chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an adverse 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse reaction). At the time of the report, VACCINATION COMPLICATION (Had an adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: Having burning pain in her arm, veins are burning; Her legs were having burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Having burning pain in her arm, veins are burning) and BURNING SENSATION (Her legs were having burning sensation) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Acid reflux (oesophageal). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), MULTI VITAMIN & MINERAL for an unknown indication.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (Having burning pain in her arm, veins are burning) and BURNING SENSATION (Her legs were having burning sensation). At the time of the report, PAIN (Having burning pain in her arm, veins are burning) and BURNING SENSATION (Her legs were having burning sensation) had not resolved.            Concomitant medications included Multi-Vitamin and ultra-mega vitamins.  Treatment information was not provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: left side chest pain like someone was pushing down on chest; shortness of breath/hurts to take a deep breath in; Flu like symptoms; lightheaded; cold tingling sensation along both arms and both legs; very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (left side chest pain like someone was pushing down on chest), DYSPNOEA (shortness of breath/hurts to take a deep breath in), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (lightheaded) and PARAESTHESIA (cold tingling sensation along both arms and both legs) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PARAESTHESIA (cold tingling sensation along both arms and both legs) and FATIGUE (very tired). August 2021, the patient experienced DIZZINESS (lightheaded). On 30-Aug-2021, the patient experienced CHEST PAIN (left side chest pain like someone was pushing down on chest) and DYSPNOEA (shortness of breath/hurts to take a deep breath in). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Sleeplessness, at a dose of Unknown and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleeplessness, at a dose of Unknown. At the time of the report, CHEST PAIN (left side chest pain like someone was pushing down on chest) and DYSPNOEA (shortness of breath/hurts to take a deep breath in) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (lightheaded), PARAESTHESIA (cold tingling sensation along both arms and both legs) and FATIGUE (very tired) outcome was unknown.            No concomitant medication were reported.   This case was linked to MOD-2021-301521 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: left side chest pain like someone was pushing down on chest; shortness of breath/hurts to take a deep breath in; Flu like symptoms; lightheaded; cold tingling sensation along both arms and both legs; very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (left side chest pain like someone was pushing down on chest), DYSPNOEA (shortness of breath/hurts to take a deep breath in), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (lightheaded) and PARAESTHESIA (cold tingling sensation along both arms and both legs) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PARAESTHESIA (cold tingling sensation along both arms and both legs) and FATIGUE (very tired). August 2021, the patient experienced DIZZINESS (lightheaded). On 30-Aug-2021, the patient experienced CHEST PAIN (left side chest pain like someone was pushing down on chest) and DYSPNOEA (shortness of breath/hurts to take a deep breath in). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Sleeplessness, at a dose of Unknown and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleeplessness, at a dose of Unknown. At the time of the report, CHEST PAIN (left side chest pain like someone was pushing down on chest) and DYSPNOEA (shortness of breath/hurts to take a deep breath in) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (lightheaded), PARAESTHESIA (cold tingling sensation along both arms and both legs) and FATIGUE (very tired) outcome was unknown.            No concomitant medication were reported.   This case was linked to MOD-2021-301521 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: vision changes/it was swirling; milky-cloudy-like vision. my vision is a little cloudy; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision changes/it was swirling) and VISION BLURRED (milky-cloudy-like vision. my vision is a little cloudy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced VISION BLURRED (milky-cloudy-like vision. my vision is a little cloudy). On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision changes/it was swirling). At the time of the report, VISUAL IMPAIRMENT (vision changes/it was swirling) and VISION BLURRED (milky-cloudy-like vision. my vision is a little cloudy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant information was provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow-up information received on 30-AUG-2021 contains significant information. New events were updated.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient may be getting a vaccine from a refrozen vial; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Patient may be getting a vaccine from a refrozen vial) 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 PRODUCT STORAGE ERROR (Patient may be getting a vaccine from a refrozen vial). At the time of the report, PRODUCT STORAGE ERROR (Patient may be getting a vaccine from a refrozen vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient missed her second dose of Modena; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed her second dose of Modena) 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 PRODUCT DOSE OMISSION ISSUE (patient missed her second dose of Modena). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed her second dose of Modena) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus infection
Clinical narrative: tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of CORONAVIRUS INFECTION (tested 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 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORONAVIRUS INFECTION (tested positive for COVID). At the time of the report, CORONAVIRUS INFECTION (tested positive for COVID) 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 provided. No treatment medications were provided. Patient stated that- patient got the vaccine on 8/12 and tested positive for Covid on Monday could it be a false positive?; Sender's Comments: Based on the information that the vaccine does not include virus capable of transmitting COVID-19, the event is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Yesterday and today I'm having diarrhea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Yesterday and today I'm having diarrhea) 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 DIARRHOEA (Yesterday and today I'm having diarrhea). At the time of the report, DIARRHOEA (Yesterday and today I'm having diarrhea) 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 was provided.  No Treatment  medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: If the vaccine causes a sore throat; Chills; Body aches; Fatigue; 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 OROPHARYNGEAL PAIN (If the vaccine causes a sore throat), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 OROPHARYNGEAL PAIN (If the vaccine causes a sore throat), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL PAIN (If the vaccine causes a sore throat), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Condition aggravated, Decreased appetite, Fatigue
Clinical narrative: I was very very sweaty/ I woke up in a pool of sweat; Symptoms are much worse; I was a little tired; slight fever; chills; I am very weak; I can hardly walk; I totally lost my appetite; The injection site blew; It is very hard/ It is like a ball; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat) and CONDITION AGGRAVATED (Symptoms are much worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Polymyalgia rheumatica. Concomitant products included INSULIN, METFORMIN and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), INJECTION SITE SWELLING (The injection site blew) and VACCINATION SITE INDURATION (It is very hard/ It is like a ball). On 29-Aug-2021, the patient experienced PYREXIA (slight fever) and CHILLS (chills). On an unknown date, the patient experienced HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse) and FATIGUE (I was a little tired). At the time of the report, ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk) and DECREASED APPETITE (I totally lost my appetite) had not resolved and HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse), INJECTION SITE SWELLING (The injection site blew), VACCINATION SITE INDURATION (It is very hard/ It is like a ball), PYREXIA (slight fever), CHILLS (chills) and FATIGUE (I was a little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes FIBRIC ACID for Diabetes.  No treatment medication were provided by the reporter   This case was linked to MOD-2021-301856, MOD-2021-301864 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Injection site swelling, Mobility decreased, Pyrexia, Vaccination site induration
Clinical narrative: I was very very sweaty/ I woke up in a pool of sweat; Symptoms are much worse; I was a little tired; slight fever; chills; I am very weak; I can hardly walk; I totally lost my appetite; The injection site blew; It is very hard/ It is like a ball; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat) and CONDITION AGGRAVATED (Symptoms are much worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Polymyalgia rheumatica. Concomitant products included INSULIN, METFORMIN and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), INJECTION SITE SWELLING (The injection site blew) and VACCINATION SITE INDURATION (It is very hard/ It is like a ball). On 29-Aug-2021, the patient experienced PYREXIA (slight fever) and CHILLS (chills). On an unknown date, the patient experienced HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse) and FATIGUE (I was a little tired). At the time of the report, ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk) and DECREASED APPETITE (I totally lost my appetite) had not resolved and HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse), INJECTION SITE SWELLING (The injection site blew), VACCINATION SITE INDURATION (It is very hard/ It is like a ball), PYREXIA (slight fever), CHILLS (chills) and FATIGUE (I was a little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes FIBRIC ACID for Diabetes.  No treatment medication were provided by the reporter   This case was linked to MOD-2021-301856, MOD-2021-301864 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: I was very very sweaty/ I woke up in a pool of sweat; Symptoms are much worse; I was a little tired; slight fever; chills; I am very weak; I can hardly walk; I totally lost my appetite; The injection site blew; It is very hard/ It is like a ball; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat) and CONDITION AGGRAVATED (Symptoms are much worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Polymyalgia rheumatica. Concomitant products included INSULIN, METFORMIN and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), INJECTION SITE SWELLING (The injection site blew) and VACCINATION SITE INDURATION (It is very hard/ It is like a ball). On 29-Aug-2021, the patient experienced PYREXIA (slight fever) and CHILLS (chills). On an unknown date, the patient experienced HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse) and FATIGUE (I was a little tired). At the time of the report, ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk) and DECREASED APPETITE (I totally lost my appetite) had not resolved and HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse), INJECTION SITE SWELLING (The injection site blew), VACCINATION SITE INDURATION (It is very hard/ It is like a ball), PYREXIA (slight fever), CHILLS (chills) and FATIGUE (I was a little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes FIBRIC ACID for Diabetes.  No treatment medication were provided by the reporter   This case was linked to MOD-2021-301856, MOD-2021-301864 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Mobility decreased
Clinical narrative: couldn't move; was unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't move) and GAIT INABILITY (was unable to walk) in an 80-year-old male patient 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 30-Aug-2021, the patient experienced MOBILITY DECREASED (couldn't move) and GAIT INABILITY (was unable to walk). At the time of the report, MOBILITY DECREASED (couldn't move) and GAIT INABILITY (was unable to walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced "stuff like that" on 30-aug-2021  No Concomitant drugs were reported. No Treatment information  were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: I was a little tired; I had a slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was a little tired) and PYREXIA (I had a slight fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Polymyalgia rheumatica. Concomitant products included INSULIN, METFORMIN and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (I was a little tired) and PYREXIA (I had a slight fever). At the time of the report, FATIGUE (I was a little tired) and PYREXIA (I had a slight fever) 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 Fibric acid for the indication of Diabetes was reported. No Treatment medications were provided.   This case was linked to MOD-2021-301830 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the second dose less than  25 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose less than  25 days from the first dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose less than  25 days from the first dose). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose less than  25 days from the first dose) had resolved.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received , contains non significant information experiencing any adverse events aftereither dose of vaccine and denied further follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing since received booster; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing since received booster) 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 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COUGH (Coughing since received booster). At the time of the report, COUGH (Coughing since received booster) outcome was unknown.            NO concomitants were provided. No treatment is reported. requested for follow-up since incomplete patient and dosage details provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment drugs were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: minor body aches for a few hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor body aches for a few hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Prostate cancer.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN (minor body aches for a few hours). At the time of the report, PAIN (minor body aches for a few hours) had resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-302008 (Patient Link).   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Eczema, Illness, Mobility decreased
Clinical narrative: severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.; can't move her right hand; making more sick; crying; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.), MOBILITY DECREASED (can't move her right hand), ILLNESS (making more sick) and CRYING (crying) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema (prone to eczema her whole life.).    On 13-Aug-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 ECZEMA (severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.), MOBILITY DECREASED (can't move her right hand), ILLNESS (making more sick) and CRYING (crying). At the time of the report, ECZEMA (severe eczema after receiving the first dose / eczema all over her body, the back of legs, shoulders, arms.) had not resolved and MOBILITY DECREASED (can't move her right hand), ILLNESS (making more sick) and CRYING (crying) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was reported. Patient reported that in april after seeing her doctor she was able to get it under control and it all went away.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia, Osteoarthritis
Clinical narrative: stiffness; Patient had osteoarthritis but it seems to explain exacerbated; overall joint and muscle pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), OSTEOARTHRITIS (Patient had osteoarthritis but it seems to explain exacerbated), ARTHRALGIA (overall joint and muscle pain) and MYALGIA (muscle pain) 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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), OSTEOARTHRITIS (Patient had osteoarthritis but it seems to explain exacerbated), ARTHRALGIA (overall joint and muscle pain) and MYALGIA (muscle pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), OSTEOARTHRITIS (Patient had osteoarthritis but it seems to explain exacerbated), ARTHRALGIA (overall joint and muscle pain) and MYALGIA (muscle pain) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered Yes when  asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered Yes asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) 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 (Consumer answered Yes when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.). At the time of the report, VACCINATION COMPLICATION (Consumer answered asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pruritus, Sensitisation, Vaccination site pain
Clinical narrative: Slight soreness when touching the injection site; My underarm area feels itchy and hurts; Arm pit lymph nodes continued to be sensitive three days after the vaccine; Arm pit lymph nodes continued to be sensitive three days after the vaccine; My underarm area feels itchy and hurts; This spontaneous case was reported by a consumer and describes the occurrence of SENSITISATION (Arm pit lymph nodes continued to be sensitive three days after the vaccine), PRURITUS (My underarm area feels itchy and hurts), VACCINATION SITE PAIN (Slight soreness when touching the injection site), AXILLARY PAIN (My underarm area feels itchy and hurts) and LYMPHADENOPATHY (Arm pit lymph nodes continued to be sensitive three days after the vaccine) 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 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SENSITISATION (Arm pit lymph nodes continued to be sensitive three days after the vaccine) and VACCINATION SITE PAIN (Slight soreness when touching the injection site). an unknown date, the patient experienced PRURITUS (My underarm area feels itchy and hurts), AXILLARY PAIN (My underarm area feels itchy and hurts) and LYMPHADENOPATHY (Arm pit lymph nodes continued to be sensitive three days after the vaccine). On 01-Sep-2021, SENSITISATION (Arm pit lymph nodes continued to be sensitive three days after the vaccine), PRURITUS (My underarm area feels itchy and hurts), AXILLARY PAIN (My underarm area feels itchy and hurts) and LYMPHADENOPATHY (Arm pit lymph nodes continued to be sensitive three days after the vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Slight soreness when touching the injection site) had not resolved.            Concomitant medications were not provided. Treatment medication was not provided.   This case was linked to MOD-2021-304953, MOD-2021-304944 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow-up received: events were added and events outcome were updated; 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: Epistaxis, Nasal congestion
Clinical narrative: Nose is somewhat bloody and full of mucous; Nose full of mucous; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose is somewhat bloody and full of mucous) and NASAL CONGESTION (Nose full of mucous) 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 EPISTAXIS (Nose is somewhat bloody and full of mucous) and NASAL CONGESTION (Nose full of mucous). At the time of the report, EPISTAXIS (Nose is somewhat bloody and full of mucous) and NASAL CONGESTION (Nose full of mucous) outcome was unknown.            Treatment medication was  not reported. Concomitant medications were not provided by the reporter.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac disorder, Clonus, Heart rate, Heart rate increased
Clinical narrative: it's actually in pain/ it's hurting; still having heart trouble; heart is beating fast; Legs are shaking, legs started really really shaking; Clonus; Really nervous; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (it's actually in pain/ it's hurting) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal cord injury (T12 vertebrae fracture), Vertebral fracture, Heart rate increased (had a little episode of a little bit of a fast heart rate and they gave him heart monitors, but he did not have any heart condition, it was just one episode.) in 1998 and Surgery (Fused from T10 to L2.). Concurrent medical conditions included Disability.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced TREMOR (Legs are shaking, legs started really really shaking), CLONUS (Clonus) and NERVOUSNESS (Really nervous). 21-Aug-2021, the patient experienced HEART RATE INCREASED (heart is beating fast). On 01-Sep-2021, the patient experienced ANGINA PECTORIS (it's actually in pain/ it's hurting) (seriousness criterion medically significant) and CARDIAC DISORDER (still having heart trouble). At the time of the report, ANGINA PECTORIS (it's actually in pain/ it's hurting), TREMOR (Legs are shaking, legs started really really shaking), CLONUS (Clonus), NERVOUSNESS (Really nervous) and HEART RATE INCREASED (heart is beating fast) had not resolved and CARDIAC DISORDER (still having heart trouble) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Heart rate: high (High) Heart rate elevated - high. On 01-Sep-2021, Heart rate: high (High) still high.     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.   Relevant concomitant medications were not reported.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received contains significant information. Events Angina pectoris, Cardiac disorder and Heart rate increased are added; Case is upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Tremor
Clinical narrative: it's actually in pain/ it's hurting; still having heart trouble; heart is beating fast; Legs are shaking, legs started really really shaking; Clonus; Really nervous; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (it's actually in pain/ it's hurting) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal cord injury (T12 vertebrae fracture), Vertebral fracture, Heart rate increased (had a little episode of a little bit of a fast heart rate and they gave him heart monitors, but he did not have any heart condition, it was just one episode.) in 1998 and Surgery (Fused from T10 to L2.). Concurrent medical conditions included Disability.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced TREMOR (Legs are shaking, legs started really really shaking), CLONUS (Clonus) and NERVOUSNESS (Really nervous). 21-Aug-2021, the patient experienced HEART RATE INCREASED (heart is beating fast). On 01-Sep-2021, the patient experienced ANGINA PECTORIS (it's actually in pain/ it's hurting) (seriousness criterion medically significant) and CARDIAC DISORDER (still having heart trouble). At the time of the report, ANGINA PECTORIS (it's actually in pain/ it's hurting), TREMOR (Legs are shaking, legs started really really shaking), CLONUS (Clonus), NERVOUSNESS (Really nervous) and HEART RATE INCREASED (heart is beating fast) had not resolved and CARDIAC DISORDER (still having heart trouble) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Heart rate: high (High) Heart rate elevated - high. On 01-Sep-2021, Heart rate: high (High) still high.     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.   Relevant concomitant medications were not reported.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received contains significant information. Events Angina pectoris, Cardiac disorder and Heart rate increased are added; Case is upgraded to serious.; 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: Customer has not received their second dose 3-4 months after getting first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Customer has not received their second dose 3-4 months after getting first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Customer has not received their second dose 3-4 months after getting first dose). In 2021, PRODUCT DOSE OMISSION ISSUE (Customer has not received their second dose 3-4 months after getting first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose from this expired vial was given to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose from this expired vial was given to a patient) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose from this expired vial was given to a patient). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (dose from this expired vial was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported by patient.  Patient reported that vial was moved from the freezer to the refrigerator on 22Aug2021 and the vial remained in the refrigerator, The caller verified the vial never went through any temperature excursions. Also, the caller confirmed the vial was first punctured on 30 Aug 2021. Caller wanted to know that whether she needed to repeat the dose or can they continue with the vaccine series as normal.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Vaccination site reaction
Clinical narrative: My injection site is magnetic, a magnet stuck to my arm; My arm is swollen and has soreness; My arm is swollen and has soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (My injection site is magnetic, a magnet stuck to my arm), PERIPHERAL SWELLING (My arm is swollen and has soreness) and MYALGIA (My arm is swollen and has soreness) 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 28-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (My injection site is magnetic, a magnet stuck to my arm), PERIPHERAL SWELLING (My arm is swollen and has soreness) and MYALGIA (My arm is swollen and has soreness). At the time of the report, VACCINATION SITE REACTION (My injection site is magnetic, a magnet stuck to my arm) outcome was unknown and PERIPHERAL SWELLING (My arm is swollen and has soreness) and MYALGIA (My arm is swollen and has soreness) had not resolved.            Reportedly, The patient went to her nail salon and was told that the Moderna COVID-19 vaccine makes the patient magnetic, and at the nail salon a paperclip had stuck to her injection site. The patient did not provide concern for safety to follow up.   Treatment product information was not provided. Concomitant product use was not provided.   Reporter did not allow further contact