chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site itchy; Headache; Hot around the injection; Hurt around the injection; Red spot around injection/injection site is 2.5 inches round red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot around the injection), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Hurt around the injection), VACCINATION SITE ERYTHEMA (Red spot around injection/injection site is 2.5 inches round red) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).  On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot around the injection), VACCINATION SITE PAIN (Hurt around the injection) and VACCINATION SITE ERYTHEMA (Red spot around injection/injection site is 2.5 inches round red). On 04-Jan-2021, the patient experienced HEADACHE (Headache). On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy). On 04-Jan-2021, VACCINATION SITE PAIN (Hurt around the injection) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot around the injection), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE ERYTHEMA (Red spot around injection/injection site is 2.5 inches round red) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. Treatment information was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash, Vomiting
Clinical narrative: rash all over arm that looks like chicken pox; body ache; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over arm that looks like chicken pox), MYALGIA (body ache) and VOMITING (throwing up) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over arm that looks like chicken pox), MYALGIA (body ache) and VOMITING (throwing up). At the time of the report, RASH (rash all over arm that looks like chicken pox), MYALGIA (body ache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Peripheral swelling, Tremor
Clinical narrative: swelling arm; metallic taste; trembling lips; A spontaneous report was received  from a healthcare professional concerning a 46 year old, female patient who experienced arm swelling/peripheral swelling, trembling lips and metallic taste in her mouth since taking the vaccine.  The patient's medical history was not provided.  Concomitant product use was not provided by reporter.  On an unknown date in Jan 2021, the patient received a dose of mRNA-1273 Batch number 039K20A on intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unspecified date the patient received the vaccine 2 days ago, and experience swelling in her arm but it went away in a couple of hours. Then she felt trembling lips and metallic taste in her mouth.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the arm swelling  was resolved.  The outcome of the trembling lips and metallic taste in the mouth was not resolved.; Reporter'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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm soreness; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was provided).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache). On 10-Jan-2021, PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included Advil.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 concomitant medications were reported. No treatment related information has been reported.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up information received on 12-Apr-2021 contains non-significant information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under collar bone (clavicle); This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node under collar bone (clavicle)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not reported).   On 04-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 LYMPHADENOPATHY (Swollen lymph node under collar bone (clavicle)). At the time of the report, LYMPHADENOPATHY (Swollen lymph node under collar bone (clavicle)) 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.   Company Comment  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: Exposure via breast milk
Clinical narrative: She is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (She is breastfeeding) in a  patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (She is breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (She is breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. This is a case for the baby exposed to product via breast milk. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Additional information - Contact information provided; Sender's Comments: This case report concerns a  breastfeeding female patient of unspecified age who was administered mRNA-1273 vaccine Lot# unknown (vaccine exposure via breast milk). There was no associated adverse event reported for the event of vaccine exposure via breast milk.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: Throwing up; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VOMITING (Throwing up) and CHILLS (Chills). At the time of the report, VOMITING (Throwing up) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Patient didn't take anything to treat the symptoms and also wasn't taking any other medication.; 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: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tonsillar hypertrophy
Clinical narrative: ENlarged Tonsils with pus; Discomfort in the throat and little pain; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (ENlarged Tonsils with pus) and OROPHARYNGEAL PAIN (Discomfort in the throat and little pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not provided).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced TONSILLAR HYPERTROPHY (ENlarged Tonsils with pus) and OROPHARYNGEAL PAIN (Discomfort in the throat and little pain). In January 2021, TONSILLAR HYPERTROPHY (ENlarged Tonsils with pus) and OROPHARYNGEAL PAIN (Discomfort in the throat and little pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol 500mg every 6 hour for the first day when she felt symptoms. No antibiotics were taken.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, Parosmia
Clinical narrative: Experiencing an increase in smell and in taste; Experiencing an increase in smell and in taste; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Experiencing an increase in smell and in taste) and DYSGEUSIA (Experiencing an increase in smell and in taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 14-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 PAROSMIA (Experiencing an increase in smell and in taste) and DYSGEUSIA (Experiencing an increase in smell and in taste). At the time of the report, PAROSMIA (Experiencing an increase in smell and in taste) and DYSGEUSIA (Experiencing an increase in smell and in taste) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) I have never tested positive prior to receiving the first injection..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Ill-defined disorder, Oropharyngeal discomfort, Palpitations
Clinical narrative: started feeling like my throat was closing up; hard time swallowing; Got shaky; heart racing; felt like I was in a tunnel; Every inch of my body is screaming; This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing) and FEELING ABNORMAL (felt like I was in a tunnel) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 14-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 OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing), FEELING ABNORMAL (felt like I was in a tunnel) and ILL-DEFINED DISORDER (Every inch of my body is screaming). At the time of the report, OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing), FEELING ABNORMAL (felt like I was in a tunnel) and ILL-DEFINED DISORDER (Every inch of my body is screaming) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: started feeling like my throat was closing up; hard time swallowing; Got shaky; heart racing; felt like I was in a tunnel; Every inch of my body is screaming; This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing) and FEELING ABNORMAL (felt like I was in a tunnel) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 14-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 OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing), FEELING ABNORMAL (felt like I was in a tunnel) and ILL-DEFINED DISORDER (Every inch of my body is screaming). At the time of the report, OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing), FEELING ABNORMAL (felt like I was in a tunnel) and ILL-DEFINED DISORDER (Every inch of my body is screaming) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Urticaria
Clinical narrative: Hives that went from her stomach to her neck; chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives that went from her stomach to her neck), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 59-year-old female 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives that went from her stomach to her neck), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives that went from her stomach to her neck), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No 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 events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore Right Arm; 30 Weeks Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Right Arm) and MATERNAL EXPOSURE DURING PREGNANCY (30 Weeks Pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory tract infection (In OCT-2020, tested negative for COVID-19). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), BUDESONIDE (PULMICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Jun-2020 and the estimated date of delivery was 24-Mar-2021. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Right Arm) and MATERNAL EXPOSURE DURING PREGNANCY (30 Weeks Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 12-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (30 Weeks Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Right Arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: negative (Negative) Negative.     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 concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Patient had previous pregnancy one and delivered Live, full-term birth baby.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Pain in liver area; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up). At the time of the report, HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 12-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up). At the time of the report, HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) 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: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Pyrexia, Swelling
Clinical narrative: got 1st dose then feels sick, sore and swollen arm.; got 1st dose then feels sick, sore and swollen arm; got 1st dose then feels sick, sore and swollen arm; Now has fever; tiredness; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (got 1st dose then feels sick, sore and swollen arm.), PAIN IN EXTREMITY (got 1st dose then feels sick, sore and swollen arm), SWELLING (got 1st dose then feels sick, sore and swollen arm), PYREXIA (Now has fever) and FATIGUE (tiredness) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced FEELING ABNORMAL (got 1st dose then feels sick, sore and swollen arm.), PAIN IN EXTREMITY (got 1st dose then feels sick, sore and swollen arm), SWELLING (got 1st dose then feels sick, sore and swollen arm), PYREXIA (Now has fever) and FATIGUE (tiredness). At the time of the report, FEELING ABNORMAL (got 1st dose then feels sick, sore and swollen arm.), PAIN IN EXTREMITY (got 1st dose then feels sick, sore and swollen arm), SWELLING (got 1st dose then feels sick, sore and swollen arm), PYREXIA (Now has fever) and FATIGUE (tiredness) 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 medications taken by the patient was not provided.  Treatment information was  not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reacts to your vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION (reacts to your vaccine) 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 (reacts to your vaccine). At the time of the report, VACCINATION COMPLICATION (reacts to your vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site pain
Clinical narrative: bruising and redness at the vaccine site; severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling; bruising and redness at the vaccine site; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE BRUISING (bruising and redness at the vaccine site), VACCINATION SITE HYPERSENSITIVITY (severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling), VACCINATION SITE ERYTHEMA (bruising and redness at the vaccine site) and VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J0A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Allergic reaction to wasp sting. Concomitant products included EPINEPHRINE (EPIPEN) for Shellfish allergy.  On 07-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 INJECTION SITE BRUISING (bruising and redness at the vaccine site), VACCINATION SITE HYPERSENSITIVITY (severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling), VACCINATION SITE ERYTHEMA (bruising and redness at the vaccine site) and VACCINATION SITE PAIN (sore arm).   At the time of the report, INJECTION SITE BRUISING (bruising and redness at the vaccine site), VACCINATION SITE HYPERSENSITIVITY (severe hypersensitivity reaction at the vaccine site/Urticaria, Severe reddness and Swelling), VACCINATION SITE ERYTHEMA (bruising and redness at the vaccine site) and VACCINATION SITE PAIN (sore arm) 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.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: New adverse events added.; 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 discolouration, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site hot; Injection site was red; Lump on the injection site; Injection site hurt to the touch; Arm was swollen; Black and blue on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. 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: Vaccination site warmth
Clinical narrative: Injection site hot; Injection site was red; Lump on the injection site; Injection site hurt to the touch; Arm was swollen; Black and blue on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. 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: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm kind of sore; Arm red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm kind of sore) and VACCINATION SITE ERYTHEMA (Arm red) 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 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm kind of sore) and VACCINATION SITE ERYTHEMA (Arm red). On 06-Jan-2021, VACCINATION SITE PAIN (Arm kind of sore) and VACCINATION SITE ERYTHEMA (Arm red) had resolved.        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: 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Discomfort, Lip swelling, Pruritus
Clinical narrative: Tachycardia; Blood Pressure was high; Started Itching; Swollen Lips; Chest was tight; Tongue Heavy; A spontaneous report was received from a 53-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed itching, lips swollen, tongue heavy, chest tightness, tachycardia and blood pressure was high.   The patient's medical history, as provided by the reporter, included asthma and high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included hydrochlorothiazide valsartan and fluticasone propionate salmeterol xinafoate.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 12 Jan 2021 while waiting in the observation room post vaccination, the patient started itching and lips became swollen. Her tongue was heavy, and chest felt tight. She went home and the reaction started again. On 13 Jan 2021, the patient was seen in the emergency room and experienced tachycardia and high blood pressure. Treatment for the event included diphenhydramine injection and prednisone by mouth on 12 Jan 2021. On 13 Jan 2021, treatment included diphenhydramine intravenous, nebulizer treatment, famotidine, and cetirizine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed itching, lips swollen, tongue heavy, chest tightness, tachycardia and blood pressure was high, were considered unknown.; Reporter'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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; Blood Pressure was high; Started Itching; Swollen Lips; Chest was tight; Tongue Heavy; A spontaneous report was received from a 53-year-old female nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed itching, lips swollen, tongue heavy, chest tightness, tachycardia and blood pressure was high.   The patient's medical history, as provided by the reporter, included asthma and high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included hydrochlorothiazide valsartan and fluticasone propionate salmeterol xinafoate.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 12 Jan 2021 while waiting in the observation room post vaccination, the patient started itching and lips became swollen. Her tongue was heavy, and chest felt tight. She went home and the reaction started again. On 13 Jan 2021, the patient was seen in the emergency room and experienced tachycardia and high blood pressure. Treatment for the event included diphenhydramine injection and prednisone by mouth on 12 Jan 2021. On 13 Jan 2021, treatment included diphenhydramine intravenous, nebulizer treatment, famotidine, and cetirizine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed itching, lips swollen, tongue heavy, chest tightness, tachycardia and blood pressure was high, were considered unknown.; Reporter'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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm is little hard; Arm is swollen; Arm is little red; Arm was hurting a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 11-Jan-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Arm is little hard) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for an unknown indication.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Arm is little hard). At the time of the report, VACCINATION SITE INDURATION (Arm is little hard) 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 was received.; 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy
Clinical narrative: Dizziness/lightheadedness; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other and describes the occurrence of DIZZINESS (Dizziness/lightheadedness) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Jan-2021, the patient experienced DIZZINESS (Dizziness/lightheadedness) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, DIZZINESS (Dizziness/lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment information were not reported.  Company comment: This is a case of product exposure during pregnancy with the associated AE, dizziness, for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. However, based on the current available information and temporal association between the use of the product and the start date of the event, dizziness, a causal relationship cannot be excluded.  The reporter stated that they no longer have access to this patient's chart.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No newinformation; Sender's Comments: This is a case of product exposure during pregnancy with the associated AE, dizziness, for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. However, based on the current available information and temporal association between the use of the product and the start date of the event, dizziness, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness around the injection site; Soreness under her armpits; Redness around the injection site; Swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness around the injection site), AXILLARY PAIN (Soreness under her armpits), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site), AXILLARY PAIN (Soreness under her armpits), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness around the injection site), AXILLARY PAIN (Soreness under her armpits), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE SWELLING (Swelling around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included iced injection site and applied heat.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in an elderly 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) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.  Reporter stated that the patient age was above 80 years.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Updated reporter information, patient demographics, product start date, event start date and outcome.; 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: F
Vaccine: COVID19
Symptoms: Bursitis, Lymphadenopathy
Clinical narrative: Bursitis; Swollen lymphoid; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BURSITIS (Bursitis) and LYMPHADENOPATHY (Swollen lymphoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURSITIS (Bursitis) and LYMPHADENOPATHY (Swollen lymphoid). At the time of the report, BURSITIS (Bursitis) and LYMPHADENOPATHY (Swollen lymphoid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a dentist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 04-Jan-2021 to 07-Jan-2021. Concomitant products included PARACETAMOL (TYLENOL) from 04-Jan-2021 to 05-Jan-2021 for COVID-19.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Flu-like symptoms, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: TCR Form reported 2nd dose information and AEs from 2nd dose; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Swelling
Clinical narrative: Brain fog; Swollen right side; fatigue; severe pain; A spontaneous report was received from a consumer, concerning a female patient of  age 60 years, who received Moderna's COVID-19 vaccine and experienced brain fog, swelling, fatigue and pain.   The patient reported having medical history of fibromyalgia and arthritis. Concomitant product use was not provided by the reporter.  On 17-JAN-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) via unknown route for COVID-19 infection prophylaxis.   On 17-JAN-2021, after first dose of vaccine, the patient experienced brain fog, swelling, fatigue and pain. Patient  reported undergoing medication.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events, brain fog, swelling, fatigue and pain  was considered to be unknown at the time of this report.; 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.