chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 years old patient was administered 1st dose of Moderna covid-19 vaccine) 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drainage, Seasonal allergy, Throat irritation
Clinical narrative: seasonal allergies; scratchy throat; Drainage; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (seasonal allergies), THROAT IRRITATION (scratchy throat) and DRAINAGE (Drainage) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management. Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure management, POTASSIUM for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced SEASONAL ALLERGY (seasonal allergies), THROAT IRRITATION (scratchy throat) and DRAINAGE (Drainage). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Throat irritation and Drainage, at a dose of 1 dosage form. At the time of the report, SEASONAL ALLERGY (seasonal allergies), THROAT IRRITATION (scratchy throat) and DRAINAGE (Drainage) 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.   The second dose of Moderna COVID-19 vaccine was scheduled for  20 May 2021.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose given to patient under eighteen years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to patient under eighteen years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to patient under eighteen years old). On 18-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to patient under eighteen years old) 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 product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Headache, Illness, Nausea
Clinical narrative: nausea; became so ill; throwing up like twice a day; not able to get out of bed,being really fatigued; not able to eat; extreme headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches). On 19-May-2021, the patient experienced NAUSEA (nausea). On 30-Apr-2021, ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches) had resolved. At the time of the report, NAUSEA (nausea) had 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.   no concomitant medication reported. patient wanted to know the side effects of the second dose and possible consequence of have only the first shot.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nausea; became so ill; throwing up like twice a day; not able to get out of bed,being really fatigued; not able to eat; extreme headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches). On 19-May-2021, the patient experienced NAUSEA (nausea). On 30-Apr-2021, ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches) had resolved. At the time of the report, NAUSEA (nausea) had 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.   no concomitant medication reported. patient wanted to know the side effects of the second dose and possible consequence of have only the first shot.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Underdose, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Injection placed in wrong area of arm-too high; Incorrect dosage; Bruised left arm; pain at injection site left arm; Bleeding left arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding left arm), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection placed in wrong area of arm-too high), UNDERDOSE (Incorrect dosage), VACCINATION SITE BRUISING (Bruised left arm) and VACCINATION SITE PAIN (pain at injection site left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C217 and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding left arm). On 19-May-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection placed in wrong area of arm-too high), UNDERDOSE (Incorrect dosage), VACCINATION SITE BRUISING (Bruised left arm) and VACCINATION SITE PAIN (pain at injection site left arm). On 22-Apr-2021, VACCINATION SITE HAEMORRHAGE (Bleeding left arm) had resolved. At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection placed in wrong area of arm-too high), UNDERDOSE (Incorrect dosage), VACCINATION SITE BRUISING (Bruised left arm) and VACCINATION SITE PAIN (pain at injection site left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the 1st dose of mRNA-1273 (lot #009C21A) and  start date of the event of vaccination site bleeding, a causal relationship cannot be excluded. Additionally, vaccine underdose and administered at inappropriate site were reported for second dose of  mRNA-1273 (lot # 003C217) with associated adverse events of vaccination site bruising and vaccination site pain, assessed as possibly related due to temporal association.; Sender's Comments: Based on the current available information and temporal association between the 1st dose of mRNA-1273 (lot #009C21A) and  start date of the event of vaccination site bleeding, a causal relationship cannot be excluded. Additionally, vaccine underdose and administered at inappropriate site were reported for second dose of  mRNA-1273 (lot # 003C217) with associated adverse events of vaccination site bruising and vaccination site pain, assessed as possibly related due to temporal association.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Hypoaesthesia, Vaccination site pain
Clinical narrative: loss of appetite/maybe due to depression/decreased appetite persisting; numbness of the left hand; sore arm (injection arm ); joint pain at the wrist/joint pain at the fingers; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite/maybe due to depression/decreased appetite persisting), HYPOAESTHESIA (numbness of the left hand), VACCINATION SITE PAIN (sore arm (injection arm )), ARTHRALGIA (joint pain at the wrist/joint pain at the fingers) and FATIGUE (fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included Depression since an unknown date.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm (injection arm )), ARTHRALGIA (joint pain at the wrist/joint pain at the fingers) and FATIGUE (fatigue). On 14-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite/maybe due to depression/decreased appetite persisting). 14-Apr-2021, the patient experienced HYPOAESTHESIA (numbness of the left hand). At the time of the report, DECREASED APPETITE (loss of appetite/maybe due to depression/decreased appetite persisting) had not resolved and HYPOAESTHESIA (numbness of the left hand), VACCINATION SITE PAIN (sore arm (injection arm )), ARTHRALGIA (joint pain at the wrist/joint pain at the fingers) and FATIGUE (fatigue) outcome was unknown. loss of appetite may be due to depression patient was undergoing.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.    This case was linked to MOD-2021-147816 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Treatment information not reported.   This case was linked to MOD-2021-244799 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Vomiting
Clinical narrative: Getting sick; continous nausea and vomiting; delayed nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Getting sick), VOMITING (continous nausea and vomiting) and NAUSEA (delayed nausea) 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 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced ILLNESS (Getting sick), VOMITING (continous nausea and vomiting) and NAUSEA (delayed nausea). At the time of the report, ILLNESS (Getting sick), VOMITING (continous nausea and vomiting) and NAUSEA (delayed nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  It was reported that patient went to emergency room and was treated with anti-nausea medication.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Bruised and later it turned black and blue; turned black and blue; red in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruised and later it turned black and blue), VACCINATION SITE DISCOLOURATION (turned black and blue) and VACCINATION SITE ERYTHEMA (red in the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruised and later it turned black and blue), VACCINATION SITE DISCOLOURATION (turned black and blue) and VACCINATION SITE ERYTHEMA (red in the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruised and later it turned black and blue), VACCINATION SITE DISCOLOURATION (turned black and blue) and VACCINATION SITE ERYTHEMA (red in the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.  Patient reported no adverse event with dose 1.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Administered Pfizer vaccine instead of moderna for the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Administered Pfizer vaccine instead of moderna for the second dose) 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) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Administered Pfizer vaccine instead of moderna for the second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Administered Pfizer vaccine instead of moderna for the second dose) 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.   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Myalgia, Weight decreased
Clinical narrative: "I lost over 25 pounds by this time"; Muscle pain on both shoulders; Decreased appetite / not feeling hungry/ eating only few bites; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Decreased appetite / not feeling hungry/ eating only few bites), WEIGHT DECREASED ("I lost over 25 pounds by this time") and MYALGIA (Muscle pain on both shoulders) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DECREASED APPETITE (Decreased appetite / not feeling hungry/ eating only few bites) and MYALGIA (Muscle pain on both shoulders). On 19-May-2021, the patient experienced WEIGHT DECREASED ("I lost over 25 pounds by this time"). At the time of the report, DECREASED APPETITE (Decreased appetite / not feeling hungry/ eating only few bites) had not resolved and WEIGHT DECREASED ("I lost over 25 pounds by this time") and MYALGIA (Muscle pain on both shoulders) had resolved.            No concomitant medications were provided. No treatment medications were taken by the patient. Action taken with mRNA-1273 in response to the events was not applicable.  The patient stated that she was not enjoying what she was eating, and quoted " I am picky now what I eat".   This case was linked to MOD-2021-147680 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort, Myalgia, Pain, Pain in extremity
Clinical narrative: Any sudden movement give me pain(7 in the pain scale); The inner part and top part where the injection went in is swollen; Pain transferred to the right arm,Pain goes down to the arm; Hardly can lift the arm; Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Any sudden movement give me pain(7 in the pain scale)), LIMB DISCOMFORT (Hardly can lift the arm), PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) and MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Fibromyalgia, Arthritis, Hyperlipidemia, Chronic obstructive pulmonary disease and Bipolar disorder.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (Hardly can lift the arm) and MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts). On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm). On an unknown date, the patient experienced PAIN (Any sudden movement give me pain(7 in the pain scale)) and VACCINATION SITE SWELLING (The inner part and top part where the injection went in is swollen). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. At the time of the report, PAIN (Any sudden movement give me pain(7 in the pain scale)), LIMB DISCOMFORT (Hardly can lift the arm), PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm), MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts) and VACCINATION SITE SWELLING (The inner part and top part where the injection went in is swollen) outcome was unknown.            Patient's inner part and top part where the injection went became swollen.  Doctor suggested the patient for Physical Therapy but the patient not joined.  Treatment includes Doctor prescribed medication for muscle pain.  Concomitant product information includes 3 pills for bipolar.  Action taken with mRNA-1273 in response to the events is not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Any sudden movement give me pain(7 in the pain scale); The inner part and top part where the injection went in is swollen; Pain transferred to the right arm,Pain goes down to the arm; Hardly can lift the arm; Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Any sudden movement give me pain(7 in the pain scale)), LIMB DISCOMFORT (Hardly can lift the arm), PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) and MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Fibromyalgia, Arthritis, Hyperlipidemia, Chronic obstructive pulmonary disease and Bipolar disorder.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (Hardly can lift the arm) and MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts). On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm). On an unknown date, the patient experienced PAIN (Any sudden movement give me pain(7 in the pain scale)) and VACCINATION SITE SWELLING (The inner part and top part where the injection went in is swollen). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. At the time of the report, PAIN (Any sudden movement give me pain(7 in the pain scale)), LIMB DISCOMFORT (Hardly can lift the arm), PAIN IN EXTREMITY (Pain transferred to the right arm,Pain goes down to the arm), MYALGIA (Muscle pain in the left arm of the shot/pain goes down to her elbow,arm hurts) and VACCINATION SITE SWELLING (The inner part and top part where the injection went in is swollen) outcome was unknown.            Patient's inner part and top part where the injection went became swollen.  Doctor suggested the patient for Physical Therapy but the patient not joined.  Treatment includes Doctor prescribed medication for muscle pain.  Concomitant product information includes 3 pills for bipolar.  Action taken with mRNA-1273 in response to the events is not applicable.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Localized sore arm at the site of injection; a 16 year old female patient was administered Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old female patient was administered Moderna Covid-19 vaccine) and VACCINATION SITE PAIN (Localized sore arm at the site of injection) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06B21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021 at 9:57 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021 at 10:53 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021 at 9:57 AM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old female patient was administered Moderna Covid-19 vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (Localized sore arm at the site of injection). On 19-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old female patient was administered Moderna Covid-19 vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Localized sore arm at the site of injection) 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 considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old female patient was administered Moderna Covid-19 vaccine) to have an unknown relationship. No further causality assessment was provided for VACCINATION SITE PAIN (Localized sore arm at the site of injection).    No concomitant products were reported.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information included demographic details of the patient, second dose information and additional event.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Fatigue) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, IBUPROFEN, AZITHROMYCIN and AMOXICILLIN for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 09-Apr-2021, the patient experienced FATIGUE (Fatigue). On 10-Apr-2021, FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-147931 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pyrexia, Rash pruritic, Wheezing
Clinical narrative: wheezing/ tight chest; wheezing/ tight chest; extremely itchy rash on feet, palms of hands; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WHEEZING (wheezing/ tight chest), CHEST DISCOMFORT (wheezing/ tight chest), RASH PRURITIC (extremely itchy rash on feet, palms of hands) and PYREXIA (fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-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 15-May-2021, the patient experienced WHEEZING (wheezing/ tight chest), CHEST DISCOMFORT (wheezing/ tight chest), RASH PRURITIC (extremely itchy rash on feet, palms of hands) and PYREXIA (fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, WHEEZING (wheezing/ tight chest), CHEST DISCOMFORT (wheezing/ tight chest), RASH PRURITIC (extremely itchy rash on feet, palms of hands) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were provided. Patient had been to urgent care (who tested her for COVID) who was unable to distinguish what was wrong. She went to emergency room at Rhode Island Hospital. They performed test and they ran test on her (x-ray due to wheezing/ tight chest). They said they were sure that it had nothing to do with the vaccine.  Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested.   Patient went to emergency room and they said they were sure that it had nothing to do with the vaccine.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: sore arm; itchy face; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face). At the time of the report, PAIN IN EXTREMITY (sore arm) and PRURITUS (itchy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Med Info Agent: Staff
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: High fever 103.6F; Pain on injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever 103.6F) and VACCINATION SITE PAIN (Pain on injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 044B21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PYREXIA (High fever 103.6F) and VACCINATION SITE PAIN (Pain on injection site.). At the time of the report, PYREXIA (High fever 103.6F) and VACCINATION SITE PAIN (Pain on injection site.) outcome was unknown.            No concomitant medications were mentioned. No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: Left arm sore; feeling light headed; In bed most of today; 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 PAIN IN EXTREMITY (Left arm sore), DIZZINESS (feeling light headed) and FATIGUE (In bed most of today) 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 18-May-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 19-May-2021, the patient experienced PAIN IN EXTREMITY (Left arm sore), DIZZINESS (feeling light headed) and FATIGUE (In bed most of today). At the time of the report, PAIN IN EXTREMITY (Left arm sore), DIZZINESS (feeling light headed) and FATIGUE (In bed most of today) outcome 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: Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 after first dose; Missed second dose (beyond 42 days); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (Missed second dose (beyond 42 days)) 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 SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose) and PRODUCT DOSE OMISSION ISSUE (Missed second dose (beyond 42 days)). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose (beyond 42 days)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced MYALGIA (Arm was sore). At the time of the report, MYALGIA (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-147966 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amnesia, Back pain, Dizziness, Fatigue
Clinical narrative: he has ongoing bad taste in her mouth; lost her memory; pain in her back; upset stomach; Pain in her teeth; dizzy; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (he has ongoing bad taste in her mouth), AMNESIA (lost her memory), BACK PAIN (pain in her back), ABDOMINAL DISCOMFORT (upset stomach) and TOOTHACHE (Pain in her teeth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (he has ongoing bad taste in her mouth), AMNESIA (lost her memory), BACK PAIN (pain in her back), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and FATIGUE (fatigue). At the time of the report, TASTE DISORDER (he has ongoing bad taste in her mouth) had not resolved and AMNESIA (lost her memory), BACK PAIN (pain in her back), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-148081 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received: Route of administration and outcome of the events was updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Taste disorder, Toothache
Clinical narrative: he has ongoing bad taste in her mouth; lost her memory; pain in her back; upset stomach; Pain in her teeth; dizzy; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (he has ongoing bad taste in her mouth), AMNESIA (lost her memory), BACK PAIN (pain in her back), ABDOMINAL DISCOMFORT (upset stomach) and TOOTHACHE (Pain in her teeth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (he has ongoing bad taste in her mouth), AMNESIA (lost her memory), BACK PAIN (pain in her back), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and FATIGUE (fatigue). At the time of the report, TASTE DISORDER (he has ongoing bad taste in her mouth) had not resolved and AMNESIA (lost her memory), BACK PAIN (pain in her back), ABDOMINAL DISCOMFORT (upset stomach), TOOTHACHE (Pain in her teeth), DIZZINESS (dizzy), RASH (rash) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-148081 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received: Route of administration and outcome of the events was updated.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to age < 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to age < 18) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to age < 18). On 30-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to age < 18) had 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.   No Concomitant Medications were provided. No Treatment medications were provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: Hard to sleep; Experiencing pretty intense headache; Pretty nauseous; Arm was just sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard to sleep), PAIN IN EXTREMITY (Arm was just sore), HEADACHE (Experiencing pretty intense headache) and NAUSEA (Pretty nauseous) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A1 and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was just sore). On 19-May-2021, the patient experienced INSOMNIA (Hard to sleep), HEADACHE (Experiencing pretty intense headache) and NAUSEA (Pretty nauseous). At the time of the report, INSOMNIA (Hard to sleep), PAIN IN EXTREMITY (Arm was just sore), HEADACHE (Experiencing pretty intense headache) and NAUSEA (Pretty nauseous) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-147945 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a patient was adminstered a 2 hours old vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient was adminstered a 2 hours old vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient was adminstered a 2 hours old vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient was adminstered a 2 hours old vaccine) 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 product use was not provided by the reporter.  Treatment information was not provided.    Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Tired; High fever of 100 degrees; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), PYREXIA (High fever of 100 degrees) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b218a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-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 18-May-2021, the patient experienced FATIGUE (Tired), PYREXIA (High fever of 100 degrees) and NAUSEA (Nausea). The patient was treated with Manual therapy (cold water and ice cubes ) for Pyrexia. At the time of the report, FATIGUE (Tired), PYREXIA (High fever of 100 degrees) and NAUSEA (Nausea) was resolving.            No concomitant medication provided by the reporter    Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Cough, Pain in extremity, Pyrexia
Clinical narrative: Cough; No taste; Fever; Pain at injection arm that is going also to chest and breast; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), AGEUSIA (No taste), PAIN IN EXTREMITY (Pain at injection arm that is going also to chest and breast) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CIPROFLOXACIN HYDROCHLORIDE (CYPREX) for Allergy, GABAPENTIN for Fibromyalgia.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PAIN IN EXTREMITY (Pain at injection arm that is going also to chest and breast). On 18-May-2021, the patient experienced COUGH (Cough), AGEUSIA (No taste) and PYREXIA (Fever). At the time of the report, COUGH (Cough), AGEUSIA (No taste), PAIN IN EXTREMITY (Pain at injection arm that is going also to chest and breast) and PYREXIA (Fever) 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.   treatment to the events not provided.