chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: felt like someone was crushing her hand,; could not walk; feet were burning; legs give out every now; tremors are worse; It is terrible/It is awful/Felt everything was accelerated; bad shoulder which felt like was on fire; 103 degrees fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now) and TREMOR (tremors are worse) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, Tremor and Peripheral neuropathy. Concomitant products included PREGABALIN (LYRICA), DULOXETINE HYDROCHLORIDE (CYMBALTA), OXCARBAZEPINE and VALPROATE SEMISODIUM (DIVALPROEX) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now), TREMOR (tremors are worse), FEELING ABNORMAL (It is terrible/It is awful/Felt everything was accelerated), ARTHRALGIA (bad shoulder which felt like was on fire) and PYREXIA (103 degrees fever). At the time of the report, PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now), TREMOR (tremors are worse), FEELING ABNORMAL (It is terrible/It is awful/Felt everything was accelerated), ARTHRALGIA (bad shoulder which felt like was on fire) and PYREXIA (103 degrees fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment listed.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Missed 2nd dose allocated time frame; Caught covid end of January/they caught covid and were not able to complete the dosing series; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose allocated time frame) and COVID-19 (Caught covid end of January/they caught covid and were not able to complete the dosing series) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose allocated time frame) and COVID-19 (Caught covid end of January/they caught covid and were not able to complete the dosing series). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose allocated time frame) and COVID-19 (Caught covid end of January/they caught covid and were not able to complete the dosing series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non- significant follow up
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Have Had covid and second dose is coming; 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 COVID-19 (Have Had covid and second dose is coming) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 29-Apr-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 COVID-19 (Have Had covid and second dose is coming). At the time of the report, COVID-19 (Have Had covid and second dose is coming) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  second dose was schedules on 27 May 2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The piece where I have red is hot; Arm is red; Arm swollen; 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 SITE WARMTH (The piece where I have red is hot), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (Arm swollen) 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 SITE WARMTH (The piece where I have red is hot), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (Arm swollen). At the time of the report, VACCINATION SITE WARMTH (The piece where I have red is hot), VACCINATION SITE ERYTHEMA (Arm is red) and VACCINATION SITE SWELLING (Arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The reporter submitted Adverse event via text/text to speak application.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021 contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to a 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00621CA) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered to a 15 year old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up accepted on 27-May-2021
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Entire arms hurts; Hot at the injection site; Hard at the injection site; Full body rash; Red at the injection site; Arm is really huge at the injection site, swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Entire arms hurts), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), RASH (Full body rash) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PAIN IN EXTREMITY (Entire arms hurts), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), RASH (Full body rash), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE SWELLING (Arm is really huge at the injection site, swollen). At the time of the report, PAIN IN EXTREMITY (Entire arms hurts), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), RASH (Full body rash), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE SWELLING (Arm is really huge at the injection site, swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Entire arms hurts; Hot at the injection site; Hard at the injection site; Full body rash; Red at the injection site; Arm is really huge at the injection site, swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Entire arms hurts), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), RASH (Full body rash) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PAIN IN EXTREMITY (Entire arms hurts), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), RASH (Full body rash), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE SWELLING (Arm is really huge at the injection site, swollen). At the time of the report, PAIN IN EXTREMITY (Entire arms hurts), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), RASH (Full body rash), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE SWELLING (Arm is really huge at the injection site, swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine administered to unauthorized age group; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to unauthorized age group) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 24-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to unauthorized age group).   At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to unauthorized age group) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Most recent FOLLOW-UP information incorporated above includes:  On 25-May-2021: nonsignificant follow up
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling abnormal; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.  Based on the current case data, this case has been classified as invalid. This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of FEELING ABNORMAL (Feeling abnormal).     No Medical History information was reported.  On an unknown date, the patient experienced FEELING ABNORMAL (Feeling abnormal). At the time of the report, FEELING ABNORMAL (Feeling abnormal) outcome was unknown. Not Provided      This case was linked to MOD-2021-168356 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Throat feel a little sore for 5 days now; 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 OROPHARYNGEAL PAIN (Throat feel a little sore for 5 days now) 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 OROPHARYNGEAL PAIN (Throat feel a little sore for 5 days now). At the time of the report, OROPHARYNGEAL PAIN (Throat feel a little sore for 5 days now) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Myalgia, Pyrexia
Clinical narrative: Feeling hot; Headache; Body aches; Low grade fever; Chills; 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 FEELING HOT (Feeling hot), HEADACHE (Headache), MYALGIA (Body aches), PYREXIA (Low grade fever) and CHILLS (Chills) 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 FEELING HOT (Feeling hot), HEADACHE (Headache), MYALGIA (Body aches), PYREXIA (Low grade fever) and CHILLS (Chills). At the time of the report, FEELING HOT (Feeling hot), HEADACHE (Headache), MYALGIA (Body aches), PYREXIA (Low grade fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.; Reporter's Comments: N/A; Sender's Comments: N/A
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEART RATE INCREASED (rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80). At the time of the report, HEART RATE INCREASED (rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up upended
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on thigh/ rash on arm; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rash on thigh/ rash on arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on thigh/ rash on arm). At the time of the report, RASH (rash on thigh/ rash on arm) had resolved. 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.   Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-may-2021 contains non-significant information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Gait inability, Mobility decreased, Pyrexia
Clinical narrative: Not able to walk anymore; Can't get from the front door to the car; Trembling like she has Parkinson's; can't turn over in bed; she's hurting; Face swollen; Fever; Joints started hurting; leg and hips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Face swollen), GAIT INABILITY (Not able to walk anymore), MOBILITY DECREASED (Can't get from the front door to the car), TREMOR (Trembling like she has Parkinson's) and DISCOMFORT (can't turn over in bed; she's hurting) in a 71-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 was reported.  Concomitant products included TRAMADOL and MELOXICAM (MOBIC) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Fever ) and ARTHRALGIA (Joints started hurting; leg and hips). On 21-Jan-2021, the patient experienced SWELLING FACE (Face swollen). On an unknown date, the patient experienced GAIT INABILITY (Not able to walk anymore), MOBILITY DECREASED (Can't get from the front door to the car), TREMOR (Trembling like she has Parkinson's) and DISCOMFORT (can't turn over in bed; she's hurting). On 21-Jan-2021, PYREXIA (Fever ) outcome was unknown. At the time of the report, SWELLING FACE (Face swollen), GAIT INABILITY (Not able to walk anymore), MOBILITY DECREASED (Can't get from the front door to the car), TREMOR (Trembling like she has Parkinson's), DISCOMFORT (can't turn over in bed; she's hurting) and ARTHRALGIA (Joints started hurting; leg and hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced face swollen and took her to Urgent Care. They gave her a shot (didn't give the name). The night of the first dose, her joints started hurting; leg and hips and was not able to walk anymore. She can't get from the front door to the car. She's on a walker and was taken to an orthopedic. But continued to get worse in her joints. She went from walking 2 miles a day to not walking. She was taken to a specialist in Birmingham. She can't turn over in bed and was hurting. She can't hold a pen for writing.    This case was linked to MOD-2021-168525 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 and contains non significant information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tremor
Clinical narrative: Not able to walk anymore; Can't get from the front door to the car; Trembling like she has Parkinson's; can't turn over in bed; she's hurting; Face swollen; Fever; Joints started hurting; leg and hips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Face swollen), GAIT INABILITY (Not able to walk anymore), MOBILITY DECREASED (Can't get from the front door to the car), TREMOR (Trembling like she has Parkinson's) and DISCOMFORT (can't turn over in bed; she's hurting) in a 71-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 was reported.  Concomitant products included TRAMADOL and MELOXICAM (MOBIC) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Fever ) and ARTHRALGIA (Joints started hurting; leg and hips). On 21-Jan-2021, the patient experienced SWELLING FACE (Face swollen). On an unknown date, the patient experienced GAIT INABILITY (Not able to walk anymore), MOBILITY DECREASED (Can't get from the front door to the car), TREMOR (Trembling like she has Parkinson's) and DISCOMFORT (can't turn over in bed; she's hurting). On 21-Jan-2021, PYREXIA (Fever ) outcome was unknown. At the time of the report, SWELLING FACE (Face swollen), GAIT INABILITY (Not able to walk anymore), MOBILITY DECREASED (Can't get from the front door to the car), TREMOR (Trembling like she has Parkinson's), DISCOMFORT (can't turn over in bed; she's hurting) and ARTHRALGIA (Joints started hurting; leg and hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced face swollen and took her to Urgent Care. They gave her a shot (didn't give the name). The night of the first dose, her joints started hurting; leg and hips and was not able to walk anymore. She can't get from the front door to the car. She's on a walker and was taken to an orthopedic. But continued to get worse in her joints. She went from walking 2 miles a day to not walking. She was taken to a specialist in Birmingham. She can't turn over in bed and was hurting. She can't hold a pen for writing.    This case was linked to MOD-2021-168525 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 and contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lethargy, Malaise, Myalgia
Clinical narrative: Not feeling well; Lethargy; Injection site pain; Muscle aches; Tiredness; Low grade fever; 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 MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches) and FATIGUE (Tiredness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever). At the time of the report, MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever) outcome was unknown. Not Provided          No concomitant product use was provided by the reporter.  No treatment medication was provided.   The patient submitted AE via a chat online stating that had second covid vaccine last night and woke up not feeling well.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: XML File attached on 25-May-2021 and contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Not feeling well; Lethargy; Injection site pain; Muscle aches; Tiredness; Low grade fever; 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 MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches) and FATIGUE (Tiredness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever). At the time of the report, MALAISE (Not feeling well), LETHARGY (Lethargy), INJECTION SITE PAIN (Injection site pain), MYALGIA (Muscle aches), FATIGUE (Tiredness) and PYREXIA (Low grade fever) outcome was unknown. Not Provided          No concomitant product use was provided by the reporter.  No treatment medication was provided.   The patient submitted AE via a chat online stating that had second covid vaccine last night and woke up not feeling well.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: XML File attached on 25-May-2021 and contains non significant information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Pain in extremity, Vaccination complication, Vomiting
Clinical narrative: Had not eaten anything; Arm Soreness; Almost blacked out from second dose; Vomiting; Stomach felt upset/Queasy/Sick to her stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach felt upset/Queasy/Sick to her stomach), DECREASED APPETITE (Had not eaten anything), PAIN IN EXTREMITY (Arm Soreness), VACCINATION COMPLICATION (Almost blacked out from second dose) and VOMITING (Vomiting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach felt upset/Queasy/Sick to her stomach) and VOMITING (Vomiting). On an unknown date, the patient experienced DECREASED APPETITE (Had not eaten anything), PAIN IN EXTREMITY (Arm Soreness) and VACCINATION COMPLICATION (Almost blacked out from second dose). On 27-Feb-2021, ABDOMINAL DISCOMFORT (Stomach felt upset/Queasy/Sick to her stomach) and VOMITING (Vomiting) had resolved. At the time of the report, DECREASED APPETITE (Had not eaten anything), PAIN IN EXTREMITY (Arm Soreness) and VACCINATION COMPLICATION (Almost blacked out from second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-022869 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; 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 PYREXIA (Fever) 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, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Rash, Rash erythematous
Clinical narrative: bumps are red in color; though in the beginning , those bumps as acne; bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (bumps are red in color), DERMATITIS ACNEIFORM (though in the beginning , those bumps as acne) and RASH (bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 06-May-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 RASH ERYTHEMATOUS (bumps are red in color), DERMATITIS ACNEIFORM (though in the beginning , those bumps as acne) and RASH (bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm). At the time of the report, RASH ERYTHEMATOUS (bumps are red in color), DERMATITIS ACNEIFORM (though in the beginning , those bumps as acne) and RASH (bumps broke out at the injection arm (right arm)/bumps broke out a lot in the right hand/bumps developed in the left arm/bumps in the left hand are 3 in number,bumps extending up to the palm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm for a day) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm for a day). At the time of the report, MYALGIA (sore arm for a day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication included.  No treatment was provided by the reporter.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended-NNI
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m208) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided          no concomitant medications are reported. treatment to the events not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up information received on 25-may-2021 it does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: sore arm; Slight pain at injection site; 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 MYALGIA (sore arm) and VACCINATION SITE PAIN (Slight pain at injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm) and VACCINATION SITE PAIN (Slight pain at injection site). At the time of the report, MYALGIA (sore arm) and VACCINATION SITE PAIN (Slight pain at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication history not provided. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-MAY-2021. contain non significant information
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CALCIUM for an unknown indication.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced INSOMNIA (Insomnia). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Insomnia) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications include antivirals, immune boosters. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up accepted on 27-May-2021
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: burning; itching; rash down his entire body; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (burning), PRURITUS (itching) and RASH (rash down his entire body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-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 BURNING SENSATION (burning), PRURITUS (itching) and RASH (rash down his entire body). The patient was treated with DIPHENHYDRAMINE ACEFYLLINATE at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning), PRURITUS (itching) and RASH (rash down his entire body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up appended to AER
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headache right side and back right side; 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 DIZZINESS (Dizziness) and HEADACHE (Headache right side and back right side) 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) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache right side and back right side). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache right side and back right side) outcome was unknown. Not Provided          Concomitant medication history not provided. Treatment information was unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-MMY-2021, contain non significant follow up information. NNI
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: had a terrible time with both moderna shots; 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 FEELING ABNORMAL (had a terrible time with both moderna shots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 (had a terrible time with both moderna shots). At the time of the report, FEELING ABNORMAL (had a terrible time with both moderna shots) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided. Treatment medication information was not provided.   This case was linked to MOD-2021-168246 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25 May 2021.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Nausea
Clinical narrative: Dizziness; i am getting worst; nausea; 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 DIZZINESS (Dizziness), CONDITION AGGRAVATED (i am getting worst) and NAUSEA (nausea) 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 05-May-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 DIZZINESS (Dizziness), CONDITION AGGRAVATED (i am getting worst) and NAUSEA (nausea). At the time of the report, DIZZINESS (Dizziness), CONDITION AGGRAVATED (i am getting worst) and NAUSEA (nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information reported.  Patient stated he/she took 1st dose 15 days ago and started to feel dizzy and nausea. Stated that he/she thought temporary but now feeling it would get worst and concerned whether to take 2nd dose or not.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Nonsignificant Follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Have had diarrhea since the first shot; 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 DIARRHOEA (Have had diarrhea since the first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Have had diarrhea since the first shot). At the time of the report, DIARRHOEA (Have had diarrhea since the first shot) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended ON 25-MAY-2021. Agency document attached.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Insomnia, Pain in extremity, Vaccination site pain
Clinical narrative: Can't sleep on his left arm / Cannot sleep on his left side; Reduced motor function; Prolonged pain; Sore joint; Sore left arm / Pain does not go away; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep on his left arm / Cannot sleep on his left side), PAIN IN EXTREMITY (Sore left arm / Pain does not go away), HYPOKINESIA (Reduced motor function), VACCINATION SITE PAIN (Prolonged pain) and ARTHRALGIA (Sore joint) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 0Z9AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2012. Concomitant products included LOSARTAN from 2012 to an unknown date for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm / Pain does not go away) and ARTHRALGIA (Sore joint). On an unknown date, the patient experienced INSOMNIA (Can't sleep on his left arm / Cannot sleep on his left side), HYPOKINESIA (Reduced motor function) and VACCINATION SITE PAIN (Prolonged pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (Can't sleep on his left arm / Cannot sleep on his left side), HYPOKINESIA (Reduced motor function) and VACCINATION SITE PAIN (Prolonged pain) outcome was unknown and PAIN IN EXTREMITY (Sore left arm / Pain does not go away) and ARTHRALGIA (Sore joint) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021: No N ew information On 26-Jul-2021: Significant Follow up received on 26-Jul-2021. Reporter phone number and E-mail ID changed , Patient demographics, race and ethnicity were updated, Historical condition and concomitant medication were added. New adverse event and event outcome was updated.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sickness; 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 ILLNESS (Sickness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended for Document Attachment
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Myalgia, Tachyarrhythmia
Clinical narrative: lack of strength in her wrist; she had arm pain; experiencing strong tachyarrhythmia; shortness of breath during night; This spontaneous case was reported by a consumer and describes the occurrence of TACHYARRHYTHMIA (experiencing strong tachyarrhythmia), DYSPNEA (shortness of breath during night), ASTHENIA (lack of strength in her wrist) and MYALGIA (she had arm pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot#016B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TACHYARRHYTHMIA (experiencing strong tachyarrhythmia) and DYSPNEA (shortness of breath during night). On an unknown date, the patient experienced ASTHENIA (lack of strength in her wrist) and MYALGIA (she had arm pain). At the time of the report, TACHYARRHYTHMIA (experiencing strong tachyarrhythmia) had not resolved and DYSPNEA (shortness of breath during night), ASTHENIA (lack of strength in her wrist) and MYALGIA (she had arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.