chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dermatitis, Pruritus, Skin exfoliation
Clinical narrative: Dermatitis of scalp; Alopecia; Patient's head stared itching; Patient's head stared flaking; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (Dermatitis of scalp), PRURITUS (Patient's head stared itching), SKIN EXFOLIATION (Patient's head stared flaking) and ALOPECIA (Alopecia) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included CIDP. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) and TRIAMCINOLONE ACETONIDE (KENALOG 40) for CIDP.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Patient's head stared itching) and SKIN EXFOLIATION (Patient's head stared flaking). On 27-Jan-2021, the patient experienced ALOPECIA (Alopecia). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DERMATITIS (Dermatitis of scalp). The patient was treated with CLOBETASOL for Itching, at a dose of 1 dosage form. At the time of the report, DERMATITIS (Dermatitis of scalp) had not resolved and PRURITUS (Patient's head stared itching), SKIN EXFOLIATION (Patient's head stared flaking) and ALOPECIA (Alopecia) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       On 18 Jun 2021, the patient's hair started to fall out. On 27 Jun 2021, the patient was diagnosed with Alopecia.   This case was linked to MOD-2021-229351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Updated reporter's address, patient's age, DOB, medical history, concomitant medications, batch/lot number, start date of the suspect product,treatment medications and new events were added.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Sluggishness
Clinical narrative: feel sluggish; tiredness/tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (feel sluggish) and FATIGUE (tiredness/tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 SLUGGISHNESS (feel sluggish) and FATIGUE (tiredness/tired). At the time of the report, SLUGGISHNESS (feel sluggish) and FATIGUE (tiredness/tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dermatitis, Pruritus, Skin exfoliation
Clinical narrative: Alopecia; Patient's head stared itching; Patient's head stared flaking; Patient's hair started to fall out; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Patient's head stared itching), SKIN EXFOLIATION (Patient's head stared flaking), DERMATITIS (Patient's hair started to fall out) and ALOPECIA (Alopecia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Alopecia since 27-Jun-2021 and CIDP. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Patient's head stared itching), SKIN EXFOLIATION (Patient's head stared flaking) and DERMATITIS (Patient's hair started to fall out). On 27-Jun-2021, the patient experienced ALOPECIA (Alopecia). The patient was treated with CLOBETASOL ongoing since an unknown date for Itchy scalp, at a dose of 1 dosage form. At the time of the report, PRURITUS (Patient's head stared itching) and SKIN EXFOLIATION (Patient's head stared flaking) had not resolved and DERMATITIS (Patient's hair started to fall out) and ALOPECIA (Alopecia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-229344.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up received on 01-JUL-2021. Medical history, Concomitant products and treatment medication ,drug information  and events were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Palpitations
Clinical narrative: I have been tired; my heart races occasionally; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I have been tired) and PALPITATIONS (my heart races occasionally) 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 FATIGUE (I have been tired) and PALPITATIONS (my heart races occasionally). At the time of the report, FATIGUE (I have been tired) and PALPITATIONS (my heart races occasionally) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Nodes) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen Lymph Nodes). At the time of the report, LYMPHADENOPATHY (Swollen Lymph Nodes) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Thursday he had the chills; Fever of 99 then at night 101; bit more tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Thursday he had the chills), PYREXIA (Fever of 99 then at night 101) and FATIGUE (bit more tired) in a 70-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Thursday he had the chills), PYREXIA (Fever of 99 then at night 101) and FATIGUE (bit more tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Thursday he had the chills) and PYREXIA (Fever of 99 then at night 101) had resolved and FATIGUE (bit more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 and 101 (High) 101.         Concomitant medication was not provided . Patient was in hospital for aneurysm procedure.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up received on 21-JUL-2021. Patient details added. Treatment medications provided. New events added.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had not resolved.            No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: excessive urination; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (excessive urination) 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 POLLAKIURIA (excessive urination). At the time of the report, POLLAKIURIA (excessive urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus infection
Clinical narrative: daughter has rsv and is due for her second shot Tuesday; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (daughter has rsv and is due for her second shot Tuesday) in an 18-year-old female patient 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 RESPIRATORY SYNCYTIAL VIRUS INFECTION (daughter has rsv and is due for her second shot Tuesday). At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (daughter has rsv and is due for her second shot Tuesday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: red blotches on left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches on left arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotches on left arm). At the time of the report, RASH MACULAR (red blotches on left arm) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) for events was not applicable.  No concomitant medications were reported. No treatment information was provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Severe heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Severe heart inflammation) in a 21-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Severe heart inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Severe heart inflammation) outcome was unknown.            No relevant concomitant medications were reported.   Very limited information regarding this event has been provided at this time, however, based on the available information, a causal relationship cannot be excluded.  Further information is not expected   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Upon internal review on 04-AUG-2021, this case was revised and initials, age, gender, events related to patient were updated. Reporter type was updated. Vaccine information updated.; Sender's Comments: Very limited information regarding this event has been provided at this time, however, based on the available information, a causal relationship cannot be excluded.  Further information is not expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Urticaria
Clinical narrative: sore throat; Hives all over; stuffed up nose; on and off fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), URTICARIA (Hives all over), NASAL CONGESTION (stuffed up nose) and PYREXIA (on and off fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Aneurysm cerebral since 2005 and Blood pressure.   On 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), URTICARIA (Hives all over), NASAL CONGESTION (stuffed up nose) and PYREXIA (on and off fever). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), URTICARIA (Hives all over), NASAL CONGESTION (stuffed up nose) and PYREXIA (on and off fever) outcome was unknown. Not Provided          Concomitant medication information was provided as Blood pressure medication.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Redness/ redness has spread; Swelling on the inside about the size of an orange; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness/ redness has spread) and SWELLING (Swelling on the inside about the size of an orange) 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 19-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced ERYTHEMA (Redness/ redness has spread) and SWELLING (Swelling on the inside about the size of an orange). At the time of the report, ERYTHEMA (Redness/ redness has spread) and SWELLING (Swelling on the inside about the size of an orange) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: sore arm; feel weak; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ASTHENIA (feel weak) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and ASTHENIA (feel weak). At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (feel weak) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of macular rash (red blotchy rash) and erythematous rash (red blotchy rash) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced macular rash (red blotchy rash) and erythematous rash (red blotchy rash). At the time of the report, macular rash (red blotchy rash) and erythematous rash (red blotchy rash) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: arm twitching after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (arm twitching after my 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 MUSCLE TWITCHING (arm twitching after my vaccine). At the time of the report, MUSCLE TWITCHING (arm twitching after my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscular dystrophy
Clinical narrative: muscular dystrophy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR DYSTROPHY (muscular dystrophy) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR DYSTROPHY (muscular dystrophy). At the time of the report, MUSCULAR DYSTROPHY (muscular dystrophy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was mentioned. No treatment medication was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: My mouth staying dry; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (My mouth staying dry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (My mouth staying dry). At the time of the report, DRY MOUTH (My mouth staying dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were reported.   No Treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in  joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in  joints) 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 20-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced ARTHRALGIA (Pain in  joints). At the time of the report, ARTHRALGIA (Pain in  joints) outcome was unknown.            No treatment was reported. No concomitant medication was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: sore muscles/muscle aches; weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore muscles/muscle aches) and ASTHENIA (weakness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore muscles/muscle aches) and ASTHENIA (weakness). At the time of the report, MYALGIA (sore muscles/muscle aches) and ASTHENIA (weakness) outcome was unknown.            No concomitant and treatment information was provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: moderate diarrhea up to 72 hours; modarate to severe rash on my forearms and top of my both hands; muscle/joint pains; chills; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (moderate diarrhea up to 72 hours), RASH (modarate to severe rash on my forearms and top of my both hands), ARTHRALGIA (muscle/joint pains), CHILLS (chills) and HEADACHE (headache) in a 59-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.     The patient's past medical history included Pruritus (in the late 80s.) in 1980, Rash and Protein S (Protein S/Factor Leiden defficiency). Concurrent medical conditions included Allergy NOS (Allergy to the Sun or mys sweat while outside. Mainly forearms and top of my hands.), Drug allergy (IV Benadryl), Penicillin allergy (She had Allergy to penicillin prescribed for tooth ache in 01/2014 prior to root canal tx.), Drug allergy (She had Allergy to hydrocodone   prescribed for tooth ache in 01/2014 prior to root canal tx.), Thyroid disorder, Blood pressure high (HBP) and Diabetic (May be pre-diabetic). Concomitant products included VALSARTAN for Blood pressure high, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (moderate diarrhea up to 72 hours), RASH (modarate to severe rash on my forearms and top of my both hands), ARTHRALGIA (muscle/joint pains), CHILLS (chills), HEADACHE (headache) and PYREXIA (Fever). At the time of the report, DIARRHOEA (moderate diarrhea up to 72 hours), RASH (modarate to severe rash on my forearms and top of my both hands), ARTHRALGIA (muscle/joint pains), CHILLS (chills), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not Applicable. Patient stated that Exactly two weeks after her 2nd vaccine his son got sick with Covid. They both  shared the same house. She was isolated and  was careful . she never got sick or experienced any symptos of Covid at that time. She was still recovering from the hysterectomy and had to wait for the root canal since she was on Lovenox tx following her recent surgery She experienced SEVERE hives on her hands and forearms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: moderate diarrhea up to 72 hours; modarate to severe rash on my forearms and top of my both hands; muscle/joint pains; chills; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (moderate diarrhea up to 72 hours), RASH (modarate to severe rash on my forearms and top of my both hands), ARTHRALGIA (muscle/joint pains), CHILLS (chills) and HEADACHE (headache) in a 59-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.     The patient's past medical history included Pruritus (in the late 80s.) in 1980, Rash and Protein S (Protein S/Factor Leiden defficiency). Concurrent medical conditions included Allergy NOS (Allergy to the Sun or mys sweat while outside. Mainly forearms and top of my hands.), Drug allergy (IV Benadryl), Penicillin allergy (She had Allergy to penicillin prescribed for tooth ache in 01/2014 prior to root canal tx.), Drug allergy (She had Allergy to hydrocodone   prescribed for tooth ache in 01/2014 prior to root canal tx.), Thyroid disorder, Blood pressure high (HBP) and Diabetic (May be pre-diabetic). Concomitant products included VALSARTAN for Blood pressure high, METOPROLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (moderate diarrhea up to 72 hours), RASH (modarate to severe rash on my forearms and top of my both hands), ARTHRALGIA (muscle/joint pains), CHILLS (chills), HEADACHE (headache) and PYREXIA (Fever). At the time of the report, DIARRHOEA (moderate diarrhea up to 72 hours), RASH (modarate to severe rash on my forearms and top of my both hands), ARTHRALGIA (muscle/joint pains), CHILLS (chills), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not Applicable. Patient stated that Exactly two weeks after her 2nd vaccine his son got sick with Covid. They both  shared the same house. She was isolated and  was careful . she never got sick or experienced any symptos of Covid at that time. She was still recovering from the hysterectomy and had to wait for the root canal since she was on Lovenox tx following her recent surgery She experienced SEVERE hives on her hands and forearms.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: I got body sharp pain after vaccinated; 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 MYALGIA (I got body sharp pain after vaccinated) 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 MYALGIA (I got body sharp pain after vaccinated). At the time of the report, MYALGIA (I got body sharp pain after vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site dysaesthesia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling at the injection site; Burning at the injection site; Posible dermal injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE DYSAESTHESIA (Burning at the injection site) and VACCINATION SITE ERYTHEMA (Posible dermal injection) 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 SITE SWELLING (Swelling at the injection site), VACCINATION SITE DYSAESTHESIA (Burning at the injection site) and VACCINATION SITE ERYTHEMA (Posible dermal injection). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE DYSAESTHESIA (Burning at the injection site) and VACCINATION SITE ERYTHEMA (Posible dermal injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant and treatment medications were not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: ¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.) in a 48-year-old female patient 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 FATIGUE (¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.). At the time of the report, FATIGUE (¨Minimum of tiredness , from 0 to 10 it was a 2 or 3 , that lasted around 2 days.¨ After the 2nd dose.) 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  were not reported  Treatment was not specified
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second Moderna Covid-19 Vaccine 9 days after receiving their first Moderna Covid-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: around where i got the shot has a muscle knot in it that hurts; around where i got the shot has a muscle knot in it that hurts/swelling & knot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (around where i got the shot has a muscle knot in it that hurts) and VACCINATION SITE SWELLING (around where i got the shot has a muscle knot in it that hurts/swelling & knot area) 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 SITE PAIN (around where i got the shot has a muscle knot in it that hurts) and VACCINATION SITE SWELLING (around where i got the shot has a muscle knot in it that hurts/swelling & knot area). At the time of the report, VACCINATION SITE PAIN (around where i got the shot has a muscle knot in it that hurts) and VACCINATION SITE SWELLING (around where i got the shot has a muscle knot in it that hurts/swelling & knot area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021 and was forwarded to Moderna on 19-Jun-2021.    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 HERPES ZOSTER (Shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Information was Reported. No Treatment Information was Reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at injection site for about 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site for about 2 weeks) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZOA) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-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 16-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at injection site for about 2 weeks). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. On 02-Mar-2021, VACCINATION SITE RASH (rash at injection site for about 2 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medical information were not reported. treatment includes ice.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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 HERPES ZOSTER (Shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided. No concomitant medication information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in leg; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingling in leg) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PARAESTHESIA (Tingling in leg). At the time of the report, PARAESTHESIA (Tingling in leg) 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 medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (fatigue) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, NAUSEA (Nausea) and FATIGUE (fatigue) outcome was unknown.            No concomitant and treatment medication details were provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed her second dose Moderna vaccine appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her second dose Moderna vaccine appointment) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PRODUCT DOSE OMISSION ISSUE (Missed her second dose Moderna vaccine appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed her second dose Moderna vaccine appointment) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received, included reporter address was updated.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: orange pee after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (orange pee after the 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHROMATURIA (orange pee after the vaccine). At the time of the report, CHROMATURIA (orange pee after the vaccine) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I got my 1st dose, but missed my 2nd. What should I do?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my 1st dose, but missed my 2nd. What should I do?) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my 1st dose, but missed my 2nd. What should I do?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my 1st dose, but missed my 2nd. What should I do?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: I have a rash where the injection shot was given in my left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (I have a rash where the injection shot was given in my left arm) 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 SITE RASH (I have a rash where the injection shot was given in my left arm). At the time of the report, VACCINATION SITE RASH (I have a rash where the injection shot was given in my left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersensitivity, Myalgia, Nasopharyngitis
Clinical narrative: "felt like has cold"; increase in daily allergies; Fatigue; Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Sore Arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy (Daily allergies.). Concomitant products included IBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC) and BENZONATATE (TESSALON) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (Sore Arm). On an unknown date, the patient experienced NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.             Concomitant drug included high blood pressure pills. Treatment medication was not reported.  No adverse event was reported after dose 1.   This case was linked to MOD-2021-258007 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received patient email address was added, AE  sore arm was added after first shot