chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Migraine, Vaccination site pain, Wheezing
Clinical narrative: Wheezing; Catching his breath; Arm sore; Triggered his migraine; This spontaneous case was reported by a health care professional and describes the occurrence of MIGRAINE (Triggered his migraine), WHEEZING (Wheezing), DYSPNOEA (Catching his breath) and VACCINATION SITE PAIN (Arm sore) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20.2A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Migraine, Allergy and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, ALBUTEROL SULFATE for Asthma, GABAPENTIN and GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MIGRAINE (Triggered his migraine) and VACCINATION SITE PAIN (Arm sore). On 07-Jan-2021, the patient experienced WHEEZING (Wheezing) and DYSPNOEA (Catching his breath). On 07-Jan-2021, MIGRAINE (Triggered his migraine) and VACCINATION SITE PAIN (Arm sore) had resolved. At the time of the report, WHEEZING (Wheezing) and DYSPNOEA (Catching his breath) 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: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the onset date of the reported event of fatigue, 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 onset date of the reported event of fatigue, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose increased, Body temperature increased, Dizziness, Fatigue
Clinical narrative: Nasal congestion; BS elevated tto 200, the 3rd night after up to 300; Weakness; Fatigue; Fever of 100.9; Headache; Pain at injection site; Swelling at injection site; Redness at injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), DIZZINESS (Dizziness) and FATIGUE (Fatigue) 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.     Concurrent medical conditions included Type 2 diabetes mellitus (20 years,Taking metformin). Concomitant products included METFORMIN for Type 2 diabetes mellitus.    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 DIZZINESS (Dizziness). On 30-Dec-2020, the patient experienced NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, NASAL CONGESTION (Nasal congestion), ASTHENIA (Weakness), DIZZINESS (Dizziness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood glucose increased: 200 High. On 31-Dec-2020, Blood glucose increased: 300 High. On an unknown date, Blood glucose increased: 150 normal. On an unknown date, Body temperature increased: 100.9 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events was unknown.   Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Nasal congestion; BS elevated tto 200, the 3rd night after up to 300; Weakness; Fatigue; Fever of 100.9; Headache; Pain at injection site; Swelling at injection site; Redness at injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), DIZZINESS (Dizziness) and FATIGUE (Fatigue) 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.     Concurrent medical conditions included Type 2 diabetes mellitus (20 years,Taking metformin). Concomitant products included METFORMIN for Type 2 diabetes mellitus.    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 DIZZINESS (Dizziness). On 30-Dec-2020, the patient experienced NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, NASAL CONGESTION (Nasal congestion), ASTHENIA (Weakness), DIZZINESS (Dizziness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood glucose increased: 200 High. On 31-Dec-2020, Blood glucose increased: 300 High. On an unknown date, Blood glucose increased: 150 normal. On an unknown date, Body temperature increased: 100.9 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events was unknown.   Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Nasal congestion; BS elevated tto 200, the 3rd night after up to 300; Weakness; Fatigue; Fever of 100.9; Headache; Pain at injection site; Swelling at injection site; Redness at injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), DIZZINESS (Dizziness) and FATIGUE (Fatigue) 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.     Concurrent medical conditions included Type 2 diabetes mellitus (20 years,Taking metformin). Concomitant products included METFORMIN for Type 2 diabetes mellitus.    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 DIZZINESS (Dizziness). On 30-Dec-2020, the patient experienced NASAL CONGESTION (Nasal congestion), BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, NASAL CONGESTION (Nasal congestion), ASTHENIA (Weakness), DIZZINESS (Dizziness), FATIGUE (Fatigue), PYREXIA (Fever of 100.9), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and BLOOD GLUCOSE INCREASED (BS elevated tto 200, the 3rd night after up to 300) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood glucose increased: 200 High. On 31-Dec-2020, Blood glucose increased: 300 High. On an unknown date, Blood glucose increased: 150 normal. On an unknown date, Body temperature increased: 100.9 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events was unknown.   Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal chest pain, Myalgia
Clinical narrative: Rib cage pain; Muscle pain; Joint pain in thumb; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Rib cage pain), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain in thumb) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib cage pain), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain in thumb). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Rib cage pain) and ARTHRALGIA (Joint pain in thumb) had not resolved and MYALGIA (Muscle pain) 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 for the event included Naprosyn.; Sender's Comments: Although a temporal association cannot be defined, based on the information provided and the known safety profile of the vaccine a causal association between the product administration and the reported events cannot be excluded.  Arthralgia and myalgia are consistent with the known safety profile of the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Nasal congestion
Clinical narrative: Loss of smell for 24 hours; Nasal congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (Loss of smell for 24 hours) and NASAL CONGESTION (Nasal congestion) in a 61-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 (Medical history not reported).    On 07-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 ANOSMIA (Loss of smell for 24 hours) and NASAL CONGESTION (Nasal congestion). On 09-Jan-2021, ANOSMIA (Loss of smell for 24 hours) and NASAL CONGESTION (Nasal congestion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Axillary pain, Lymphadenopathy, Nausea, Sleep deficit
Clinical narrative: Deep pain in left arm pit , along side left breast , shoulder blade; Swollen lymph nodes; Didnt sleep; Stomach ache; Arm hurt; Bad Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache), SLEEP DEFICIT (Didnt sleep) and AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) in a 48-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.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache) and SLEEP DEFICIT (Didnt sleep). On 11-Jan-2021, the patient experienced AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. On 07-Jan-2021, VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache) and SLEEP DEFICIT (Didnt sleep) outcome was unknown. At the time of the report, AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Deep pain in left arm pit , along side left breast , shoulder blade; Swollen lymph nodes; Didnt sleep; Stomach ache; Arm hurt; Bad Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache), SLEEP DEFICIT (Didnt sleep) and AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) in a 48-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.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache) and SLEEP DEFICIT (Didnt sleep). On 11-Jan-2021, the patient experienced AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. On 07-Jan-2021, VACCINATION SITE PAIN (Arm hurt), NAUSEA (Bad Nausea), ABDOMINAL PAIN UPPER (Stomach ache) and SLEEP DEFICIT (Didnt sleep) outcome was unknown. At the time of the report, AXILLARY PAIN (Deep pain in left arm pit , along side left breast , shoulder blade) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 43-year-old male 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 reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Feeling abnormal, Influenza like illness, Nasal congestion
Clinical narrative: lost her sense of smell; lost her sense of taste; Feels yucky; mild flu like symptoms; horrible nasal congestion; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms) and NASAL CONGESTION (horrible nasal congestion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K2019) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms), NASAL CONGESTION (horrible nasal congestion) and PYREXIA (low grade fever). At the time of the report, ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms), NASAL CONGESTION (horrible nasal congestion) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lost her sense of smell; lost her sense of taste; Feels yucky; mild flu like symptoms; horrible nasal congestion; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms) and NASAL CONGESTION (horrible nasal congestion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K2019) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms), NASAL CONGESTION (horrible nasal congestion) and PYREXIA (low grade fever). At the time of the report, ANOSMIA (lost her sense of smell), AGEUSIA (lost her sense of taste), FEELING ABNORMAL (Feels yucky), INFLUENZA LIKE ILLNESS (mild flu like symptoms), NASAL CONGESTION (horrible nasal congestion) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain she had almost 7, 8 days after receiving the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain she had almost 7, 8 days after receiving the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain she had almost 7, 8 days after receiving the shot). At the time of the report, PAIN (Pain she had almost 7, 8 days after receiving the shot) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 4-06-2021 included no new information.  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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site rash
Clinical narrative: Tightness at the injection site; Red rash at the injection site is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Tightness at the injection site) and VACCINATION SITE RASH (Red rash at the injection site is spreading) in a 72-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 adverse event history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Tightness at the injection site) and VACCINATION SITE RASH (Red rash at the injection site is spreading). At the time of the report, VACCINATION SITE INDURATION (Tightness at the injection site) and VACCINATION SITE RASH (Red rash at the injection site is spreading) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported Treatment medications were not provided by the reporter.  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   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: The additional information contains: New event updated On 22-Jun-2021: Follow up received on 22-JUN-21 contains TCR : AE outcome as recovered. The patient informed  he was fine.; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Vaccination site erythema
Clinical narrative: Red spot at the injection site, 2-3 inches in diameter; Muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue) and VACCINATION SITE ERYTHEMA (Red spot at the injection site, 2-3 inches in diameter) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VARICELLA VACCINE in 2020.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue). On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at the injection site, 2-3 inches in diameter). The patient was treated with IBUPROFEN at a dose of unknown. At the time of the report, MUSCLE FATIGUE (Muscle fatigue) and VACCINATION SITE ERYTHEMA (Red spot at the injection site, 2-3 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Date of birth of patient, events, treatment drug and historical vaccine were added. On 13-Apr-2021: Email address and mailing address of the reporter added.; 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Tongue disorder, Vaccination site pruritus
Clinical narrative: spots in his tongue; Diarrhea; itching at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching at the injection site) and TONGUE DISORDER (spots in his tongue) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history reported.   On 07-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 DIARRHOEA (Diarrhea) and VACCINATION SITE PRURITUS (itching at the injection site). On 11-Jan-2021, the patient experienced TONGUE DISORDER (spots in his tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 09-Jan-2021, DIARRHOEA (Diarrhea) and VACCINATION SITE PRURITUS (itching at the injection site) had resolved. At the time of the report, TONGUE DISORDER (spots in his tongue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported.; Sender's Comments: This case concerns a 46-year-old male who had nonserious events of unexpected diarrhea and tongue disorder and expected vaccination site pruritus.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment with diphenhydramine. Pruritus and diarrhea resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Influenza, Nausea
Clinical narrative: very tired; Light headed/Light headedness; Feel nauseous; headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Light headed/Light headedness), NAUSEA (Feel nauseous), FATIGUE (very tired) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (patient reported allergic to macrolides.) and Hashimoto's disease in 2000. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-2000 to an unknown date for an unknown indication.    On 08-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (headache). On 08-Jan-2021 at 2:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Light headed/Light headedness) and NAUSEA (Feel nauseous). On 08-Jan-2021 at 8:00 PM, the patient experienced FATIGUE (very tired). On 10-Jan-2021, DIZZINESS (Light headed/Light headedness) and NAUSEA (Feel nauseous) had resolved. On 18-Jan-2021, FATIGUE (very tired) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Influenza: negative (Negative) Patient tested negative for Influenza.. In 2021, SARS-CoV-2 antibody test: not evident (Negative) Not evident. In 2021, SARS-CoV-2 test: negative (Negative) Patient tested negative for COVID-19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported Negative to CSV Test.   No treatment medication is provided.   This case was linked to MOD-2021-218938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up received and reporter information updated, patient information updated, vaccine information updated, event information and outcomes updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: very tired; Light headed/Light headedness; Feel nauseous; headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Light headed/Light headedness), NAUSEA (Feel nauseous), FATIGUE (very tired) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (patient reported allergic to macrolides.) and Hashimoto's disease in 2000. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-2000 to an unknown date for an unknown indication.    On 08-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (headache). On 08-Jan-2021 at 2:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Light headed/Light headedness) and NAUSEA (Feel nauseous). On 08-Jan-2021 at 8:00 PM, the patient experienced FATIGUE (very tired). On 10-Jan-2021, DIZZINESS (Light headed/Light headedness) and NAUSEA (Feel nauseous) had resolved. On 18-Jan-2021, FATIGUE (very tired) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Influenza: negative (Negative) Patient tested negative for Influenza.. In 2021, SARS-CoV-2 antibody test: not evident (Negative) Not evident. In 2021, SARS-CoV-2 test: negative (Negative) Patient tested negative for COVID-19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported Negative to CSV Test.   No treatment medication is provided.   This case was linked to MOD-2021-218938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up received and reporter information updated, patient information updated, vaccine information updated, event information and outcomes updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Cough, Fatigue, Headache
Clinical narrative: Headache; Chills; Fatigue; Nausea; Upset stomach; Cough; Tenderness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), VACCINATION SITE PAIN (Tenderness at the injection site), HEADACHE (Headache) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at the injection site). On 09-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough) and NAUSEA (Nausea). On 10-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved and VACCINATION SITE PAIN (Tenderness at the injection site) 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.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Headache; Chills; Fatigue; Nausea; Upset stomach; Cough; Tenderness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), VACCINATION SITE PAIN (Tenderness at the injection site), HEADACHE (Headache) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at the injection site). On 09-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough) and NAUSEA (Nausea). On 10-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved and VACCINATION SITE PAIN (Tenderness at the injection site) 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.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: Hard spot at that injection site; Fatigue; Fever; Fatigue; Redness is growing in that location; Itchy in the location; Left arm tingling; Irritated in that location; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left arm tingling), VACCINATION SITE IRRITATION (Irritated in that location), VACCINATION SITE INDURATION (Hard spot at that injection site), VACCINATION SITE PRURITUS (Itchy in the location) and the first episode of FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard spot at that injection site), the first episode of FATIGUE (Fatigue), PYREXIA (Fever) and the second episode of FATIGUE (Fatigue). In January 2021, the patient experienced PARAESTHESIA (Left arm tingling), VACCINATION SITE IRRITATION (Irritated in that location), VACCINATION SITE PRURITUS (Itchy in the location) and VACCINATION SITE ERYTHEMA (Redness is growing in that location). At the time of the report, PARAESTHESIA (Left arm tingling), VACCINATION SITE IRRITATION (Irritated in that location), VACCINATION SITE INDURATION (Hard spot at that injection site), VACCINATION SITE PRURITUS (Itchy in the location), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness is growing in that location) and the last episode of FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant product use was not provided by the reporter.  Treatment information included Benadryl and Tylenol, but not confirm whether patient received it.; 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation, Vaccination site pruritus
Clinical narrative: Hard spot at that injection site; Fatigue; Fever; Fatigue; Redness is growing in that location; Itchy in the location; Left arm tingling; Irritated in that location; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left arm tingling), VACCINATION SITE IRRITATION (Irritated in that location), VACCINATION SITE INDURATION (Hard spot at that injection site), VACCINATION SITE PRURITUS (Itchy in the location) and the first episode of FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard spot at that injection site), the first episode of FATIGUE (Fatigue), PYREXIA (Fever) and the second episode of FATIGUE (Fatigue). In January 2021, the patient experienced PARAESTHESIA (Left arm tingling), VACCINATION SITE IRRITATION (Irritated in that location), VACCINATION SITE PRURITUS (Itchy in the location) and VACCINATION SITE ERYTHEMA (Redness is growing in that location). At the time of the report, PARAESTHESIA (Left arm tingling), VACCINATION SITE IRRITATION (Irritated in that location), VACCINATION SITE INDURATION (Hard spot at that injection site), VACCINATION SITE PRURITUS (Itchy in the location), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness is growing in that location) and the last episode of FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant product use was not provided by the reporter.  Treatment information included Benadryl and Tylenol, but not confirm whether patient received it.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site hot; Puritic skin reaction in the site of the injection/itching; Raised red area at the injection site/Red injection site; raised red area at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Raised red area at the injection site/Red injection site), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Puritic skin reaction in the site of the injection/itching) and VACCINATION SITE SWELLING (raised red area at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced VACCINATION SITE ERYTHEMA (Raised red area at the injection site/Red injection site), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Puritic skin reaction in the site of the injection/itching) and VACCINATION SITE SWELLING (raised red area at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Raised red area at the injection site/Red injection site), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Puritic skin reaction in the site of the injection/itching) and VACCINATION SITE SWELLING (raised red area at the injection site) 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 medication was not reported. Treatment medication was not reported. 9-10 days post injection the patient experienced a pruritic skin reaction in the site of the injection. This included itching, hot, raised red area at the injection site.; Sender's Comments: This case concerns a patient of unknown age and gender who had NS events of unexpected vaccination site reaction, vaccination site pruritus, and expected vaccination site erythema.  Event onset occurred 9-10 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Area had become itchy; axillary lymph nodes were very swollen; Left arm area started turning red, red area is currently 2in x 2in area; left arm area was slightly raised; Sore Arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE MASS (left arm area was slightly raised), VACCINATION SITE PRURITUS (Area had become itchy), LYMPHADENOPATHY (axillary lymph nodes were very swollen) and VACCINATION SITE ERYTHEMA (Left arm area started turning red, red area is currently 2in x 2in area) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to sulfa products).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 08-Jan-2021, the patient experienced VACCINATION SITE MASS (left arm area was slightly raised), LYMPHADENOPATHY (axillary lymph nodes were very swollen) and VACCINATION SITE ERYTHEMA (Left arm area started turning red, red area is currently 2in x 2in area). On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Area had become itchy). At the time of the report, PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE MASS (left arm area was slightly raised), VACCINATION SITE PRURITUS (Area had become itchy), LYMPHADENOPATHY (axillary lymph nodes were very swollen) and VACCINATION SITE ERYTHEMA (Left arm area started turning red, red area is currently 2in x 2in area) 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.   On 04-Jan-2021, patient received a TB skin test in the left arm.. Patient thought that this may have contributed to the reaction.   No concomitant medications were reported. Patient has not taken any treatment.; Reporter's Comments: This case concerns a 29-year-old female who had NS events of unexpected pain in extremity, vaccination site mass and expected vaccination site erythema, vaccination site pruritus, lymphadenopathy.  Event onset Day 1 after first dose mRNA-1273, with further events on Day 7. She had TB skin test on Day 3. Treatment and outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.