chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            Treatment information was not provided After 2nd dose patient stated that was laying around and ended up running to the bathroom vomiting. Almost 24 hours later the same thing happened, and the same thing happened again an hour before the case was reported.    This case was linked to MOD-2021-302066 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bone lesion, Bone pain, Cyst, Mobility decreased, Pain in extremity
Clinical narrative: Arm painful from the shoulder down to the elbow/ sharp toothache type pain; bone lesion; cyst on my left arm; barely lift my arm over my shoulder; Bone hurts; skin itches; Rash in the vaccination arm; My left arm is swollen it is very painful from the shoulder down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow), PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm) and MOBILITY DECREASED (barely lift my arm over my shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 032821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm), MOBILITY DECREASED (barely lift my arm over my shoulder), BONE PAIN (Bone hurts), PRURITUS (skin itches) and RASH (Rash in the vaccination arm). At the time of the report, PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow) had not resolved and PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm), MOBILITY DECREASED (barely lift my arm over my shoulder), BONE PAIN (Bone hurts), PRURITUS (skin itches) and RASH (Rash in the vaccination arm) outcome was unknown. Not Provided          The concomitant history was not reported. The treatment history was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Arm painful from the shoulder down to the elbow/ sharp toothache type pain; bone lesion; cyst on my left arm; barely lift my arm over my shoulder; Bone hurts; skin itches; Rash in the vaccination arm; My left arm is swollen it is very painful from the shoulder down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow), PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm) and MOBILITY DECREASED (barely lift my arm over my shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 032821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm), MOBILITY DECREASED (barely lift my arm over my shoulder), BONE PAIN (Bone hurts), PRURITUS (skin itches) and RASH (Rash in the vaccination arm). At the time of the report, PERIPHERAL SWELLING (My left arm is swollen it is very painful from the shoulder down to the elbow) had not resolved and PAIN IN EXTREMITY (Arm painful from the shoulder down to the elbow/ sharp toothache type pain), BONE LESION (bone lesion), CYST (cyst on my left arm), MOBILITY DECREASED (barely lift my arm over my shoulder), BONE PAIN (Bone hurts), PRURITUS (skin itches) and RASH (Rash in the vaccination arm) outcome was unknown. Not Provided          The concomitant history was not reported. The treatment history was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: How long will my side effects last??/Consumer answered "Yes" to having side effects/experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (How long will my side effects last??/Consumer answered "Yes" to having side effects/experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (How long will my side effects last??/Consumer answered "Yes" to having side effects/experienced a side effect). At the time of the report, ADVERSE REACTION (How long will my side effects last??/Consumer answered "Yes" to having side effects/experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Intentional dose omission, Migraine, Mobility decreased, Myalgia
Clinical narrative: The patient did not receive the second dose; Pain all over the body was severe; Vaccine triggered migraines; Arm was incredibly swelled; Arm was painful; Arm was red; Patient couldn't move; Throwing up a lot; Very very high fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful) and ERYTHEMA (Arm was red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful), ERYTHEMA (Arm was red), MOBILITY DECREASED (Patient couldn't move), VOMITING (Throwing up a lot) and PYREXIA (Very very high fever). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (The patient did not receive the second dose). On 10-Jan-2021, MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful), ERYTHEMA (Arm was red), MOBILITY DECREASED (Patient couldn't move), VOMITING (Throwing up a lot) and PYREXIA (Very very high fever) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (The patient did not receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The reporter stated that the patient experienced significant reaction following the vaccination and thought of the patient would have to be hospitalized.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: TCR Received includes updated Reporter information- Email
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: The patient did not receive the second dose; Pain all over the body was severe; Vaccine triggered migraines; Arm was incredibly swelled; Arm was painful; Arm was red; Patient couldn't move; Throwing up a lot; Very very high fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful) and ERYTHEMA (Arm was red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful), ERYTHEMA (Arm was red), MOBILITY DECREASED (Patient couldn't move), VOMITING (Throwing up a lot) and PYREXIA (Very very high fever). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (The patient did not receive the second dose). On 10-Jan-2021, MYALGIA (Pain all over the body was severe), MIGRAINE (Vaccine triggered migraines), PERIPHERAL SWELLING (Arm was incredibly swelled), PAIN IN EXTREMITY (Arm was painful), ERYTHEMA (Arm was red), MOBILITY DECREASED (Patient couldn't move), VOMITING (Throwing up a lot) and PYREXIA (Very very high fever) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (The patient did not receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The reporter stated that the patient experienced significant reaction following the vaccination and thought of the patient would have to be hospitalized.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: TCR Received includes updated Reporter information- Email
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: I had itching where I had calcifications removed from my breast; I had a burning sensation across the top of both breast; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (I had a burning sensation across the top of both breast) and PRURITUS (I had itching where I had calcifications removed from my breast   ) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced SKIN BURNING SENSATION (I had a burning sensation across the top of both breast) and PRURITUS (I had itching where I had calcifications removed from my breast   ). At the time of the report, SKIN BURNING SENSATION (I had a burning sensation across the top of both breast) and PRURITUS (I had itching where I had calcifications removed from my breast   ) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-302031 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm that she got the shot in is extremely hot to the touch; arm is swollen; arm is bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm that she got the shot in is extremely hot to the touch), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE ERYTHEMA (arm is bright red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy since an unknown date.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm that she got the shot in is extremely hot to the touch), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE ERYTHEMA (arm is bright red). At the time of the report, VACCINATION SITE WARMTH (arm that she got the shot in is extremely hot to the touch), VACCINATION SITE SWELLING (arm is swollen) and VACCINATION SITE ERYTHEMA (arm is bright red) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  It was reported that patient is currently on chemotherapy regimen. And she didn't have these events with the first two doses.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Had the Moderna vaccine, given the Phyzer for the booster; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Had the Moderna vaccine, given the Phyzer for the booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INTERCHANGE OF VACCINE PRODUCTS (Had the Moderna vaccine, given the Phyzer for the booster). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Had the Moderna vaccine, given the Phyzer for the booster) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood immunoglobulin G, Blood immunoglobulin M, Cough, Fatigue
Clinical narrative: sharp pain in heart; feeling run down; Dry cough, comes and goes in waves, coughing; seemed sick; Musle pain; headaches; This spontaneous case was reported by a nurse and describes the occurrence of ANGINA PECTORIS (sharp pain in heart) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (sharp pain in heart) (seriousness criterion medically significant), FATIGUE (feeling run down), COUGH (Dry cough, comes and goes in waves, coughing), MALAISE (seemed sick), MYALGIA (Musle pain) and HEADACHE (headaches). The patient was treated with AZITHROMYCIN (Z-PAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGINA PECTORIS (sharp pain in heart), FATIGUE (feeling run down), COUGH (Dry cough, comes and goes in waves, coughing), MALAISE (seemed sick), MYALGIA (Musle pain) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Blood immunoglobulin G: positive (Positive) antibodies positive for IgG. On 29-Aug-2021, Blood immunoglobulin M: negative (Negative) Antibodies negative for IgM.. On 29-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     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. Treatment medication includes cough medicine. Patients had taken both the doses and was still producing spike protein.  Company comment: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary to assess causality.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received  contains Additional events like sharp chest and heart pain, headache, muscle pain.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary to assess causality.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: sharp pain in heart; feeling run down; Dry cough, comes and goes in waves, coughing; seemed sick; Musle pain; headaches; This spontaneous case was reported by a nurse and describes the occurrence of ANGINA PECTORIS (sharp pain in heart) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (sharp pain in heart) (seriousness criterion medically significant), FATIGUE (feeling run down), COUGH (Dry cough, comes and goes in waves, coughing), MALAISE (seemed sick), MYALGIA (Musle pain) and HEADACHE (headaches). The patient was treated with AZITHROMYCIN (Z-PAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGINA PECTORIS (sharp pain in heart), FATIGUE (feeling run down), COUGH (Dry cough, comes and goes in waves, coughing), MALAISE (seemed sick), MYALGIA (Musle pain) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Blood immunoglobulin G: positive (Positive) antibodies positive for IgG. On 29-Aug-2021, Blood immunoglobulin M: negative (Negative) Antibodies negative for IgM.. On 29-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     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. Treatment medication includes cough medicine. Patients had taken both the doses and was still producing spike protein.  Company comment: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary to assess causality.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received  contains Additional events like sharp chest and heart pain, headache, muscle pain.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary to assess causality.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: Arm being sore; small red spots and a small dot; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Arm being sore) and VACCINATION SITE ERYTHEMA (small red spots and a small dot ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm being sore) and VACCINATION SITE ERYTHEMA (small red spots and a small dot ). At the time of the report, PAIN IN EXTREMITY (Arm being sore) and VACCINATION SITE ERYTHEMA (small red spots and a small dot ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that got up my knuckles  whether they are from vaccine or spider bites. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort
Clinical narrative: Legs are tender to touch; Pain seems more severe behind knees/Experienced pain down both legs to ankle; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs are tender to touch) and ARTHRALGIA (Pain seems more severe behind knees/Experienced pain down both legs to ankle) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Leg pain (three times) since 22-Aug-2021.   On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced LIMB DISCOMFORT (Legs are tender to touch) and ARTHRALGIA (Pain seems more severe behind knees/Experienced pain down both legs to ankle). At the time of the report, LIMB DISCOMFORT (Legs are tender to touch) and ARTHRALGIA (Pain seems more severe behind knees/Experienced pain down both legs to ankle) outcome was unknown.     No concomitant information was provided by the reporter.  No treatment information was provided.  The patient stated that the pain in the legs and knees started a day before the vaccination (22-AUG-2021). The patient stated that the pain in the legs lasts for 16 minutes for each episode and it goes away. The patient inquired if it was a blood clot. It was unknown if the patient was treated for the reported events.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information received: Added medical history. Updated inarrative supplement
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Product dose omission issue
Clinical narrative: More than 36 days, and has not received 2nd dose; shortness of breath a week after vaccine; some light headedness right after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath a week after vaccine), DIZZINESS (some light headedness right after the vaccine) and PRODUCT DOSE OMISSION ISSUE (More than 36 days, and has not received 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath a week after vaccine) and DIZZINESS (some light headedness right after the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days, and has not received 2nd dose). At the time of the report, DYSPNOEA (shortness of breath a week after vaccine), DIZZINESS (some light headedness right after the vaccine) and PRODUCT DOSE OMISSION ISSUE (More than 36 days, and has not received 2nd dose) had resolved.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.; 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. Causality assessment for Product dose omission issue is Not applicable
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: lack of energy off and on; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lack of energy off and on) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-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 ASTHENIA (lack of energy off and on). At the time of the report, ASTHENIA (lack of energy off and on) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-302164 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Vaccination site pain
Clinical narrative: Feeling worn; Felt tired; sore at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of DEPRESSED MOOD (Feeling worn), FATIGUE (Felt tired) and VACCINATION SITE PAIN (sore at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (treatable).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DEPRESSED MOOD (Feeling worn), FATIGUE (Felt tired) and VACCINATION SITE PAIN (sore at the injection site). At the time of the report, DEPRESSED MOOD (Feeling worn), FATIGUE (Felt tired) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered "Yes" to having side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Incorrect product administration duration
Clinical narrative: lack of energy off and on; the duration is a lot longer; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lack of energy off and on) and INCORRECT PRODUCT ADMINISTRATION DURATION (the duration is a lot longer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (lack of energy off and on) and INCORRECT PRODUCT ADMINISTRATION DURATION (the duration is a lot longer). At the time of the report, ASTHENIA (lack of energy off and on) outcome was unknown and INCORRECT PRODUCT ADMINISTRATION DURATION (the duration is a lot longer) had resolved.            The patient got 2 doses of vaccination and one of the doses was on 25th august 2021. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-302152 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Can I take medicine for side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Can I take medicine for side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Can I take medicine for side effects). At the time of the report, VACCINATION COMPLICATION (Can I take medicine for side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Heart rate, Nausea
Clinical narrative: Sore arm; Fever; Nausea; Headache; Very very tired; Chest pounding/Heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Chest pounding/Heart palpitation), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Scoliosis, Neurological disorder NOS, Dystonia, Anemia, Autoimmune disorder (autoimmune disease but its not official diagnosis), Sulfonamide allergy, Allergy to antibiotic, Drug allergy (most oral antifungals) and Drug allergy (muscle relaxant: Baclofen).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Chest pounding/Heart palpitation). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Very very tired). At the time of the report, PALPITATIONS (Chest pounding/Heart palpitation) had not resolved and PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Very very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Heart rate: 90-125 (High) High. On 25-Aug-2021, Heart rate: normal (normal) normal. On an unknown date, Body temperature: 102 (High) fever of 102.         Patient reported concomitant medication as corticosteroids used for autoimmune disease.  No treatment medication was  reported by patient.  Patient reported that she contacted HCP and she  was told to monitor her symptoms and she is scheduled for EKG test.   This case was linked to MOD-2021-302231 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Sore arm; Fever; Nausea; Headache; Very very tired; Chest pounding/Heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Chest pounding/Heart palpitation), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Scoliosis, Neurological disorder NOS, Dystonia, Anemia, Autoimmune disorder (autoimmune disease but its not official diagnosis), Sulfonamide allergy, Allergy to antibiotic, Drug allergy (most oral antifungals) and Drug allergy (muscle relaxant: Baclofen).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Chest pounding/Heart palpitation). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Very very tired). At the time of the report, PALPITATIONS (Chest pounding/Heart palpitation) had not resolved and PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Very very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Heart rate: 90-125 (High) High. On 25-Aug-2021, Heart rate: normal (normal) normal. On an unknown date, Body temperature: 102 (High) fever of 102.         Patient reported concomitant medication as corticosteroids used for autoimmune disease.  No treatment medication was  reported by patient.  Patient reported that she contacted HCP and she  was told to monitor her symptoms and she is scheduled for EKG test.   This case was linked to MOD-2021-302231 (Patient Link).
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Feeling hot, Pain, Rash
Clinical narrative: soreness/soreness in whole body- including joints, muscle/soreness in whole body; covid arm; red down the arm; hot muscle; rash down the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness/soreness in whole body- including joints, muscle/soreness in whole body), VACCINATION SITE REACTION (covid arm), ERYTHEMA (red down the arm), FEELING HOT (hot muscle) and RASH (rash down the arm) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-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 an unknown date, the patient experienced PAIN (soreness/soreness in whole body- including joints, muscle/soreness in whole body), VACCINATION SITE REACTION (covid arm), ERYTHEMA (red down the arm), FEELING HOT (hot muscle) and RASH (rash down the arm). At the time of the report, PAIN (soreness/soreness in whole body- including joints, muscle/soreness in whole body), VACCINATION SITE REACTION (covid arm), ERYTHEMA (red down the arm), FEELING HOT (hot muscle) and RASH (rash down the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Body temperature: 100.9 (High) Fever 100.9 F.         Reportedly, one week after the first dose which they had recovered from after using Ice as a treatment.  Consent for safety follow up was granted.  Treatment product information was not provided. Concomitant product use was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-302240 (Patient Link).
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: soreness/soreness in whole body- including joints, muscle/soreness in whole body; covid arm; red down the arm; hot muscle; rash down the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness/soreness in whole body- including joints, muscle/soreness in whole body), VACCINATION SITE REACTION (covid arm), ERYTHEMA (red down the arm), FEELING HOT (hot muscle) and RASH (rash down the arm) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-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 an unknown date, the patient experienced PAIN (soreness/soreness in whole body- including joints, muscle/soreness in whole body), VACCINATION SITE REACTION (covid arm), ERYTHEMA (red down the arm), FEELING HOT (hot muscle) and RASH (rash down the arm). At the time of the report, PAIN (soreness/soreness in whole body- including joints, muscle/soreness in whole body), VACCINATION SITE REACTION (covid arm), ERYTHEMA (red down the arm), FEELING HOT (hot muscle) and RASH (rash down the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Body temperature: 100.9 (High) Fever 100.9 F.         Reportedly, one week after the first dose which they had recovered from after using Ice as a treatment.  Consent for safety follow up was granted.  Treatment product information was not provided. Concomitant product use was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-302240 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: Started getting really cold /like I'm catching a bad cold; Arm has been very very sore; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Started getting really cold /like I'm catching a bad cold) and PAIN IN EXTREMITY (Arm has been very very sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Arm has been very very sore). On an unknown date, the patient experienced NASOPHARYNGITIS (Started getting really cold /like I'm catching a bad cold). At the time of the report, NASOPHARYNGITIS (Started getting really cold /like I'm catching a bad cold) and PAIN IN EXTREMITY (Arm has been very very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: she experienced itchiness on her arm after the second vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (she experienced itchiness on her arm after the second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection and Cold sores lip. Concurrent medical conditions included Multiple allergies. Concomitant products included DOXYCYCLINE for Urinary tract infection.    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, the patient experienced PRURITUS (she experienced itchiness on her arm after the second vaccine). At the time of the report, PRURITUS (she experienced itchiness on her arm after the second vaccine) outcome was unknown.            Treatment medication were not reported The patient had taken prophylactic antibiotics for a long standing med history of urinary tract infections    This case was linked to MOD-2021-302212 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: body swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (body swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (body swelling). At the time of the report, SWELLING (body swelling) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided Treatment information was not provided   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Impaired work ability, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: 1st dose, felt really really bad; 1st dose, could not move their arm; Went to work, could not move arm, left work; 1st dose, arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (1st dose, felt really really bad), LIMB DISCOMFORT (1st dose, could not move their arm), PAIN IN EXTREMITY (1st dose, arm was sore) and IMPAIRED WORK ABILITY (Went to work, could not move arm, left work) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (1st dose, felt really really bad), LIMB DISCOMFORT (1st dose, could not move their arm), PAIN IN EXTREMITY (1st dose, arm was sore) and IMPAIRED WORK ABILITY (Went to work, could not move arm, left work). At the time of the report, FEELING ABNORMAL (1st dose, felt really really bad), LIMB DISCOMFORT (1st dose, could not move their arm), PAIN IN EXTREMITY (1st dose, arm was sore) and IMPAIRED WORK ABILITY (Went to work, could not move arm, left work) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided.   Treatment information was not  provided.   This case was linked to MOD-2021-302230 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: Did not get a second dose; She experienced significant side effects; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get a second dose) and VACCINATION COMPLICATION (She experienced significant side effects) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get a second dose) and VACCINATION COMPLICATION (She experienced significant side effects). In 2021, PRODUCT DOSE OMISSION ISSUE (Did not get a second dose) had resolved. At the time of the report, VACCINATION COMPLICATION (She experienced significant side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided by the reporter She experienced significant side effects which scared her mother from getting the 2nd dose of the vaccine. She did not experience any symptoms and has not received any treatments.