chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain in extremity
Clinical narrative: high sensitivity to cold; chills; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (high sensitivity to cold), CHILLS (chills) and PAIN IN EXTREMITY (pain in the arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced CHILLS (chills) and PAIN IN EXTREMITY (pain in the arm). On 11-Jan-2021, the patient experienced FEELING COLD (high sensitivity to cold). On 31-Dec-2020, CHILLS (chills) and PAIN IN EXTREMITY (pain in the arm) had resolved. At the time of the report, FEELING COLD (high sensitivity to cold) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included ibuprofen.  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.   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: Chills, Headache
Clinical narrative: Chills; Headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). In January 2021, CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. Treatment information included ibuprofen was reported.  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.; 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash is itchy on the injection site; Rash on injection site, the size of a couple of quarters; Rash is raised on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Rash is itchy on the injection site), VACCINATION SITE RASH (Rash on injection site, the size of a couple of quarters) and VACCINATION SITE SWELLING (Rash is raised on the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Rash is itchy on the injection site), VACCINATION SITE RASH (Rash on injection site, the size of a couple of quarters) and VACCINATION SITE SWELLING (Rash is raised on the injection site). At the time of the report, VACCINATION SITE PRURITUS (Rash is itchy on the injection site), VACCINATION SITE RASH (Rash on injection site, the size of a couple of quarters) and VACCINATION SITE SWELLING (Rash is raised on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood thinner. Treatment included ice pack.; 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: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol 2 tablets was taken as treatment for headache.  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.   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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus allergic, Vaccination site pain
Clinical narrative: sore in her arm  (injection site); redness from allergic reaction to bandaid; remarkable itchy allergic reaction to bandaid (latex); This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Laboratory details was not provided.  Treatment information was not provided.  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.; 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: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Muscle spasms, Nasopharyngitis, Neck pain
Clinical narrative: Lingering soreness in my arm up to my neck now; Diarrhea; Fever; Tested positive for Covid; Felt like i got cold; sore arm at moderate level of pain; Chills; Cramps in my feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm at moderate level of pain), CHILLS (Chills), MUSCLE SPASMS (Cramps in my feet), NECK PAIN (Lingering soreness in my arm up to my neck now) and NASOPHARYNGITIS (Felt like i got cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE and ESTRADIOL.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at moderate level of pain), CHILLS (Chills) and MUSCLE SPASMS (Cramps in my feet). On 10-Jan-2021, the patient experienced NASOPHARYNGITIS (Felt like i got cold). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid). On an unknown date, the patient experienced NECK PAIN (Lingering soreness in my arm up to my neck now). On 06-Jan-2021, CHILLS (Chills) and MUSCLE SPASMS (Cramps in my feet) had resolved. On 07-Jan-2021, VACCINATION SITE PAIN (sore arm at moderate level of pain) outcome was unknown. At the time of the report, NECK PAIN (Lingering soreness in my arm up to my neck now), NASOPHARYNGITIS (Felt like i got cold), DIARRHOEA (Diarrhea), PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included over the counter advil and Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: Lingering soreness in my arm up to my neck now; Diarrhea; Fever; Tested positive for Covid; Felt like i got cold; sore arm at moderate level of pain; Chills; Cramps in my feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm at moderate level of pain), CHILLS (Chills), MUSCLE SPASMS (Cramps in my feet), NECK PAIN (Lingering soreness in my arm up to my neck now) and NASOPHARYNGITIS (Felt like i got cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE and ESTRADIOL.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm at moderate level of pain), CHILLS (Chills) and MUSCLE SPASMS (Cramps in my feet). On 10-Jan-2021, the patient experienced NASOPHARYNGITIS (Felt like i got cold). On 11-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid). On an unknown date, the patient experienced NECK PAIN (Lingering soreness in my arm up to my neck now). On 06-Jan-2021, CHILLS (Chills) and MUSCLE SPASMS (Cramps in my feet) had resolved. On 07-Jan-2021, VACCINATION SITE PAIN (sore arm at moderate level of pain) outcome was unknown. At the time of the report, NECK PAIN (Lingering soreness in my arm up to my neck now), NASOPHARYNGITIS (Felt like i got cold), DIARRHOEA (Diarrhea), PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included over the counter advil and Tylenol.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site bruising, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Now its itching very bad at the injection site; It hurts around the injection site; It is really really warm to touch; Itchy at the injection site; Redness is back again,red circle is getting bigger every day; slight headache; Left arm sore; Red circle around injection site; warm to touch; Bruise around injection site; Hard around injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PRURITUS (Now its itching very bad at the injection site), HEADACHE (slight headache) and VACCINATION SITE PAIN (It hurts around the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid. Concomitant products included VENLAFAXINE and VITAMINS NOS for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch). On 11-Jan-2021, the patient experienced HEADACHE (slight headache). On 12-Jan-2021, the patient experienced VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PAIN (It hurts around the injection site) and VACCINATION SITE ERYTHEMA (Redness is back again,red circle is getting bigger every day). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Now its itching very bad at the injection site). At the time of the report, VACCINATION SITE WARMTH (warm to touch) had resolved and VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PRURITUS (Now its itching very bad at the injection site), HEADACHE (slight headache), VACCINATION SITE PAIN (It hurts around the injection site) and VACCINATION SITE ERYTHEMA (Redness is back again,red circle is getting bigger every day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes cortisol cream and ibuprofen since Tuesday (twice a day since 12jan2021)   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Now its itching very bad at the injection site; It hurts around the injection site; It is really really warm to touch; Itchy at the injection site; Redness is back again,red circle is getting bigger every day; slight headache; Left arm sore; Red circle around injection site; warm to touch; Bruise around injection site; Hard around injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PRURITUS (Now its itching very bad at the injection site), HEADACHE (slight headache) and VACCINATION SITE PAIN (It hurts around the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid. Concomitant products included VENLAFAXINE and VITAMINS NOS for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch). On 11-Jan-2021, the patient experienced HEADACHE (slight headache). On 12-Jan-2021, the patient experienced VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PAIN (It hurts around the injection site) and VACCINATION SITE ERYTHEMA (Redness is back again,red circle is getting bigger every day). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Now its itching very bad at the injection site). At the time of the report, VACCINATION SITE WARMTH (warm to touch) had resolved and VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PRURITUS (Now its itching very bad at the injection site), HEADACHE (slight headache), VACCINATION SITE PAIN (It hurts around the injection site) and VACCINATION SITE ERYTHEMA (Redness is back again,red circle is getting bigger every day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes cortisol cream and ibuprofen since Tuesday (twice a day since 12jan2021)   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Myalgia, Paraesthesia
Clinical narrative: mild phlegm; Body temperature goes from hot to cold; Chills; Headache; low grade fever; muscle ache; tingling around the neck; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (tingling around the neck), PRODUCTIVE COUGH (mild phlegm), FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold), CHILLS (Chills) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PARAESTHESIA (tingling around the neck), CHILLS (Chills), HEADACHE (Headache), PYREXIA (low grade fever) and MYALGIA (muscle ache). On 14-Jan-2021, the patient experienced PRODUCTIVE COUGH (mild phlegm) and FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling around the neck), PRODUCTIVE COUGH (mild phlegm), FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold), CHILLS (Chills), HEADACHE (Headache), PYREXIA (low grade fever) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia
Clinical narrative: mild phlegm; Body temperature goes from hot to cold; Chills; Headache; low grade fever; muscle ache; tingling around the neck; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (tingling around the neck), PRODUCTIVE COUGH (mild phlegm), FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold), CHILLS (Chills) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PARAESTHESIA (tingling around the neck), CHILLS (Chills), HEADACHE (Headache), PYREXIA (low grade fever) and MYALGIA (muscle ache). On 14-Jan-2021, the patient experienced PRODUCTIVE COUGH (mild phlegm) and FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling around the neck), PRODUCTIVE COUGH (mild phlegm), FEELING OF BODY TEMPERATURE CHANGE (Body temperature goes from hot to cold), CHILLS (Chills), HEADACHE (Headache), PYREXIA (low grade fever) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm touch at the injection site; Itchy at the injection site; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE INDURATION (Red knot at the site of injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE INDURATION (Red knot at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date at an unspecified dose and frequency. In January 2021, VACCINATION SITE INDURATION (Red knot at the site of injection) was resolving. At the time of the report, VACCINATION SITE WARMTH (Warm touch at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment included topical steroid cream.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Left Arm Hurts; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left Arm Hurts) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL), ASPIRIN ALUMINUM, TURMERIC [CURCUMA LONGA RHIZOME] and COENZYME Q10 [UBIDECARENONE] for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Left Arm Hurts) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Left Arm Hurts) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included Paracetamol, 1 glass of wine and 2 beers.   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. Further information has been requested; 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. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Loss of range of motion in her left arm; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Loss of range of motion in her left arm) and VACCINATION SITE PAIN (Arm pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Loss of range of motion in her left arm) and VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Loss of range of motion in her left arm) and VACCINATION SITE PAIN (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds reported.    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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood glucose increased, Chills, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), NECK PAIN (Neck was a little sore), BACK PAIN (Back hurting), TEMPERATURE REGULATION DISORDER (Trouble getting warm) and ARTHRALGIA (Joint pain) in a 45-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.     The patient's past medical history included Type 1 diabetes mellitus since an unknown date and COVID-19 in December 2020.    On 14-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced NECK PAIN (Neck was a little sore), BACK PAIN (Back hurting), HEADACHE (Hadache) and FATIGUE (Tired). On 14-Jan-2021 at 6:00 PM, the patient experienced PAIN (Body aches), TEMPERATURE REGULATION DISORDER (Trouble getting warm), ARTHRALGIA (Joint pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), NECK PAIN (Neck was a little sore), BACK PAIN (Back hurting), TEMPERATURE REGULATION DISORDER (Trouble getting warm), ARTHRALGIA (Joint pain), CHILLS (Chills), HEADACHE (Hadache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood glucose increased: elevated (High) Blood sugar is elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.; 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Temperature regulation disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), NECK PAIN (Neck was a little sore), BACK PAIN (Back hurting), TEMPERATURE REGULATION DISORDER (Trouble getting warm) and ARTHRALGIA (Joint pain) in a 45-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.     The patient's past medical history included Type 1 diabetes mellitus since an unknown date and COVID-19 in December 2020.    On 14-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced NECK PAIN (Neck was a little sore), BACK PAIN (Back hurting), HEADACHE (Hadache) and FATIGUE (Tired). On 14-Jan-2021 at 6:00 PM, the patient experienced PAIN (Body aches), TEMPERATURE REGULATION DISORDER (Trouble getting warm), ARTHRALGIA (Joint pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), NECK PAIN (Neck was a little sore), BACK PAIN (Back hurting), TEMPERATURE REGULATION DISORDER (Trouble getting warm), ARTHRALGIA (Joint pain), CHILLS (Chills), HEADACHE (Hadache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood glucose increased: elevated (High) Blood sugar is elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.; 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Shaking/tremor; Headaches; Body aches; Temperature a 100; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking/tremor), HEADACHE (Headaches), MYALGIA (Body aches), PYREXIA (Temperature a 100) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Thyroid disorder NOS.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced TREMOR (Shaking/tremor), HEADACHE (Headaches), MYALGIA (Body aches), PYREXIA (Temperature a 100), CHILLS (Chills) and NAUSEA (Nausea). On 14-Jan-2021, TREMOR (Shaking/tremor), PYREXIA (Temperature a 100), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, HEADACHE (Headaches) and MYALGIA (Body aches) had not 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.   The events shaking, chills, with nausea, tremors and temperature a 100 were  resolved on 14 Jan 2021  Treatment for the event included paracetamol.  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.; 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking/tremor; Headaches; Body aches; Temperature a 100; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking/tremor), HEADACHE (Headaches), MYALGIA (Body aches), PYREXIA (Temperature a 100) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Thyroid disorder NOS.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced TREMOR (Shaking/tremor), HEADACHE (Headaches), MYALGIA (Body aches), PYREXIA (Temperature a 100), CHILLS (Chills) and NAUSEA (Nausea). On 14-Jan-2021, TREMOR (Shaking/tremor), PYREXIA (Temperature a 100), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, HEADACHE (Headaches) and MYALGIA (Body aches) had not 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.   The events shaking, chills, with nausea, tremors and temperature a 100 were  resolved on 14 Jan 2021  Treatment for the event included paracetamol.  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.; 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.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash up and down whole arm; Rash over arms Itching really bad; This spontaneous case was reported by a consumer and describes the occurrence of   in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (Neuropathy) and Arthritis (Arthritis.). Concurrent medical conditions included Diabetes (Diabetes) and Allergy (Seasonal allergies). Concomitant products included PIPERAZINE CITRATE (CITRAZINE), LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOMER [LEVOCETIRIZINE DIHYDROCHLORIDE]), VITAMIN 15 and GABAPENTIN for an unknown indication.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Laboratory details were not provided.  Treatment information was provided as cortisone.  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.   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: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the event, was not reported.  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.   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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Pain on her chest; Fever; Headache; Chills; soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain on her chest), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (soreness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (soreness). On 14-Jan-2021, the patient experienced CHEST PAIN (Pain on her chest). At the time of the report, CHEST PAIN (Pain on her chest), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Further information has been requested; 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. Further information has been requested
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Urticaria
Clinical narrative: Hives; Extremely itchy; The rash was still lingering and still a litle bit of an itch; Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives), PRURITUS (Extremely itchy), RASH PRURITIC (The rash was still lingering and still a litle bit of an itch) and RASH (Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced URTICARIA (Hives), PRURITUS (Extremely itchy), RASH PRURITIC (The rash was still lingering and still a litle bit of an itch) and RASH (Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks). At the time of the report, URTICARIA (Hives), PRURITUS (Extremely itchy) and RASH (Rash on her bodystarting at her chest down to her knees then radiating to her back towards her buttocks) was resolving and RASH PRURITIC (The rash was still lingering and still a litle bit of an itch) 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.   No relevant concomitant medications were reported. The patient was treated with Benadryl (diphenhydramine).  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Vaccination site induration, Vaccination site pain
Clinical narrative: Back pain; Vaccination site hard; Headache; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), VACCINATION SITE INDURATION (Vaccination site hard), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D391L20A) for COVID-19 vaccination.     The patient's past medical history included Laminectomy spinal in 1998.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced BACK PAIN (Back pain), VACCINATION SITE INDURATION (Vaccination site hard), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with ROSUVASTATIN ongoing since an unknown date at a dose of 20 mg. On 14-Jan-2021, BACK PAIN (Back pain), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) had resolved. At the time of the report, VACCINATION SITE INDURATION (Vaccination site hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient was treated with Aleve (naproxen).  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Dizziness, Ear pain, Headache
Clinical narrative: Behind ears hurts/tense; Blood pressure; blood sugar was 54mg/dl; blood pressure was high 140/80, 149/96 mmHg; Dizziness; severe headache; Lightheaded; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheaded), HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg), DIZZINESS (Dizziness) and EAR PAIN (Behind ears hurts/tense) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.), Blood pressure low and SARS-CoV-2 test.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Lightheaded) and HEADACHE (severe headache). On 08-Jan-2021, the patient experienced HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg) and DIZZINESS (Dizziness). On 14-Jan-2021, the patient experienced EAR PAIN (Behind ears hurts/tense) and BLOOD PRESSURE MEASUREMENT (Blood pressure). At the time of the report, DIZZINESS (Lightheaded), HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg), DIZZINESS (Dizziness), EAR PAIN (Behind ears hurts/tense), BLOOD PRESSURE MEASUREMENT (Blood pressure) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 54 mg/dl (Low) low. On 08-Jan-2021, Blood pressure measurement: 140/80 mmHg (High) high. On 14-Jan-2021, Blood pressure measurement: 149/96 mmHg (High) high. On 14-Jan-2021, Heart rate: 67 (normal) breathes per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No con meds reported.   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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypertension, Hypoglycaemia
Clinical narrative: Behind ears hurts/tense; Blood pressure; blood sugar was 54mg/dl; blood pressure was high 140/80, 149/96 mmHg; Dizziness; severe headache; Lightheaded; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheaded), HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg), DIZZINESS (Dizziness) and EAR PAIN (Behind ears hurts/tense) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.), Blood pressure low and SARS-CoV-2 test.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Lightheaded) and HEADACHE (severe headache). On 08-Jan-2021, the patient experienced HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg) and DIZZINESS (Dizziness). On 14-Jan-2021, the patient experienced EAR PAIN (Behind ears hurts/tense) and BLOOD PRESSURE MEASUREMENT (Blood pressure). At the time of the report, DIZZINESS (Lightheaded), HYPOGLYCAEMIA (blood sugar was 54mg/dl), HYPERTENSION (blood pressure was high 140/80, 149/96 mmHg), DIZZINESS (Dizziness), EAR PAIN (Behind ears hurts/tense), BLOOD PRESSURE MEASUREMENT (Blood pressure) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 54 mg/dl (Low) low. On 08-Jan-2021, Blood pressure measurement: 140/80 mmHg (High) high. On 14-Jan-2021, Blood pressure measurement: 149/96 mmHg (High) high. On 14-Jan-2021, Heart rate: 67 (normal) breathes per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No con meds reported.   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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the vaccination site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the vaccination site). On 14-Jan-2021, VACCINATION SITE PAIN (Soreness at the vaccination site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event as reported, he was going to take ibuprofen for the pain but forgot.  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.; 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.