chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: He is so very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (He is so very weak) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung transplant (Double lung transplant done 12 years ago).   On 30-Aug-2021, the patient 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 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 30-Aug-2021, the patient experienced ASTHENIA (He is so very weak). At the time of the report, ASTHENIA (He is so very weak) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Headache, Myalgia
Clinical narrative: sharp pain in chest and heart; sharp pain in chest and heart; muscle pain; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (sharp pain in chest and heart) 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 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (sharp pain in chest and heart) (seriousness criterion medically significant), CHEST PAIN (sharp pain in chest and heart), MYALGIA (muscle pain) and HEADACHE (headaches). At the time of the report, ANGINA PECTORIS (sharp pain in chest and heart), CHEST PAIN (sharp pain in chest and heart), MYALGIA (muscle pain) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by reporter. It was reported that the patient worked at the hospital and they are mandating vaccines by Oct2021  Treatment information was not reported by reporter.  Company Comment: Very limited information regarding this event has been provided at this time. Further information is not expected..The event was downgrade due the patient did not seek medical help.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected..The event was downgrade due the patient did not seek medical help.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Illness, Pyrexia
Clinical narrative: So sick for days; generalized weakness; fever; headache; shivering; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (So sick for days), ASTHENIA (generalized weakness), PYREXIA (fever), HEADACHE (headache) and CHILLS (shivering) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     The patient's past medical history included DVT (4 years ago but hasn't been taking blood thinners or presented any symptoms since) and First pregnancy (4 years ago). Concomitant products included VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced ILLNESS (So sick for days), ASTHENIA (generalized weakness), PYREXIA (fever), HEADACHE (headache) and CHILLS (shivering). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 01-Jul-2021, ILLNESS (So sick for days), ASTHENIA (generalized weakness), PYREXIA (fever), HEADACHE (headache) and CHILLS (shivering) 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.   This case was linked to MOD-2021-303289 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Body temperature, Chronic myeloid leukaemia, Dizziness
Clinical narrative: Chronic myeloid leukemia; weakness; Night sweats; Fever,temperature over 103 degrees,low fever; Dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced ASTHENIA (weakness), NIGHT SWEATS (Night sweats), PYREXIA (Fever,temperature over 103 degrees,low fever), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 10-Aug-2021, the patient experienced CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia), ASTHENIA (weakness), NIGHT SWEATS (Night sweats), PYREXIA (Fever,temperature over 103 degrees,low fever), DIZZINESS (Dizzy) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Body temperature: 103 (High) 103 degrees. On 10-Aug-2021, Blood test: chronic myeloid leukemia. (abnormal) chronic myeloid leukemia..         The concomitant medications were not reported.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.   This case was linked to MOD-2021-303146.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Night sweats, Pyrexia
Clinical narrative: Chronic myeloid leukemia; weakness; Night sweats; Fever,temperature over 103 degrees,low fever; Dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced ASTHENIA (weakness), NIGHT SWEATS (Night sweats), PYREXIA (Fever,temperature over 103 degrees,low fever), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 10-Aug-2021, the patient experienced CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, CHRONIC MYELOID LEUKAEMIA (Chronic myeloid leukemia), ASTHENIA (weakness), NIGHT SWEATS (Night sweats), PYREXIA (Fever,temperature over 103 degrees,low fever), DIZZINESS (Dizzy) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Body temperature: 103 (High) 103 degrees. On 10-Aug-2021, Blood test: chronic myeloid leukemia. (abnormal) chronic myeloid leukemia..         The concomitant medications were not reported.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.   This case was linked to MOD-2021-303146.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bone disorder, Fatigue, Feeling cold, Somnolence
Clinical narrative: he could not get warm; Bone cold; he slept a lot; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (he could not get warm), BONE DISORDER (Bone cold), SOMNOLENCE (he slept a lot) and FATIGUE (exhausted) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 044A21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Prostate cancer (Immunocompromised with prostrate cancer.). Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREDNISONE ACETATE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), ATORVASTATIN, BUMETANIDE, CHOLECALCIFEROL, CLOPIDOGREL BISULFATE (PLAVIX), FAMOTIDINE (PEPCID [FAMOTIDINE]), FINASTERIDE (PROSCAR), METOPROLOL SUCCINATE (TOPROL XL), METFORMIN and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced FEELING COLD (he could not get warm) (seriousness criterion medically significant), BONE DISORDER (Bone cold) (seriousness criterion medically significant), SOMNOLENCE (he slept a lot) (seriousness criterion medically significant) and FATIGUE (exhausted) (seriousness criterion medically significant). At the time of the report, FEELING COLD (he could not get warm), BONE DISORDER (Bone cold), SOMNOLENCE (he slept a lot) and FATIGUE (exhausted) outcome was unknown.            No treatment informations were reported.  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. No further information is expected. Event terms, onset dates, outcomes and seriousness captured per Narrative, "bone cold" seems to be a typo error.   This case was linked to MOD-2021-303355 (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. No further information is expected. Event terms, onset dates, outcomes and seriousness captured per Narrative, "bone cold" seems to be a typo error.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had more symptoms with this vaccine than the patient had with the other two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had more symptoms with this vaccine than the patient had with the other two) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.   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 COMPLICATION (had more symptoms with this vaccine than the patient had with the other two). At the time of the report, VACCINATION COMPLICATION (had more symptoms with this vaccine than the patient had with the other two) outcome was unknown.            Treatment information was not reported.  It was reported that, the patient had more symptoms with her third dose of  vaccine than the patient had with the other two. The events related to second dose were not reported.   This case was linked to MOD-2021-303360, MOD-2021-301320 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Pain in extremity, Pruritus, Rash, Vaccination site pain
Clinical narrative: Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted; Arm hurt; Vision loss; developed a rash on his arms, upper chest, legs, tops of his feet and stomach/; Arm hurt; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Vision loss) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0110(orD)21A and s 033821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reported that, he had first symptoms on 13-MAR-2021.).   On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 31-May-2021, the patient experienced RASH (developed a rash on his arms, upper chest, legs, tops of his feet and stomach/). In June 2021, the patient experienced BLINDNESS (Vision loss) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced PRURITUS (Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted) and PAIN IN EXTREMITY (Arm hurt). At the time of the report, BLINDNESS (Vision loss), PAIN IN EXTREMITY (Arm hurt), RASH (developed a rash on his arms, upper chest, legs, tops of his feet and stomach/), VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown and PRURITUS (Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant medication reported. There was no treatment medication reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received on 01-SEP-2021 Contains No new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted; Arm hurt; Vision loss; developed a rash on his arms, upper chest, legs, tops of his feet and stomach/; Arm hurt; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Vision loss) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0110(orD)21A and s 033821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reported that, he had first symptoms on 13-MAR-2021.).   On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 31-May-2021, the patient experienced RASH (developed a rash on his arms, upper chest, legs, tops of his feet and stomach/). In June 2021, the patient experienced BLINDNESS (Vision loss) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced PRURITUS (Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted) and PAIN IN EXTREMITY (Arm hurt). At the time of the report, BLINDNESS (Vision loss), PAIN IN EXTREMITY (Arm hurt), RASH (developed a rash on his arms, upper chest, legs, tops of his feet and stomach/), VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown and PRURITUS (Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant medication reported. There was no treatment medication reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received on 01-SEP-2021 Contains No new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Prediabetes (Borderline Pre-Diabets).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner). On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner) had resolved.            The patient weight reported as 200 with unknown units  Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up information include patient demographics, relevant medical history and vaccine facility information were added.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received the 3rd dose from a vial that had been more than 12 hours at room temperature   ) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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 EXPIRED PRODUCT ADMINISTERED (a patient received the 3rd dose from a vial that had been more than 12 hours at room temperature   ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received the 3rd dose from a vial that had been more than 12 hours at room temperature   ) outcome was unknown. Concomitant and Treatment was not specified.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Ear congestion, Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 antibody test
Clinical narrative: Swallowing issues; Ears congested; Sore throat on the  left side; Red tonsil; Swollen glands in throat and neck; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 antibody test: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported that she had visited  Health Care Professional (Second contact) who advised her to undergo COVID test.; 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.  More information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar erythema
Clinical narrative: Swallowing issues; Ears congested; Sore throat on the  left side; Red tonsil; Swollen glands in throat and neck; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Swallowing issues), EAR CONGESTION (Ears congested), OROPHARYNGEAL PAIN (Sore throat on the  left side), TONSILLAR ERYTHEMA (Red tonsil) and LYMPHADENOPATHY (Swollen glands in throat and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 antibody test: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported that she had visited  Health Care Professional (Second contact) who advised her to undergo COVID test.; 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.  More information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain, Vaccination site reaction
Clinical narrative: It's like puffy at the injection site; It hurts; Top of her arm swollen; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (It's like puffy at the injection site), PAIN IN EXTREMITY (It hurts), PERIPHERAL SWELLING (Top of her arm swollen) and VACCINATION SITE PAIN (Soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 31-Aug-2021, the patient experienced VACCINATION SITE REACTION (It's like puffy at the injection site), PAIN IN EXTREMITY (It hurts) and PERIPHERAL SWELLING (Top of her arm swollen). At the time of the report, VACCINATION SITE REACTION (It's like puffy at the injection site) and VACCINATION SITE PAIN (Soreness) outcome was unknown and PAIN IN EXTREMITY (It hurts) and PERIPHERAL SWELLING (Top of her arm swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Nausea, Pyrexia
Clinical narrative: got pretty sick with the second dose/just sick all over; just felt terrible/felt real bad; Felt nauseated /nauseous; felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got pretty sick with the second dose/just sick all over), FEELING ABNORMAL (just felt terrible/felt real bad), NAUSEA (Felt nauseated /nauseous) and PYREXIA (felt feverish) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (got pretty sick with the second dose/just sick all over), FEELING ABNORMAL (just felt terrible/felt real bad), NAUSEA (Felt nauseated /nauseous) and PYREXIA (felt feverish). On 26-Mar-2021, ILLNESS (got pretty sick with the second dose/just sick all over), FEELING ABNORMAL (just felt terrible/felt real bad), NAUSEA (Felt nauseated /nauseous) and PYREXIA (felt feverish) had resolved.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The patient asked whether the patient could take a booster or third dose or not.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up information included updated narrative
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Musculoskeletal stiffness, Myalgia, Swelling
Clinical narrative: neck was tender to touch on the left side; could not move her neck; It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling); sore arm/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (neck was tender to touch on the left side), MUSCULOSKELETAL STIFFNESS (could not move her neck), SWELLING (It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling)) and MYALGIA (sore arm/sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL and METFORMIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced MYALGIA (sore arm/sore arm). On 23-Feb-2021, the patient experienced HYPERAESTHESIA (neck was tender to touch on the left side), MUSCULOSKELETAL STIFFNESS (could not move her neck) and SWELLING (It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling)). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form and IBUPROFEN for Swelling, at a dose of 1 dosage form. On 10-Feb-2021, MYALGIA (sore arm/sore arm) had resolved. On 08-Mar-2021, HYPERAESTHESIA (neck was tender to touch on the left side), MUSCULOSKELETAL STIFFNESS (could not move her neck) and SWELLING (It looked like she had mumps on 1 side and she thought it was a bug bite, The nurse said she had seen this (neck swelling)) had resolved.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Arm is sore to the touch; His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there; His arm is sore to the touch and it is a little red at the site, and it itches.; A little red at the site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore to the touch), VACCINATION SITE INDURATION (His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there), VACCINATION SITE PRURITUS (His arm is sore to the touch and it is a little red at the site, and it itches.) and VACCINATION SITE ERYTHEMA (A little red at the site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMLODIPINE, FINASTERIDE, FUROSEMIDE, UMECLIDINIUM BROMIDE (INCRUSE ELLIPTA), LISINOPRIL, METFORMIN, PHENTERMINE, PREDNISOLONE, FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), LOVASTATIN and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore to the touch), VACCINATION SITE INDURATION (His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there), VACCINATION SITE PRURITUS (His arm is sore to the touch and it is a little red at the site, and it itches.) and VACCINATION SITE ERYTHEMA (A little red at the site). At the time of the report, PAIN IN EXTREMITY (Arm is sore to the touch), VACCINATION SITE INDURATION (His arm is sore to the touch and it is a little red at the site, and it itches. He states he can feel a knot there), VACCINATION SITE PRURITUS (His arm is sore to the touch and it is a little red at the site, and it itches.) and VACCINATION SITE ERYTHEMA (A little red at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Feeling hot, Headache
Clinical narrative: Flu like symptoms; Sore throat; Heart starts pounding / Heart beating; Chest hurts / Slight soreness in sternum area; Shortness of breath; Hot / Felt very very hot; Arms are shaking uncountably; Achy all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area) and DYSPNOEA (Shortness of breath) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Anxiety, MULTIVITAMIN GUMMY BEARS for an unknown indication.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area), DYSPNOEA (Shortness of breath), FEELING HOT (Hot / Felt very very hot), TREMOR (Arms are shaking uncountably), MYALGIA (Achy all over ) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area), DYSPNOEA (Shortness of breath), FEELING HOT (Hot / Felt very very hot), TREMOR (Arms are shaking uncountably), MYALGIA (Achy all over ) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Body temperature: 95 degrees fahrenheit (abnormal) 95 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated the event arms are shaking uncountably as not constant it comes and goes. Treatment drug Tylenol which patient took helped a little with the flu like symptoms.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Oropharyngeal pain, Palpitations, Tremor
Clinical narrative: Flu like symptoms; Sore throat; Heart starts pounding / Heart beating; Chest hurts / Slight soreness in sternum area; Shortness of breath; Hot / Felt very very hot; Arms are shaking uncountably; Achy all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area) and DYSPNOEA (Shortness of breath) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Anxiety, MULTIVITAMIN GUMMY BEARS for an unknown indication.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area), DYSPNOEA (Shortness of breath), FEELING HOT (Hot / Felt very very hot), TREMOR (Arms are shaking uncountably), MYALGIA (Achy all over ) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (Sore throat), PALPITATIONS (Heart starts pounding / Heart beating), CHEST PAIN (Chest hurts / Slight soreness in sternum area), DYSPNOEA (Shortness of breath), FEELING HOT (Hot / Felt very very hot), TREMOR (Arms are shaking uncountably), MYALGIA (Achy all over ) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Body temperature: 95 degrees fahrenheit (abnormal) 95 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated the event arms are shaking uncountably as not constant it comes and goes. Treatment drug Tylenol which patient took helped a little with the flu like symptoms.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Skin irritation, Swelling, Tenderness, Vaccination complication
Clinical narrative: hyaluronic acid fillers in her face have reacted; face ached; areas of filler are swollen; areas of filler are tender; areas of filler are a little irritated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (hyaluronic acid fillers in her face have reacted), FACIAL PAIN (face ached), SWELLING (areas of filler are swollen), TENDERNESS (areas of filler are tender) and SKIN IRRITATION (areas of filler are a little irritated) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced VACCINATION COMPLICATION (hyaluronic acid fillers in her face have reacted), FACIAL PAIN (face ached), SWELLING (areas of filler are swollen), TENDERNESS (areas of filler are tender) and SKIN IRRITATION (areas of filler are a little irritated). At the time of the report, VACCINATION COMPLICATION (hyaluronic acid fillers in her face have reacted), FACIAL PAIN (face ached), SWELLING (areas of filler are swollen), TENDERNESS (areas of filler are tender) and SKIN IRRITATION (areas of filler are a little irritated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: rapid heart beat; high fever; horrid headache; uncontrollable chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat), PYREXIA (high fever), HEADACHE (horrid headache), CHILLS (uncontrollable chills) and MYALGIA (body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart beat), PYREXIA (high fever), HEADACHE (horrid headache), CHILLS (uncontrollable chills) and MYALGIA (body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (rapid heart beat) was resolving and PYREXIA (high fever), HEADACHE (horrid headache), CHILLS (uncontrollable chills) and MYALGIA (body aches) outcome was unknown.            No Concomitant were reported   This case was linked to MOD-2021-303864 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received 1mL dose instead of 0.5mL; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 01-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL). On 01-Sep-2021, ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment information was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Arthralgia, Atrial flutter, Bone pain, Chest pain
Clinical narrative: Agitation; Heart pounding; Heartbeats increased; Sternal pain; Vaccination adverse reaction; Premature atrial contraction; Bone pain; Atrial flutter; Throat discomfort; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain) and VACCINATION COMPLICATION (Vaccination adverse reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LATANOPROST and TIMOLOL for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain), VACCINATION COMPLICATION (Vaccination adverse reaction), SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction), BONE PAIN (Bone pain), ATRIAL FLUTTER (Atrial flutter), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and ARTHRALGIA (Joint pain). At the time of the report, AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain), VACCINATION COMPLICATION (Vaccination adverse reaction), SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction), BONE PAIN (Bone pain), ATRIAL FLUTTER (Atrial flutter), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Non-Significant Follow up
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oropharyngeal discomfort, Palpitations, Supraventricular extrasystoles, Vaccination complication
Clinical narrative: Agitation; Heart pounding; Heartbeats increased; Sternal pain; Vaccination adverse reaction; Premature atrial contraction; Bone pain; Atrial flutter; Throat discomfort; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain) and VACCINATION COMPLICATION (Vaccination adverse reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LATANOPROST and TIMOLOL for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain), VACCINATION COMPLICATION (Vaccination adverse reaction), SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction), BONE PAIN (Bone pain), ATRIAL FLUTTER (Atrial flutter), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and ARTHRALGIA (Joint pain). At the time of the report, AGITATION (Agitation), PALPITATIONS (Heart pounding), HEART RATE INCREASED (Heartbeats increased), CHEST PAIN (Sternal pain), VACCINATION COMPLICATION (Vaccination adverse reaction), SUPRAVENTRICULAR EXTRASYSTOLES (Premature atrial contraction), BONE PAIN (Bone pain), ATRIAL FLUTTER (Atrial flutter), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Non-Significant Follow up