chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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) UNKNOWN. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       NO CONCOMITANT AND TREATMENT DRUGS WERE USED.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeding disorder, Feeling abnormal, Joint swelling
Clinical narrative: dizziness; unable to eat; had swelling all over her left arm and shoulder that she was not able to lay down; felt bad; had swelling all over her left arm and shoulder that she was not able to lay down; fever; chills; throwing up; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), FEELING ABNORMAL (felt bad) and JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), FEELING ABNORMAL (felt bad), JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), PYREXIA (fever), CHILLS (chills) and VOMITING (throwing up). At the time of the report, DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), PYREXIA (fever), CHILLS (chills) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown.  Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: dizziness; unable to eat; had swelling all over her left arm and shoulder that she was not able to lay down; felt bad; had swelling all over her left arm and shoulder that she was not able to lay down; fever; chills; throwing up; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), FEELING ABNORMAL (felt bad) and JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), FEELING ABNORMAL (felt bad), JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), PYREXIA (fever), CHILLS (chills) and VOMITING (throwing up). At the time of the report, DIZZINESS (dizziness), FEEDING DISORDER (unable to eat), PERIPHERAL SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), JOINT SWELLING (had swelling all over her left arm and shoulder that she was not able to lay down), PYREXIA (fever), CHILLS (chills) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown.  Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: dizzy; fatigued; nauseous; 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 (dizzy), FATIGUE (fatigued) and NAUSEA (nauseous) 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 DIZZINESS (dizzy), FATIGUE (fatigued) and NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), FATIGUE (fatigued) and NAUSEA (nauseous) 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.  Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Really bad headache/Headache comes back every often and last for 3days; 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 HEADACHE (Really bad headache/Headache comes back every often and last for 3days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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 HEADACHE (Really bad headache/Headache comes back every often and last for 3days). At the time of the report, HEADACHE (Really bad headache/Headache comes back every often and last for 3days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle ache) outcome was unknown.            Treatment details not provided
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Feeling cold, Pyrexia, Vaccination site pain
Clinical narrative: extreme dry mouth; Feeling cold; Fever; painful arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (extreme dry mouth), FEELING COLD (Feeling cold), PYREXIA (Fever) and VACCINATION SITE PAIN (painful arm at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING COLD (Feeling cold), PYREXIA (Fever) and VACCINATION SITE PAIN (painful arm at the injection site). On an unknown date, the patient experienced DRY MOUTH (extreme dry mouth). On 22-Apr-2021, FEELING COLD (Feeling cold) had resolved. On 23-Apr-2021, PYREXIA (Fever) and VACCINATION SITE PAIN (painful arm at the injection site) had resolved. At the time of the report, DRY MOUTH (extreme dry mouth) had not resolved.            No relevant concomitant medications were reported.   Treatment information was not provided.   This case was linked to MOD-2021-077832 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neck pain, Vaccination complication
Clinical narrative: neck pain; mild headache/Chronic headache; body ache; Very rough 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very rough 3 days), NECK PAIN (neck pain), HEADACHE (mild headache/Chronic headache) and MYALGIA (body ache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 025B21A) for COVID-19 vaccination.     No Medical History reported.  Concurrent medical conditions included Penicillin allergy. Concomitant products included ATORVASTATIN from 09-Jan-2020 to an unknown date for Cholesterol.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION COMPLICATION (Very rough 3 days), HEADACHE (mild headache/Chronic headache) and MYALGIA (body ache). On an unknown date, the patient experienced NECK PAIN (neck pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 1 dosage form. On 01-May-2021, VACCINATION COMPLICATION (Very rough 3 days) had resolved. On 28-May-2021, MYALGIA (body ache) had resolved. At the time of the report, NECK PAIN (neck pain) outcome was unknown and HEADACHE (mild headache/Chronic headache) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received on 07-JUL-2021 contains: added information of the events- headache, neck pain; Added event outcomes- from unknown to not recovered and recovered.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I'm still feeling so sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I'm still feeling so sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I'm still feeling so sick). At the time of the report, ILLNESS (I'm still feeling so sick) had not resolved.        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 product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19; 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 (Tested positive for Covid 19) 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 COVID-19 (Tested positive for Covid 19). At the time of the report, COVID-19 (Tested positive for Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID 19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    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 VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment medication was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included 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 PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive the second dose of the Moderna COVID-19 vaccine/four month gap after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Joint dislocation, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: chills; fever; headache lasting for two days; local right arm pain at injection site; began having tingleness in right arm from shoulder; Right Shoulder being dislocated; something wrong with right shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site) and PARAESTHESIA (began having tingleness in right arm from shoulder) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site), PARAESTHESIA (began having tingleness in right arm from shoulder), JOINT DISLOCATION (Right Shoulder being dislocated) and MUSCULOSKELETAL DISCOMFORT (something wrong with right shoulder.). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site), PARAESTHESIA (began having tingleness in right arm from shoulder), JOINT DISLOCATION (Right Shoulder being dislocated) and MUSCULOSKELETAL DISCOMFORT (something wrong with right shoulder.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: chills; fever; headache lasting for two days; local right arm pain at injection site; began having tingleness in right arm from shoulder; Right Shoulder being dislocated; something wrong with right shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site) and PARAESTHESIA (began having tingleness in right arm from shoulder) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site), PARAESTHESIA (began having tingleness in right arm from shoulder), JOINT DISLOCATION (Right Shoulder being dislocated) and MUSCULOSKELETAL DISCOMFORT (something wrong with right shoulder.). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever), HEADACHE (headache lasting for two days), VACCINATION SITE PAIN (local right arm pain at injection site), PARAESTHESIA (began having tingleness in right arm from shoulder), JOINT DISLOCATION (Right Shoulder being dislocated) and MUSCULOSKELETAL DISCOMFORT (something wrong with right shoulder.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (rash at injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash after the 2nd dose of Moderna vaccine,rash spreading all over the body, rash still spreading; 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 RASH (Rash after the 2nd dose of Moderna vaccine,rash spreading all over the body, rash still spreading) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash after the 2nd dose of Moderna vaccine,rash spreading all over the body, rash still spreading). At the time of the report, RASH (Rash after the 2nd dose of Moderna vaccine,rash spreading all over the body, rash still spreading) had not resolved.            No concomitant medications was not provided. Treatment medication was not provided. Action taken with mRNA-1273  in response to the event was not applicable.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Alopecia, Feeding disorder, Frustration tolerance decreased, Musculoskeletal discomfort
Clinical narrative: Burning sensation in my nose; Burning sensation in my nose and my mouth; Stomach is upset; Hardly eat anything; Everything taste terrible; My back seems to be getting a little bit better; Frustrating; Loss of hair; Everything smell gross; This spontaneous case was reported by a non-health professional and describes the occurrence of NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything) and TASTE DISORDER (Everything taste terrible) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything), TASTE DISORDER (Everything taste terrible), MUSCULOSKELETAL DISCOMFORT (My back seems to be getting a little bit better), FRUSTRATION TOLERANCE DECREASED (Frustrating), ALOPECIA (Loss of hair) and PAROSMIA (Everything smell gross). At the time of the report, NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), TASTE DISORDER (Everything taste terrible), MUSCULOSKELETAL DISCOMFORT (My back seems to be getting a little bit better), ALOPECIA (Loss of hair) and PAROSMIA (Everything smell gross) had not resolved and ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything) and FRUSTRATION TOLERANCE DECREASED (Frustrating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Significant FUP- new event added, product details, gender, age, outcome updated
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Oral discomfort, Parosmia, Taste disorder
Clinical narrative: Burning sensation in my nose; Burning sensation in my nose and my mouth; Stomach is upset; Hardly eat anything; Everything taste terrible; My back seems to be getting a little bit better; Frustrating; Loss of hair; Everything smell gross; This spontaneous case was reported by a non-health professional and describes the occurrence of NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything) and TASTE DISORDER (Everything taste terrible) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything), TASTE DISORDER (Everything taste terrible), MUSCULOSKELETAL DISCOMFORT (My back seems to be getting a little bit better), FRUSTRATION TOLERANCE DECREASED (Frustrating), ALOPECIA (Loss of hair) and PAROSMIA (Everything smell gross). At the time of the report, NASAL DISCOMFORT (Burning sensation in my nose), ORAL DISCOMFORT (Burning sensation in my nose and my mouth), TASTE DISORDER (Everything taste terrible), MUSCULOSKELETAL DISCOMFORT (My back seems to be getting a little bit better), ALOPECIA (Loss of hair) and PAROSMIA (Everything smell gross) had not resolved and ABDOMINAL DISCOMFORT (Stomach is upset), FEEDING DISORDER (Hardly eat anything) and FRUSTRATION TOLERANCE DECREASED (Frustrating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Significant FUP- new event added, product details, gender, age, outcome updated
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain 2 days duration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain 2 days duration) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ATENOLOL and VITAMINS NOS for an unknown indication.    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 VACCINATION SITE PAIN (Injection site pain 2 days duration). At the time of the report, VACCINATION SITE PAIN (Injection site pain 2 days duration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: tired; slight headache; felt achy, had a sore arm; slight fever; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tired), HEADACHE (slight headache), MYALGIA (felt achy, had a sore arm) and PYREXIA (slight fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced FATIGUE (tired), HEADACHE (slight headache), MYALGIA (felt achy, had a sore arm) and PYREXIA (slight fever). On 29-Apr-2021, FATIGUE (tired), HEADACHE (slight headache), MYALGIA (felt achy, had a sore arm) and PYREXIA (slight fever) had resolved.        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 medications were not mentioned. Treatment medications were not provided   This case was linked to MOD-2021-186933 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: red blotches on some parts of the body/ looks like a sunburn; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches on some parts of the body/ looks like a sunburn) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-May-2021, the patient experienced RASH MACULAR (red blotches on some parts of the body/ looks like a sunburn). At the time of the report, RASH MACULAR (red blotches on some parts of the body/ looks like a sunburn) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; 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) and HEADACHE (Headache) 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 PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lung disorder, Pyrexia
Clinical narrative: lungs hire; 100.4 temp; Headache; 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 LUNG DISORDER (lungs hire), PYREXIA (100.4 temp), HEADACHE (Headache) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (lungs hire), PYREXIA (100.4 temp), HEADACHE (Headache) and CHILLS (chills). At the time of the report, LUNG DISORDER (lungs hire), PYREXIA (100.4 temp), HEADACHE (Headache) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: other (Inconclusive) 100.4.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: What are some side effect of the 2nd dos of modern vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are some side effect of the 2nd dos of modern vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION COMPLICATION (What are some side effect of the 2nd dos of modern vaccine). At the time of the report, VACCINATION COMPLICATION (What are some side effect of the 2nd dos of modern vaccine) outcome was unknown.            No concomitant and treatment information were available.
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Myalgia
Clinical narrative: severe muscle aches; extreme lethargy; 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 (severe muscle aches) and LETHARGY (extreme lethargy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced MYALGIA (severe muscle aches) and LETHARGY (extreme lethargy). At the time of the report, MYALGIA (severe muscle aches) and LETHARGY (extreme lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: symptoms of flue; pain; nausea; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (symptoms of flue), PAIN (pain), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age 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 INFLUENZA LIKE ILLNESS (symptoms of flue), PAIN (pain), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (symptoms of flue), PAIN (pain), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            no concomitant medications are provided. treatment to the events not  reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: symptoms of flue; pain; nausea; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (symptoms of flue), PAIN (pain), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age 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 INFLUENZA LIKE ILLNESS (symptoms of flue), PAIN (pain), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (symptoms of flue), PAIN (pain), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            no concomitant medications are provided. treatment to the events not  reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered 14 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 14 days after the first shot) 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 14 days after the first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 14 days after the first shot) outcome was unknown.            no concomitant drugs and treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: have experienced a side effect; Is it ok to take pain meds after the vaccine?; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 29-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have experienced a side effect) and MYALGIA (Is it ok to take pain meds after the vaccine?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have experienced a side effect) and MYALGIA (Is it ok to take pain meds after the vaccine?). At the time of the report, VACCINATION COMPLICATION (have experienced a side effect) and MYALGIA (Is it ok to take pain meds after the vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO CONCOMITANT AND TREATMENT DRUGS WERE USED
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vascular pain
Clinical narrative: Medical vein pain; Really swollen; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR PAIN (Medical vein pain) and SWELLING (Really swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced VASCULAR PAIN (Medical vein pain) and SWELLING (Really swollen). At the time of the report, VASCULAR PAIN (Medical vein pain) and SWELLING (Really swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided  No treatment medications provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swollen injection site; super itchy; 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 SWELLING (swollen injection site) and VACCINATION SITE PRURITUS (super itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PRURITUS (super itchy). At the time of the report, VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE PRURITUS (super itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Daily Headaches; 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 HEADACHE (Daily Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     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 HEADACHE (Daily Headaches). At the time of the report, HEADACHE (Daily Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: nausea; 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 NAUSEA (nausea) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and CHILLS (chills). At the time of the report, NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            No concomitant medication details were reported. No Treatment Medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Each day more of my large joints hurt. Not the small joints.; 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 ARTHRALGIA (Each day more of my large joints hurt. Not the small joints.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced ARTHRALGIA (Each day more of my large joints hurt. Not the small joints.). At the time of the report, ARTHRALGIA (Each day more of my large joints hurt. Not the small joints.) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: arm is tingling  from fingers to my shoulder; 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 PARAESTHESIA (arm is tingling  from fingers to my shoulder) 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 PARAESTHESIA (arm is tingling  from fingers to my shoulder). At the time of the report, PARAESTHESIA (arm is tingling  from fingers to my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; 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 FATIGUE (Tiredness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were provided. No treatment information was provided.