chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Headache, Myalgia, Pyrexia
Clinical narrative: Difficulty breathing; Body pain; Fever of 101; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), MYALGIA (Body pain), PYREXIA (Fever of 101) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Bronchitis. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In April 2021, the patient experienced DYSPNOEA (Difficulty breathing), MYALGIA (Body pain), PYREXIA (Fever of 101) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Difficulty breathing) had not resolved and MYALGIA (Body pain), PYREXIA (Fever of 101) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101.         No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site reaction, Tenderness
Clinical narrative: Felt small circle on injection site; Pain on injection site; Skin was red; Arm was tender; 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 ERYTHEMA (Skin was red), TENDERNESS (Arm was tender), INJECTION SITE REACTION (Felt small circle on injection site) and INJECTION SITE PAIN (Pain on injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 23-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 ERYTHEMA (Skin was red), TENDERNESS (Arm was tender) and INJECTION SITE PAIN (Pain on injection site). On 01-May-2021, the patient experienced INJECTION SITE REACTION (Felt small circle on injection site). The patient was treated with NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Skin was red), TENDERNESS (Arm was tender), INJECTION SITE REACTION (Felt small circle on injection site) and INJECTION SITE PAIN (Pain on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Muscle spasms, Paraesthesia
Clinical narrative: facial and feet tingling; dulled sensation to her left ankle down around her left foot as well as in her lower abdomen; muscle spasms; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (facial and feet tingling), HYPOAESTHESIA (dulled sensation to her left ankle down around her left foot as well as in her lower abdomen), MUSCLE SPASMS (muscle spasms) and LYMPHADENOPATHY (swollen lymph nodes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PARAESTHESIA (facial and feet tingling), HYPOAESTHESIA (dulled sensation to her left ankle down around her left foot as well as in her lower abdomen), MUSCLE SPASMS (muscle spasms) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, PARAESTHESIA (facial and feet tingling) had resolved, HYPOAESTHESIA (dulled sensation to her left ankle down around her left foot as well as in her lower abdomen) and MUSCLE SPASMS (muscle spasms) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medicines were  not reported  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-101643 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: difficult, felt like a knot under the skin; very sore, from injection site to the wrist, severe thing that's happened in my life, brought me to my knees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (difficult, felt like a knot under the skin) and VACCINATION SITE PAIN (very sore, from injection site to the wrist, severe thing that's happened in my life, brought me to my knees) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030MZ0A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PAIN (very sore, from injection site to the wrist, severe thing that's happened in my life, brought me to my knees). On 02-May-2021, the patient experienced VACCINATION SITE INDURATION (difficult, felt like a knot under the skin). The patient was treated with IBUPROFEN in May 2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE INDURATION (difficult, felt like a knot under the skin) and VACCINATION SITE PAIN (very sore, from injection site to the wrist, severe thing that's happened in my life, brought me to my knees) outcome was unknown.            No Patient lab data was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-101830 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received and No New Information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101830:Neighbor's case
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: rash on breasts/more on right breast and less on left, bumpy and red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rash on breasts/more on right breast and less on left, bumpy and red) and PRURITUS (itchy) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced RASH ERYTHEMATOUS (rash on breasts/more on right breast and less on left, bumpy and red) and PRURITUS (itchy). The patient was treated with HYDROGEN PEROXIDE at a dose of UNK dosage form and OXYTETRACYCLINE CALCIUM (TERRAMICINA [OXYTETRACYCLINE CALCIUM]) at a dose of UNK dosage form. At the time of the report, RASH ERYTHEMATOUS (rash on breasts/more on right breast and less on left, bumpy and red) and PRURITUS (itchy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated drug and events start date.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling down the side of my neck; numbness and tingling down the side of my neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness and tingling down the side of my neck) and PARAESTHESIA (numbness and tingling down the side of my neck) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Root canal procedure (one month prior to first vaccine dose) in February 2021.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPOAESTHESIA (numbness and tingling down the side of my neck) and PARAESTHESIA (numbness and tingling down the side of my neck). At the time of the report, HYPOAESTHESIA (numbness and tingling down the side of my neck) and PARAESTHESIA (numbness and tingling down the side of my neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; both biceps, chest, torso and both legs; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (hives; both biceps, chest, torso and both legs) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, the patient experienced URTICARIA (hives; both biceps, chest, torso and both legs). On 11-Apr-2021, URTICARIA (hives; both biceps, chest, torso and both legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Lip blister, Lip swelling
Clinical narrative: lost appetite; blister on it's lip; lip got swollen; Had Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite), LIP BLISTER (blister on it's lip), LIP SWELLING (lip got swollen) and CHILLS (Had Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant in 2012.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (lost appetite), LIP BLISTER (blister on it's lip), LIP SWELLING (lip got swollen) and CHILLS (Had Chills). At the time of the report, DECREASED APPETITE (lost appetite), LIP BLISTER (blister on it's lip), LIP SWELLING (lip got swollen) and CHILLS (Had Chills) 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 was reported.  Treatment information included Valacyclovir for 5 days.   This case was linked to MOD-2021-101635 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes on right breast; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes on right breast) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 032M204) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on right breast). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes on right breast) outcome was unknown. Not Provided          This case was linked to MOD-2021-048471 (E2B Linked Report).; Sender's Comments:  MOD-2021-048471:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Decreased appetite, Fatigue, Muscle spasms
Clinical narrative: tightness in chest; muscle spasm,cramps in calves; loss of appetite; body ache; joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest), MUSCLE SPASMS (muscle spasm,cramps in calves), DECREASED APPETITE (loss of appetite), MYALGIA (body ache) and ARTHRALGIA (joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 30-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) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced CHEST DISCOMFORT (tightness in chest), MUSCLE SPASMS (muscle spasm,cramps in calves), DECREASED APPETITE (loss of appetite), MYALGIA (body ache), ARTHRALGIA (joint pain) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (tightness in chest), DECREASED APPETITE (loss of appetite), MYALGIA (body ache), ARTHRALGIA (joint pain) and FATIGUE (fatigue) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment medication included Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: tightness in chest; muscle spasm,cramps in calves; loss of appetite; body ache; joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest), MUSCLE SPASMS (muscle spasm,cramps in calves), DECREASED APPETITE (loss of appetite), MYALGIA (body ache) and ARTHRALGIA (joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 30-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) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced CHEST DISCOMFORT (tightness in chest), MUSCLE SPASMS (muscle spasm,cramps in calves), DECREASED APPETITE (loss of appetite), MYALGIA (body ache), ARTHRALGIA (joint pain) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (tightness in chest), DECREASED APPETITE (loss of appetite), MYALGIA (body ache), ARTHRALGIA (joint pain) and FATIGUE (fatigue) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment medication included Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash on the inside of the elbow; Itchiness on the inside of the elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash on the inside of the elbow) and PRURITUS (Itchiness on the inside of the elbow) in a 57-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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on the inside of the elbow) and PRURITUS (Itchiness on the inside of the elbow). At the time of the report, RASH ERYTHEMATOUS (Red rash on the inside of the elbow) and PRURITUS (Itchiness on the inside of the elbow) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave 2nd dose to a patient 2 weeks after patient received their 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave 2nd dose to a patient 2 weeks after patient received their 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave 2nd dose to a patient 2 weeks after patient received their 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave 2nd dose to a patient 2 weeks after patient received their 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: patient has all the side effects listed; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION COMPLICATION (patient has all the side effects listed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) unknown. On an unknown date, the patient experienced VACCINATION COMPLICATION (patient has all the side effects listed). At the time of the report, VACCINATION COMPLICATION (patient has all the side effects listed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling of body temperature change, SARS-CoV-2 test
Clinical narrative: COVID-19; feeling hot and then cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold) and COVID-19 (COVID-19 ) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold). On 29-Apr-2021, the patient experienced COVID-19 (COVID-19 ). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 27-Apr-2021, FEELING OF BODY TEMPERATURE CHANGE (feeling hot and then cold) had resolved. On 03-May-2021, COVID-19 (COVID-19 ) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 02-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Urticaria
Clinical narrative: painful arm; arm is red and warm; arm is red and warm; hives on the arm and under the armpit.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), ERYTHEMA (arm is red and warm), FEELING HOT (arm is red and warm) and URTICARIA (hives on the arm and under the armpit.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant (Patient had liver transplant in 2012) in 2012.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm), ERYTHEMA (arm is red and warm), FEELING HOT (arm is red and warm) and URTICARIA (hives on the arm and under the armpit.). At the time of the report, PAIN IN EXTREMITY (painful arm), ERYTHEMA (arm is red and warm), FEELING HOT (arm is red and warm) and URTICARIA (hives on the arm and under the armpit.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101623.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: slight headache; son received the vaccine at the age of 16; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son received the vaccine at the age of 16) and HEADACHE (slight headache) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son received the vaccine at the age of 16). On an unknown date, the patient experienced HEADACHE (slight headache). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (son received the vaccine at the age of 16) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment or concomitant medication were reported.  The reporter wanted to know if it was ok for the patient to be under the age of 18.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: difficulty breathing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and COUGH (coughing) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing) and COUGH (coughing). At the time of the report, DYSPNOEA (difficulty breathing) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (light headedness). At the time of the report, DIZZINESS (light headedness) outcome was unknown. Not Provided          Concomitant medication use was not reported.  Treatment information was not reported. Patient experienced Elevated blood pressure.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Somnolence
Clinical narrative: itching is so bad all over the body; drowsy; I can hardly function; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (itching is so bad all over the body), SOMNOLENCE (drowsy) and FEELING ABNORMAL (I can hardly function) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-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 an unknown date, the patient experienced PRURITUS (itching is so bad all over the body), SOMNOLENCE (drowsy) and FEELING ABNORMAL (I can hardly function). At the time of the report, PRURITUS (itching is so bad all over the body), SOMNOLENCE (drowsy) and FEELING ABNORMAL (I can hardly function) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-015143 (Patient Link).   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Rash
Clinical narrative: rash on her neck area; mild tingling in her face; swollen lymph nodes above the collar bone; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash on her neck area), PARAESTHESIA (mild tingling in her face) and LYMPHADENOPATHY (swollen lymph nodes above the collar bone) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RASH (rash on her neck area), PARAESTHESIA (mild tingling in her face) and LYMPHADENOPATHY (swollen lymph nodes above the collar bone). On 28-Mar-2021, PARAESTHESIA (mild tingling in her face) had resolved. At the time of the report, RASH (rash on her neck area) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes above the collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101615 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Induration, Rash
Clinical narrative: bumps are hardening; Rash; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (bumps are hardening) and RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INDURATION (bumps are hardening) and RASH (Rash). At the time of the report, INDURATION (bumps are hardening) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash, Rash macular, Vaccination site pain, Vaccination site pruritus
Clinical narrative: spot was blotchy; spot was warm to touch; rashes on the surrounding; spot was itchy; spot was swollen; tenderness on the injection site for a couple of days; bit of a chill; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (spot was blotchy), VACCINATION SITE WARMTH (spot was warm to touch), RASH (rashes on the surrounding), VACCINATION SITE PRURITUS (spot was itchy) and CHILLS (bit of a chill) in a 40-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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CHILLS (bit of a chill), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE PAIN (tenderness on the injection site for a couple of days). On 01-May-2021, the patient experienced RASH MACULAR (spot was blotchy), VACCINATION SITE WARMTH (spot was warm to touch), RASH (rashes on the surrounding), VACCINATION SITE PRURITUS (spot was itchy) and VACCINATION SITE SWELLING (spot was swollen). At the time of the report, RASH MACULAR (spot was blotchy), VACCINATION SITE WARMTH (spot was warm to touch), RASH (rashes on the surrounding), VACCINATION SITE PRURITUS (spot was itchy), CHILLS (bit of a chill), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE SWELLING (spot was swollen) and VACCINATION SITE PAIN (tenderness on the injection site for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information for the events was provided.  Patient  reported she would be going to see her primary healthcare physician the day after the report was given.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: spot was blotchy; spot was warm to touch; rashes on the surrounding; spot was itchy; spot was swollen; tenderness on the injection site for a couple of days; bit of a chill; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (spot was blotchy), VACCINATION SITE WARMTH (spot was warm to touch), RASH (rashes on the surrounding), VACCINATION SITE PRURITUS (spot was itchy) and CHILLS (bit of a chill) in a 40-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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CHILLS (bit of a chill), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE PAIN (tenderness on the injection site for a couple of days). On 01-May-2021, the patient experienced RASH MACULAR (spot was blotchy), VACCINATION SITE WARMTH (spot was warm to touch), RASH (rashes on the surrounding), VACCINATION SITE PRURITUS (spot was itchy) and VACCINATION SITE SWELLING (spot was swollen). At the time of the report, RASH MACULAR (spot was blotchy), VACCINATION SITE WARMTH (spot was warm to touch), RASH (rashes on the surrounding), VACCINATION SITE PRURITUS (spot was itchy), CHILLS (bit of a chill), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE SWELLING (spot was swollen) and VACCINATION SITE PAIN (tenderness on the injection site for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information for the events was provided.  Patient  reported she would be going to see her primary healthcare physician the day after the report was given.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Two weeks later, she received her second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two weeks later, she received her second dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 008C21A) 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) 2 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two weeks later, she received her second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two weeks later, she received her second dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Chills, Dizziness, Dry eye, Facial discomfort
Clinical narrative: muscle cramps; lightheaded dizziness; eyes felt dry; muscles in face felt tight; bladder started to act up and urination every few minutes; pressure around eyes; tingling in tongue; not feeling herself; muscle tightness; tiredness; soreness; began to vomit; headaches; chills; drop in blood sugar in a friend; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend), PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), DRY EYE (eyes felt dry) and FACIAL DISCOMFORT (muscles in face felt tight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine in February 2021. Past adverse reactions to the above products included Adverse event with Influenza vaccine.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-1900, the patient experienced BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend). On 09-Apr-2021, the patient experienced PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), MYALGIA (muscle tightness), FATIGUE (tiredness), INJECTION SITE PAIN (soreness), VOMITING (began to vomit), HEADACHE (headaches) and CHILLS (chills). On 10-Apr-2021, the patient experienced DRY EYE (eyes felt dry), FACIAL DISCOMFORT (muscles in face felt tight), POLLAKIURIA (bladder started to act up and urination every few minutes) and PERIORBITAL DISCOMFORT (pressure around eyes). On 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle cramps) and DIZZINESS (lightheaded dizziness). At the time of the report, BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend), PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), DRY EYE (eyes felt dry), FACIAL DISCOMFORT (muscles in face felt tight), POLLAKIURIA (bladder started to act up and urination every few minutes), PERIORBITAL DISCOMFORT (pressure around eyes), MUSCLE SPASMS (muscle cramps), DIZZINESS (lightheaded dizziness), MYALGIA (muscle tightness), FATIGUE (tiredness), INJECTION SITE PAIN (soreness), VOMITING (began to vomit), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to MOD21-085383, MOD21-085590, MOD21-085592, US-MODERNATX, INC.-MOD-2021-101678 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-085383: MOD21-085590: MOD21-085592: US-MODERNATX, INC.-MOD-2021-101678:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Muscle spasms
Clinical narrative: muscle cramps; lightheaded dizziness; eyes felt dry; muscles in face felt tight; bladder started to act up and urination every few minutes; pressure around eyes; tingling in tongue; not feeling herself; muscle tightness; tiredness; soreness; began to vomit; headaches; chills; drop in blood sugar in a friend; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend), PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), DRY EYE (eyes felt dry) and FACIAL DISCOMFORT (muscles in face felt tight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine in February 2021. Past adverse reactions to the above products included Adverse event with Influenza vaccine.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-1900, the patient experienced BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend). On 09-Apr-2021, the patient experienced PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), MYALGIA (muscle tightness), FATIGUE (tiredness), INJECTION SITE PAIN (soreness), VOMITING (began to vomit), HEADACHE (headaches) and CHILLS (chills). On 10-Apr-2021, the patient experienced DRY EYE (eyes felt dry), FACIAL DISCOMFORT (muscles in face felt tight), POLLAKIURIA (bladder started to act up and urination every few minutes) and PERIORBITAL DISCOMFORT (pressure around eyes). On 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle cramps) and DIZZINESS (lightheaded dizziness). At the time of the report, BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend), PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), DRY EYE (eyes felt dry), FACIAL DISCOMFORT (muscles in face felt tight), POLLAKIURIA (bladder started to act up and urination every few minutes), PERIORBITAL DISCOMFORT (pressure around eyes), MUSCLE SPASMS (muscle cramps), DIZZINESS (lightheaded dizziness), MYALGIA (muscle tightness), FATIGUE (tiredness), INJECTION SITE PAIN (soreness), VOMITING (began to vomit), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to MOD21-085383, MOD21-085590, MOD21-085592, US-MODERNATX, INC.-MOD-2021-101678 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-085383: MOD21-085590: MOD21-085592: US-MODERNATX, INC.-MOD-2021-101678:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia oral, Periorbital discomfort, Pollakiuria, Vomiting
Clinical narrative: muscle cramps; lightheaded dizziness; eyes felt dry; muscles in face felt tight; bladder started to act up and urination every few minutes; pressure around eyes; tingling in tongue; not feeling herself; muscle tightness; tiredness; soreness; began to vomit; headaches; chills; drop in blood sugar in a friend; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend), PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), DRY EYE (eyes felt dry) and FACIAL DISCOMFORT (muscles in face felt tight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine in February 2021. Past adverse reactions to the above products included Adverse event with Influenza vaccine.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-1900, the patient experienced BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend). On 09-Apr-2021, the patient experienced PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), MYALGIA (muscle tightness), FATIGUE (tiredness), INJECTION SITE PAIN (soreness), VOMITING (began to vomit), HEADACHE (headaches) and CHILLS (chills). On 10-Apr-2021, the patient experienced DRY EYE (eyes felt dry), FACIAL DISCOMFORT (muscles in face felt tight), POLLAKIURIA (bladder started to act up and urination every few minutes) and PERIORBITAL DISCOMFORT (pressure around eyes). On 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle cramps) and DIZZINESS (lightheaded dizziness). At the time of the report, BLOOD GLUCOSE DECREASED (drop in blood sugar in a friend), PARAESTHESIA ORAL (tingling in tongue), MALAISE (not feeling herself), DRY EYE (eyes felt dry), FACIAL DISCOMFORT (muscles in face felt tight), POLLAKIURIA (bladder started to act up and urination every few minutes), PERIORBITAL DISCOMFORT (pressure around eyes), MUSCLE SPASMS (muscle cramps), DIZZINESS (lightheaded dizziness), MYALGIA (muscle tightness), FATIGUE (tiredness), INJECTION SITE PAIN (soreness), VOMITING (began to vomit), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to MOD21-085383, MOD21-085590, MOD21-085592, US-MODERNATX, INC.-MOD-2021-101678 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-085383: MOD21-085590: MOD21-085592: US-MODERNATX, INC.-MOD-2021-101678:
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: had an outbreak of Herpes; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (had an outbreak of Herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes infection.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HERPES VIRUS INFECTION (had an outbreak of Herpes). At the time of the report, HERPES VIRUS INFECTION (had an outbreak of Herpes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient had outbreak of Herpes approximately two weeks after the first dose. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042BZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-101555 (E2B Linked Report). This case was linked to MOD-2021-101685 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101555:Crosslinked case