chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Again, about two weeks later, the hip joint pain returned; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Again, about two weeks later, the hip joint pain returned) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 02SL20A) for COVID-19 vaccination.     No medication history information was provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN and ATENOLOL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-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 ARTHRALGIA (Again, about two weeks later, the hip joint pain returned). At the time of the report, ARTHRALGIA (Again, about two weeks later, the hip joint pain returned) had resolved.            Concomitant medication includes Olm ned flesh hctz 40-25.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Additional information received and reporters information added, patient demographics added, concomitant medications added.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness on the entire face after the first shot; Pain in  left arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the entire face after the first shot), PAIN IN EXTREMITY (Pain in  left arm) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy (Mild Neuropathy in feet,) and Vitamin deficiency (B).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on the entire face after the first shot), PAIN IN EXTREMITY (Pain in  left arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Jan-2021, HYPOAESTHESIA (Numbness on the entire face after the first shot) had resolved. On 21-Jan-2021, PAIN IN EXTREMITY (Pain in  left arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported.  Patient was not sure about Benadryl.   This case was linked to MOD-2021-289712, MOD-2021-290616 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Wrong technique in device usage process
Clinical narrative: storage condition; Vaccine administered after being expired; syringe was given chance to warm up a bit while waiting on the patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after being expired), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (syringe was given chance to warm up a bit while waiting on the patients) and PRODUCT STORAGE ERROR (storage condition) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after being expired) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (syringe was given chance to warm up a bit while waiting on the patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (storage condition). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after being expired), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (syringe was given chance to warm up a bit while waiting on the patients) and PRODUCT STORAGE ERROR (storage condition) 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 concomitants were reported no treatment drugs were reported Vaccine was stored in fridge before administration No visual changes of vaccine Maximum temperature was 41 degrees Fahrenheit with average temperature of 39.8 degrees Fahrenheit and minimum: 38.6 degrees Fahrenheit
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Heart rate, Myalgia, Oxygen saturation
Clinical narrative: Pain in the chest; warm; Arm was sore; Chilly/ it comes and goes 2 or 3 times; This spontaneous case was reported by a non-health professional and describes the occurrence of CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times). At the time of the report, CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: >60 (normal) Normal. On an unknown date, Oxygen saturation: >94 (normal) Blood oxygen level normal, more than 94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency but was told to return 24 hours later since the nurse said it was not an emergency.  Concomitant medication was not provided.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Pain in the chest; warm; Arm was sore; Chilly/ it comes and goes 2 or 3 times; This spontaneous case was reported by a non-health professional and describes the occurrence of CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times). At the time of the report, CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: >60 (normal) Normal. On an unknown date, Oxygen saturation: >94 (normal) Blood oxygen level normal, more than 94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency but was told to return 24 hours later since the nurse said it was not an emergency.  Concomitant medication was not provided.  Treatment information was not provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia, Vomiting
Clinical narrative: his stomach felt like throwing up; chills; fever; was ill for about 3 to 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was ill for about 3 to 4 days), VOMITING (his stomach felt like throwing up), CHILLS (chills) and PYREXIA (fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was ill for about 3 to 4 days), VOMITING (his stomach felt like throwing up), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (was ill for about 3 to 4 days), VOMITING (his stomach felt like throwing up), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-289826 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: I had a bad reaction to my second moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I had a bad reaction to my second moderna 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine). At the time of the report, VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Am I outside the window to receive a second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031C20A) for COVID-19 vaccination. No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Influenza like illness, Myalgia
Clinical narrative: inflammation at injection site; redness at injection site; joint aches; bit of a headache; muscle aches; flu-like symptoms; felt blah and felt icky; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), VACCINATION SITE INFLAMMATION (inflammation at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ARTHRALGIA (joint aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included statin and blood pressure medicines
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: inflammation at injection site; redness at injection site; joint aches; bit of a headache; muscle aches; flu-like symptoms; felt blah and felt icky; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), VACCINATION SITE INFLAMMATION (inflammation at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ARTHRALGIA (joint aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included statin and blood pressure medicines
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Sinusitis
Clinical narrative: sinus infection; doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) and PRODUCT DOSE OMISSION ISSUE (doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection) and PRODUCT DOSE OMISSION ISSUE (doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose). At the time of the report, SINUSITIS (sinus infection) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Patient was treated with antibiotics.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Cough, Dyspnoea
Clinical narrative: He lost his taste on the tongue; After receiving vaccine, he was coughing next day; He had shortness of breath that started on next day; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (After receiving vaccine, he was coughing next day), DYSPNOEA (He had shortness of breath that started on next day) and AGEUSIA (He lost his taste on the tongue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes and Arrhythmia (flutter arrhythmia). Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, FOLIC ACID, METFORMIN and VITAMIN B NOS for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced COUGH (After receiving vaccine, he was coughing next day) and DYSPNOEA (He had shortness of breath that started on next day). On an unknown date, the patient experienced AGEUSIA (He lost his taste on the tongue). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN DRY COUGH) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COUGH (After receiving vaccine, he was coughing next day) and AGEUSIA (He lost his taste on the tongue) outcome was unknown and DYSPNOEA (He had shortness of breath that started on next day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tenderness
Clinical narrative: Has not received the second dose; Tenderness in both underarms; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in both underarms) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced TENDERNESS (Tenderness in both underarms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Tenderness, at an unspecified dose and frequency. On 05-Jun-2021, TENDERNESS (Tenderness in both underarms) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that she had not received the second dose of the Moderna COVID-19 vaccine.  No concomitant product use was provided by the reporter.  The patient received the first dose of the Moderna COVID-19 vaccine on 03June2021 and the dose was given in the patients left arms. The next day 04June2021, after the first dose the patient reported experiencing tenderness in both underarms. The patient explained the tenderness under the arms went away within 24 hours. The patient took Tylenol to help with the symptom. The patient does not take any daily medications. The patient stated they lost their vaccine card and they are unable to provide the lot number at this time. The patient has not received the second dose of the Moderna COVID-19 vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Hyperhidrosis
Clinical narrative: Hot/cold feeling; Sweating; Flu like symptoms; Chills; Fever; bad headache; really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired). On 11-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired) had resolved.            No concomitant product reported by reporter. No treatment medication reported by reporter. Side effects lasted for about 24 hours. No side effects are present at the time of the call.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Hot/cold feeling; Sweating; Flu like symptoms; Chills; Fever; bad headache; really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired). On 11-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired) had resolved.            No concomitant product reported by reporter. No treatment medication reported by reporter. Side effects lasted for about 24 hours. No side effects are present at the time of the call.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Vial was not completely in liquid state prior to the administration; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration). On 18-Aug-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration) had resolved.            No concomitant medication was provided. No treatment medication was provided. Reporter reported that the vial was not fully thawed and the administrator warmed it in her hand "was almost fully liquid" before administration.  Nurse stated that she took the vial out of the freezer in the morning around 7AM and the vial thawed for 2 hours but was not completely in liquid state prior to the medical assistant administering the dose to the patient.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received and contains nonsignificant information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Electrocardiogram, Laboratory test, Vomiting
Clinical narrative: Severe upper abdominal pain, Recurring episodes upper abdominal pain; Vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) and VOMITING (Vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On 09-Aug-2021, ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Laboratory test: abnormal (abnormal) abnormal revealed some  irregular numbers.     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 concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient got first dose in April and has not gotten the second dose yet.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.) 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 are provided by the reporter.   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypoaesthesia, Illness, Pyrexia
Clinical narrative: COVID-19; Lack of efficacy; numbness 2 fingers; was sick starting 3 days before testing positive; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy), ILLNESS (was sick starting 3 days before testing positive), HYPOAESTHESIA (numbness 2 fingers) and PYREXIA (fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (on Ocrevus infusion twice a year.). Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced PYREXIA (fever). On 07-Aug-2021, the patient experienced ILLNESS (was sick starting 3 days before testing positive). On 10-Aug-2021, the patient experienced COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy) and HYPOAESTHESIA (numbness 2 fingers). At the time of the report, COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy), ILLNESS (was sick starting 3 days before testing positive) and HYPOAESTHESIA (numbness 2 fingers) outcome was unknown and PYREXIA (fever) had resolved.            No treatment medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort
Clinical narrative: I suffer from exhaustion; can barely hold my head up on both shots; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots). At the time of the report, FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots) outcome was unknown.            No concomitant and treatment medication was provide by patient.     Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Reporter is discussing about her husband's AE and medical condition. On 18-Aug-2021: Reporter is discussing about her husband's AE and medical condition.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Drug ineffective
Clinical narrative: COVID-19; Loss of taste and smell; Loss of taste and smell; Congestion; Cough here and there; Sneeze here and there; Body fatigue; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion) and COUGH (Cough here and there) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The consumer have received first dose of Moderna COVID-19 vaccine on 21 May 2021 and second dose on 21 June 2021. The consumer had tested positive for COVID-19 on 16 Aug 2021 and her symptoms are loss of taste and smell, congestion, cough here and there, sneeze here and there and body fatigue.  No concomitant product use was provided by the reporter.    No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, SARS-CoV-2 test, Sneezing
Clinical narrative: COVID-19; Loss of taste and smell; Loss of taste and smell; Congestion; Cough here and there; Sneeze here and there; Body fatigue; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion) and COUGH (Cough here and there) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), NASAL CONGESTION (Congestion), COUGH (Cough here and there), SNEEZING (Sneeze here and there), FATIGUE (Body fatigue) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The consumer have received first dose of Moderna COVID-19 vaccine on 21 May 2021 and second dose on 21 June 2021. The consumer had tested positive for COVID-19 on 16 Aug 2021 and her symptoms are loss of taste and smell, congestion, cough here and there, sneeze here and there and body fatigue.  No concomitant product use was provided by the reporter.    No treatment medications were reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive Positive.         No concomitant medication was reported. No treatment medication was reported.  Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This is a case of lack of efficacy of the product.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This is a case of lack of efficacy of the product.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Productive cough, Pulmonary congestion
Clinical narrative: low blood pressure (9 days) (80/40's); blood pressure went up 190/98; lungs became congested/congestion; coughing up phlegm; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lungs became congested/congestion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (had a heart attack at 62 years old) and Lyme disease. Concomitant products included CLOPIDOGREL, ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, LISINOPRIL, SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PULMONARY CONGESTION (lungs became congested/congestion) (seriousness criterion medically significant) and PRODUCTIVE COUGH (coughing up phlegm). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (low blood pressure (9 days) (80/40's)) and BLOOD PRESSURE INCREASED (blood pressure went up 190/98). At the time of the report, PULMONARY CONGESTION (lungs became congested/congestion) had not resolved and PRODUCTIVE COUGH (coughing up phlegm), BLOOD PRESSURE DECREASED (low blood pressure (9 days) (80/40's)) and BLOOD PRESSURE INCREASED (blood pressure went up 190/98) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) 80/40's and increased (High) 190/98.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included statins drugs.  Treatment was not given.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 02FL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) (seriousness criterion medically significant). At the time of the report, RASH (She has had problems with a rash since/ a rash on her shoulder/ rash on her breasts/ She has a rash on her upper body/ a rash on her arm and head/a rash on her chest) outcome was unknown.            Concomitant medication included Zedia.  After the second shot of vaccination, patient visited dermatologist, a family practice, and the emergency room. She had problems with a rash since. The doctor prescribed with something to put on the head for the rash so she could sleep at night. Patient had salves, lotions but nothing had helped her.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Feeling abnormal, Lip dry, Pruritus
Clinical narrative: skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes; It burns/on the sides of the mouth and the lips they just burns; Dry skin; I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been; it's dry, on the sides of the mouth and the lips; Itchy; Redness/It's all over my neck. It just everywhere"; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been) and LIP DRY (it's dry, on the sides of the mouth and the lips) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013421A and 012A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 positive and was hospitalized 8 days) in August 2020 and Lumpectomy.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-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 SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been), LIP DRY (it's dry, on the sides of the mouth and the lips), PRURITUS (Itchy) and ERYTHEMA (Redness/It's all over my neck. It just everywhere"). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK, qid 7 days. At the time of the report, SKIN DISCOMFORT (skin issue/skin issue around the eyes, mouth, palm all broken out/comes and goes), SKIN BURNING SENSATION (It burns/on the sides of the mouth and the lips they just burns), DRY SKIN (Dry skin), FEELING ABNORMAL (I'm having stuff i never had, had seraph but in the legs, the mouth and the eyes have never been), LIP DRY (it's dry, on the sides of the mouth and the lips), PRURITUS (Itchy) and ERYTHEMA (Redness/It's all over my neck. It just everywhere") had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Laboratory details: Biopsy done but results were not provided