chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Feeling abnormal, Headache, Pain
Clinical narrative: a headache; her whole body sore; it put her back in bed; has been running a fever; feeling awful; her whole body achy; she has weakness in her leg; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg) and HEADACHE (a headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN, ATORVASTATIN, METOPROLOL, OMEPRAZOLE, SUCRALFATE, Janumet                                                        Sitagliptin-metformin, METHOCARBAMOL, ACARBOSE, GABAPENTIN, FERROUS SULFATE, HYDROCODONE and LISINOPRIL for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg), PAIN (her whole body sore) and BACK PAIN (it put her back in bed). On 07-Apr-2021, the patient experienced HEADACHE (a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg), HEADACHE (a headache), PAIN (her whole body sore) and BACK PAIN (it put her back in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a headache; her whole body sore; it put her back in bed; has been running a fever; feeling awful; her whole body achy; she has weakness in her leg; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg) and HEADACHE (a headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN, ATORVASTATIN, METOPROLOL, OMEPRAZOLE, SUCRALFATE, Janumet                                                        Sitagliptin-metformin, METHOCARBAMOL, ACARBOSE, GABAPENTIN, FERROUS SULFATE, HYDROCODONE and LISINOPRIL for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg), PAIN (her whole body sore) and BACK PAIN (it put her back in bed). On 07-Apr-2021, the patient experienced HEADACHE (a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (has been running a fever), FEELING ABNORMAL (feeling awful), PAIN (her whole body achy), ASTHENIA (she has weakness in her leg), HEADACHE (a headache), PAIN (her whole body sore) and BACK PAIN (it put her back in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling hot, Tachycardia
Clinical narrative: Strong tachycardia; Heat in body; Heat in ears; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Strong tachycardia), FEELING HOT (Heat in body) and EAR DISCOMFORT (Heat in ears) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Apr-2021, the patient experienced TACHYCARDIA (Strong tachycardia), FEELING HOT (Heat in body) and EAR DISCOMFORT (Heat in ears). At the time of the report, TACHYCARDIA (Strong tachycardia), FEELING HOT (Heat in body) and EAR DISCOMFORT (Heat in ears) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided by reporter.  No treatment information was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Left arm started feeling numb and ticklish, both legs below knees; Left leg felt prickly; Weakness in my left leg; Dizzy; Numbness in my lip and face, jaw; Something in my throat; Fatigue; Past the 42 day range, not received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat), HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees) and PARAESTHESIA (Left leg felt prickly) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day range, not received the 2nd dose). On 25-Mar-2021, the patient experienced DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat) and FATIGUE (Fatigue). On an unknown date, the patient experienced HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees), PARAESTHESIA (Left leg felt prickly) and ASTHENIA (Weakness in my left leg). At the time of the report, DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat), HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees), PARAESTHESIA (Left leg felt prickly), ASTHENIA (Weakness in my left leg), PRODUCT DOSE OMISSION ISSUE (Past the 42 day range, not received the 2nd dose) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information or concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followup received on 29-June-2021 and contains significant information
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Paraesthesia, Product dose omission issue
Clinical narrative: Left arm started feeling numb and ticklish, both legs below knees; Left leg felt prickly; Weakness in my left leg; Dizzy; Numbness in my lip and face, jaw; Something in my throat; Fatigue; Past the 42 day range, not received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat), HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees) and PARAESTHESIA (Left leg felt prickly) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day range, not received the 2nd dose). On 25-Mar-2021, the patient experienced DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat) and FATIGUE (Fatigue). On an unknown date, the patient experienced HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees), PARAESTHESIA (Left leg felt prickly) and ASTHENIA (Weakness in my left leg). At the time of the report, DIZZINESS (Dizzy), HYPOAESTHESIA (Numbness in my lip and face, jaw), OROPHARYNGEAL DISCOMFORT (Something in my throat), HYPOAESTHESIA (Left arm started feeling numb and ticklish, both legs below knees), PARAESTHESIA (Left leg felt prickly), ASTHENIA (Weakness in my left leg), PRODUCT DOSE OMISSION ISSUE (Past the 42 day range, not received the 2nd dose) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information or concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followup received on 29-June-2021 and contains significant information
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Insomnia
Clinical narrative: Asthma; lot of cough; could not sleep for 3 nights; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma), COUGH (lot of cough) and INSOMNIA (could not sleep for 3 nights) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tonsillitis.    On 31-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 ASTHMA (Asthma), COUGH (lot of cough) and INSOMNIA (could not sleep for 3 nights). At the time of the report, ASTHMA (Asthma), COUGH (lot of cough) and INSOMNIA (could not sleep for 3 nights) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment Medications include Codeine
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: fatigue; muscle pain; chills; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Malaise, Nausea
Clinical narrative: COVID-19; Feels out of sorts and feels ill; Very fatigue; Nausea; does not feel like herself; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING ABNORMAL (does not feel like herself), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (TIADYLT ER), ESOMEPRAZOLE, CELECOXIB (CELEBREX), ACETYLSALICYLIC ACID (ASPIRIN), CALCIUM and VITAMIN D3 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 14-Mar-2021, the patient experienced FEELING ABNORMAL (does not feel like herself). On 15-Mar-2021, the patient experienced COVID-19 (COVID-19), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID-19), FEELING ABNORMAL (does not feel like herself), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID-19; Feels out of sorts and feels ill; Very fatigue; Nausea; does not feel like herself; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING ABNORMAL (does not feel like herself), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM HYDROCHLORIDE (TIADYLT ER), ESOMEPRAZOLE, CELECOXIB (CELEBREX), ACETYLSALICYLIC ACID (ASPIRIN), CALCIUM and VITAMIN D3 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 14-Mar-2021, the patient experienced FEELING ABNORMAL (does not feel like herself). On 15-Mar-2021, the patient experienced COVID-19 (COVID-19), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea). At the time of the report, COVID-19 (COVID-19), FEELING ABNORMAL (does not feel like herself), MALAISE (Feels out of sorts and feels ill), FATIGUE (Very fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Mild body ache; Pressure at the back of neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild body ache) and NECK PAIN (Pressure at the back of neck) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (Mild body ache) and NECK PAIN (Pressure at the back of neck). At the time of the report, PAIN (Mild body ache) and NECK PAIN (Pressure at the back of neck) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) 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 06-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 EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment medications were not provided by the reporter.   This case was linked to MOD21-070451 (E2B Linked Report).; Sender's Comments:  MOD21-070451:Crossed linked as per source doc
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Somnolence
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), feeling abnormal (felt "spacey"), somnolence (slept for a longer period of time), fatigue and tiredness in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016B21A) for COVID-19 immunization. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Apr 2, 2021, patient experienced pain in extremity (sore arm). On Apr 4, 2021, patient experienced feeling abnormal (felt "spacey"). On Apr 5, 2021, patient experienced somnolence (slept for a longer period of time), fatigue and tiredness. On Apr 5, 2021, somnolence (slept for a longer period of time), fatigue and tiredness resolved. On Apr 6, 2021, pain in extremity (sore arm) and feeling abnormal (felt "spacey") resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant product use or treatment medication.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: large bump under the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (large bump under the arm pit) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. In April 2021, the patient experienced AXILLARY MASS (large bump under the arm pit). At the time of the report, AXILLARY MASS (large bump under the arm pit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Insomnia, Muscle spasms, Nerve compression, Pain
Clinical narrative: Constantly in pain; Can't walk without a walker; Can't get any sleep; Lower part of her body hurts; Knots on both hips and legs; Cramps; she has two discs that is pushing on her nerves; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Constantly in pain), GAIT DISTURBANCE (Can't walk without a walker), INSOMNIA (Can't get any sleep), PAIN (Lower part of her body hurts) and SWELLING (Knots on both hips and legs) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Constantly in pain), GAIT DISTURBANCE (Can't walk without a walker), INSOMNIA (Can't get any sleep), PAIN (Lower part of her body hurts), SWELLING (Knots on both hips and legs), MUSCLE SPASMS (Cramps) and NERVE COMPRESSION (she has two discs that is pushing on her nerves). At the time of the report, PAIN (Constantly in pain), GAIT DISTURBANCE (Can't walk without a walker), INSOMNIA (Can't get any sleep), PAIN (Lower part of her body hurts), SWELLING (Knots on both hips and legs), MUSCLE SPASMS (Cramps) and NERVE COMPRESSION (she has two discs that is pushing on her nerves) outcome was unknown.            Doctor confirmed to her that she has two discs that is pushing on her nerves causing her not to walk was not caused by the Moderna vaccine  Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: On 17-05-2021, follow document was attached and it contains TCR : AE details and New Event ( Nerve Compression ) was added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Constantly in pain; Can't walk without a walker; Can't get any sleep; Lower part of her body hurts; Knots on both hips and legs; Cramps; she has two discs that is pushing on her nerves; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Constantly in pain), GAIT DISTURBANCE (Can't walk without a walker), INSOMNIA (Can't get any sleep), PAIN (Lower part of her body hurts) and SWELLING (Knots on both hips and legs) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Constantly in pain), GAIT DISTURBANCE (Can't walk without a walker), INSOMNIA (Can't get any sleep), PAIN (Lower part of her body hurts), SWELLING (Knots on both hips and legs), MUSCLE SPASMS (Cramps) and NERVE COMPRESSION (she has two discs that is pushing on her nerves). At the time of the report, PAIN (Constantly in pain), GAIT DISTURBANCE (Can't walk without a walker), INSOMNIA (Can't get any sleep), PAIN (Lower part of her body hurts), SWELLING (Knots on both hips and legs), MUSCLE SPASMS (Cramps) and NERVE COMPRESSION (she has two discs that is pushing on her nerves) outcome was unknown.            Doctor confirmed to her that she has two discs that is pushing on her nerves causing her not to walk was not caused by the Moderna vaccine  Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: On 17-05-2021, follow document was attached and it contains TCR : AE details and New Event ( Nerve Compression ) was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Pain in her arm; Headache; Felt lightheaded; Lightheaded comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm), HEADACHE (Headache), DIZZINESS (Felt lightheaded) and DIZZINESS (Lightheaded comes and goes) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Felt lightheaded) and DIZZINESS (Lightheaded comes and goes). On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in her arm), HEADACHE (Headache), DIZZINESS (Felt lightheaded) and DIZZINESS (Lightheaded comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE PAIN (pain at 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.   Treatment was unknown.   This case was linked to MOD-2021-072089 (E2B Linked Report).; Sender's Comments:  MOD-2021-072089:2nd dose -MODERNATX, INC.-MOD-2021-072089:1st dose
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid-19 after 1st dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021. The most recent information was received on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after 1st dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after 1st dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, COVID-19: positive (Positive) Positive. On an unknown date, COVID-19: negative (Negative) Negative.     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 medications were provided. No Treatment Medications were provided. He stated that he had never been positive for Covid-19 and did not remember reporting this or other events.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant Follow up received on 23 June 2021. Added new laboratory data.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: Fatigue; Felt Sick; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ILLNESS (Felt Sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Fatigue) and ILLNESS (Felt Sick). At the time of the report, FATIGUE (Fatigue) and ILLNESS (Felt Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-070298, MOD21-071138,MOD21-071139 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070298:crosslink for DOSE 2 MOD21-071138,MOD21-071139:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Musculoskeletal chest pain, Oropharyngeal discomfort
Clinical narrative: constant tickling in her throat; ribs to hurt; sore throat; coughing; tremors; achy/body ached; cold/chills; fever of 103F; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT, MUSCULOSKELETAL CHEST PAIN, OROPHARYNGEAL PAIN, COUGH, and TREMOR in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B29A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced TREMOR, PAIN, CHILLS, and PYREXIA. On 03-Apr-2021, the patient experienced OROPHARYNGEAL PAIN and COUGH. On 05-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN. On 06-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT. The patient was treated with ROBITUSSIN for Cough, at a dose of 1 dosage form and TYLENOL for Fever, at a dose of 1 dosage form. On 02-Apr-2021, TREMOR had resolved. On 03-Apr-2021, PAIN, CHILLS, and PYREXIA had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT, MUSCULOSKELETAL CHEST PAIN, OROPHARYNGEAL PAIN, and COUGH outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 f (High). On an unknown date, Body temperature: 100 f (High).         Concomitant product information, if any, was not provided by the reporter.   This case was linked to MOD-2021-068400, MOD-2021-070272. Sender's Comments:  MOD-2021-068400: first dose case ID-MOD-2021-068400 MOD-2021-070272:mSecond dose case ID- MOD-2021-070272
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Tremor
Clinical narrative: constant tickling in her throat; ribs to hurt; sore throat; coughing; tremors; achy/body ached; cold/chills; fever of 103F; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT, MUSCULOSKELETAL CHEST PAIN, OROPHARYNGEAL PAIN, COUGH, and TREMOR in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B29A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced TREMOR, PAIN, CHILLS, and PYREXIA. On 03-Apr-2021, the patient experienced OROPHARYNGEAL PAIN and COUGH. On 05-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN. On 06-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT. The patient was treated with ROBITUSSIN for Cough, at a dose of 1 dosage form and TYLENOL for Fever, at a dose of 1 dosage form. On 02-Apr-2021, TREMOR had resolved. On 03-Apr-2021, PAIN, CHILLS, and PYREXIA had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT, MUSCULOSKELETAL CHEST PAIN, OROPHARYNGEAL PAIN, and COUGH outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 f (High). On an unknown date, Body temperature: 100 f (High).         Concomitant product information, if any, was not provided by the reporter.   This case was linked to MOD-2021-068400, MOD-2021-070272. Sender's Comments:  MOD-2021-068400: first dose case ID-MOD-2021-068400 MOD-2021-070272:mSecond dose case ID- MOD-2021-070272
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, Serum ferritin increased, Vitamin D, Vitamin D decreased
Clinical narrative: Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021; Vitamin D levels were also a bit low on the first test; This spontaneous case was reported by an other health care professional and describes the occurrence of SERUM FERRITIN INCREASED (Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021) and VITAMIN D DECREASED (Vitamin D levels were also a bit low on the first test) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney absent (Had only one kidney, because they donated one 12 years ago) in 2009.   On 11-Jan-2021 at 11:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021 at 10:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced SERUM FERRITIN INCREASED (Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021) and VITAMIN D DECREASED (Vitamin D levels were also a bit low on the first test). The patient was treated with VITAMIN D3 for Vitamin D supplementation, at an unspecified dose and frequency. At the time of the report, SERUM FERRITIN INCREASED (Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021) and VITAMIN D DECREASED (Vitamin D levels were also a bit low on the first test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Serum ferritin: 400 (High) Ferritin levels were high (400), more than double the maximum expected (150). On 01-Mar-2021, Vitamin D: low (Low) A bit low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 contains non-significant information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Feeling hot, Injection site mass, Pain in extremity
Clinical narrative: feels hot; Redness; bubbles on the skin; sore in the arm; lump size of softball; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore in the arm), INJECTION SITE MASS (lump size of softball), FEELING HOT (feels hot), ERYTHEMA (Redness) and BLISTER (bubbles on the skin) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore in the arm), INJECTION SITE MASS (lump size of softball), ERYTHEMA (Redness) and BLISTER (bubbles on the skin). On an unknown date, the patient experienced FEELING HOT (feels hot). At the time of the report, PAIN IN EXTREMITY (sore in the arm), INJECTION SITE MASS (lump size of softball), FEELING HOT (feels hot), ERYTHEMA (Redness) and BLISTER (bubbles on the skin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included water pill and depression pill Treatment for the events included Benadryl and ibuprofen
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypersensitivity, Induration, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened) and hypersensitivity (allergies) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 1, 2021, patient experienced pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened), hypersensitivity (allergies) and rash (a huge, large, wide rash below the site of injection). At the time of the report, pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened), hypersensitivity (allergies) and rash (a huge, large, wide rash below the site of injection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications not provided. Treatment included Zyrtec and Benadryl. This case linked to MOD-2021-148597 (patient link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened) and hypersensitivity (allergies) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 1, 2021, patient experienced pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened), hypersensitivity (allergies) and rash (a huge, large, wide rash below the site of injection). At the time of the report, pruritus (itchy/itching was so intense), erythema (redness), feeling hot (hot-to-touch), induration (one spot seemed a little hardened), hypersensitivity (allergies) and rash (a huge, large, wide rash below the site of injection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications not provided. Treatment included Zyrtec and Benadryl. This case linked to MOD-2021-148597 (patient link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Possible incorrect administration of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-070271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070271:crosslink for DOSE 1
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: 102 fever; Feels tired; chills; body was aching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body was aching), PYREXIA (102 fever), FATIGUE (Feels tired) and PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Apr-2021, the patient experienced CHILLS (chills) and MYALGIA (body was aching). On 06-Apr-2021, the patient experienced PYREXIA (102 fever) and FATIGUE (Feels tired). At the time of the report, CHILLS (chills), MYALGIA (body was aching), PYREXIA (102 fever), FATIGUE (Feels tired) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: The patient received the vaccine at 16 years of age; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (The patient received the vaccine at 16 years of age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced OFF LABEL USE (The patient received the vaccine at 16 years of age). On 07-Apr-2021, OFF LABEL USE (The patient received the vaccine at 16 years of age) 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.   Concomitant product use was not provided by the reporter. No treatment information was reported.   This case was linked to MOD21-071309 (E2B Linked Report).; Sender's Comments:  MOD21-071309:Cross linked case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Knee operation
Clinical narrative: knee surgery after the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of KNEE OPERATION (knee surgery after the first dose of vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), LOSARTAN and ROSUVASTATIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced KNEE OPERATION (knee surgery after the first dose of vaccine). At the time of the report, KNEE OPERATION (knee surgery after the first dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: 102 fever; Feels tired; chills; body was aching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (chills), PAIN (body was aching), PYREXIA (102 fever) and FATIGUE (Feels tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Apr-2021, the patient experienced CHILLS (chills) and PAIN (body was aching). On 06-Apr-2021, the patient experienced PYREXIA (102 fever) and FATIGUE (Feels tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills), PAIN (body was aching), PYREXIA (102 fever) and FATIGUE (Feels tired) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-070301 (Patient Link).