chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), PAIN (never felt this kind of pain,it's like it's in the bone), MALAISE (feeling sick) and FEELING ABNORMAL (Make my life horrible) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PAIN (never felt this kind of pain,it's like it's in the bone). On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), MALAISE (feeling sick), FEELING ABNORMAL (Make my life horrible), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't take a shower), PAIN (terrible pain), COVID-19 (Got COVID) and ILLNESS (little bit sick for 5 days). At the time of the report, PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), PAIN (never felt this kind of pain,it's like it's in the bone), MALAISE (feeling sick), FEELING ABNORMAL (Make my life horrible), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't take a shower), PAIN (terrible pain), COVID-19 (Got COVID) and ILLNESS (little bit sick for 5 days) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. 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 and treatment medications were not provided by reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness postural, Eyelid disorder, Headache, Nausea
Clinical narrative: Vertigo; around his eye was black from the nose and all around the left eye/ Nose is all black and blue; Top of right eye - eyelid is black; Dizziness with position changes; Pain on the left forehead - right above the eye/ Headache; nausea/ nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo), SKIN DISCOLOURATION (around his eye was black from the nose and all around the left eye/ Nose is all black and blue), EYELID DISORDER (Top of right eye - eyelid is black), DIZZINESS POSTURAL (Dizziness with position changes) and HEADACHE (Pain on the left forehead - right above the eye/ Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VERTIGO (Vertigo), SKIN DISCOLOURATION (around his eye was black from the nose and all around the left eye/ Nose is all black and blue), EYELID DISORDER (Top of right eye - eyelid is black), DIZZINESS POSTURAL (Dizziness with position changes), HEADACHE (Pain on the left forehead - right above the eye/ Headache) and NAUSEA (nausea/ nauseous). At the time of the report, VERTIGO (Vertigo), EYELID DISORDER (Top of right eye - eyelid is black) and HEADACHE (Pain on the left forehead - right above the eye/ Headache) had resolved, SKIN DISCOLOURATION (around his eye was black from the nose and all around the left eye/ Nose is all black and blue) and DIZZINESS POSTURAL (Dizziness with position changes) outcome was unknown and NAUSEA (nausea/ nauseous) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative.         Black eye resolved on unreported date. On  06/05/2021, the patient awoke with a Black eye (left) again. No Relevant concomitant medications was reported. Treatment was not taken by the patient.   This case was linked to MOD-2021-067353, MOD-2021-209386, MOD-2021-244811 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up received on 16MAY- 2021. Non significant follow up On 05-Jun-2021: Follow up received on 05-JUN-2021, updated on outcomes of events from unknown to recovered and recovering. Details of first dose and adverse events experienced by his wife was updated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vertigo
Clinical narrative: Vertigo; around his eye was black from the nose and all around the left eye/ Nose is all black and blue; Top of right eye - eyelid is black; Dizziness with position changes; Pain on the left forehead - right above the eye/ Headache; nausea/ nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo), SKIN DISCOLOURATION (around his eye was black from the nose and all around the left eye/ Nose is all black and blue), EYELID DISORDER (Top of right eye - eyelid is black), DIZZINESS POSTURAL (Dizziness with position changes) and HEADACHE (Pain on the left forehead - right above the eye/ Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VERTIGO (Vertigo), SKIN DISCOLOURATION (around his eye was black from the nose and all around the left eye/ Nose is all black and blue), EYELID DISORDER (Top of right eye - eyelid is black), DIZZINESS POSTURAL (Dizziness with position changes), HEADACHE (Pain on the left forehead - right above the eye/ Headache) and NAUSEA (nausea/ nauseous). At the time of the report, VERTIGO (Vertigo), EYELID DISORDER (Top of right eye - eyelid is black) and HEADACHE (Pain on the left forehead - right above the eye/ Headache) had resolved, SKIN DISCOLOURATION (around his eye was black from the nose and all around the left eye/ Nose is all black and blue) and DIZZINESS POSTURAL (Dizziness with position changes) outcome was unknown and NAUSEA (nausea/ nauseous) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) Negative.         Black eye resolved on unreported date. On  06/05/2021, the patient awoke with a Black eye (left) again. No Relevant concomitant medications was reported. Treatment was not taken by the patient.   This case was linked to MOD-2021-067353, MOD-2021-209386, MOD-2021-244811 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up received on 16MAY- 2021. Non significant follow up On 05-Jun-2021: Follow up received on 05-JUN-2021, updated on outcomes of events from unknown to recovered and recovering. Details of first dose and adverse events experienced by his wife was updated.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Induration, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; dizziness; arm was hard; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness), INDURATION (arm was hard), PYREXIA (Fever) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness), INDURATION (arm was hard), PYREXIA (Fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GLUCOSE, POTASSIUM CITRATE, SODIUM CITRATE ACID (PAEDIALYTE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness), INDURATION (arm was hard), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   This case was linked to MOD-2021-106463 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: Cough, after the 2nd dose vaccine.; Fever, after the 2nd dose vaccine.; Headache, after the 2nd dose vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough, after the 2nd dose vaccine.), PYREXIA (Fever, after the 2nd dose vaccine.) and HEADACHE (Headache, after the 2nd dose 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 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 COUGH (Cough, after the 2nd dose vaccine.), PYREXIA (Fever, after the 2nd dose vaccine.) and HEADACHE (Headache, after the 2nd dose vaccine.). At the time of the report, COUGH (Cough, after the 2nd dose vaccine.), PYREXIA (Fever, after the 2nd dose vaccine.) and HEADACHE (Headache, after the 2nd dose vaccine.) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable    This case was linked to MOD21-086685, US-MODERNATX, INC.-MOD-2021-106915, US-MODERNATX, INC.-MOD-2021-106829 (E2B Linked Report).; Sender's Comments:  MOD21-086685: US-MODERNATX, INC.-MOD-2021-106829:Case for patient nephew US-MODERNATX, INC.-MOD-2021-106915:Case for patient nephew
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination site pain
Clinical narrative: Fingers Cramp; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Fingers Cramp) and VACCINATION SITE PAIN (vaccination site pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol, Asthma, Depression, Allergy to animals (Cats), Allergy to plants (Trees), Grass allergy (Grasses), Allergy to chemicals (Sulfates), Allergy (Protronics) and Allergy (Seasick patch). Concomitant products included MONTELUKAST and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, ROSUVASTATIN for Cholesterol, ESCITALOPRAM for Depression, BISOPROLOL for Hypertension, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 31-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 29-Apr-2021, the patient experienced MUSCLE SPASMS (Fingers Cramp). At the time of the report, MUSCLE SPASMS (Fingers Cramp) had resolved and VACCINATION SITE PAIN (vaccination site pain) 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.   Treatment medications were not provided.   This case was linked to MOD-2021-106535 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up Information Received on 24-JUN-2021  contains No New Information On 29-Jun-2021: Follow up received on 29-JUN-2021. Updated patient demographic details[Race, Weight, height]. medical history, allergic information. Added new Event [ Finger Cramps].
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Colitis, Malaise, Nasal congestion, Pyrexia
Clinical narrative: congestion; feeling under the weather; colitis flare up; not feeling well; elevated temperature of 99.4; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion), MALAISE (feeling under the weather), COLITIS (colitis flare up), MALAISE (not feeling well) and PYREXIA (elevated temperature of 99.4) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Colitis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced NASAL CONGESTION (congestion), MALAISE (feeling under the weather), COLITIS (colitis flare up), MALAISE (not feeling well) and PYREXIA (elevated temperature of 99.4). At the time of the report, NASAL CONGESTION (congestion), MALAISE (feeling under the weather), COLITIS (colitis flare up), MALAISE (not feeling well) and PYREXIA (elevated temperature of 99.4) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, COVID-19: (Negative) tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling hot, Joint swelling, Nausea
Clinical narrative: blurred vision; whole body felt like it was on fire; shivers but has normal temp (98.25F); nausea; swelling of the joints; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision), FEELING HOT (whole body felt like it was on fire) and CHILLS (shivers but has normal temp (98.25F)) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-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 04-May-2021, the patient experienced JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), FEELING HOT (whole body felt like it was on fire), CHILLS (shivers but has normal temp (98.25F)) and NAUSEA (nausea). On an unknown date, the patient experienced VISION BLURRED (blurred vision). At the time of the report, JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision), FEELING HOT (whole body felt like it was on fire), CHILLS (shivers but has normal temp (98.25F)) and NAUSEA (nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking Medical for unknown indication.Patient treatment information was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurred vision; whole body felt like it was on fire; shivers but has normal temp (98.25F); nausea; swelling of the joints; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision), FEELING HOT (whole body felt like it was on fire) and CHILLS (shivers but has normal temp (98.25F)) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-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 04-May-2021, the patient experienced JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), FEELING HOT (whole body felt like it was on fire), CHILLS (shivers but has normal temp (98.25F)) and NAUSEA (nausea). On an unknown date, the patient experienced VISION BLURRED (blurred vision). At the time of the report, JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision), FEELING HOT (whole body felt like it was on fire), CHILLS (shivers but has normal temp (98.25F)) and NAUSEA (nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking Medical for unknown indication.Patient treatment information was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Got a cold from daughter; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Got a cold from daughter) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03621A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced NASOPHARYNGITIS (Got a cold from daughter). At the time of the report, NASOPHARYNGITIS (Got a cold from daughter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Constipation, Incontinence
Clinical narrative: Experiencing stomach cramps; Constipation; Incontinence; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Experiencing stomach cramps), CONSTIPATION (Constipation), INCONTINENCE (Incontinence) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3, Breast cancer NOS stage III and Thyroid cancer stage III. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CLONAZEPAM, LOSARTAN, DARIFENACIN HYDROBROMIDE (ENABLEX [DARIFENACIN HYDROBROMIDE]), FERROUS SULFATE and VITAMIN D3 for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Experiencing stomach cramps), CONSTIPATION (Constipation), INCONTINENCE (Incontinence) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN UPPER (Experiencing stomach cramps), CONSTIPATION (Constipation), INCONTINENCE (Incontinence) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Per source, the patient said she saw a medication that starts with "N", but could not recall the full name. The patient wanted to know if she could take that medication due to her kidney disease. She said it sounds like "NSAID" but it is not an NSAID. No further information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dehydration, Feeling abnormal, Headache
Clinical narrative: I felt dehydrated; didn't feel like talking to her children and husband; Any sounds were making her very sick; really bad vomiting,Vomiting was every 10-15 minutes; Headache was throbbing and excruciating pain; fever; chills; really really bad migraine; weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (really really bad migraine), ASTHENIA (weakness), DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband) and ILLNESS (Any sounds were making her very sick) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZIA OR 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced MIGRAINE (really really bad migraine), ASTHENIA (weakness), VOMITING (really bad vomiting,Vomiting was every 10-15 minutes), HEADACHE (Headache was throbbing and excruciating pain), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband) and ILLNESS (Any sounds were making her very sick). At the time of the report, MIGRAINE (really really bad migraine), ASTHENIA (weakness), DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband), ILLNESS (Any sounds were making her very sick), VOMITING (really bad vomiting,Vomiting was every 10-15 minutes), HEADACHE (Headache was throbbing and excruciating pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Migraine, Pyrexia, Vomiting
Clinical narrative: I felt dehydrated; didn't feel like talking to her children and husband; Any sounds were making her very sick; really bad vomiting,Vomiting was every 10-15 minutes; Headache was throbbing and excruciating pain; fever; chills; really really bad migraine; weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (really really bad migraine), ASTHENIA (weakness), DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband) and ILLNESS (Any sounds were making her very sick) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZIA OR 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced MIGRAINE (really really bad migraine), ASTHENIA (weakness), VOMITING (really bad vomiting,Vomiting was every 10-15 minutes), HEADACHE (Headache was throbbing and excruciating pain), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband) and ILLNESS (Any sounds were making her very sick). At the time of the report, MIGRAINE (really really bad migraine), ASTHENIA (weakness), DEHYDRATION (I felt dehydrated), FEELING ABNORMAL (didn't feel like talking to her children and husband), ILLNESS (Any sounds were making her very sick), VOMITING (really bad vomiting,Vomiting was every 10-15 minutes), HEADACHE (Headache was throbbing and excruciating pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Myalgia
Clinical narrative: Loss of appetite; Diarrhea; Fever; Aches and pains; Chills; Soreness in all joints; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains), CHILLS (Chills) and ARTHRALGIA (Soreness in all joints). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form twice a day. At the time of the report, DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains), CHILLS (Chills) and ARTHRALGIA (Soreness in all joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their daughter who post receiving the vaccine dose experienced aches, pains, chills, fever, diarrhea, soreness in all joints, a cough and loss of appetite. The patient's symptoms began on 29-Apr-2021 and still not resolved.  The patient went to urgent care and got a steroid and anti-inflammatory shot. The patient also reported that they were taking Motrin then 6 hours later taking 2 extra strength Tylenol.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Loss of appetite; Diarrhea; Fever; Aches and pains; Chills; Soreness in all joints; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains), CHILLS (Chills) and ARTHRALGIA (Soreness in all joints). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form twice a day. At the time of the report, DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), PYREXIA (Fever), MYALGIA (Aches and pains), CHILLS (Chills) and ARTHRALGIA (Soreness in all joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their daughter who post receiving the vaccine dose experienced aches, pains, chills, fever, diarrhea, soreness in all joints, a cough and loss of appetite. The patient's symptoms began on 29-Apr-2021 and still not resolved.  The patient went to urgent care and got a steroid and anti-inflammatory shot. The patient also reported that they were taking Motrin then 6 hours later taking 2 extra strength Tylenol.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after vaccination; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid after vaccination) and DRUG INEFFECTIVE (Lack of drug effect) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) for Autoimmune disorder.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced COVID-19 (tested positive for Covid after vaccination). 04-May-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 04-May-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (tested positive for Covid after vaccination) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.         Treatment information was not provided.  This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.   This case was linked to MOD-2021-016951 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Upon internal review on 11-AUG-2021, an event lack of effect was added to the case.; Sender's Comments: This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: The rash peels, is red; itchy rash; the mild rash came back on the right side of her body; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (The rash peels, is red), RASH PRURITIC (itchy rash) and RASH (the mild rash came back on the right side of her body) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), EZETIMIBE (ZETIA), FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]), METOPROLOL, AMLODIPINE, OLMESARTAN, ALPRAZOLAM (XANAX), DIGOXIN, MULTIVITAMINS [VITAMINS NOS], FISH OIL, VITAMIN E NOS, COLECALCIFEROL (VITAMIN D 3), DENOSUMAB (PROLIA) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced RASH (the mild rash came back on the right side of her body). On 04-May-2021, the patient experienced RASH ERYTHEMATOUS (The rash peels, is red) and RASH PRURITIC (itchy rash). At the time of the report, RASH ERYTHEMATOUS (The rash peels, is red), RASH PRURITIC (itchy rash) and RASH (the mild rash came back on the right side of her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that rash comes back, seems like every two weeks on the right side of her body. Treatment included  Anti-itch Gold Bond Cream, Benadryl 25 mg twice daily. Concomitant medication includes osteo BioFlex.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose given about 60 days ago, missed 2nd dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose given about 60 days ago, missed 2nd dose.) in a 71-year-old female patient 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 DOSE OMISSION ISSUE (1st dose given about 60 days ago, missed 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose given about 60 days ago, missed 2nd dose.) outcome was unknown. Not Provided      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 drugs were reported. No treatment drugs are not provided by reporter
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Product dose omission issue
Clinical narrative: shortness of breath; over 42 days since first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD and Leukemia.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine). At the time of the report, DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After getting first shot of Moderna COVID-19 Vaccine patient experienced shortness of breathe and the pulomonologist put her on nebulizer.  Concomitant medication includes IgA transfusions, Blood Pressure medicines, Thyroid medicine, Nebulizer.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Event information is updated
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain, Vaccination site erythema
Clinical narrative: Headache; Sore neck; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NECK PAIN (Sore neck) and VACCINATION SITE ERYTHEMA (Redness around injection site) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced HEADACHE (Headache), NECK PAIN (Sore neck) and VACCINATION SITE ERYTHEMA (Redness around injection site). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. On 05-May-2021, HEADACHE (Headache) had resolved. At the time of the report, NECK PAIN (Sore neck) and VACCINATION SITE ERYTHEMA (Redness around injection site) outcome was unknown. Not Provided      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 provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Vaccination site pain
Clinical narrative: some speeches came out unclear; arm sore after 3 hours after the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore after 3 hours after the shot) and SPEECH DISORDER (some speeches came out unclear) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Food allergy, Allergy to animal (allergy to cats), Allergy to plants (trees), Grass allergy, Allergy to chemicals (sulfates), Allergy to metals (allergy to portronics), Allergy (seasick patch), Depression, Asthma and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Anticoagulant therapy, MONTELUKAST and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, BISOPROLOL for Blood pressure high, ROSUVASTATIN for Cholesterol, ESCITALOPRAM for Depression.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm sore after 3 hours after the shot). On 01-May-2021, the patient experienced SPEECH DISORDER (some speeches came out unclear). On 04-May-2021, SPEECH DISORDER (some speeches came out unclear) had resolved. At the time of the report, PAIN IN EXTREMITY (arm sore after 3 hours after the shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.   This case was linked to MOD-2021-106502 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: The follow up received on 06-june-2021 contains NNI On 29-Jun-2021: The significant follow-up received on 29-06-2021.It contains Patient's height,weight,race was updated and historical condition like allergy to medications,food cat,trees and other products was added In event tab speech disorder was again reported on 02-04-2021 in which outcome was not resolved and fingers cramp event was added.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Palpitations
Clinical narrative: "He was dizzy bad"; "He said 'I feel a little tired'"; "His heart was racing a little bit"; "He said 'pizza tasted like steel" too"; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS ("His heart was racing a little bit"), DYSGEUSIA ("He said 'pizza tasted like steel" too"), DIZZINESS ("He was dizzy bad") and FATIGUE ("He said 'I feel a little tired'") 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PALPITATIONS ("His heart was racing a little bit") and DYSGEUSIA ("He said 'pizza tasted like steel" too"). On an unknown date, the patient experienced DIZZINESS ("He was dizzy bad") and FATIGUE ("He said 'I feel a little tired'"). On 03-Apr-2021, PALPITATIONS ("His heart was racing a little bit") had resolved. At the time of the report, DYSGEUSIA ("He said 'pizza tasted like steel" too"), DIZZINESS ("He was dizzy bad") and FATIGUE ("He said 'I feel a little tired'") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-106871, US-MODERNATX, INC.-MOD-2021-106610 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106871:Mother case US-MODERNATX, INC.-MOD-2021-106610:Reporter's case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Skin discolouration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: More than 36 days after the first dose without receiving the second dose; Left arm swelled up; Red from injection site almost all the way down to the elbow; Itch was terrible; no bumps but white spots in the redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch was terrible), SKIN DISCOLOURATION (no bumps but white spots in the redness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose), VACCINATION SITE SWELLING (Left arm swelled up) and VACCINATION SITE ERYTHEMA (Red from injection site almost all the way down to the elbow) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002C21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and METOPROLOL for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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 PRURITUS (Itch was terrible), SKIN DISCOLOURATION (no bumps but white spots in the redness), VACCINATION SITE SWELLING (Left arm swelled up) and VACCINATION SITE ERYTHEMA (Red from injection site almost all the way down to the elbow). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). At the time of the report, PRURITUS (Itch was terrible), SKIN DISCOLOURATION (no bumps but white spots in the redness), VACCINATION SITE SWELLING (Left arm swelled up) and VACCINATION SITE ERYTHEMA (Red from injection site almost all the way down to the elbow) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) had resolved.            Concomitant product use was provided by the reporter as Unspecified Inhalers. Treatment information was provided as cetirizine and unspecified topical products.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: NNI
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) had resolved. Not Provided      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 medication were provided. No concomitant medication were provided. The vial  was first punctured on 04 MAY 2021 at 9:30AM.   This case was linked to MOD21-087072, MOD21-087071, MOD21-087063, MOD21-087013, MOD21-087012, MOD21-086959, MOD21-087011, US-MODERNATX, INC.-MOD-2021-106706 (E2B Linked Report).; Sender's Comments:  MOD21-087072: MOD21-087071: MOD21-087063: MOD21-087013: MOD21-087012: MOD21-086959: MOD21-087011: US-MODERNATX, INC.-MOD-2021-106706:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: hearing ticking sound in ears after 3 days of 1st dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (hearing ticking sound in ears after 3 days of 1st dose of vaccination) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included METFORMIN, ATORVASTATIN and AMLODIPINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced TINNITUS (hearing ticking sound in ears after 3 days of 1st dose of vaccination). At the time of the report, TINNITUS (hearing ticking sound in ears after 3 days of 1st dose of vaccination) 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.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue
Clinical narrative: FEET STARTING SWELLING; NEVER GOT SECOND DOSE OF VACCINE; This spontaneous case was reported by an other caregiver and describes the occurrence of PERIPHERAL SWELLING (FEET STARTING SWELLING) and PRODUCT DOSE OMISSION ISSUE (NEVER GOT SECOND DOSE OF VACCINE) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PERIPHERAL SWELLING (FEET STARTING SWELLING) and PRODUCT DOSE OMISSION ISSUE (NEVER GOT SECOND DOSE OF VACCINE). At the time of the report, PERIPHERAL SWELLING (FEET STARTING SWELLING) and PRODUCT DOSE OMISSION ISSUE (NEVER GOT SECOND DOSE OF VACCINE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ring in her ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ring in her ears) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C19B21A) 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) 1 dosage form. On 21-Apr-2021, the patient experienced TINNITUS (Ring in her ears). At the time of the report, TINNITUS (Ring in her ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment was received by the patient. The patient wanted to know if the second dose of vaccine, which was due on 5 May 2021, should be delayed because of the side effect.