dose 1
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1st dose given 29 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0788C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. The patient had no known drug allergies and no chronic or long standing health conditions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: significant follow up : patient demographics (age, ethnicity, race) updated and narrative updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Flushing, Pain, Pruritus
Clinical narrative: Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe; Itching hives; Patient stated it felt like she was burning out her skin; Painful hives; Feeling hot; Flushing; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives) and FEELING HOT (Feeling hot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity reaction, Drug allergy (Heart rate increase), Allergy (Once trouble waking up and another time woke up prematurely), Asthma and Hay fever.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever) had resolved.     No concomitant medications were reported.  Treatment details included Benadryl and Benadryl cream which did not help at all.   This case was linked to MOD-2021-258907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received on 13-Aug-2021: Medical history and event outcome updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation, Urticaria
Clinical narrative: Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe; Itching hives; Patient stated it felt like she was burning out her skin; Painful hives; Feeling hot; Flushing; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives) and FEELING HOT (Feeling hot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypersensitivity reaction, Drug allergy (Heart rate increase), Allergy (Once trouble waking up and another time woke up prematurely), Asthma and Hay fever.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever) had resolved.     No concomitant medications were reported.  Treatment details included Benadryl and Benadryl cream which did not help at all.   This case was linked to MOD-2021-258907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received on 13-Aug-2021: Medical history and event outcome updated
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Inappropriate schedule of product administration, Myalgia
Clinical narrative: COVID-19; I got the moderna vaccine April (two shots spaced apart by three weeks); Nasal congestion; Loss of taste; Loss of smell; runny nose; ache/ muscle ache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jul-2021. The most recent information was received on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache). At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) positive (source of sample is nose).         No concomitant medications were provided. No treatment medication information was provided. The patient confirmed having COVID-19 after receiving MODERNA vaccine three months earlier.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Significant Follow up appended : laboratory data added, new events of muscle aches, nasal congestion/runny nose, loss of taste loss of smell were added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COVID-19; I got the moderna vaccine April (two shots spaced apart by three weeks); Nasal congestion; Loss of taste; Loss of smell; runny nose; ache/ muscle ache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jul-2021. The most recent information was received on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache). At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) positive (source of sample is nose).         No concomitant medications were provided. No treatment medication information was provided. The patient confirmed having COVID-19 after receiving MODERNA vaccine three months earlier.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Significant Follow up appended : laboratory data added, new events of muscle aches, nasal congestion/runny nose, loss of taste loss of smell were added.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: I can tell there is fever in it just by touching it; Big knot on my left arm where I got my shot at; It itches but it hurts for me to scratch it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07LB21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it). At the time of the report, VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-288661 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Reporter details and events outcome were updated for dose 1.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; Painful, difficult arm; Rash and blister on the site of injection and itchiness; Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness) and RASH (Rash on the neck and other side of neck, very red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Lidocaine).    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and HYDROCORTISONE for Adverse event, at a dose of UNK dosage form. On 01-Aug-2021, PAIN IN EXTREMITY (Painful, difficult arm) had resolved. On 02-Aug-2021, ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: TCR Received on 17-AUG-2021 and It included reporter contact details
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; Painful, difficult arm; Rash and blister on the site of injection and itchiness; Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness) and RASH (Rash on the neck and other side of neck, very red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Lidocaine).    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and HYDROCORTISONE for Adverse event, at a dose of UNK dosage form. On 01-Aug-2021, PAIN IN EXTREMITY (Painful, difficult arm) had resolved. On 02-Aug-2021, ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: TCR Received on 17-AUG-2021 and It included reporter contact details
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: i feel sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i feel sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (i feel sick). At the time of the report, MALAISE (i feel sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: Sore arm in the injection arm on the first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm in the injection arm on the first dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm in the injection arm on the first dose). At the time of the report, MYALGIA (Sore arm in the injection arm on the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, Heart rate increased: 137-154 bpm (High) 137-154 bpm during standing and walking..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant use was reported. No treatment medication was reported.   This case was linked to MOD-2021-284724 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia
Clinical narrative: Red spots on legs; Feels like needles in my veins, they sting; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red spots on legs) and PARAESTHESIA (Feels like needles in my veins, they sting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red spots on legs) and PARAESTHESIA (Feels like needles in my veins, they sting). At the time of the report, ERYTHEMA (Red spots on legs) and PARAESTHESIA (Feels like needles in my veins, they sting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No Treatment medications were provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia
Clinical narrative: Was unable to stand straight for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Was unable to stand straight for 48 hours) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 040B21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included INFLIXIMAB (REMICADE) from 24-Mar-2021 to an unknown date for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSSTASIA (Was unable to stand straight for 48 hours). At the time of the report, DYSSTASIA (Was unable to stand straight for 48 hours) outcome was unknown.            Patient was not sure of her experience was related to the vaccine.  On 14-Apr-2021 she received her second dose of the Moderna vaccine (lot no 040B21A, expiration date 01-Jan-1900) and had no problems.  She stated that she was doing fine and the side effect happened once. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Expired vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-285598 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Possible temperature excursion; Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved.        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.   No concomitant medications were reported. No treatment information was provided.  The nurse reported a possible temperature excursion at facility. According to the nurse, the shipment of vaccines were received on 08-Jul-2021 to a different team and was placed in the refrigerator. The nurse received vaccines on 30-Jul-2021 and remained in the refrigerator but was missing the expiration label of when they were previously placed in the fridge. The nurse was unaware that the vaccines were initially received and placed in the fridge 08-Jul-2021. The max temperature reached was 41.4 F and min 40.6 F. The number of Moderna vials affected were 4 vials. Of those 4 vials, 3 of the vials were used to administer vaccinations to 9 patients over 3 days from 09-Aug-2021 to 11-Aug-2021. At the time of excursion the vials remained refrigerated. The 1 vial that was not used was discarded. The nurse reported not noticing any vaccine state changes. The patient received an expired vaccine past 30 days in the fridge.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was also not reported.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Not applicable) was Not applicable.  The nurse reports that the shipment of vaccines were received on 08-July-2021 to a different team and was placed in the refrigerator. The vaccines were received to her 30-July-2021 and remained in the refrigerator but was missing the expiration label of when they were previously placed in the fridge.  The nurse was unaware that the vaccines were initially received and placed in the fridge 08-July-2021. The max temperature reached was 41.4F and min 40.6F. The number of Moderna vials affected were 4 vials (Lot# 038C21A). Of those 4 vials, 3 of the vials were used to administer vaccinations to 9 patients over 3 days 09-August-2021-11-August-2021. At the time of excursion the vials remained refrigerated. The 1 vial that was not used was discarded. The nurse reported not noticing any vaccine state changes. Patient's received an expired vaccine past 30 days in the fridge. AE contains info for Patient 7.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: possible temperature excursion; Patient received an expired vaccine; received an expired vaccine past 30 days in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (possible temperature excursion), EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (possible temperature excursion), EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (possible temperature excursion) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (received an expired vaccine past 30 days in the fridge) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported. This adverse events information was for patient 2.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Arthritic pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthritic pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Arthritic pain). At the time of the report, ARTHRALGIA (Arthritic pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-129705 (E2B Linked Report).; Sender's Comments:  MOD21-129705:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Illness, Intentional dose omission, Nerve injury
Clinical narrative: Unilateral Vestibular Hypofunction in her right ear; Equilibrium Instability; quite sick; Hadn't been well; dizziness; Hadn't been well and didn't get second shot; Nerve Damage; Full episode of vertigo/Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (Nerve Damage), VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick) and VACCINATION COMPLICATION (Hadn't been well) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced NERVE INJURY (Nerve Damage) and VERTIGO (Full episode of vertigo/Vertigo). On an unknown date, the patient experienced VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick), VACCINATION COMPLICATION (Hadn't been well), DIZZINESS (dizziness) and INTENTIONAL DOSE OMISSION (Hadn't been well and didn't get second shot). At the time of the report, NERVE INJURY (Nerve Damage), VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick), VACCINATION COMPLICATION (Hadn't been well) and DIZZINESS (dizziness) outcome was unknown and VERTIGO (Full episode of vertigo/Vertigo) and INTENTIONAL DOSE OMISSION (Hadn't been well and didn't get second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported