chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: Petechiae vascular; This spontaneous case was reported by a health care professional and describes the occurrence of PETECHIAE (Petechiae vascular) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PETECHIAE (Petechiae vascular). At the time of the report, PETECHIAE (Petechiae vascular) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (tachycardia) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021 at 1:00 PM, the patient experienced TACHYCARDIA (tachycardia). At the time of the report, TACHYCARDIA (tachycardia) had not 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.   Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs. The causality assessment remains as not applicable in this case.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination site erythema
Clinical narrative: Sore Arm; Chills; Red Mark on Injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red Mark on Injection site) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red Mark on Injection site). At the time of the report, PAIN IN EXTREMITY (Sore Arm), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red Mark on Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: rash near the injection site of arm; red near the injection site of arm; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (rash near the injection site of arm) and VACCINATION SITE ERYTHEMA (red near the injection site of arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE RASH (rash near the injection site of arm) and VACCINATION SITE ERYTHEMA (red near the injection site of arm). On 01-Jan-2021, VACCINATION SITE RASH (rash near the injection site of arm) and VACCINATION SITE ERYTHEMA (red near the injection site of arm) 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.   No relevant concomitant medications were reported. No treatment information was provided.; 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Insomnia
Clinical narrative: sweating; Muscle weakness; Feeling hot; excessive thrist; could not sleep all night; went to the bathroom several times; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist) and INSOMNIA (could not sleep all night) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema on 10-Oct-1988. Concurrent medical conditions included Allergy to antibiotic (bactrim) and Lactose intolerance. Concomitant products included VITAMIN B COMPLEX and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced HYPERHIDROSIS (sweating). 14-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist), INSOMNIA (could not sleep all night), POLLAKIURIA (went to the bathroom several times), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 16-Jan-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist), INSOMNIA (could not sleep all night), POLLAKIURIA (went to the bathroom several times) and HEADACHE (Headache) had not resolved.            Concomitant medication include: Multivitamins, glucosamin chondritin, vitamin b complex as nutrients no treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added contact information patient  relevant history,  concomitant medication, events. updated patient contact information and demographics.; 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. Causality for Inappropriate schedule of product administration is not applicable.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pollakiuria, Pyrexia, Thirst
Clinical narrative: sweating; Muscle weakness; Feeling hot; excessive thrist; could not sleep all night; went to the bathroom several times; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist) and INSOMNIA (could not sleep all night) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema on 10-Oct-1988. Concurrent medical conditions included Allergy to antibiotic (bactrim) and Lactose intolerance. Concomitant products included VITAMIN B COMPLEX and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced HYPERHIDROSIS (sweating). 14-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist), INSOMNIA (could not sleep all night), POLLAKIURIA (went to the bathroom several times), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 16-Jan-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (Muscle weakness), FEELING HOT (Feeling hot), THIRST (excessive thrist), INSOMNIA (could not sleep all night), POLLAKIURIA (went to the bathroom several times) and HEADACHE (Headache) had not resolved.            Concomitant medication include: Multivitamins, glucosamin chondritin, vitamin b complex as nutrients no treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added contact information patient  relevant history,  concomitant medication, events. updated patient contact information and demographics.; 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. Causality for Inappropriate schedule of product administration is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache
Clinical narrative: tested positive for COVID; mild cough; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), COUGH (mild cough), FATIGUE (extreme fatigue) and HEADACHE (headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COUGH (mild cough), FATIGUE (extreme fatigue) and HEADACHE (headache). On 31-Dec-2020, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID), COUGH (mild cough), FATIGUE (extreme fatigue) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was advised to take Vitamin B and Zinc as treatment medications.  No Concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Reporter contact information updated; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity, Rash
Clinical narrative: Severe soreness under left arm; Soreness in the armpit; Rash on the back of the arm; Lymph nodes swelling; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Severe soreness under left arm), AXILLARY PAIN (Soreness in the armpit), RASH (Rash on the back of the arm) and LYMPHADENOPATHY (Lymph nodes swelling) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Nov-2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe soreness under left arm), AXILLARY PAIN (Soreness in the armpit), RASH (Rash on the back of the arm) and LYMPHADENOPATHY (Lymph nodes swelling). At the time of the report, PAIN IN EXTREMITY (Severe soreness under left arm), AXILLARY PAIN (Soreness in the armpit), RASH (Rash on the back of the arm) and LYMPHADENOPATHY (Lymph nodes swelling) had not 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.   No relevant concomitant 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 event, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: ended up getting COVID before her antibodies; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (ended up getting COVID before her antibodies) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID] and LEVOTHYROXINE for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COVID-19 (ended up getting COVID before her antibodies). At the time of the report, COVID-19 (ended up getting COVID before her antibodies) outcome was unknown. Not Provided      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.   Patient received monoclonal antibody infusion as treatment.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Muscle spasms
Clinical narrative: Cramping in legs, arms and back; bump; injection site was hard; tender; Stomach sickness; Diarrhea; I had a headache; Was tired; Achy; Injection site was swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach sickness), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (injection site was hard) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 since an unknown date.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (I had a headache), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red). On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach sickness) and DIARRHOEA (Diarrhea). On 13-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE PAIN (tender). On 12-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 13-Jan-2021, ABDOMINAL DISCOMFORT (Stomach sickness) and HEADACHE (I had a headache) had resolved. On 14-Jan-2021, MUSCLE SPASMS (Cramping in legs, arms and back) had resolved. At the time of the report, VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE PAIN (tender), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for her headache, fatigue, myalgia, vaccination site swelling, vaccination site erythema, abdominal discomfort, and muscle spasms. Treatment for diarrhoea included an unknown medication. Treatment for the events vaccination site induration, vaccination site pain and vaccination mass, included that she rubbed alcohol and put ice and heat on it.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain
Clinical narrative: Cramping in legs, arms and back; bump; injection site was hard; tender; Stomach sickness; Diarrhea; I had a headache; Was tired; Achy; Injection site was swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach sickness), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (injection site was hard) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 since an unknown date.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (I had a headache), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red). On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach sickness) and DIARRHOEA (Diarrhea). On 13-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE PAIN (tender). On 12-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 13-Jan-2021, ABDOMINAL DISCOMFORT (Stomach sickness) and HEADACHE (I had a headache) had resolved. On 14-Jan-2021, MUSCLE SPASMS (Cramping in legs, arms and back) had resolved. At the time of the report, VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE PAIN (tender), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for her headache, fatigue, myalgia, vaccination site swelling, vaccination site erythema, abdominal discomfort, and muscle spasms. Treatment for diarrhoea included an unknown medication. Treatment for the events vaccination site induration, vaccination site pain and vaccination mass, included that she rubbed alcohol and put ice and heat on it.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Cramping in legs, arms and back; bump; injection site was hard; tender; Stomach sickness; Diarrhea; I had a headache; Was tired; Achy; Injection site was swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach sickness), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump) and VACCINATION SITE INDURATION (injection site was hard) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 since an unknown date.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (I had a headache), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red). On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach sickness) and DIARRHOEA (Diarrhea). On 13-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping in legs, arms and back), VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE PAIN (tender). On 12-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 13-Jan-2021, ABDOMINAL DISCOMFORT (Stomach sickness) and HEADACHE (I had a headache) had resolved. On 14-Jan-2021, MUSCLE SPASMS (Cramping in legs, arms and back) had resolved. At the time of the report, VACCINATION SITE MASS (bump), VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE PAIN (tender), FATIGUE (Was tired), MYALGIA (Achy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for her headache, fatigue, myalgia, vaccination site swelling, vaccination site erythema, abdominal discomfort, and muscle spasms. Treatment for diarrhoea included an unknown medication. Treatment for the events vaccination site induration, vaccination site pain and vaccination mass, included that she rubbed alcohol and put ice and heat on it.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm; Itches constantly; Bigger; Vaccination site erythema; Left deltoid region of non-dominant arm red; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itches constantly), VACCINATION SITE ERYTHEMA (Left deltoid region of non-dominant arm red), PYREXIA (Feverish) and VACCINATION SITE SWELLING (Bigger) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure (Patient on Blood Pressure medication) and Thyroid therapy.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left deltoid region of non-dominant arm red) and PYREXIA (Feverish). On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itches constantly), VACCINATION SITE SWELLING (Bigger) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Jan-2021, VACCINATION SITE ERYTHEMA (Left deltoid region of non-dominant arm red) and PYREXIA (Feverish) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itches constantly), VACCINATION SITE SWELLING (Bigger) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure and thyroid medications. . Treatment for the event also included ice.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Non significant follow up : received on 10-JUN-2021 and does not contain any 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.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body ache; Has fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and PYREXIA (Has fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-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 MYALGIA (Body ache) and PYREXIA (Has fever). At the time of the report, MYALGIA (Body ache) and PYREXIA (Has fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Feeling hot, Flushing, Hypertension
Clinical narrative: tachycardia skyrocketed; blood pressure skyrocketed; 194/113; injection site hot to the touch; feet and hands swollen; her head felt hot; feeling flush; charlie horses; Nausea; body aches/muscle aches in legs are so bad; extreme fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen) and FEELING HOT (her head felt hot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high ((several years ago with illness and pain, had since resolved)). Family history included Blood pressure abnormal.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue). At the time of the report, TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: 194/113 mmHg, 120/86 mmHg, 156/96 mmHg, 194/110 mmHg and 190/110 mmHg.     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.   Concomitantly patient was taking birth control. The treatment given was lisinopril; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Peripheral swelling, Tachycardia
Clinical narrative: tachycardia skyrocketed; blood pressure skyrocketed; 194/113; injection site hot to the touch; feet and hands swollen; her head felt hot; feeling flush; charlie horses; Nausea; body aches/muscle aches in legs are so bad; extreme fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen) and FEELING HOT (her head felt hot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high ((several years ago with illness and pain, had since resolved)). Family history included Blood pressure abnormal.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue). At the time of the report, TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: 194/113 mmHg, 120/86 mmHg, 156/96 mmHg, 194/110 mmHg and 190/110 mmHg.     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.   Concomitantly patient was taking birth control. The treatment given was lisinopril; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: tachycardia skyrocketed; blood pressure skyrocketed; 194/113; injection site hot to the touch; feet and hands swollen; her head felt hot; feeling flush; charlie horses; Nausea; body aches/muscle aches in legs are so bad; extreme fatigue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen) and FEELING HOT (her head felt hot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high ((several years ago with illness and pain, had since resolved)). Family history included Blood pressure abnormal.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue). At the time of the report, TACHYCARDIA (tachycardia skyrocketed), HYPERTENSION (blood pressure skyrocketed; 194/113), VACCINATION SITE WARMTH (injection site hot to the touch), PERIPHERAL SWELLING (feet and hands swollen), FEELING HOT (her head felt hot), FLUSHING (feeling flush), MUSCLE SPASMS (charlie horses), NAUSEA (Nausea), MYALGIA (body aches/muscle aches in legs are so bad) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: 194/113 mmHg, 120/86 mmHg, 156/96 mmHg, 194/110 mmHg and 190/110 mmHg.     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.   Concomitantly patient was taking birth control. The treatment given was lisinopril; 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Pain
Clinical narrative: Very tired; Real Achy; Bones hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Real Achy), BONE PAIN (Bones hurt) and FATIGUE (Very tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Medical history reported as COVID) in August 2020.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (Real Achy) and BONE PAIN (Bones hurt). On 13-Jan-2021, the patient experienced FATIGUE (Very tired). On 13-Jan-2021, PAIN (Real Achy), BONE PAIN (Bones hurt) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included paracetamol.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: tingling on the left arm; numbness on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling on the left arm) and VACCINATION SITE HYPOAESTHESIA (numbness on the left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0132204 or 01322021) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling on the left arm) and VACCINATION SITE HYPOAESTHESIA (numbness on the left arm). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling on the left arm) and VACCINATION SITE HYPOAESTHESIA (numbness on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Dizziness, Feeling abnormal
Clinical narrative: developed a sore arm; dizziness; Cough; Body aches; Their Joint Hurt; Headache; 99.4°F low fever, and  had 100.4 fever; felt out, like they did not know what they were feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt out, like they did not know what they were feeling), PAIN IN EXTREMITY (developed a sore arm), DIZZINESS (dizziness), COUGH (Cough) and MYALGIA (Body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced FEELING ABNORMAL (felt out, like they did not know what they were feeling). On 13-Jan-2021, the patient experienced DIZZINESS (dizziness), COUGH (Cough), MYALGIA (Body aches), ARTHRALGIA (Their Joint Hurt), HEADACHE (Headache) and PYREXIA (99.4°F low fever, and  had 100.4 fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (developed a sore arm). At the time of the report, FEELING ABNORMAL (felt out, like they did not know what they were feeling), DIZZINESS (dizziness), COUGH (Cough), MYALGIA (Body aches), ARTHRALGIA (Their Joint Hurt) and HEADACHE (Headache) outcome was unknown, PAIN IN EXTREMITY (developed a sore arm) had resolved and PYREXIA (99.4°F low fever, and  had 100.4 fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 99.4 °F Low. On 14-Jan-2021, Body temperature: 100.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information provided included: Tylenol fast release extra strength.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: developed a sore arm; dizziness; Cough; Body aches; Their Joint Hurt; Headache; 99.4°F low fever, and  had 100.4 fever; felt out, like they did not know what they were feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt out, like they did not know what they were feeling), PAIN IN EXTREMITY (developed a sore arm), DIZZINESS (dizziness), COUGH (Cough) and MYALGIA (Body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced FEELING ABNORMAL (felt out, like they did not know what they were feeling). On 13-Jan-2021, the patient experienced DIZZINESS (dizziness), COUGH (Cough), MYALGIA (Body aches), ARTHRALGIA (Their Joint Hurt), HEADACHE (Headache) and PYREXIA (99.4°F low fever, and  had 100.4 fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (developed a sore arm). At the time of the report, FEELING ABNORMAL (felt out, like they did not know what they were feeling), DIZZINESS (dizziness), COUGH (Cough), MYALGIA (Body aches), ARTHRALGIA (Their Joint Hurt) and HEADACHE (Headache) outcome was unknown, PAIN IN EXTREMITY (developed a sore arm) had resolved and PYREXIA (99.4°F low fever, and  had 100.4 fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 99.4 °F Low. On 14-Jan-2021, Body temperature: 100.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information provided included: Tylenol fast release extra strength.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Alzheimer's disease.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Somnolence, Swelling
Clinical narrative: Shortness of breath; Fatigue; Swelling; Weakness; Sleepiness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), SWELLING (Swelling), ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no medical history reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), SWELLING (Swelling), ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), SWELLING (Swelling), ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the known information regarding the vaccine not containing the virus, the event is assessed as unlikely related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site coldness
Clinical narrative: Cold in my arm when injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (Cold in my arm when injected) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE COLDNESS (Cold in my arm when injected). At the time of the report, VACCINATION SITE COLDNESS (Cold in my arm when injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been 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 event, a causal relationship cannot be excluded.