chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and FATIGUE (Extreme fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and FATIGUE (Extreme fatigue). At the time of the report, DIARRHOEA (Diarrhea) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Aching arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aching arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Aching arms). At the time of the report, PAIN IN EXTREMITY (Aching arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. Treatment details was not reported by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: lightheadedness; significant warmth at injection site on right arm; Pain at injection site on right arm; swelling at injection site on right arm; all over body ache; Headache; fever less than=100 degree F; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm) and PYREXIA (fever less than=100 degree F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2018, Diabetes since 2019, Hypothyroidism since 2000, Acid reflux (oesophageal) since 2010, High cholesterol since 2015 and Allergy (colonoscopy preparation). Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes, SIMVASTATIN for High cholesterol, LOSARTAN for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism.   On 27-May-2021 at 8:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PYREXIA (fever less than=100 degree F). On 27-May-2021 at 2:00 PM, the patient experienced DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), MYALGIA (all over body ache) and HEADACHE (Headache). On 01-Jun-2021, DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), PYREXIA (fever less than=100 degree F), MYALGIA (all over body ache) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), PYREXIA (fever less than=100 degree F), MYALGIA (all over body ache) and HEADACHE (Headache) to have an unknown relationship.    Treatment information  was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: lightheadedness; significant warmth at injection site on right arm; Pain at injection site on right arm; swelling at injection site on right arm; all over body ache; Headache; fever less than=100 degree F; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm) and PYREXIA (fever less than=100 degree F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2018, Diabetes since 2019, Hypothyroidism since 2000, Acid reflux (oesophageal) since 2010, High cholesterol since 2015 and Allergy (colonoscopy preparation). Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes, SIMVASTATIN for High cholesterol, LOSARTAN for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism.   On 27-May-2021 at 8:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PYREXIA (fever less than=100 degree F). On 27-May-2021 at 2:00 PM, the patient experienced DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), MYALGIA (all over body ache) and HEADACHE (Headache). On 01-Jun-2021, DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), PYREXIA (fever less than=100 degree F), MYALGIA (all over body ache) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (lightheadedness), VACCINATION SITE WARMTH (significant warmth at injection site on right arm), VACCINATION SITE PAIN (Pain at injection site on right arm), VACCINATION SITE SWELLING (swelling at injection site on right arm), PYREXIA (fever less than=100 degree F), MYALGIA (all over body ache) and HEADACHE (Headache) to have an unknown relationship.    Treatment information  was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Arm is magnetic/shoulder is attracting metals after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Arm is magnetic/shoulder is attracting metals after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Arm is magnetic/shoulder is attracting metals after the vaccine). At the time of the report, ADVERSE REACTION (Arm is magnetic/shoulder is attracting metals after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site indentation, Vaccination site atrophy, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ATROPHY (Muscle deteriorated after each shot), INJECTION SITE INDENTATION (Immediately after 2nd shot Dent in arm) and VACCINATION SITE REACTION (Arm has a hole where both shots were administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ATROPHY (Muscle deteriorated after each shot), INJECTION SITE INDENTATION (Immediately after 2nd shot Dent in arm) and VACCINATION SITE REACTION (Arm has a hole where both shots were administered). At the time of the report, VACCINATION SITE ATROPHY (Muscle deteriorated after each shot), INJECTION SITE INDENTATION (Immediately after 2nd shot Dent in arm) and VACCINATION SITE REACTION (Arm has a hole where both shots were administered) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-044466 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Feeling hot, Headache, Illness, Insomnia
Clinical narrative: Dehydrated; fingers getting spasms; can barley sleep at night; feel sick like have to throw up; feel hot; feel sick like have to throw up; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up) and FEELING HOT (feel hot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up), FEELING HOT (feel hot), VOMITING (feel sick like have to throw up) and HEADACHE (Headache). At the time of the report, DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up), FEELING HOT (feel hot), VOMITING (feel sick like have to throw up) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Vomiting
Clinical narrative: Dehydrated; fingers getting spasms; can barley sleep at night; feel sick like have to throw up; feel hot; feel sick like have to throw up; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up) and FEELING HOT (feel hot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up), FEELING HOT (feel hot), VOMITING (feel sick like have to throw up) and HEADACHE (Headache). At the time of the report, DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up), FEELING HOT (feel hot), VOMITING (feel sick like have to throw up) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Peripheral swelling, Vertigo
Clinical narrative: swelling above sock line on both calves; vertigo more frequently; light headedness more frequently; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling above sock line on both calves), VERTIGO (vertigo more frequently) and DIZZINESS (light headedness more frequently) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PERIPHERAL SWELLING (swelling above sock line on both calves), VERTIGO (vertigo more frequently) and DIZZINESS (light headedness more frequently). At the time of the report, PERIPHERAL SWELLING (swelling above sock line on both calves), VERTIGO (vertigo more frequently) and DIZZINESS (light headedness more frequently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient uses walking cane to ambulate.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site is swollen) 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 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site is swollen). At the time of the report, VACCINATION SITE SWELLING (Injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.  No treatment details were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pyrexia
Clinical narrative: contracted Covid-19 after getting both shots ofModerna vaccine; fever; headaches; cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches) and COUGH (cough) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On an unknown date, the patient experienced COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches) and COUGH (cough). At the time of the report, COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches) and COUGH (cough) outcome was unknown.            No concomitant and treatment information was provided by the reporter
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Vaccine to an Underage Patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administration of Vaccine to an Underage Patient) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administration of Vaccine to an Underage Patient). On 12-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administration of Vaccine to an Underage Patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; terrible headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) and HEADACHE (terrible headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (terrible headache). At the time of the report, PYREXIA (Fever) and HEADACHE (terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Felt like she had the flu for one week.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu for one week.) 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 April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu for one week.). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. On 12-Apr-2021, INFLUENZA LIKE ILLNESS (Felt like she had the flu for one week.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Document Attached for Initial Report, Non significant Follow up
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No concomitant products were reported by the reporter. No treatment medication provided by the reporter.  The patient wore an ring that measures the readiness to face the day and mentioned that the score after the  second Moderna shot was 29 and it was bad.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: really bad lower back pain feels like a ton of pressure built up but can't pop it; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (really bad lower back pain feels like a ton of pressure built up but can't pop it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (really bad lower back pain feels like a ton of pressure built up but can't pop it). At the time of the report, BACK PAIN (really bad lower back pain feels like a ton of pressure built up but can't pop it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 19 days between first and second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (19 days between first and second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (19 days between first and second dose). On 02-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (19 days between first and second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 10 week from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (10 week from first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT DOSE OMISSION ISSUE (10 week from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (10 week from first dose) had resolved.            No concomitant medications were reported.     Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: had a stiffness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (had a stiffness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (had a stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (had a stiffness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Mobility decreased
Clinical narrative: sore throat; difficulty lifting her arm; Chills; Fatigue; headache; pain and tenderness at the injection site; congestion; redness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MOBILITY DECREASED (difficulty lifting her arm), NASAL CONGESTION (congestion), ERYTHEMA (redness) and CHILLS (Chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced NASAL CONGESTION (congestion), ERYTHEMA (redness) and VACCINATION SITE PAIN (pain and tenderness at the injection site). On 06-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), MOBILITY DECREASED (difficulty lifting her arm), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), MOBILITY DECREASED (difficulty lifting her arm), NASAL CONGESTION (congestion), ERYTHEMA (redness), CHILLS (Chills), VACCINATION SITE PAIN (pain and tenderness at the injection site), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Vaccination site pain
Clinical narrative: sore throat; difficulty lifting her arm; Chills; Fatigue; headache; pain and tenderness at the injection site; congestion; redness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MOBILITY DECREASED (difficulty lifting her arm), NASAL CONGESTION (congestion), ERYTHEMA (redness) and CHILLS (Chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced NASAL CONGESTION (congestion), ERYTHEMA (redness) and VACCINATION SITE PAIN (pain and tenderness at the injection site). On 06-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), MOBILITY DECREASED (difficulty lifting her arm), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), MOBILITY DECREASED (difficulty lifting her arm), NASAL CONGESTION (congestion), ERYTHEMA (redness), CHILLS (Chills), VACCINATION SITE PAIN (pain and tenderness at the injection site), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Swelling
Clinical narrative: chest tightness; neck swelling; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (chest tightness) and SWELLING (neck swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness) and SWELLING (neck swelling). At the time of the report, CHEST DISCOMFORT (chest tightness) and SWELLING (neck swelling) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Lymphadenopathy
Clinical narrative: pain started on upper stomach straight up to the heart area; soreness of lymph node in left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pain started on upper stomach straight up to the heart area) and LYMPHADENOPATHY (soreness of lymph node in left arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Apr-2021, the patient experienced LYMPHADENOPATHY (soreness of lymph node in left arm). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (pain started on upper stomach straight up to the heart area). At the time of the report, ABDOMINAL PAIN UPPER (pain started on upper stomach straight up to the heart area) and LYMPHADENOPATHY (soreness of lymph node in left arm) outcome was unknown.            Concomitant medications were not reported.   Lab data on an unknown date include Blood pressure measurement and Pulse rate which are normal.  Treatment was not reported.   This case was linked to MOD-2021-066529 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Parosmia
Clinical narrative: Smell of gasoline regularly; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smell of gasoline regularly) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Headache. Concomitant products included TOPIRAMATE (TOPAMAX) and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAROSMIA (Smell of gasoline regularly) and CHILLS (Chills). At the time of the report, PAROSMIA (Smell of gasoline regularly) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-027634 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: Face was cleared of eczema; Unexpected therapeutic effect; Feels very rested; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (Face was cleared of eczema), THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic effect) and ENERGY INCREASED (Feels very rested) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema and Food allergy.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (Face was cleared of eczema), THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic effect) and ENERGY INCREASED (Feels very rested). At the time of the report, PRE-EXISTING CONDITION IMPROVED (Face was cleared of eczema) and THERAPEUTIC RESPONSE UNEXPECTED (Unexpected therapeutic effect) had resolved and ENERGY INCREASED (Feels very rested) outcome was unknown.        Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Neck pain
Clinical narrative: Arm was going numb; Neck and head were hurting; Intense head pain; Really fatigued/ exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm was going numb), NECK PAIN (Neck and head were hurting), HEADACHE (Intense head pain) and FATIGUE (Really fatigued/ exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID potentially in April and May).    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Arm was going numb), NECK PAIN (Neck and head were hurting), HEADACHE (Intense head pain) and FATIGUE (Really fatigued/ exhausted). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Arm was going numb), NECK PAIN (Neck and head were hurting), HEADACHE (Intense head pain) and FATIGUE (Really fatigued/ exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter.   Eight days the vaccination, the patient experienced intense head pain and her arm was going numb. She states that it was not a regular headache and occurred in one spot behind her head. She reported takin g Excedrin but that did not help. She was also prescribed with a steroid and antibiotics after the doctor thought she had an ear infection, but that did not help her symptoms. Her neck and head were hurting for the past 8 days.   Other treatment information included Steroid and Antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Neck pain, Swelling
Clinical narrative: painful lump in the back of my neck; painful lump in the back of my neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (painful lump in the back of my neck), HEADACHE (headache) and NECK PAIN (painful lump in the back of my neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (painful lump in the back of my neck), HEADACHE (headache) and NECK PAIN (painful lump in the back of my neck). At the time of the report, SWELLING (painful lump in the back of my neck), HEADACHE (headache) and NECK PAIN (painful lump in the back of my neck) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: herpes outbreak after having the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (herpes outbreak after having the vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (herpes outbreak after having the vaccine.). At the time of the report, HERPES VIRUS INFECTION (herpes outbreak after having the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Myalgia, Pyrexia
Clinical narrative: Vaccine administered after it was stored at room temperature for 18 hours; Headache; Muscle aches; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LISINOPRIL, FUROSEMIDE, METOPROLOL and WARFARIN for an unknown indication.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received and new events were added.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: tingling sensation in my bad foot; Great pain around the area that was operated on; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation in my bad foot) and PAIN (Great pain around the area that was operated on) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     The patient's past medical history included Complex regional pain syndrome (CRPS) in February 2021 and Trimalleolar fracture ( trimalleolar fracture with Weber C) in February 2021.    On 13-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling sensation in my bad foot) and PAIN (Great pain around the area that was operated on). At the time of the report, PARAESTHESIA (tingling sensation in my bad foot) and PAIN (Great pain around the area that was operated on) outcome was unknown.        mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were provided.   This case was linked to MOD-2021-223783 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: No new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events was not Applicable.     This case was linked to MOD-2021-027635 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: slight tender arm, pain in extremity, sore arm; chills; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slight tender arm, pain in extremity, sore arm), CHILLS (chills) and PYREXIA (pyrexia) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (pyrexia). On an unknown date, the patient experienced PAIN IN EXTREMITY (slight tender arm, pain in extremity, sore arm). At the time of the report, PAIN IN EXTREMITY (slight tender arm, pain in extremity, sore arm) had resolved and CHILLS (chills) and PYREXIA (pyrexia) outcome was unknown.            Concomitant medications were not reported.   Treatment was not reported.   This case was linked to MOD-2021-066673 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Lots of aches; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lots of aches), PYREXIA (fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product AMANTADINE HYDROCHLORIDE (GOCOVRI) capsule, coated, extended release for Dyskinesia and Parkinson's disease.    Concurrent medical conditions included Dyskinesia and Parkinson's disease.   On 30-Jan-2018, the patient started AMANTADINE HYDROCHLORIDE (GOCOVRI) (Oral) 1 dosage form. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Lots of aches), PYREXIA (fever) and CHILLS (Chills). At the time of the report, PAIN (Lots of aches), PYREXIA (fever) and CHILLS (Chills) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. No concomitant medications were reported.   This case was linked to MOD-2021-037788 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (Chills) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (Chills) outcome was unknown. Not Provided          No concomitant medication were provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact