chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness of body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of body) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 026D21A) 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) (Intramuscular) 1. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (Soreness of body). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (Soreness of body) had resolved.            Concomitant medication were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286320 (Patient Link).   Reporter did not allow further contact; 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: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: I felt a hardness of my calf muscle which I found unusual; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I felt a hardness of my calf muscle which I found unusual) 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 MUSCULOSKELETAL STIFFNESS (I felt a hardness of my calf muscle which I found unusual). At the time of the report, MUSCULOSKELETAL STIFFNESS (I felt a hardness of my calf muscle which I found unusual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue lasted 2-3 days max; soreness lasted 2-3 days max; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness lasted 2-3 days max) and FATIGUE (fatigue lasted 2-3 days max) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness lasted 2-3 days max) (seriousness criterion disability). On an unknown date, the patient experienced FATIGUE (fatigue lasted 2-3 days max) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (soreness lasted 2-3 days max) and FATIGUE (fatigue lasted 2-3 days max) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286678 (Patient Link).; 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: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Illness, Influenza like illness, Myalgia
Clinical narrative: Was very sick; Back ache; Felt like flu; Sore throat; Felt like had covid; Fever; very sore all over/ very sore all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat) and COVID-19 (Felt like had covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Felt like had covid), PYREXIA (Fever) and MYALGIA (very sore all over/ very sore all over). At the time of the report, ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Felt like had covid), PYREXIA (Fever) and MYALGIA (very sore all over/ very sore all over) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Was very sick; Back ache; Felt like flu; Sore throat; Felt like had covid; Fever; very sore all over/ very sore all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat) and COVID-19 (Felt like had covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Felt like had covid), PYREXIA (Fever) and MYALGIA (very sore all over/ very sore all over). At the time of the report, ILLNESS (Was very sick), BACK PAIN (Back ache), INFLUENZA LIKE ILLNESS (Felt like flu), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Felt like had covid), PYREXIA (Fever) and MYALGIA (very sore all over/ very sore all over) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  No treatment medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Joint warmth, Malaise
Clinical narrative: unwell; Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble; Feels very weak; Hot to touch left elbow; Fatigue; Headache; Musclepain; Swelling at injection site; Hot to touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (unwell), MELANOCYTIC NAEVUS (Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble), ASTHENIA (Feels very weak), VACCINATION SITE WARMTH (Hot to touch injection site) and JOINT WARMTH (Hot to touch left elbow) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (levoquine), Drug allergy (narcus), Allergy to antibiotic (microbid), Allergy to antibiotic (clindamycin), Drug allergy (lyrica), Drug allergy (haldol) and Drug allergy (ketamine).    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 14-Aug-2021, the patient experienced MELANOCYTIC NAEVUS (Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble), ASTHENIA (Feels very weak), JOINT WARMTH (Hot to touch left elbow), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Musclepain). On an unknown date, the patient experienced MALAISE (unwell). On 13-Aug-2021, VACCINATION SITE WARMTH (Hot to touch injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved. At the time of the report, MALAISE (unwell), MELANOCYTIC NAEVUS (Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble), ASTHENIA (Feels very weak), JOINT WARMTH (Hot to touch left elbow), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Musclepain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Significant follow-up received contains: added events-fatigue, headache, muscle pain, asthenia,malaise
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Melanocytic naevus, Myalgia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: unwell; Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble; Feels very weak; Hot to touch left elbow; Fatigue; Headache; Musclepain; Swelling at injection site; Hot to touch injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (unwell), MELANOCYTIC NAEVUS (Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble), ASTHENIA (Feels very weak), VACCINATION SITE WARMTH (Hot to touch injection site) and JOINT WARMTH (Hot to touch left elbow) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (levoquine), Drug allergy (narcus), Allergy to antibiotic (microbid), Allergy to antibiotic (clindamycin), Drug allergy (lyrica), Drug allergy (haldol) and Drug allergy (ketamine).    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 14-Aug-2021, the patient experienced MELANOCYTIC NAEVUS (Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble), ASTHENIA (Feels very weak), JOINT WARMTH (Hot to touch left elbow), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Musclepain). On an unknown date, the patient experienced MALAISE (unwell). On 13-Aug-2021, VACCINATION SITE WARMTH (Hot to touch injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved. At the time of the report, MALAISE (unwell), MELANOCYTIC NAEVUS (Swelling of mole on left elbow/Increased size of a mole on left elbow/now swelling, size has grown as a quarter/ mole described as size as a little pebble), ASTHENIA (Feels very weak), JOINT WARMTH (Hot to touch left elbow), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Musclepain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Significant follow-up received contains: added events-fatigue, headache, muscle pain, asthenia,malaise
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 3 months since first dose/received my first vaccine May 17th and missed my second vaccine in June; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (3 months since first dose/received my first vaccine May 17th and missed my second vaccine in June) 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 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (3 months since first dose/received my first vaccine May 17th and missed my second vaccine in June). In June 2021, PRODUCT DOSE OMISSION ISSUE (3 months since first dose/received my first vaccine May 17th and missed my second vaccine in June) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: arm is getting weaker; Pain in arm/ hard to raise the arm up; difficulty sleeping at night; swelling to the side under my arm; I can't lay on on my side; pain with movement 9/10 pain scale; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm) and DISCOMFORT (I can't lay on on my side) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031AZ1A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OLMESARTAN, LEVOTHYROXINE, ATENOLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm), DISCOMFORT (I can't lay on on my side) and MYALGIA (pain with movement 9/10 pain scale). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm), DISCOMFORT (I can't lay on on my side) and MYALGIA (pain with movement 9/10 pain scale) outcome was unknown.            The patient consulted with her healthcare professional and had X-Ray and was prescribed with Tylenol. Doctor might order MRI but still for approval
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm is getting weaker; Pain in arm/ hard to raise the arm up; difficulty sleeping at night; swelling to the side under my arm; I can't lay on on my side; pain with movement 9/10 pain scale; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm) and DISCOMFORT (I can't lay on on my side) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031AZ1A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OLMESARTAN, LEVOTHYROXINE, ATENOLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm), DISCOMFORT (I can't lay on on my side) and MYALGIA (pain with movement 9/10 pain scale). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm), DISCOMFORT (I can't lay on on my side) and MYALGIA (pain with movement 9/10 pain scale) outcome was unknown.            The patient consulted with her healthcare professional and had X-Ray and was prescribed with Tylenol. Doctor might order MRI but still for approval
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysphonia, Oropharyngeal pain
Clinical narrative: started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam's apple is, it feels a little sore; voice dropped about 2 degrees/voice dropped way down/voice felt different; hurt my right shoulder/shoulder is achy; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam's apple is, it feels a little sore), DYSPHONIA (voice dropped about 2 degrees/voice dropped way down/voice felt different) and ARTHRALGIA (hurt my right shoulder/shoulder is achy) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (cephamycin), Drug allergy (Flagyl) and Penicillin allergy (Penicillin). Concomitant products included METOPROLOL, SIMVASTATIN, CLOPIDOGREL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and AMLODIPINE for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced ARTHRALGIA (hurt my right shoulder/shoulder is achy). On 12-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam's apple is, it feels a little sore) and DYSPHONIA (voice dropped about 2 degrees/voice dropped way down/voice felt different). At the time of the report, OROPHARYNGEAL PAIN (started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam's apple is, it feels a little sore), DYSPHONIA (voice dropped about 2 degrees/voice dropped way down/voice felt different) and ARTHRALGIA (hurt my right shoulder/shoulder is achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site hypoaesthesia, Pain
Clinical narrative: Numbness in the arm where injection was given; Soreness; 6 months pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA (Numbness in the arm where injection was given), PAIN (Soreness) and EXPOSURE DURING PREGNANCY (6 months pregnant) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced INJECTION SITE HYPOAESTHESIA (Numbness in the arm where injection was given), PAIN (Soreness) and EXPOSURE DURING PREGNANCY (6 months pregnant). At the time of the report, INJECTION SITE HYPOAESTHESIA (Numbness in the arm where injection was given), PAIN (Soreness) and EXPOSURE DURING PREGNANCY (6 months pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm as it have just received the shot today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm as it have just received the shot today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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 PAIN IN EXTREMITY (pain in the arm as it have just received the shot today). At the time of the report, PAIN IN EXTREMITY (pain in the arm as it have just received the shot today) outcome was unknown.            No concomitant medication were provided.  Treatment medication was not provided
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chronic obstructive pulmonary disease, Confusional state, Depression, Dyspnoea
Clinical narrative: COPD; Trouble breathing; shuffling instead of walking; depressed; losing weight; confused; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 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 May 2021, the patient experienced CONFUSIONAL STATE (confused). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion hospitalization), DYSPNOEA (Trouble breathing), GAIT DISTURBANCE (shuffling instead of walking), DEPRESSION (depressed) and WEIGHT DECREASED (losing weight). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and DYSPNOEA (Trouble breathing) was resolving and CONFUSIONAL STATE (confused), GAIT DISTURBANCE (shuffling instead of walking), DEPRESSION (depressed) and WEIGHT DECREASED (losing weight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Blood test: normal (normal) normal.         No concomitant medication reported.  Daughter of patient called to report that he had his second dose of the Moderna vaccine in late Feb. At the end of May he started acting confused almost like an Alzheimer's patient. He was sharp as a tack, cutting his own lawn, and working out at the gym. He is now a completely different person he has trouble breathing, shuffles instead of walking, losing weight, and very depressed. Approximately 28Jul 2021 he had perfectly normal bloodwork. Two weeks ago his breathing was so bad he went to the emergency room and was admitted to the hospital. The diagnosis was out of control COPD, they stabilized it and sent him home.  She did not have vaccine information or the exact number of days and dates of hospitalization.   No treatment was provided.  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. COPD does not happen overnight. It is a chronic disease developing through the years. Unlikely, that the events are related to the vaccine. Further information is expected.; 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. COPD does not happen overnight. It is a chronic disease developing through the years.  Unlikely, that the events are related to the vaccine. Further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Weight decreased
Clinical narrative: COPD; Trouble breathing; shuffling instead of walking; depressed; losing weight; confused; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 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 May 2021, the patient experienced CONFUSIONAL STATE (confused). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion hospitalization), DYSPNOEA (Trouble breathing), GAIT DISTURBANCE (shuffling instead of walking), DEPRESSION (depressed) and WEIGHT DECREASED (losing weight). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and DYSPNOEA (Trouble breathing) was resolving and CONFUSIONAL STATE (confused), GAIT DISTURBANCE (shuffling instead of walking), DEPRESSION (depressed) and WEIGHT DECREASED (losing weight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Blood test: normal (normal) normal.         No concomitant medication reported.  Daughter of patient called to report that he had his second dose of the Moderna vaccine in late Feb. At the end of May he started acting confused almost like an Alzheimer's patient. He was sharp as a tack, cutting his own lawn, and working out at the gym. He is now a completely different person he has trouble breathing, shuffles instead of walking, losing weight, and very depressed. Approximately 28Jul 2021 he had perfectly normal bloodwork. Two weeks ago his breathing was so bad he went to the emergency room and was admitted to the hospital. The diagnosis was out of control COPD, they stabilized it and sent him home.  She did not have vaccine information or the exact number of days and dates of hospitalization.   No treatment was provided.  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. COPD does not happen overnight. It is a chronic disease developing through the years. Unlikely, that the events are related to the vaccine. Further information is expected.; 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. COPD does not happen overnight. It is a chronic disease developing through the years.  Unlikely, that the events are related to the vaccine. Further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Vomiting
Clinical narrative: Left arm was hurting on and off after first vaccine; Nausea; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was hurting on and off after first vaccine), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Diabetes, Blood pressure and Sleep apnea.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (Left arm was hurting on and off after first vaccine), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). On 08-May-2021, NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm was hurting on and off after first vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported  No treatment medication were reported   This case was linked to MOD-2021-286731 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Had a stiff neck and arm; Neck pain moving up to the back of my head; Sometimes I can't lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Had a stiff neck and arm), NECK PAIN (Neck pain moving up to the back of my head) and MOBILITY DECREASED (Sometimes I can't lift my arm) 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 24-Jul-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 MUSCULOSKELETAL STIFFNESS (Had a stiff neck and arm), NECK PAIN (Neck pain moving up to the back of my head) and MOBILITY DECREASED (Sometimes I can't lift my arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Had a stiff neck and arm), NECK PAIN (Neck pain moving up to the back of my head) and MOBILITY DECREASED (Sometimes I can't lift my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication information was provided. No concomitant medication information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: had excruciating shoulder pain.; They gave the shot right into the bone; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (had excruciating shoulder pain.) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave the shot right into the bone) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Heart attack 3 stents.) in 2016 and Stent placement in August 2016. Concurrent medical conditions included Bladder cancer (bladder cancer was treated with BCG.) since 2014 and COPD (Chronic obstructive pulmonary disease.) since 2020.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ARTHRALGIA (had excruciating shoulder pain.) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave the shot right into the bone). On 11-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave the shot right into the bone) had resolved. At the time of the report, ARTHRALGIA (had excruciating shoulder pain.) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received with no new information.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Difficulty breathing secondary to Zofran (After the Second Dose); Left Arm hurts  (After the Second Dose); Fatigue on and off (After the Second Dose); Nausea; Low grade Fever 99.3F  (After the Second Dose); Chills  (After the Second Dose); Swollen Lymph node in left side of the neck  (After the Second Dose); Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine), FATIGUE (Fatigue on and off (After the Second Dose)) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery since an unknown date, Diabetes since an unknown date, Blood pressure high since an unknown date and Sleep apnea.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 28-Jul-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), FATIGUE (Fatigue on and off (After the Second Dose)), NAUSEA (Nausea), PYREXIA (Low grade Fever 99.3F  (After the Second Dose)), CHILLS (Chills  (After the Second Dose)) and LYMPHADENOPATHY (Swollen Lymph node in left side of the neck  (After the Second Dose)). On 30-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea, at an unspecified dose and frequency. On 30-Jul-2021, DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), FATIGUE (Fatigue on and off (After the Second Dose)), NAUSEA (Nausea), PYREXIA (Low grade Fever 99.3F  (After the Second Dose)), CHILLS (Chills  (After the Second Dose)) and LYMPHADENOPATHY (Swollen Lymph node in left side of the neck  (After the Second Dose)) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved.            Reporter heard about pericarditis and myocarditis and she was afraid to get the second dose. Also thinks she makes more antibody this way by waiting longer between the two shots   This case was linked to MOD-2021-286712 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Difficulty breathing secondary to Zofran (After the Second Dose); Left Arm hurts  (After the Second Dose); Fatigue on and off (After the Second Dose); Nausea; Low grade Fever 99.3F  (After the Second Dose); Chills  (After the Second Dose); Swollen Lymph node in left side of the neck  (After the Second Dose); Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine), FATIGUE (Fatigue on and off (After the Second Dose)) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery since an unknown date, Diabetes since an unknown date, Blood pressure high since an unknown date and Sleep apnea.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 28-Jul-2021, the patient experienced PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), FATIGUE (Fatigue on and off (After the Second Dose)), NAUSEA (Nausea), PYREXIA (Low grade Fever 99.3F  (After the Second Dose)), CHILLS (Chills  (After the Second Dose)) and LYMPHADENOPATHY (Swollen Lymph node in left side of the neck  (After the Second Dose)). On 30-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea, at an unspecified dose and frequency. On 30-Jul-2021, DYSPNOEA (Difficulty breathing secondary to Zofran (After the Second Dose)) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Left Arm hurts  (After the Second Dose)), FATIGUE (Fatigue on and off (After the Second Dose)), NAUSEA (Nausea), PYREXIA (Low grade Fever 99.3F  (After the Second Dose)), CHILLS (Chills  (After the Second Dose)) and LYMPHADENOPATHY (Swollen Lymph node in left side of the neck  (After the Second Dose)) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved.            Reporter heard about pericarditis and myocarditis and she was afraid to get the second dose. Also thinks she makes more antibody this way by waiting longer between the two shots   This case was linked to MOD-2021-286712 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye pruritus, Headache, Paranasal sinus discomfort, Pruritus
Clinical narrative: itchy eyes; sinus pressure; itchy ears; Also experienced headache; 3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears), HEADACHE (Also experienced headache) and PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease and Immunocompromised.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks). On an unknown date, the patient experienced EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears) and HEADACHE (Also experienced headache). At the time of the report, EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears), HEADACHE (Also experienced headache) and PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 101f (High) Fever. On 01-Aug-2021, Body temperature: 101f (High) Fever. In August 2021, Body temperature: 99.4f-99.6f (High) Fever for 2 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: itchy eyes; sinus pressure; itchy ears; Also experienced headache; 3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears), HEADACHE (Also experienced headache) and PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease and Immunocompromised.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks). On an unknown date, the patient experienced EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears) and HEADACHE (Also experienced headache). At the time of the report, EYE PRURITUS (itchy eyes), PARANASAL SINUS DISCOMFORT (sinus pressure), PRURITUS (itchy ears), HEADACHE (Also experienced headache) and PYREXIA (3hours after the injection had fever running at around 101F for the first couple of days/now running at 99.4F-99.6F for 2 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 101f (High) Fever. On 01-Aug-2021, Body temperature: 101f (High) Fever. In August 2021, Body temperature: 99.4f-99.6f (High) Fever for 2 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site warmth
Clinical narrative: arm is hot at the injection site; The redness is growing.; arm is red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is hot at the injection site), ERYTHEMA (The redness is growing.) and VACCINATION SITE ERYTHEMA (arm is red 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 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 VACCINATION SITE WARMTH (arm is hot at the injection site), ERYTHEMA (The redness is growing.) and VACCINATION SITE ERYTHEMA (arm is red at the injection site). At the time of the report, VACCINATION SITE WARMTH (arm is hot at the injection site) and VACCINATION SITE ERYTHEMA (arm is red at the injection site) outcome was unknown and ERYTHEMA (The redness is growing.) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: My daughter seems to be having a reaction at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (My daughter seems to be having a reaction at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (My daughter seems to be having a reaction at the injection site). At the time of the report, VACCINATION SITE REACTION (My daughter seems to be having a reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant drugs were reported. No Treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I received my first Moderna vaccine in March 2021.  I was unable to return for the second dose.  What can I do?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first Moderna vaccine in March 2021.  I was unable to return for the second dose.  What can I do?) 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 March 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 (I received my first Moderna vaccine in March 2021.  I was unable to return for the second dose.  What can I do?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I received my first Moderna vaccine in March 2021.  I was unable to return for the second dose.  What can I do?) had resolved.            No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.   Reporter did not allow further contact