chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (joint ache), MYALGIA (muscle ache), DIARRHOEA (diarrhea), COUGH (slight cough) and OROPHARYNGEAL PAIN (sore throat) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced ARTHRALGIA (joint ache), MYALGIA (muscle ache), DIARRHOEA (diarrhea), COUGH (slight cough) and OROPHARYNGEAL PAIN (sore throat). On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID -19 test positive). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint ache), MYALGIA (muscle ache), DIARRHOEA (diarrhea), COUGH (slight cough), OROPHARYNGEAL PAIN (sore throat) and SARS-COV-2 TEST POSITIVE (COVID -19 test positive) 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.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: redness; red rash at the neck, face ears and injection site; arm tender; red rash at injection site; arm itchy; arm felt warm touch; injection site redness; diarrhea; fatigue; headache; nausea; body ache; This spontaneous case was reported by a nurse and describes the occurrence of   in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-004726 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non significant Follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: redness; red rash at the neck, face ears and injection site; arm tender; red rash at injection site; arm itchy; arm felt warm touch; injection site redness; diarrhea; fatigue; headache; nausea; body ache; This spontaneous case was reported by a nurse and describes the occurrence of   in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-004726 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non significant Follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: redness; red rash at the neck, face ears and injection site; arm tender; red rash at injection site; arm itchy; arm felt warm touch; injection site redness; diarrhea; fatigue; headache; nausea; body ache; This spontaneous case was reported by a nurse and describes the occurrence of   in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-004726 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non significant Follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site pruritus, Injection site urticaria
Clinical narrative: welts in her arm and armpit; arm started to get itchy; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), INJECTION SITE PRURITUS (arm started to get itchy) and INJECTION SITE URTICARIA (welts in her arm and armpit) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). On 09-Jan-2021, the patient experienced INJECTION SITE PRURITUS (arm started to get itchy). On 11-Jan-2021, the patient experienced INJECTION SITE URTICARIA (welts in her arm and armpit). The patient was treated with HYDROCORTISONE on 09-Jan-2021 at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles), INJECTION SITE PRURITUS (arm started to get itchy) and INJECTION SITE URTICARIA (welts in her arm and armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up report included no new information; Sender's Comments: Very limited information regarding these events has been provided at this time. The shingles event may be related to the patient's pre-existing conditions. A causal relationship cannot be excluded for the injection site urticaria and pruritus events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Right arm hurt; Itchy; Bumpy and hard; Arm red; Arm felt hard; Swollen; Arm really hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red) and INJECTION SITE REACTION (Arm felt hard) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included No adverse event (No reported medical history).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE REACTION (Arm felt hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE WARMTH (Arm really hot). At the time of the report, PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE REACTION (Arm felt hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE WARMTH (Arm really hot) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Right arm hurt; Itchy; Bumpy and hard; Arm red; Arm felt hard; Swollen; Arm really hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red) and INJECTION SITE REACTION (Arm felt hard) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included No adverse event (No reported medical history).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE REACTION (Arm felt hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE WARMTH (Arm really hot). At the time of the report, PAIN IN EXTREMITY (Right arm hurt), INJECTION SITE PRURITUS (Itchy), INDURATION (Bumpy and hard), INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE REACTION (Arm felt hard), INJECTION SITE SWELLING (Swollen) and INJECTION SITE WARMTH (Arm really hot) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No medical history reported).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced 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.   Concomitant product use was not provided by the reporter.  The patient did not receive treatment for the event.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus went from low barely noticeable to very severe; This spontaneous case was reported by an other and describes the occurrence of TINNITUS (Tinnitus went from low barely noticeable to very severe) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TINNITUS (Tinnitus went from low barely noticeable to very severe). At the time of the report, TINNITUS (Tinnitus went from low barely noticeable to very severe) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site paraesthesia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: tingling; 1-1/2 inch red and swollen circle at injection site which was warm to touch; 2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch; 1-1/2 inch red and swollen circle at injection site which was warm to touch; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE WARMTH (1-1/2 inch red and swollen circle at injection site which was warm to touch), VACCINATION SITE SWELLING (2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch) and VACCINATION SITE ERYTHEMA (1-1/2 inch red and swollen circle at injection site which was warm to touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 immunization.     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 08-Jan-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE WARMTH (1-1/2 inch red and swollen circle at injection site which was warm to touch), VACCINATION SITE SWELLING (2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch) and VACCINATION SITE ERYTHEMA (1-1/2 inch red and swollen circle at injection site which was warm to touch). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE WARMTH (1-1/2 inch red and swollen circle at injection site which was warm to touch), VACCINATION SITE SWELLING (2 by 1-1/2 inch red and swollen circle at injection site which was warm to touch) and VACCINATION SITE ERYTHEMA (1-1/2 inch red and swollen circle at injection site which was warm to touch) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  The patient had a two by one and a half inch red and swollen circle at the injection site which was warm to touch days after receiving the vaccine. The reporter stated the side effects are not getting worse but seem to be subsiding. She said there was less tingling. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for Covid-19; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for Covid-19) in a 37-year-old male 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 reported).   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive for Covid-19). At the time of the report, COVID-19 (positive for Covid-19) outcome was unknown. Asymptomatic with positive COVID-19 test    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Illness, Pain in extremity
Clinical narrative: Fever; headache; chills; sweating; sick all day; slightly sore are; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slightly sore are), PYREXIA (Fever), HEADACHE (headache), CHILLS (chills) and HYPERHIDROSIS (sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (slightly sore are). On 11-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and ILLNESS (sick all day). At the time of the report, PAIN IN EXTREMITY (slightly sore are), PYREXIA (Fever), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and ILLNESS (sick all day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; headache; chills; sweating; sick all day; slightly sore are; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slightly sore are), PYREXIA (Fever), HEADACHE (headache), CHILLS (chills) and HYPERHIDROSIS (sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (slightly sore are). On 11-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and ILLNESS (sick all day). At the time of the report, PAIN IN EXTREMITY (slightly sore are), PYREXIA (Fever), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and ILLNESS (sick all day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash
Clinical narrative: Diarrhea; Full body wheal rash; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea) and RASH (Full body wheal rash) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced DIARRHOEA (Diarrhea) and RASH (Full body wheal rash). On 01-Jan-2021, RASH (Full body wheal rash) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events two days after vaccination, a causal relationship cannot be excluded. Further information has been requested
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain
Clinical narrative: episode of pain in her pelvic area on both the right and left side all of a sudden; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (episode of pain in her pelvic area on both the right and left side all of a sudden) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dehydration (Medical history reported as patient had dehydration in the past.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PELVIC PAIN (episode of pain in her pelvic area on both the right and left side all of a sudden). At the time of the report, PELVIC PAIN (episode of pain in her pelvic area on both the right and left side all of a sudden) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment included drinking water.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: received first dose in late December and I'm pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received first dose in late December and I'm pregnant) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In December 2020, the patient experienced EXPOSURE DURING PREGNANCY (received first dose in late December and I'm pregnant). In December 2020, EXPOSURE DURING PREGNANCY (received first dose in late December and I'm pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Body temperature increased, COVID-19, Chills
Clinical narrative: really sick like the flu; Abdominal cramping; Bloated stomach; Gassy; Diarrhe; Felt tired; fever over 100°F; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu) and DIARRHOEA (Diarrhe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was  reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100f High. On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Flatulence, Headache, Influenza like illness
Clinical narrative: really sick like the flu; Abdominal cramping; Bloated stomach; Gassy; Diarrhe; Felt tired; fever over 100°F; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu) and DIARRHOEA (Diarrhe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was  reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100f High. On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: really sick like the flu; Abdominal cramping; Bloated stomach; Gassy; Diarrhe; Felt tired; fever over 100°F; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu) and DIARRHOEA (Diarrhe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was  reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, FATIGUE (Felt tired), PYREXIA (fever over 100°F), CHILLS (Chills), INFLUENZA LIKE ILLNESS (really sick like the flu), DIARRHOEA (Diarrhe), ABDOMINAL PAIN (Abdominal cramping), ABDOMINAL DISTENSION (Bloated stomach), FLATULENCE (Gassy), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100f High. On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site rash, Pyrexia
Clinical narrative: redness at the injection site; a rash at the injection site came back with redness and continued to get bigger; general fatigue; Fever; a little red lump arises at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (a little red lump arises at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (a rash at the injection site came back with redness and continued to get bigger), FATIGUE (general fatigue) and PYREXIA (Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.   The patient's past medical history included No adverse effect (No Medical History Provided).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced INJECTION SITE MASS (a little red lump arises at the injection site), FATIGUE (general fatigue) and PYREXIA (Fever). On 08-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (a rash at the injection site came back with redness and continued to get bigger). On 31-Dec-2020, INJECTION SITE MASS (a little red lump arises at the injection site), FATIGUE (general fatigue) and PYREXIA (Fever) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (a rash at the injection site came back with redness and continued to get bigger) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Company Comment  Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Injection. The events of injection site mass, injection site redness, injection site rash, fatigue,and fever are consistent with symptoms of COVID-19. hence also assessed as unrelated to mRNA-1273 use.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: Fever; Nausea; Tired/fatigue; Chills; Light headiness; General Weakness; Shaky; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Tired/fatigue). In January 2021, the patient experienced DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Tired/fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-223091.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-jun-2021 had start date of the events updated and outcome of the events updated from unknown to recovered/resolved.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Fever; Nausea; Tired/fatigue; Chills; Light headiness; General Weakness; Shaky; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Tired/fatigue). In January 2021, the patient experienced DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Light headiness), ASTHENIA (General Weakness), TREMOR (Shaky), MYALGIA (Achiness) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Tired/fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-223091.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-jun-2021 had start date of the events updated and outcome of the events updated from unknown to recovered/resolved.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant patient received the first dose of Moderna covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of Moderna covid-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 28-Mar-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of Moderna covid-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of Moderna covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported. On unknown date in Jul 2020, the pregnancy test was positive.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Sinus headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ACETYLSALICYLIC ACID (ASPIRINE) and ROSUVASTATIN for an unknown indication.  On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced SINUS HEADACHE (Sinus headache). At the time of the report, SINUS HEADACHE (Sinus headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Soreness in arm) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced AXILLARY PAIN (Soreness in arm).   On 14-Jan-2021, AXILLARY PAIN (Soreness in arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Outcome of an event updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: having body aches; chills; headache; fever (100.9°F); A spontaneous report was received from a consumer concerning a 26-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having body aches/ Myalgia, chills, headache and fever (100.9°F)/ pyrexia.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 11 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 012LZ0A) in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, after receiving mRNA-1273, the patient experienced having body aches, chills, headache and fever (100.9°F).   Treatment for the events were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, having body aches, chills, headache, fever (100.9°F) were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness in the injection site muscle; This spontaneous case was reported by a dental hygienist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Tenderness in the injection site muscle) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness in the injection site muscle). At the time of the report, VACCINATION SITE PAIN (Tenderness in the injection site muscle) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Slight fever; chills; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (Slight fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever) and CHILLS (chills). At the time of the report, PYREXIA (Slight fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 11-Jan-2021, the patient experienced PYREXIA (Slight fever). On 12-Jan-2021, VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (Slight fever) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported using ice packs and over the counter Acetaminophen as treatment medication from onset date of symptoms until last night (11-Jan-2021).  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On 11-Jan-2021, the patient experienced PYREXIA (Slight fever). On 12-Jan-2021, VACCINATION COMPLICATION (she felt yuck), VACCINATION SITE PAIN (felt like someone hit her left arm with a sledgehammer), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (Slight fever) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported using ice packs and over the counter Acetaminophen as treatment medication from onset date of symptoms until last night (11-Jan-2021).  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.