chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing/pulsing/high pitch buzz in her left ear/constant pulsing ringing in left ear) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced TINNITUS (Ringing/pulsing/high pitch buzz in her left ear/constant pulsing ringing in left ear). At the time of the report, TINNITUS (Ringing/pulsing/high pitch buzz in her left ear/constant pulsing ringing in left ear) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Action taken with mRNA-1273 was not applicable.  The patient reported that she saw her PCP in April for the continuous ringing in her left ear but there was nothing irregular.   This case was linked to US-MODERNATX, INC.-MOD-2021-072554 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021 Contains Reporter contact detail was updated, patient demographic details were updated, current condition was added, concomitant medication was added, event verbatim; constant pulsing ringing in left ear was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072554:CROSSLINKED WITH DOSE 2
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: I feel miserable; Bad chill; My head is pounding; My temperature is 104 °F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel miserable), CHILLS (Bad chill), HEADACHE (My head is pounding) and PYREXIA (My temperature is 104 °F) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (I feel miserable), CHILLS (Bad chill), HEADACHE (My head is pounding) and PYREXIA (My temperature is 104 °F). At the time of the report, FEELING ABNORMAL (I feel miserable), CHILLS (Bad chill), HEADACHE (My head is pounding) and PYREXIA (My temperature is 104 °F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included Tylenol.; 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.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Hypoaesthesia, Neck pain, Vaccination site erythema
Clinical narrative: arm went numb little bit; hot at the injection site; neck hurt bad; chest pain; right shoulder pain; red at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain) and ARTHRALGIA (right shoulder pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (about 5 months ago). Concurrent medical conditions included Hypercholesterolemia and Hernia.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain), ARTHRALGIA (right shoulder pain), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain), ARTHRALGIA (right shoulder pain), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's Past medication history included steroid injection a year ago. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Significant follow up received on 19-Jul-2021 and updated the outcome of the events. All events are recovered now. Second dose details were given.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm went numb little bit; hot at the injection site; neck hurt bad; chest pain; right shoulder pain; red at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain) and ARTHRALGIA (right shoulder pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (about 5 months ago). Concurrent medical conditions included Hypercholesterolemia and Hernia.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain), ARTHRALGIA (right shoulder pain), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, HYPOAESTHESIA (arm went numb little bit), VACCINATION SITE WARMTH (hot at the injection site), NECK PAIN (neck hurt bad), CHEST PAIN (chest pain), ARTHRALGIA (right shoulder pain), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's Past medication history included steroid injection a year ago. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Significant follow up received on 19-Jul-2021 and updated the outcome of the events. All events are recovered now. Second dose details were given.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Lip pruritus, Pruritus
Clinical narrative: itching on her face; itching on her lips; itching on her ears; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on her face), LIP PRURITUS (itching on her lips) and EAR PRURITUS (itching on her ears) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Patient was allergic to flagyl, Vicodin, arthromycin and Bactrim.), Seasonal allergy since 1985 and Depression since 1987. Concomitant products included LORATADINE from 2005 to an unknown date for Allergy, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 1993 to an unknown date for Depression, LANSOPRAZOLE (PREVACID) from 2018 to an unknown date for Heartburn, AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Nerve pain, MAGNESIUM for an unknown indication.    On 08-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRURITUS (itching on her face), LIP PRURITUS (itching on her lips) and EAR PRURITUS (itching on her ears). On 09-Apr-2021, PRURITUS (itching on her face), LIP PRURITUS (itching on her lips) and EAR PRURITUS (itching on her ears) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Patient reported getting acupuncture same day of vaccine administration.        Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021 contains Added patient's demographics, concomitant drugs. Updated medical history and event outcome to recovered.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Nervousness
Clinical narrative: Nausea; Nervousness in the inside; weird side effects; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), NERVOUSNESS (Nervousness in the inside) and FEELING ABNORMAL (weird side effects) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS on 11-Jan-2021. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, FOLIC ACID for Blood folic acid, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (Nausea), NERVOUSNESS (Nervousness in the inside) and FEELING ABNORMAL (weird side effects). At the time of the report, NAUSEA (Nausea) and FEELING ABNORMAL (weird side effects) had not resolved and NERVOUSNESS (Nervousness in the inside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient lost 10 lbs due to nausea.The nausea has been going on for about 5 weeks now.  Treatment included anti-anxiety medicine.  On 02-Apr-2021, the patient received her second shot on her LEFT Arm.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: A new event, feeling abnormal (weird side effects) was added to the case.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site mass, Vaccination site rash
Clinical narrative: Pain on arm of injection ("not as intense as before"); Rash on arm of injection; Lump on injection site; Intense pain on arm of injection ("could not move or lift it"); Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Intense pain on arm of injection ("could not move or lift it")), FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain on arm of injection ("not as intense as before")), VACCINATION SITE RASH (Rash on arm of injection) and VACCINATION SITE MASS (Lump on injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0401421A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ROSUVASTATIN, SPIRONOLACTONE, ISOTRETINOIN (ZENATANE), FLUOXETINE and VILAZODONE HYDROCHLORIDE (VIIBRYD) for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Intense pain on arm of injection ("could not move or lift it")) and FATIGUE (Tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on arm of injection ("not as intense as before")), VACCINATION SITE RASH (Rash on arm of injection) and VACCINATION SITE MASS (Lump on injection site). On 31-Mar-2021, PAIN IN EXTREMITY (Intense pain on arm of injection ("could not move or lift it")) and FATIGUE (Tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on arm of injection ("not as intense as before")), VACCINATION SITE RASH (Rash on arm of injection) and VACCINATION SITE MASS (Lump on injection site) outcome was unknown.        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.   Treatment information were not provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16yo patient that accidentally got the 1st dose the of Moderna Covid-19 vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yo patient that accidentally got the 1st dose the of Moderna Covid-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yo patient that accidentally got the 1st dose the of Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16yo patient that accidentally got the 1st dose the of Moderna Covid-19 vaccine) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: no new information
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; Hives on his back; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching) and URTICARIA (Hives on his back) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRURITUS (Itching) and URTICARIA (Hives on his back). At the time of the report, PRURITUS (Itching) and URTICARIA (Hives on his back) outcome was unknown.        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 product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-072253 (E2B Linked Report).; Sender's Comments:  MOD21-072253:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Fatigue, Myalgia
Clinical narrative: Cough; Body ache; Runny nose; Sore throat; Loss of taste and smell; Loss of taste and smell; Missed 2nd dose, at recommended interval; Muscle ache; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and AGEUSIA (Loss of taste and smell) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, at recommended interval), MYALGIA (Muscle ache) and FATIGUE (Feeling very tired). At the time of the report, COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, at recommended interval), MYALGIA (Muscle ache) and FATIGUE (Feeling very tired) 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 included Tylenol.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Product dose omission issue, Rhinorrhoea
Clinical narrative: Cough; Body ache; Runny nose; Sore throat; Loss of taste and smell; Loss of taste and smell; Missed 2nd dose, at recommended interval; Muscle ache; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and AGEUSIA (Loss of taste and smell) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, at recommended interval), MYALGIA (Muscle ache) and FATIGUE (Feeling very tired). At the time of the report, COUGH (Cough), PAIN (Body ache), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, at recommended interval), MYALGIA (Muscle ache) and FATIGUE (Feeling very tired) 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 included Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: whole body feels weak/difficult for her to get around; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (whole body feels weak/difficult for her to get around) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Rheumatoid arthritis.  No medical history was provided by reporter.  No concomitant medication reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (whole body feels weak/difficult for her to get around). At the time of the report, ASTHENIA (whole body feels weak/difficult for her to get around) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), ABDOMINAL DISCOMFORT (upset stomach and couldn't eat, had no appetite), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), RASH (she woke up with a rash that covers her entire upper arm) and FATIGUE (fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE for an unknown indication. On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), ABDOMINAL DISCOMFORT (upset stomach and couldn't eat, had no appetite), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), FATIGUE (fatigue), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). On 10-Apr-2021, the patient experienced RASH (she woke up with a rash that covers her entire upper arm). On 09-Apr-2021, ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), FATIGUE (fatigue), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, RASH (she woke up with a rash that covers her entire upper arm) outcome was unknown. Treatment was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), ABDOMINAL DISCOMFORT (upset stomach and couldn't eat, had no appetite), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), RASH (she woke up with a rash that covers her entire upper arm) and FATIGUE (fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE for an unknown indication. On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), ABDOMINAL DISCOMFORT (upset stomach and couldn't eat, had no appetite), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), FATIGUE (fatigue), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). On 10-Apr-2021, the patient experienced RASH (she woke up with a rash that covers her entire upper arm). On 09-Apr-2021, ASTHENIA (weakness, fatigue, chills, headache, nausea, fever), DECREASED APPETITE (upset stomach and couldn't eat, had no appetite), FATIGUE (fatigue), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, RASH (she woke up with a rash that covers her entire upper arm) outcome was unknown. Treatment was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depression, Fatigue, Insomnia, Pain in extremity
Clinical narrative: Last night my arm starting hurting a bit; During the night I couldn't sleep and I was up every hour; 'm bipolar and I get this wave of depression over me; I'm feeling very weak and tired; My injection site is a little pink but it's not red red; I'm feeling very weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Last night my arm starting hurting a bit), INSOMNIA (During the night I couldn't sleep and I was up every hour), DEPRESSION ('m bipolar and I get this wave of depression over me), ASTHENIA (I'm feeling very weak and tired) and VACCINATION SITE DISCOLOURATION (My injection site is a little pink but it's not red red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY, INSOMNIA, DEPRESSION, ASTHENIA, VACCINATION SITE DISCOLOURATION and FATIGUE. At the time of the report, PAIN IN EXTREMITY had resolved, INSOMNIA, DEPRESSION, ASTHENIA, and FATIGUE had not resolved and VACCINATION SITE DISCOLOURATION outcome was unknown. Not Provided.          Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-223823.   Most recent FOLLOW-UP information incorporated above included on 16-Jun-2021: Event outcome updated. On 14-Jul-2021: Follow up received on 14-07-2021 contain no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Last night my arm starting hurting a bit; During the night I couldn't sleep and I was up every hour; 'm bipolar and I get this wave of depression over me; I'm feeling very weak and tired; My injection site is a little pink but it's not red red; I'm feeling very weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Last night my arm starting hurting a bit), INSOMNIA (During the night I couldn't sleep and I was up every hour), DEPRESSION ('m bipolar and I get this wave of depression over me), ASTHENIA (I'm feeling very weak and tired) and VACCINATION SITE DISCOLOURATION (My injection site is a little pink but it's not red red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY, INSOMNIA, DEPRESSION, ASTHENIA, VACCINATION SITE DISCOLOURATION and FATIGUE. At the time of the report, PAIN IN EXTREMITY had resolved, INSOMNIA, DEPRESSION, ASTHENIA, and FATIGUE had not resolved and VACCINATION SITE DISCOLOURATION outcome was unknown. Not Provided.          Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-223823.   Most recent FOLLOW-UP information incorporated above included on 16-Jun-2021: Event outcome updated. On 14-Jul-2021: Follow up received on 14-07-2021 contain no new information.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Over the time period to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Over the time period to get the second dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Over the time period to get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over the time period to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Burning sensation, Fatigue, Pain in extremity
Clinical narrative: sleepiness; "more intense" pain; pain upon injection administration; tiredness; "burning feeling" under left armpit; "pinching feeling" under left armpit; "pinching feeling" by left breast; "burning feeling" by left breast; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), SOMNOLENCE (sleepiness), VACCINATION SITE PAIN (pain upon injection administration), AXILLARY PAIN ("pinching feeling" under left armpit) and BREAST PAIN ("pinching feeling" by left breast) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) and AMLODIPINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 24-Mar-2021, the patient experienced AXILLARY PAIN ("pinching feeling" under left armpit), BREAST PAIN ("pinching feeling" by left breast), BURNING SENSATION ("burning feeling" by left breast) and BURNING SENSATION ("burning feeling" under left armpit). On 30-Mar-2021, the patient experienced FATIGUE (tiredness), SOMNOLENCE (sleepiness), VACCINATION SITE PAIN (pain upon injection administration) and PAIN IN EXTREMITY ("more intense" pain). On 01-Apr-2021, FATIGUE (tiredness) and SOMNOLENCE (sleepiness) had resolved. At the time of the report, VACCINATION SITE PAIN (pain upon injection administration), AXILLARY PAIN ("pinching feeling" under left armpit), BREAST PAIN ("pinching feeling" by left breast), BURNING SENSATION ("burning feeling" by left breast), PAIN IN EXTREMITY ("more intense" pain) and BURNING SENSATION ("burning feeling" under left armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: sleepiness; "more intense" pain; pain upon injection administration; tiredness; "burning feeling" under left armpit; "pinching feeling" under left armpit; "pinching feeling" by left breast; "burning feeling" by left breast; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), SOMNOLENCE (sleepiness), VACCINATION SITE PAIN (pain upon injection administration), AXILLARY PAIN ("pinching feeling" under left armpit) and BREAST PAIN ("pinching feeling" by left breast) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) and AMLODIPINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 24-Mar-2021, the patient experienced AXILLARY PAIN ("pinching feeling" under left armpit), BREAST PAIN ("pinching feeling" by left breast), BURNING SENSATION ("burning feeling" by left breast) and BURNING SENSATION ("burning feeling" under left armpit). On 30-Mar-2021, the patient experienced FATIGUE (tiredness), SOMNOLENCE (sleepiness), VACCINATION SITE PAIN (pain upon injection administration) and PAIN IN EXTREMITY ("more intense" pain). On 01-Apr-2021, FATIGUE (tiredness) and SOMNOLENCE (sleepiness) had resolved. At the time of the report, VACCINATION SITE PAIN (pain upon injection administration), AXILLARY PAIN ("pinching feeling" under left armpit), BREAST PAIN ("pinching feeling" by left breast), BURNING SENSATION ("burning feeling" by left breast), PAIN IN EXTREMITY ("more intense" pain) and BURNING SENSATION ("burning feeling" under left armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tenderness
Clinical narrative: arm is very tender up to her shoulder; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm is very tender up to her shoulder) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 036A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 2000 to an unknown date for Thyroid disorder NOS.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced TENDERNESS (arm is very tender up to her shoulder) and HEADACHE (Headache). At the time of the report, TENDERNESS (arm is very tender up to her shoulder) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-072540 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021 contains Updated patient demographics, second dose start date.Added concomitant medication.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072540:CROSSLINKED WITH DOSE 1
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lip swelling, Movement disorder, Muscle spasticity
Clinical narrative: Can't move arms and hands; Fingers won't work in both hand; Lips are big; Face tingling; Burning up but no fever; Feeling a lot of pain; Needle pain in all joints; Terrible headache, a bad bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Can't move arms and hands), MUSCLE SPASTICITY (Fingers won't work in both hand), LIP SWELLING (Lips are big), PARAESTHESIA (Face tingling) and SKIN BURNING SENSATION (Burning up but no fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bacterial infection. Concomitant products included METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) for Bacterial infection.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MOVEMENT DISORDER (Can't move arms and hands), MUSCLE SPASTICITY (Fingers won't work in both hand), LIP SWELLING (Lips are big), PARAESTHESIA (Face tingling), SKIN BURNING SENSATION (Burning up but no fever), PAIN (Feeling a lot of pain), ARTHRALGIA (Needle pain in all joints) and HEADACHE (Terrible headache, a bad bad headache). At the time of the report, MOVEMENT DISORDER (Can't move arms and hands), MUSCLE SPASTICITY (Fingers won't work in both hand), LIP SWELLING (Lips are big), PARAESTHESIA (Face tingling), SKIN BURNING SENSATION (Burning up but no fever), PAIN (Feeling a lot of pain), ARTHRALGIA (Needle pain in all joints) and HEADACHE (Terrible headache, a bad bad headache) outcome was unknown.            Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Skin burning sensation
Clinical narrative: Can't move arms and hands; Fingers won't work in both hand; Lips are big; Face tingling; Burning up but no fever; Feeling a lot of pain; Needle pain in all joints; Terrible headache, a bad bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Can't move arms and hands), MUSCLE SPASTICITY (Fingers won't work in both hand), LIP SWELLING (Lips are big), PARAESTHESIA (Face tingling) and SKIN BURNING SENSATION (Burning up but no fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bacterial infection. Concomitant products included METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) for Bacterial infection.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MOVEMENT DISORDER (Can't move arms and hands), MUSCLE SPASTICITY (Fingers won't work in both hand), LIP SWELLING (Lips are big), PARAESTHESIA (Face tingling), SKIN BURNING SENSATION (Burning up but no fever), PAIN (Feeling a lot of pain), ARTHRALGIA (Needle pain in all joints) and HEADACHE (Terrible headache, a bad bad headache). At the time of the report, MOVEMENT DISORDER (Can't move arms and hands), MUSCLE SPASTICITY (Fingers won't work in both hand), LIP SWELLING (Lips are big), PARAESTHESIA (Face tingling), SKIN BURNING SENSATION (Burning up but no fever), PAIN (Feeling a lot of pain), ARTHRALGIA (Needle pain in all joints) and HEADACHE (Terrible headache, a bad bad headache) outcome was unknown.            Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site pain
Clinical narrative: Worsening bronchitis that consumer had before injection; Pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Worsening bronchitis that consumer had before injection) and VACCINATION SITE PAIN (Pain at injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), PROGESTERONE, ESTRADIOL and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CONDITION AGGRAVATED (Worsening bronchitis that consumer had before injection) and VACCINATION SITE PAIN (Pain at injection). On 27-Mar-2021, VACCINATION SITE PAIN (Pain at injection) had resolved. At the time of the report, CONDITION AGGRAVATED (Worsening bronchitis that consumer had before injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-072514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-Jun-2021 contain no significant information.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with LORATADINE at a dose of 10 mg once a day. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient developed hives 9 days after first dose of vaccination.  The patient was scheduled to receive the second dose on 24-Apr-2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia
Clinical narrative: Hand numbness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA and CHILLS 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Apr-2021, the patient experienced HYPOAESTHESIA and CHILLS. At the time of the report, HYPOAESTHESIA and CHILLS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash macular, Vaccination site induration
Clinical narrative: Felt warm to touch; Arm has red spot the size of the palm of the hand; Iitchy; Arm felt thick and firm around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt warm to touch), RASH MACULAR (Arm has red spot the size of the palm of the hand), PRURITUS (Iitchy) and VACCINATION SITE INDURATION (Arm felt thick and firm around the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Felt warm to touch), RASH MACULAR (Arm has red spot the size of the palm of the hand), PRURITUS (Iitchy) and VACCINATION SITE INDURATION (Arm felt thick and firm around the injection site). At the time of the report, FEELING HOT (Felt warm to touch), RASH MACULAR (Arm has red spot the size of the palm of the hand), PRURITUS (Iitchy) and VACCINATION SITE INDURATION (Arm felt thick and firm around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event's outcome updated to recovered/resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, HYDROCHLOROTHIAZIDE, ATORVASTATIN, GABAPENTIN, MELATONIN (TRANSZONE), LISINOPRIL and PIOGLITAZONE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PAIN IN EXTREMITY (hand pain). At the time of the report, PAIN IN EXTREMITY (hand pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose) had resolved.            No concomitant medications were reported.  It was reported that the patient's wife said her husband received the second shot on 12-Apr-2021 but had no reaction with any of the doses, so she denied any further follow up.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-Jun-2021 and included information about second dose.; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # unknown  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Ocular discomfort, Reading disorder, Vision blurred, Visual impairment
Clinical narrative: eye it's blurry; if she closes her left eye, it's all darkness on the right one; cannot see clearly; cannot read; felt pressure on right eye; dry eye; eye it's foggy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OCULAR DISCOMFORT (felt pressure on right eye), DRY EYE (dry eye), VISION BLURRED (eye it's foggy), VISION BLURRED (eye it's blurry) and VISUAL IMPAIRMENT (if she closes her left eye, it's all darkness on the right one) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced OCULAR DISCOMFORT (felt pressure on right eye), DRY EYE (dry eye) and VISION BLURRED (eye it's foggy). On 08-Apr-2021, the patient experienced VISION BLURRED (eye it's blurry), VISUAL IMPAIRMENT (if she closes her left eye, it's all darkness on the right one), VISION BLURRED (cannot see clearly) and READING DISORDER (cannot read). At the time of the report, OCULAR DISCOMFORT (felt pressure on right eye), DRY EYE (dry eye), VISION BLURRED (eye it's foggy), VISUAL IMPAIRMENT (if she closes her left eye, it's all darkness on the right one), VISION BLURRED (cannot see clearly) and READING DISORDER (cannot read) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient used eye drops because her doctor told her she has dry eye.