chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right), EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck), INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear) and VACCINATION SITE PAIN (sore left arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Diabetes.Concomitant products included MELOXICAM for Arthritis, METFORMIN for Diabetes. On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck), VACCINATION SITE PAIN (sore left arm) and HEADACHE (headache). On 28-Jan-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right) and INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear). On 15-Jan-2022, HEADACHE (headache) had resolved. On 20-Jan-2022, VACCINATION SITE PAIN (sore left arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right), EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck) and INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear) had not resolved. The pain started first just during morning and night, but it was getting worse.No treatment had been given for her symptoms.This case was linked to MOD-2022-465200, MOD-2022-465201 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Headache, Insomnia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Sore left arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm after 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 011M20A and 070H21A) for COVID-19 vaccination.     Concomitant products included MELOXICAM for Arthritis, METFORMIN for Diabetes.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm after 1st dose). On 22-Jan-2021, VACCINATION SITE PAIN (Sore left arm after 1st dose) had resolved.        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.   It was reported that patient had no treatment been given. It was reported that there was no product complaint associated.   This case was linked to MOD-2022-465155, MOD-2022-465201 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm after 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 011M20A and 070H21A) for COVID-19 vaccination.     Concomitant products included MELOXICAM for Arthritis, METFORMIN for Diabetes.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm after 1st dose). On 22-Jan-2021, VACCINATION SITE PAIN (Sore left arm after 1st dose) had resolved.        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.   It was reported that patient had no treatment been given. It was reported that there was no product complaint associated.   This case was linked to MOD-2022-465155, MOD-2022-465201 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Parosmia, Rhinorrhoea, Taste disorder
Clinical narrative: sense of taste changed/taste awful; sense of smell changed/smells like onion powder/urine has started to smell like onion powder too; sniffles; soreness in his shoulder; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (sense of taste changed/taste awful), PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too), RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had symptoms for 3 days with a continuing whole body soreness for 2 months. He feels his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste) in February 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too). 23-Apr-2021, the patient experienced RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches). In April 2021, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved. In June 2021, ARTHRALGIA (soreness in his shoulder) had resolved. At the time of the report, TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. After the first dose patient had soreness in his shoulder which lasted for 2 months. After both the second and the first dose, he experienced sniffles and muscle aches which lasted less than a day for both doses. Within 3 hours of receiving his first dose of the vaccine he noticed his sense of smell and taste had changed. All things except for Dr. Pepper tasted awful. He also noticed that everything he can smell, smells like onion powder. This included his coffee, his truck and the smell of cars at a traffic light. More recently his urine has also started to smell like onion powder.   This case was linked to MOD-2022-465250 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Rhinorrhoea
Clinical narrative: sense of taste changed/taste awful; sense of smell changed/smells like onion powder/urine has started to smell like onion powder too; sniffles; soreness in his shoulder; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (sense of taste changed/taste awful), PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too), RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had symptoms for 3 days with a continuing whole body soreness for 2 months. He feels his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste) in February 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too). 23-Apr-2021, the patient experienced RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches). In April 2021, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved. In June 2021, ARTHRALGIA (soreness in his shoulder) had resolved. At the time of the report, TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. After the first dose patient had soreness in his shoulder which lasted for 2 months. After both the second and the first dose, he experienced sniffles and muscle aches which lasted less than a day for both doses. Within 3 hours of receiving his first dose of the vaccine he noticed his sense of smell and taste had changed. All things except for Dr. Pepper tasted awful. He also noticed that everything he can smell, smells like onion powder. This included his coffee, his truck and the smell of cars at a traffic light. More recently his urine has also started to smell like onion powder.   This case was linked to MOD-2022-465250 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal faeces, Attention deficit hyperactivity disorder, Blood testosterone decreased, Condition aggravated, Injection site pain
Clinical narrative: sense of taste changed/taste awful; sense of smell changed/smells like onion powder/urine has started to smell like onion powder too; sniffles; soreness in his shoulder; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (sense of taste changed/taste awful), PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too), RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had symptoms for 3 days with a continuing whole body soreness for 2 months. He feels his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste) in February 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too). 23-Apr-2021, the patient experienced RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches). In April 2021, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved. In June 2021, ARTHRALGIA (soreness in his shoulder) had resolved. At the time of the report, TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. After the first dose patient had soreness in his shoulder which lasted for 2 months. After both the second and the first dose, he experienced sniffles and muscle aches which lasted less than a day for both doses. Within 3 hours of receiving his first dose of the vaccine he noticed his sense of smell and taste had changed. All things except for Dr. Pepper tasted awful. He also noticed that everything he can smell, smells like onion powder. This included his coffee, his truck and the smell of cars at a traffic light. More recently his urine has also started to smell like onion powder.   This case was linked to MOD-2022-465250 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Parosmia, Retching, Taste disorder
Clinical narrative: sense of taste changed/taste awful; sense of smell changed/smells like onion powder/urine has started to smell like onion powder too; sniffles; soreness in his shoulder; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (sense of taste changed/taste awful), PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too), RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had symptoms for 3 days with a continuing whole body soreness for 2 months. He feels his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste) in February 2021.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too). 23-Apr-2021, the patient experienced RHINORRHOEA (sniffles), ARTHRALGIA (soreness in his shoulder) and MYALGIA (muscle aches). In April 2021, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved. In June 2021, ARTHRALGIA (soreness in his shoulder) had resolved. At the time of the report, TASTE DISORDER (sense of taste changed/taste awful) and PAROSMIA (sense of smell changed/smells like onion powder/urine has started to smell like onion powder too) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. After the first dose patient had soreness in his shoulder which lasted for 2 months. After both the second and the first dose, he experienced sniffles and muscle aches which lasted less than a day for both doses. Within 3 hours of receiving his first dose of the vaccine he noticed his sense of smell and taste had changed. All things except for Dr. Pepper tasted awful. He also noticed that everything he can smell, smells like onion powder. This included his coffee, his truck and the smell of cars at a traffic light. More recently his urine has also started to smell like onion powder.   This case was linked to MOD-2022-465250 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Parosmia, Rhinorrhoea, Taste disorder
Clinical narrative: sniffles; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (sniffles) and MYALGIA (muscle aches). At the time of the report, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved.            No concomitant medication reported.  Patient had Covid-19 symptoms (Feb 2021) for 3 days with a continuing whole body soreness for 2 months. He felt his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste.  It was reported that second dose was a little bit stronger with these symptoms. Events lasted less than a day.  No treatment information was provided.   This case was linked to MOD-2022-465162 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Rhinorrhoea
Clinical narrative: sniffles; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (sniffles) and MYALGIA (muscle aches). At the time of the report, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved.            No concomitant medication reported.  Patient had Covid-19 symptoms (Feb 2021) for 3 days with a continuing whole body soreness for 2 months. He felt his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste.  It was reported that second dose was a little bit stronger with these symptoms. Events lasted less than a day.  No treatment information was provided.   This case was linked to MOD-2022-465162 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal faeces, Attention deficit hyperactivity disorder, Blood testosterone decreased, Condition aggravated, Injection site pain
Clinical narrative: sniffles; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (sniffles) and MYALGIA (muscle aches). At the time of the report, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved.            No concomitant medication reported.  Patient had Covid-19 symptoms (Feb 2021) for 3 days with a continuing whole body soreness for 2 months. He felt his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste.  It was reported that second dose was a little bit stronger with these symptoms. Events lasted less than a day.  No treatment information was provided.   This case was linked to MOD-2022-465162 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Parosmia, Retching, Taste disorder
Clinical narrative: sniffles; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles) and MYALGIA (muscle aches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (sniffles) and MYALGIA (muscle aches). At the time of the report, RHINORRHOEA (sniffles) and MYALGIA (muscle aches) had resolved.            No concomitant medication reported.  Patient had Covid-19 symptoms (Feb 2021) for 3 days with a continuing whole body soreness for 2 months. He felt his lungs were worse with this, but day by day his breathing improved. He also lost sense of smell and taste.  It was reported that second dose was a little bit stronger with these symptoms. Events lasted less than a day.  No treatment information was provided.   This case was linked to MOD-2022-465162 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Arthritis. Concomitant products included MELOXICAM for Arthritis, METFORMIN for Diabetes.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose). On 19-Feb-2021, PAIN IN EXTREMITY (Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose) had resolved.            Patient stated that no treatment had given for her symptoms.   This case was linked to MOD-2022-465200, MOD-2022-465155 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Flushing, Heart rate
Clinical narrative: I feel flushed; light headed; Blood pressure is 95/67; This spontaneous case was reported by an other health care professional and describes the occurrence of FLUSHING (I feel flushed), BLOOD PRESSURE ABNORMAL (Blood pressure is 95/67) and DIZZINESS (light headed) 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 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BLOOD PRESSURE ABNORMAL (Blood pressure is 95/67). On 30-Jan-2022, the patient experienced FLUSHING (I feel flushed) and DIZZINESS (light headed). At the time of the report, FLUSHING (I feel flushed), BLOOD PRESSURE ABNORMAL (Blood pressure is 95/67) and DIZZINESS (light headed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: 95/67 Blood pressure was 95/67. In January 2022, Heart rate: 91 heart rate was 91.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Hyperhidrosis, Illness
Clinical narrative: Got sick; Broke out in a sweat; Was weak; Fell from being weak; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), HYPERHIDROSIS (Broke out in a sweat), ASTHENIA (Was weak), FALL (Fell from being weak) and CHILLS (Had chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (Got sick), HYPERHIDROSIS (Broke out in a sweat), ASTHENIA (Was weak), FALL (Fell from being weak) and CHILLS (Had chills). At the time of the report, ILLNESS (Got sick), HYPERHIDROSIS (Broke out in a sweat), ASTHENIA (Was weak), FALL (Fell from being weak) and CHILLS (Had chills) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysgeusia, Malaise, Pyrexia
Clinical narrative: metallic flavor in the mouth; fever; chills; Joint pain; pain in the injection site; felt unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt unwell), DYSGEUSIA (metallic flavor in the mouth), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (Joint pain) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 940915) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Sputnik (2nd dose) and Sputnik (1st dose). Past adverse reactions to the above products included No adverse event with Sputnik and Sputnik.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced MALAISE (felt unwell) and VACCINATION SITE PAIN (pain in the injection site). On 24-Jan-2022, the patient experienced DYSGEUSIA (metallic flavor in the mouth), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. In January 2022, DYSGEUSIA (metallic flavor in the mouth), CHILLS (chills) and ARTHRALGIA (Joint pain) had resolved. On 30-Jan-2022, VACCINATION SITE PAIN (pain in the injection site) had resolved. At the time of the report, MALAISE (felt unwell) and PYREXIA (fever) outcome was unknown.            At the evening of the day of vaccination he had fever, chills, joint pain, metallic flavor in the mouth. Those symptoms lasted one day. He took Paracetamol to treat those symptoms. During the next day he felt unwell and he had fever again. He took Ibuprofen to treat those symptoms. He also had pain in the injection site, that lasted until the day of reporting.  No concomitant medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: metallic flavor in the mouth; fever; chills; Joint pain; pain in the injection site; felt unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt unwell), DYSGEUSIA (metallic flavor in the mouth), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (Joint pain) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 940915) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Sputnik (2nd dose) and Sputnik (1st dose). Past adverse reactions to the above products included No adverse event with Sputnik and Sputnik.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced MALAISE (felt unwell) and VACCINATION SITE PAIN (pain in the injection site). On 24-Jan-2022, the patient experienced DYSGEUSIA (metallic flavor in the mouth), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. In January 2022, DYSGEUSIA (metallic flavor in the mouth), CHILLS (chills) and ARTHRALGIA (Joint pain) had resolved. On 30-Jan-2022, VACCINATION SITE PAIN (pain in the injection site) had resolved. At the time of the report, MALAISE (felt unwell) and PYREXIA (fever) outcome was unknown.            At the evening of the day of vaccination he had fever, chills, joint pain, metallic flavor in the mouth. Those symptoms lasted one day. He took Paracetamol to treat those symptoms. During the next day he felt unwell and he had fever again. He took Ibuprofen to treat those symptoms. He also had pain in the injection site, that lasted until the day of reporting.  No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: have been sick for the last 2 days; running a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (have been sick for the last 2 days) and PYREXIA (running a fever) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (have been sick for the last 2 days) and PYREXIA (running a fever). At the time of the report, ILLNESS (have been sick for the last 2 days) and PYREXIA (running a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: not feeling well/just not feeling well; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well/just not feeling well) and FATIGUE (tired) 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.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MALAISE (not feeling well/just not feeling well) and FATIGUE (tired). At the time of the report, MALAISE (not feeling well/just not feeling well) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported by the reporter. No concomitants medicines were reported.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Nausea, Thyroid function test, Vaccination site erythema
Clinical narrative: my back hurts/thing hurts; injection site hard and hot; very tired/exhausted/just tired/hard to get off the couch; pukey feeling; injection site all red/and rounded 3 inches across; injection site hard and hot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (my back hurts/thing hurts), VACCINATION SITE WARMTH (injection site hard and hot), FATIGUE (very tired/exhausted/just tired/hard to get off the couch), NAUSEA (pukey feeling) and VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A021A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, LITHIUM, QUETIAPINE FUMARATE (SEROQUEL), PRIMIDONE and LEVOTHYROXINE for an unknown indication.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (my back hurts/thing hurts), VACCINATION SITE WARMTH (injection site hard and hot), FATIGUE (very tired/exhausted/just tired/hard to get off the couch), NAUSEA (pukey feeling), VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) and VACCINATION SITE INDURATION (injection site hard and hot). On 30-Jan-2022, VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) was resolving. At the time of the report, BACK PAIN (my back hurts/thing hurts), FATIGUE (very tired/exhausted/just tired/hard to get off the couch) and NAUSEA (pukey feeling) outcome was unknown and VACCINATION SITE WARMTH (injection site hard and hot) and VACCINATION SITE INDURATION (injection site hard and hot) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2022, Thyroid function test: low (Low) low.         No treatment medication was provided.  No patient medical history was provided.  Patient has given higher medication for low thyroid value   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2022: Significant follow up was received which included patient occupation, Date of Birth, lab data, first, second, third dose information, concomitant medication and new events.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: my back hurts/thing hurts; injection site hard and hot; very tired/exhausted/just tired/hard to get off the couch; pukey feeling; injection site all red/and rounded 3 inches across; injection site hard and hot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (my back hurts/thing hurts), VACCINATION SITE WARMTH (injection site hard and hot), FATIGUE (very tired/exhausted/just tired/hard to get off the couch), NAUSEA (pukey feeling) and VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A021A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, LITHIUM, QUETIAPINE FUMARATE (SEROQUEL), PRIMIDONE and LEVOTHYROXINE for an unknown indication.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (my back hurts/thing hurts), VACCINATION SITE WARMTH (injection site hard and hot), FATIGUE (very tired/exhausted/just tired/hard to get off the couch), NAUSEA (pukey feeling), VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) and VACCINATION SITE INDURATION (injection site hard and hot). On 30-Jan-2022, VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) was resolving. At the time of the report, BACK PAIN (my back hurts/thing hurts), FATIGUE (very tired/exhausted/just tired/hard to get off the couch) and NAUSEA (pukey feeling) outcome was unknown and VACCINATION SITE WARMTH (injection site hard and hot) and VACCINATION SITE INDURATION (injection site hard and hot) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2022, Thyroid function test: low (Low) low.         No treatment medication was provided.  No patient medical history was provided.  Patient has given higher medication for low thyroid value   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2022: Significant follow up was received which included patient occupation, Date of Birth, lab data, first, second, third dose information, concomitant medication and new events.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 025A21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced LYMPHADENOPATHY (Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021). At the time of the report, LYMPHADENOPATHY (Swollen Lymph Node under the right armpit (Baseball size) after booster/The swelling was soft to the touch under right armpit. The swelling improved and went down to 2/3 today 28Jan2021) was resolving.            No Concomitant product use was reported.  The patient had swollen Lymph Node under the right armpit of Baseball size on 27-Jan-2021. The swelling was soft to the touch under right armpit and the swelling improved and went down by 2/3 on 28-Jan-2021, at the time of reporting.   The patient did not take any medications.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (then received a Moderna Covid-19 50mcg  booster dose 6 months after they had received the second full dose of the Moderna Primary Series) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (then received a Moderna Covid-19 50mcg booster dose 6 months after they had received the second full dose of the Moderna Primary Series). At the time of the report, ACCIDENTAL UNDERDOSE (then received a Moderna Covid-19 50mcg  booster dose 6 months after they had received the second full dose of the Moderna Primary Series) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was received two 100 mcg doses of the primary series of the Moderna Covid-19 vaccine spaced properly apart by 28 days. No concomitant medications were provided. No treatment medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: body aches; fatigue; headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (fatigue) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 16-Jan-2021, the patient experienced PAIN (body aches), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (body aches), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2022-465342 (Patient Link).
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID Disease 2 weeks after receiving a booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID Disease 2 weeks after receiving a booster) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID Disease 2 weeks after receiving a booster). At the time of the report, COVID-19 (Got COVID Disease 2 weeks after receiving a booster) outcome was unknown.            No concomitant and treatment medications were reported.  Company comment: This spontaneous case concerns a 76-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-465533 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 76-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed.  Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: body aches; fatigue; headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 13-Feb-2021, the patient experienced MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (body aches), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient did not remember which arm she received the Moderna Covid-19 vaccine.  The treatment information was unknown.   This case was linked to MOD-2022-465328, MOD-2022-465346 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Body aches; Fatigue; Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 016M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Headache). On 19-Aug-2021, the patient experienced MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   The patient received her booster dose on 27JAN2022   This case was linked to MOD-2022-465342, MOD-2022-465354, MOD-2022-465328 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Patient felt body aches; Fatigue; Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Patient felt body aches), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 16-Jan-2021, the patient experienced MYALGIA (Patient felt body aches), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Patient felt body aches), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.   This case was linked to MOD-2022-465346, MOD-2022-465342 (Patient Link).