chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: body pain/soreness; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain/soreness), CHILLS (chills) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (body pain/soreness), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, PAIN (body pain/soreness), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Event onset date was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypercoagulation, International normalised ratio decreased
Clinical narrative: result of INR test change- reduce to 1.5 to 1.7; affect the thickness of blood; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO DECREASED (result of INR test change- reduce to 1.5 to 1.7) and HYPERCOAGULATION (affect the thickness of blood) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN for Clot blood.   On 09-Feb-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 09-Feb-2021, the patient experienced INTERNATIONAL NORMALISED RATIO DECREASED (result of INR test change- reduce to 1.5 to 1.7) and HYPERCOAGULATION (affect the thickness of blood). At the time of the report, INTERNATIONAL NORMALISED RATIO DECREASED (result of INR test change- reduce to 1.5 to 1.7) and HYPERCOAGULATION (affect the thickness of blood) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, International normalised ratio decreased: (Low) INR values reduced to 1.5 to 1.7.   No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Oedema, Pyrexia, Vaccination site warmth
Clinical narrative: hot to touch; fever; swelling at the injection site; injection site redness; edema; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), PYREXIA (fever), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (injection site redness) and OEDEMA (edema) in a 47-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 medical history Provided.).    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 VACCINATION SITE WARMTH (hot to touch), PYREXIA (fever), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (injection site redness) and OEDEMA (edema). At the time of the report, VACCINATION SITE WARMTH (hot to touch), PYREXIA (fever), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (injection site redness) and OEDEMA (edema) outcome 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.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Swelling under the eyes; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Swelling under the eyes) 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 reaction.  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 EYE SWELLING (Swelling under the eyes). The patient was treated with HYALURONIC ACID (RESTYLANE) on 03-Oct-2020 at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Swelling under the eyes) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Patient is under medication for the same) and Cholesterol (Patient is under medication for the same). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), THYROID and CHOLESTEROL for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain
Clinical narrative: A horrible headache as bad as a migraine, headache; Some aches and pains; Headache; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (A horrible headache as bad as a migraine, headache), PAIN (Some aches and pains) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 22-Jan-2021, the patient experienced MIGRAINE (A horrible headache as bad as a migraine, headache), PAIN (Some aches and pains) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency.   On 22-Jan-2021, MIGRAINE (A horrible headache as bad as a migraine, headache), PAIN (Some aches and pains) and HEADACHE (Headache) had resolved.      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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Discomfort, Lymphadenopathy, Pain, Swelling
Clinical narrative: pain; discomfort; swelling in neck on the right side; lymphadenopathy-multiple swollen lymph nodes on both sides of neck; Swollen arm; Red arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tobacco user since an unknown date and Motor vehicle accident (Caused neck pain) on 29-Oct-2020. Concurrent medical conditions included Bipolar II disorder, Prediabetes, Anxiety, Hyperlipidemia and Drug allergy (Oxycodone and Chantix allergy.). Concomitant products included LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm). On 16-Feb-2021, the patient experienced PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side) and LYMPHADENOPATHY (lymphadenopathy-multiple swollen lymph nodes on both sides of neck). The patient was treated with PARACETAMOL (TYLENOL) for Lymphadenopathy, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) for Lymphadenopathy, at an unspecified dose and frequency. At the time of the report, PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm) and LYMPHADENOPATHY (lymphadenopathy-multiple swollen lymph nodes on both sides of neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Computerised tomogram: abnormal (abnormal) revealed multiple swollen lymph nodes on both sides of neck.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: pain; discomfort; swelling in neck on the right side; lymphadenopathy-multiple swollen lymph nodes on both sides of neck; Swollen arm; Red arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tobacco user since an unknown date and Motor vehicle accident (Caused neck pain) on 29-Oct-2020. Concurrent medical conditions included Bipolar II disorder, Prediabetes, Anxiety, Hyperlipidemia and Drug allergy (Oxycodone and Chantix allergy.). Concomitant products included LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm). On 16-Feb-2021, the patient experienced PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side) and LYMPHADENOPATHY (lymphadenopathy-multiple swollen lymph nodes on both sides of neck). The patient was treated with PARACETAMOL (TYLENOL) for Lymphadenopathy, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) for Lymphadenopathy, at an unspecified dose and frequency. At the time of the report, PAIN (pain), DISCOMFORT (discomfort), SWELLING (swelling in neck on the right side), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm) and LYMPHADENOPATHY (lymphadenopathy-multiple swollen lymph nodes on both sides of neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Computerised tomogram: abnormal (abnormal) revealed multiple swollen lymph nodes on both sides of neck.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment details included Tylenol.   This case was linked to MOD-2021-016905, MOD-2021-016866 (Patient Link).  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment details included Tylenol.   This case was linked to MOD-2021-016905, MOD-2021-016866 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: left shoulder started hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (left shoulder started hurting) 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 Shoulder pain (left shoulder pain) since an unknown date.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ARTHRALGIA (left shoulder started hurting). At the time of the report, ARTHRALGIA (left shoulder started hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (left shoulder started hurting) 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 Shoulder pain (left shoulder pain) since an unknown date.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ARTHRALGIA (left shoulder started hurting). At the time of the report, ARTHRALGIA (left shoulder started hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: she got a delayed reaction below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she got a delayed reaction below 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 RASH (she got a delayed reaction below the injection site). At the time of the report, VACCINATION SITE RASH (she got a delayed reaction below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.  Concomitant medication was not reported.   Upon in internal review on 21 May 2021, the age was corrected to unknown age.   This case was linked to MOD-2021-016747 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she got a delayed reaction below 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 RASH (she got a delayed reaction below the injection site). At the time of the report, VACCINATION SITE RASH (she got a delayed reaction below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.  Concomitant medication was not reported.   Upon in internal review on 21 May 2021, the age was corrected to unknown age.   This case was linked to MOD-2021-016747 (E2B Linked Report).; Sender's Comments:  MOD-2021-016747:1 reporter with 2 patients
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Injection site rash; Injection site Itchy; Bad body aches; Fever; Nausea; Bad headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Injection site Itchy), MYALGIA (Bad body aches), PYREXIA (Fever), VACCINATION SITE RASH (Injection site rash) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Apr-2021. Concurrent medical conditions included Hypertension since May 1994, Thyroid disorder since July 1994, Drug allergy (Sulpha drugs) and Penicillin allergy. Concomitant products included LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid disorder, BIOTIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Bad body aches), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Bad headache) and FATIGUE (Fatigue). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site Itchy) and VACCINATION SITE RASH (Injection site rash). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Nausea, at an unspecified dose and frequency and PROCHLORPERAZINE MALEATE (COMPAZINE [PROCHLORPERAZINE MALEATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Injection site Itchy), MYALGIA (Bad body aches), PYREXIA (Fever), VACCINATION SITE RASH (Injection site rash), NAUSEA (Nausea) and HEADACHE (Bad headache) had resolved and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 102 (High) Fever that rose  to 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: follow-up received on 20 April 2021.reporter contact details was updated, medical history details was updated, concomitant medications details was updated, event outcome details was updated, treatment details was updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection site rash; Injection site Itchy; Bad body aches; Fever; Nausea; Bad headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Injection site Itchy), MYALGIA (Bad body aches), PYREXIA (Fever), VACCINATION SITE RASH (Injection site rash) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Apr-2021. Concurrent medical conditions included Hypertension since May 1994, Thyroid disorder since July 1994, Drug allergy (Sulpha drugs) and Penicillin allergy. Concomitant products included LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid disorder, BIOTIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Bad body aches), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Bad headache) and FATIGUE (Fatigue). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site Itchy) and VACCINATION SITE RASH (Injection site rash). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Nausea, at an unspecified dose and frequency and PROCHLORPERAZINE MALEATE (COMPAZINE [PROCHLORPERAZINE MALEATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Injection site Itchy), MYALGIA (Bad body aches), PYREXIA (Fever), VACCINATION SITE RASH (Injection site rash), NAUSEA (Nausea) and HEADACHE (Bad headache) had resolved and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 102 (High) Fever that rose  to 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: follow-up received on 20 April 2021.reporter contact details was updated, medical history details was updated, concomitant medications details was updated, event outcome details was updated, treatment details was updated
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Got a hot temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Got a hot temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Got a hot temperature). At the time of the report, BODY TEMPERATURE INCREASED (Got a hot temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Got a hot temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Got a hot temperature). At the time of the report, BODY TEMPERATURE INCREASED (Got a hot temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhae; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhae) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 3:00 AM, the patient experienced DIARRHOEA (Diarrhae). At the time of the report, DIARRHOEA (Diarrhae) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient stated she took some coffee after the event. No other treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhae) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 3:00 AM, the patient experienced DIARRHOEA (Diarrhae). At the time of the report, DIARRHOEA (Diarrhae) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient stated she took some coffee after the event. No other treatment information was provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Little fever of 100.7; feeling lazy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included VITAMIN D3, ALLIUM SATIVUM (GARLIC NATURAL), ATORVASTATIN and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy). At the time of the report, PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Pyrexia: 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included two capsules of Tylenol. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included VITAMIN D3, ALLIUM SATIVUM (GARLIC NATURAL), ATORVASTATIN and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy). At the time of the report, PYREXIA (Little fever of 100.7) and FATIGUE (feeling lazy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Pyrexia: 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included two capsules of Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: allergic-like reaction; Hives itchy feeling; A little hard time breathing; Hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) 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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives). At the time of the report, HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) 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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives). At the time of the report, HYPERSENSITIVITY (allergic-like reaction), PRURITUS (Hives itchy feeling), DYSPNOEA (A little hard time breathing) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive Covid-19 test after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive Covid-19 test after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported.   No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Eructation, Flatulence
Clinical narrative: diarrhea; passing gas; Burping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FLATULENCE (passing gas) and ERUCTATION (Burping) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M204) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea), FLATULENCE (passing gas) and ERUCTATION (Burping). At the time of the report, DIARRHOEA (diarrhea) and ERUCTATION (Burping) had resolved and FLATULENCE (passing gas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had diarrhea, stomach was making noises, he is passing gas and has a bit of burping. It all continues through today. He wants to know if this is normal. He wants to know if he should receive the 2nd vaccine. As Per reporter, first episode of diarrhea occurred for 3 weeks after receiving his initial vaccine. He further reports that second episode of diarrhea occurred for 4 days following receipt of the second dose of the vaccine. He states that all symptoms have resolved and that he did not seek medical attention
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: Pain and swelling at the injection site for about 4 days, painful and slightly swollen lymph nodes in the left armpit, painful armpit when arm is pressed against the body (lasting about 7 days). Body temperature around 37.4°C lasting 32 hours starting several hours after getting the shot (usual body temperature 36.4°C). Chills and body aches lasting 24 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Pain and swelling at the injection site for about 4 days, painful and slightly swollen lymph nodes in the left armpit, painful armpit when arm is pressed against the body (lasting about 7 days). Body temperature around 37.4°C lasting 32 hours starting several hours after getting the shot (usual body temperature 36.4°C). Chills and body aches lasting 24 hours.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Feeling hot, Paraesthesia
Clinical narrative: About 3 hours after the vaccinations (around 7:15 pm) she developed  urticaria, feeling of warmth,   itching , pins/needles /tickling feeling throughout her body,  abdominal pain,  single episode of diarrhea.  Abdominal  discomfort resolved after about 45 minutes.   Mother gave Benadryl and Zyrtec at 8:00 pm.  In the emergency department she was given  dexamethasone at 10:24 pm  Her symptoms had resolved by 10:45 pm   She never had any lip, tongue, or throat swelling, no shortness of breath or difficulty breathing
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Tryptase, Urticaria
Clinical narrative: About 3 hours after the vaccinations (around 7:15 pm) she developed  urticaria, feeling of warmth,   itching , pins/needles /tickling feeling throughout her body,  abdominal pain,  single episode of diarrhea.  Abdominal  discomfort resolved after about 45 minutes.   Mother gave Benadryl and Zyrtec at 8:00 pm.  In the emergency department she was given  dexamethasone at 10:24 pm  Her symptoms had resolved by 10:45 pm   She never had any lip, tongue, or throat swelling, no shortness of breath or difficulty breathing
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Patient compliant of numbness of the left face side starting about 3 to 4 hours after vaccine-Medium
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: 7 minutes after receiving 1st dose of Moderna covid vaccine 0.5ml in the left deltoid muscle via IM route, patient felt light head and fainted.  He stated this has only happened after giving blood.  He regained consciousness immediately, BP check- given orange juice, paramedics were called and on site they evaluated patient and took over care.  Upon review, the patient was able to leave and did not need to go to the hospital.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient felt dizzy 10 minutes after receiving vaccination and stood up from the chair. She was caught by her grandmother sitting next to her and lowered to the floor. Shortly came too after being put on the floor. EMS arrived and took her vitals and patient decided not to go to the hospital. Patients fiance arrived around 45 minutes later and picked her up. Patient was 26 weeks pregnant and stated she has no history of passing out but admits she was nervous.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosis with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosis with COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No medical history information was reported.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (diagnosis with COVID-19). At the time of the report, COVID-19 (diagnosis with COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosis with COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No medical history information was reported.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (diagnosis with COVID-19). At the time of the report, COVID-19 (diagnosis with COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Vaccination site pain, Weight decreased
Clinical narrative: she has lost 10 pounds in the last 2 months; Left arm pain at injection site; Headache; Nausea; Rapid Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid Heart Beat), WEIGHT DECREASED (she has lost 10 pounds in the last 2 months), NAUSEA (Nausea), VACCINATION SITE PAIN (Left arm pain at injection site) and HEADACHE (Headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Cardiomyopathy. Concurrent medical conditions included Penicillin allergy. Concomitant products included HYDROCODONE, METOPROLOL SUCCINATE (TOPROL), VITAMIN D [VITAMIN D NOS] and DIMENHYDRINATE (DRAMAMINE) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid Heart Beat) and NAUSEA (Nausea). On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Left arm pain at injection site) and HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (she has lost 10 pounds in the last 2 months). On 03-Feb-2021, HEART RATE INCREASED (Rapid Heart Beat), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. On 04-Feb-2021, VACCINATION SITE PAIN (Left arm pain at injection site) had resolved. At the time of the report, WEIGHT DECREASED (she has lost 10 pounds in the last 2 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also include hydrocodone, Toprol, Vitamin D, Dramamine. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Additional event added and patient was feeling better and also she denied further follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red at injection site; Itching at the injection site; Swelling at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.