chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: Blister at the injection site; Itchy at the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE VESICLES (Blister at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History 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 VESICLES (Blister at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site). At the time of the report, VACCINATION SITE VESICLES (Blister at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment for the events was not provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of decreased appetite (loss her appetite), pain (all over body pain) and fatigue in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. Concomitant products included tramadol and gabapentin for an unknown indication. On Jan 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 8, 2021, patient experienced decreased appetite (loss her appetite), pain (all over body pain) and fatigue. On Jan 12, 2021, decreased appetite (loss her appetite), pain (all over body pain) and fatigue resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Other concomitant medications included unspecified blood pressure medication, blood thinner medication and cholesterol medication. Treatment medication included Bismuth subsalicylate.This case linked to MOD-2021-006211 (patient link). Reporter did not allow further contact. 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Vaccination site warmth
Clinical narrative: sore throat; inject site warm to touch; head ache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE WARMTH (inject site warm to touch) and HEADACHE (head ache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (inject site warm to touch) and HEADACHE (head ache). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE WARMTH (inject site warm to touch) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included  used heating pad on the injection site.  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) 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 concomitant medications were reported. Patient's last menstrual period was not mentioned, and conception date was unknown. The patient's estimated due date is unknown.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccination reaction 7-14 days post; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a reaction 7-14 days post vaccination.    The patient's medical history was not provided. Concomitant product use was not provided.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The nurse reported the patient had a vaccination reaction 7-14 days post vaccination. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed a reaction 7-14 days post vaccination, was considered unknown.; Reporter's Comments: This case concerns a subject who experienced a non serious  unexpected event of Vaccination complication. The event occurred 7-14 days after first dose of the study medication administration.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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Rash pruritic, Vaccination site pain
Clinical narrative: Rash on the front and back of my trunk and then it started itching for 3-4 days; Chills; Temperature of 101.5 degrees Fahrenheit; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on the front and back of my trunk and then it started itching for 3-4 days), CHILLS (Chills), PYREXIA (Temperature of 101.5 degrees Fahrenheit) and VACCINATION SITE PAIN (Sore injection site) in a 77-year-old female 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 medical history reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Temperature of 101.5 degrees Fahrenheit) and VACCINATION SITE PAIN (Sore injection site). On 07-Jan-2021, the patient experienced RASH PRURITIC (Rash on the front and back of my trunk and then it started itching for 3-4 days). On 11-Jan-2021, RASH PRURITIC (Rash on the front and back of my trunk and then it started itching for 3-4 days), CHILLS (Chills), PYREXIA (Temperature of 101.5 degrees Fahrenheit) and VACCINATION SITE PAIN (Sore injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 101.5 (Inconclusive) 101.5 degrees Fahrenheit.     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
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, GUANFACINE, APIXABAN (ELIQUIS), VALSARTAN, SIMVASTATIN and FLUOXETINE for an unknown indication.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Contusion, Fatigue, Infection, Pain
Clinical narrative: infection; patient's armpit near site of injection is "incredibly painful" and "blue"; patient's armpit near site of injection is "incredibly painful" and "blue"; Fatigue; pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INFECTION (infection), PAIN (pain), CONTUSION (patient's armpit near site of injection is "incredibly painful" and "blue"), AXILLARY PAIN (patient's armpit near site of injection is "incredibly painful" and "blue") and FATIGUE (Fatigue) in a 53-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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Jan-2021, the patient experienced PAIN (pain) and FATIGUE (Fatigue). On 15-Jan-2021, the patient experienced CONTUSION (patient's armpit near site of injection is "incredibly painful" and "blue") and AXILLARY PAIN (patient's armpit near site of injection is "incredibly painful" and "blue"). On an unknown date, the patient experienced INFECTION (infection). At the time of the report, INFECTION (infection), PAIN (pain), CONTUSION (patient's armpit near site of injection is "incredibly painful" and "blue"), AXILLARY PAIN (patient's armpit near site of injection is "incredibly painful" and "blue") and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The treatment reported was Bactrim for infection.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 28-year-old female 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 Historical condition reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 08-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: A little fatigue; A little headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little fatigue) and HEADACHE (A little headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On 11-Jan-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021 at 4:00 PM, the patient experienced FATIGUE (A little fatigue) and HEADACHE (A little headache). On 13-Jan-2021, FATIGUE (A little fatigue) and HEADACHE (A little headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal 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 MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight Soreness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Slight Soreness). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Slight Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema
Clinical narrative: slightly painful; 3 inch red circle where the injection was; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (3 inch red circle where the injection was) and PAIN (slightly painful) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (3 inch red circle where the injection was) and PAIN (slightly painful). The patient was treated with CORTISOL ACETATE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (3 inch red circle where the injection was) and PAIN (slightly painful) 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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) 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 reported medical history).    On 12-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 PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported.  Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warm  touch at the injection site; Sore at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Warm  touch at the injection site), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a 31-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 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm  touch at the injection site), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm  touch at the injection site), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) was resolving.        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. Treatment for the event included cetirizine and symptoms subsided.; 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, Pyrexia
Clinical narrative: Body aches; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (Low grade fever) 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 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Low grade fever). At the time of the report, MYALGIA (Body aches) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No information of treatment medication was given. Laboratory details was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Arthralgia, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Diarrhea; Headache; Fever; Chills; Joint pain; sore at the site of injection; Redness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) in an 81-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.     No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (sore at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (sore at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient took Tylenol as the treatment medication. Laboratory details was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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 erythema, Vaccination site pain
Clinical narrative: Diarrhea; Headache; Fever; Chills; Joint pain; sore at the site of injection; Redness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) in an 81-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.     No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (sore at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (sore at the site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient took Tylenol as the treatment medication. Laboratory details was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Asthenia, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: feels sick; body ache; congestion; fatigue; sore throat; bad headache; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), ASTHENIA (felt weak), OROPHARYNGEAL PAIN (sore throat), VACCINATION COMPLICATION (feels sick) and MYALGIA (body ache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), METHYLPHENIDATE HYDROCHLORIDE (RITALIN), ONDANSETRON (ZOFRAN [ONDANSETRON]), OMEPRAZOLE and HYDROXYZINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (bad headache) and ASTHENIA (felt weak). On 10-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (feels sick), MYALGIA (body ache), NASAL CONGESTION (congestion) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (bad headache), ASTHENIA (felt weak), OROPHARYNGEAL PAIN (sore throat), VACCINATION COMPLICATION (feels sick), MYALGIA (body ache), NASAL CONGESTION (congestion) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Prozac, Ritalin, Zofran, omeprazole, hydroxytine; 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.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination complication
Clinical narrative: feels sick; body ache; congestion; fatigue; sore throat; bad headache; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), ASTHENIA (felt weak), OROPHARYNGEAL PAIN (sore throat), VACCINATION COMPLICATION (feels sick) and MYALGIA (body ache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), METHYLPHENIDATE HYDROCHLORIDE (RITALIN), ONDANSETRON (ZOFRAN [ONDANSETRON]), OMEPRAZOLE and HYDROXYZINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (bad headache) and ASTHENIA (felt weak). On 10-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (feels sick), MYALGIA (body ache), NASAL CONGESTION (congestion) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (bad headache), ASTHENIA (felt weak), OROPHARYNGEAL PAIN (sore throat), VACCINATION COMPLICATION (feels sick), MYALGIA (body ache), NASAL CONGESTION (congestion) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Prozac, Ritalin, Zofran, omeprazole, hydroxytine; 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: Asthenia, Dizziness, Paraesthesia oral
Clinical narrative: Dizziness; Weakness; Tongue felt fuzzy and prickly; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and PARAESTHESIA ORAL (Tongue felt fuzzy and prickly) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and PARAESTHESIA ORAL (Tongue felt fuzzy and prickly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (Weakness) was resolving and PARAESTHESIA ORAL (Tongue felt fuzzy and prickly) 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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested  COVID positive; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested  COVID positive) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 28-Dec-2020, the patient experienced COVID-19 (Tested  COVID positive). At the time of the report, COVID-19 (Tested  COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test positive: positive (Positive) Positive.   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: Very limited information regarding these events 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: Back pain, Dry throat, Dysgeusia, Fatigue, Headache
Clinical narrative: breaking pain across her upper back; bad headache; tiredness; tasted the vaccine in her throat; throat felt dry; achy; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (tasted the vaccine in her throat), DRY THROAT (throat felt dry), PAIN (achy), BACK PAIN (breaking pain across her upper back) and HEADACHE (bad headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2OA.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-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 DYSGEUSIA (tasted the vaccine in her throat), DRY THROAT (throat felt dry), PAIN (achy), HEADACHE (bad headache) and FATIGUE (tiredness). On 12-Jan-2021, the patient experienced BACK PAIN (breaking pain across her upper back). At the time of the report, DYSGEUSIA (tasted the vaccine in her throat), DRY THROAT (throat felt dry), PAIN (achy), BACK PAIN (breaking pain across her upper back), HEADACHE (bad headache) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: breaking pain across her upper back; bad headache; tiredness; tasted the vaccine in her throat; throat felt dry; achy; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (tasted the vaccine in her throat), DRY THROAT (throat felt dry), PAIN (achy), BACK PAIN (breaking pain across her upper back) and HEADACHE (bad headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2OA.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-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 DYSGEUSIA (tasted the vaccine in her throat), DRY THROAT (throat felt dry), PAIN (achy), HEADACHE (bad headache) and FATIGUE (tiredness). On 12-Jan-2021, the patient experienced BACK PAIN (breaking pain across her upper back). At the time of the report, DYSGEUSIA (tasted the vaccine in her throat), DRY THROAT (throat felt dry), PAIN (achy), BACK PAIN (breaking pain across her upper back), HEADACHE (bad headache) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-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 01-Oct-2020 and the estimated date of delivery was 08-Jul-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Urticaria
Clinical narrative: Chest pressure; Hives on both ears, both cheeks side of face, both legs, both arms; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest pressure) and URTICARIA (Hives on both ears, both cheeks side of face, both legs, both arms) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) and URTICARIA (Hives on both ears, both cheeks side of face, both legs, both arms). On 11-Jan-2021, CHEST DISCOMFORT (Chest pressure) and URTICARIA (Hives on both ears, both cheeks side of face, both legs, both arms) 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.   Concomitant medications details were not reported by the reporter. Treatment included lots of water.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: fever; hot to the touch; pain,soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (pain,soreness) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE PAIN (pain,soreness). On 14-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (pain,soreness) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Pyrexia: other His temperature was taking today and it showed he has a fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   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.; 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: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received moderna vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Migraine
Clinical narrative: Dizziness; Migraine; Headache; Extreme fatigue; Body aches; Chills; vaccination site swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Body aches) 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.     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. In January 2021, the patient experienced DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue), MYALGIA (Body aches), CHILLS (Chills) and VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue), MYALGIA (Body aches), CHILLS (Chills) and VACCINATION SITE SWELLING (vaccination site swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site swelling
Clinical narrative: Dizziness; Migraine; Headache; Extreme fatigue; Body aches; Chills; vaccination site swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Body aches) 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.     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. In January 2021, the patient experienced DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue), MYALGIA (Body aches), CHILLS (Chills) and VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue), MYALGIA (Body aches), CHILLS (Chills) and VACCINATION SITE SWELLING (vaccination site swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Sore throat; Nasal congestion; Runny nose; Feel as if I had the virus, I experience the symptoms of a heavy flu; Shortness of breath; Coughing with great effort; Thorax pain due to coughing; Weakness; Sleepiness; Tiredness; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort) and CHEST PAIN (Thorax pain due to coughing) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 12-Jan-2021, the patient experienced ASTHENIA (Weakness), SOMNOLENCE (Sleepiness) and FATIGUE (Tiredness). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing) and INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion) and RHINORRHOEA (Runny nose). On 12-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion), INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu), RHINORRHOEA (Runny nose) and FATIGUE (Tiredness) 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.   Treatment medication not provided. Concomitant medication not 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.