chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Ultrasound scan, Vomiting
Clinical narrative: Leg cramps; Nausea; Chills; Pounding headache; Vomiting; Tired; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Pounding headache) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemia (Stable) and Thalassemia (Stable). Concomitant products included IRON from 17-Feb-2021 to an unknown date for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-May-2021, the patient experienced MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Pounding headache), VOMITING (Vomiting) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred  on 08-Sep-2021.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 28-May-2021, MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Pounding headache), VOMITING (Vomiting) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Laboratory test: normal normal. On 08-Jun-2021, Ultrasound scan: normal normal.         Concomitant medication included Prenatal from 17-FEB-2021 once a day.    This case was linked to MOD-2021-095487, MOD-2021-095487 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red and purple at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red and purple at the 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red and purple at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red and purple at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case has been linked with the case id- MOD-2021-045301. No concomitant medications were reported. No treatment medication were mentioned by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: NNI
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm injection site; swelling injection site; redness injection site; 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 VACCINATION SITE WARMTH (warm injection site), VACCINATION SITE SWELLING (swelling injection site) and VACCINATION SITE ERYTHEMA (redness injection site) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm injection site), VACCINATION SITE SWELLING (swelling injection site) and VACCINATION SITE ERYTHEMA (redness injection site). At the time of the report, VACCINATION SITE WARMTH (warm injection site), VACCINATION SITE SWELLING (swelling injection site) and VACCINATION SITE ERYTHEMA (redness injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine after expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 038B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HCTCZ (Hydrochlorothiazide), ROSUVASTATIN and OMEPRAZOLE for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry) 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.   Concomitant medication not reported.  Treatment medication not reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Consumer received the first dose of the vaccine at age 17; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Consumer received the first dose of the vaccine at age 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Consumer received the first dose of the vaccine at age 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Consumer received the first dose of the vaccine at age 17) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  and Treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Unspecific Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecific Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Unspecific Adverse event). At the time of the report, ADVERSE EVENT (Unspecific Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; Chill; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chill) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-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 PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chill). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Np treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16-07-2021 contain non significant information
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: slight dizziness; sore arm at vaccine location; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slight dizziness) and VACCINATION SITE PAIN (sore arm at vaccine location) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (slight dizziness) and VACCINATION SITE PAIN (sore arm at vaccine location). At the time of the report, DIZZINESS (slight dizziness) and VACCINATION SITE PAIN (sore arm at vaccine location) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 100F Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (100F Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Jun-2021, the patient experienced PYREXIA (100F Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, PYREXIA (100F Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature (36.1-37.2 degree Celsius): 37.778 degree Celsius High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Breast pain, Confusional state, Decreased appetite
Clinical narrative: Soreness in left breast; Nausea; Extreme fatigue; Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine; Equilibrium issues; Perfused perspiration/Woke up midnight with perfused sweating; Lack of appetite; General malaise; Low grade flu; Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), DECREASED APPETITE (Lack of appetite) and MALAISE (General malaise) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), DECREASED APPETITE (Lack of appetite), MALAISE (General malaise), INFLUENZA (Low grade flu), CONFUSIONAL STATE (Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). On 18-Jun-2021, the patient experienced BREAST PAIN (Soreness in left breast). On 18-Jun-2021, HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), CONFUSIONAL STATE (Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table) and NAUSEA (Nausea) had resolved. At the time of the report, ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), DECREASED APPETITE (Lack of appetite), MALAISE (General malaise), INFLUENZA (Low grade flu), BREAST PAIN (Soreness in left breast) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Influenza, Malaise, Nausea
Clinical narrative: Soreness in left breast; Nausea; Extreme fatigue; Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine; Equilibrium issues; Perfused perspiration/Woke up midnight with perfused sweating; Lack of appetite; General malaise; Low grade flu; Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), DECREASED APPETITE (Lack of appetite) and MALAISE (General malaise) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), DECREASED APPETITE (Lack of appetite), MALAISE (General malaise), INFLUENZA (Low grade flu), CONFUSIONAL STATE (Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). On 18-Jun-2021, the patient experienced BREAST PAIN (Soreness in left breast). On 18-Jun-2021, HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), CONFUSIONAL STATE (Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table) and NAUSEA (Nausea) had resolved. At the time of the report, ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), DECREASED APPETITE (Lack of appetite), MALAISE (General malaise), INFLUENZA (Low grade flu), BREAST PAIN (Soreness in left breast) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever is 102.9; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever is 102.9) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever is 102.9). At the time of the report, PYREXIA (fever is 102.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.9 (High) fever is 102.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: red itchy rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (red itchy rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 RASH PRURITIC (red itchy rash). At the time of the report, RASH PRURITIC (red itchy rash) outcome was unknown.            No concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: her neck is swellen the side of arm took the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (her neck is swellen the side of arm took the shot) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (her neck is swellen the side of arm took the shot). At the time of the report, SWELLING (her neck is swellen the side of arm took the shot) outcome was unknown.            Patient experienced the event one day after receiving the vaccine.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: brother had his second covid shot on Monday put is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (brother had his second covid shot on Monday put is not feeling well) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (brother had his second covid shot on Monday put is not feeling well). At the time of the report, MALAISE (brother had his second covid shot on Monday put is not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No  Concomitant medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: not having an appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (not having an appetite) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (not having an appetite). At the time of the report, DECREASED APPETITE (not having an appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-017971 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Can the vaccine cause weight gain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Can the vaccine cause weight gain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Can the vaccine cause weight gain). At the time of the report, WEIGHT INCREASED (Can the vaccine cause weight gain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-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 HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Patient had event two weeks after vaccine. No treatment medications were provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cough, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: Feels like a prolonged asthma attack; shortness of breath; Coughing; Flu like symptoms; Fatigue; Muscle pain, aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (Muscle pain, aches) and PYREXIA (Fever). The patient was treated with BECLOMETASONE DIPROPIONATE (QVAR) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (Muscle pain, aches) and PYREXIA (Fever) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.  It was reported that after stopping treatment drug the event reoccurred and not resolved.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Feels like a prolonged asthma attack; shortness of breath; Coughing; Flu like symptoms; Fatigue; Muscle pain, aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (Muscle pain, aches) and PYREXIA (Fever). The patient was treated with BECLOMETASONE DIPROPIONATE (QVAR) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (Muscle pain, aches) and PYREXIA (Fever) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.  It was reported that after stopping treatment drug the event reoccurred and not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very fatigued since the vaccines about a month ago; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very fatigued since the vaccines about a month ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (very fatigued since the vaccines about a month ago). At the time of the report, FATIGUE (very fatigued since the vaccines about a month ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYALGIA (Sore arm). In February 2021, MYALGIA (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included vitamins, thyroid medication.   This case was linked to MOD-2021-227771 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, White blood cell count
Clinical narrative: Improvement of a previous condition of CLL leukemia; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (since 2016).   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 mg. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: normal (normal) white cell count decreased to normal levels.         No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: severe head aches; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe head aches), FATIGUE (fatigue) and MYALGIA (body aches) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 HEADACHE (severe head aches), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, HEADACHE (severe head aches), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.            Treatment and concomitant information is not reported.   This case was linked to MOD-2021-227778.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 30-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: I just don't have as much energy; Tiredness since 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I just don't have as much energy) and FATIGUE (Tiredness since 2nd dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included THYROID and VITAMINS NOS for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ASTHENIA (I just don't have as much energy) and FATIGUE (Tiredness since 2nd dose). At the time of the report, ASTHENIA (I just don't have as much energy) and FATIGUE (Tiredness since 2nd dose) outcome was unknown.            No Treatment was reported by the reporter.   This case was linked to MOD-2021-227761 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-jun-2021 had Non significant follow up appended
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 60 days out from first dose and have not received second dose,greater than 45 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (60 days out from first dose and have not received second dose,greater than 45 days since the first dose) in a 53-year-old male patient 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. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (60 days out from first dose and have not received second dose,greater than 45 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (60 days out from first dose and have not received second dose,greater than 45 days since the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No medication history information were reported It was reported that it was greater than 45 days since the first dose. Patient lost his vaccination card and was unable to provide the lot number and date of vaccination, but say it was around 15Apr2021 when mass vaccination stared. Stated he might had received the vaccine in his right arm but was not sure.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received on 21-JUN-2021 contains No new information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness, She began going sideways and had to hold on to the counter, which scared her; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, She began going sideways and had to hold on to the counter, which scared her) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033621A) for COVID-19 vaccination.     Concomitant products included OXYGEN for an unknown indication.    On 17-Jun-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 18-Jun-2021, the patient experienced DIZZINESS (Dizziness, She began going sideways and had to hold on to the counter, which scared her). On 18-Jun-2021, DIZZINESS (Dizziness, She began going sideways and had to hold on to the counter, which scared her) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Myalgia
Clinical narrative: Weakness in muscles of upper arms; Severe head aches; Fatigue; Body aches, severe pain in muscles of upper arms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in muscles of upper arms), HEADACHE (Severe head aches), FATIGUE (Fatigue) and MYALGIA (Body aches, severe pain in muscles of upper arms) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 MUSCULAR WEAKNESS (Weakness in muscles of upper arms), HEADACHE (Severe head aches), FATIGUE (Fatigue) and MYALGIA (Body aches, severe pain in muscles of upper arms). At the time of the report, MUSCULAR WEAKNESS (Weakness in muscles of upper arms) and MYALGIA (Body aches, severe pain in muscles of upper arms) had not resolved and HEADACHE (Severe head aches) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-227764 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: Light headedness/diziness; Pain in chest; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness/diziness), CHEST PAIN (Pain in chest) and DYSPNOEA (Difficulty breathing) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0540C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced DIZZINESS (Light headedness/diziness), CHEST PAIN (Pain in chest) and DYSPNOEA (Difficulty breathing). On 18-Jun-2021, DIZZINESS (Light headedness/diziness) had resolved. At the time of the report, CHEST PAIN (Pain in chest) and DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: soreness at injection site; swelling in left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling in left armpit) and VACCINATION SITE PAIN (soreness at injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Nose infection NOS since 01-Jan-2009. Concomitant products included LORATADINE from 01-Jan-2018 to an unknown date for Allergy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling in left armpit). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 18-Jun-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, LYMPHADENOPATHY (swelling in left armpit) was resolving.            No treatment medication provided. It was reported swelling in left armpit of patient had gotten better.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up received :- Outcome change from Unknown to Recovering/Resolving, concomitant drug added, medical history updated
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick/felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick/felt sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (sick/felt sick). At the time of the report, MALAISE (sick/felt sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects of the moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects of the moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects of the moderna shot). At the time of the report, VACCINATION COMPLICATION (Side effects of the moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: aches after second dose; headaches after second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches after second dose) and HEADACHE (headaches after second 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches after second dose) and HEADACHE (headaches after second dose). At the time of the report, MYALGIA (aches after second dose) and HEADACHE (headaches after second dose) outcome was unknown.            No concomitant medication and treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: I have COVID vaccines second dose skin allergy; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I have COVID vaccines second dose skin allergy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (I have COVID vaccines second dose skin allergy). At the time of the report, ALLERGY TO VACCINE (I have COVID vaccines second dose skin allergy) outcome was unknown.            No concomitant medication was provided by the reporter. No treatment information was provided by the reporter No lab data was provided by the reporter
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Patient exhibited no symptoms and no treatment was given by the time of this call.