chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, Sinus congestion, Throat irritation
Clinical narrative: cold symptoms; runny nose; congestion in sinuses; scratchy throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), RHINORRHOEA (runny nose), SINUS CONGESTION (congestion in sinuses) and THROAT IRRITATION (scratchy throat) 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 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms), RHINORRHOEA (runny nose), SINUS CONGESTION (congestion in sinuses) and THROAT IRRITATION (scratchy throat). At the time of the report, NASOPHARYNGITIS (cold symptoms), RHINORRHOEA (runny nose), SINUS CONGESTION (congestion in sinuses) and THROAT IRRITATION (scratchy throat) outcome was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Myalgia, Pyrexia
Clinical narrative: Fever of 103ºF; severe full body ache; severe coughing; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103ºF), MYALGIA (severe full body ache) and COUGH (severe coughing) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21a and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (Fever of 103ºF), MYALGIA (severe full body ache) and COUGH (severe coughing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 103ºF), MYALGIA (severe full body ache) and COUGH (severe coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 103 (High) 103 degree F.         No concomitant medications information was reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint swelling, Myalgia, Neck pain
Clinical narrative: shoulder and neck pain in the mornings; muscle soreness; headaches; both of his ankles are swelling; fever for two days; elbow and wrist hurt for one day; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (shoulder and neck pain in the mornings), JOINT SWELLING (both of his ankles are swelling), ARTHRALGIA (elbow and wrist hurt for one day   ), PYREXIA (fever for two days) and MYALGIA (muscle soreness) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced ARTHRALGIA (elbow and wrist hurt for one day   ). On 21-May-2021, the patient experienced PYREXIA (fever for two days). On 26-May-2021, the patient experienced JOINT SWELLING (both of his ankles are swelling). On an unknown date, the patient experienced NECK PAIN (shoulder and neck pain in the mornings), MYALGIA (muscle soreness) and HEADACHE (headaches). At the time of the report, NECK PAIN (shoulder and neck pain in the mornings), JOINT SWELLING (both of his ankles are swelling), PYREXIA (fever for two days), MYALGIA (muscle soreness) and HEADACHE (headaches) outcome was unknown and ARTHRALGIA (elbow and wrist hurt for one day   ) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided  Treatment medications - Epsom salt   This case was linked to MOD-2021-182432 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: shoulder and neck pain in the mornings; muscle soreness; headaches; both of his ankles are swelling; fever for two days; elbow and wrist hurt for one day; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (shoulder and neck pain in the mornings), JOINT SWELLING (both of his ankles are swelling), ARTHRALGIA (elbow and wrist hurt for one day   ), PYREXIA (fever for two days) and MYALGIA (muscle soreness) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced ARTHRALGIA (elbow and wrist hurt for one day   ). On 21-May-2021, the patient experienced PYREXIA (fever for two days). On 26-May-2021, the patient experienced JOINT SWELLING (both of his ankles are swelling). On an unknown date, the patient experienced NECK PAIN (shoulder and neck pain in the mornings), MYALGIA (muscle soreness) and HEADACHE (headaches). At the time of the report, NECK PAIN (shoulder and neck pain in the mornings), JOINT SWELLING (both of his ankles are swelling), PYREXIA (fever for two days), MYALGIA (muscle soreness) and HEADACHE (headaches) outcome was unknown and ARTHRALGIA (elbow and wrist hurt for one day   ) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided  Treatment medications - Epsom salt   This case was linked to MOD-2021-182432 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Labored breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored breathing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Labored breathing). At the time of the report, DYSPNOEA (Labored breathing) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment medication were not provided by the reporter.   This case was linked to MOD-2021-182518 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 30 people were administered the vaccines for past 24hours (stored in between  8° to 25°C); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (30 people were administered the vaccines for past 24hours (stored in between  8° to 25°C)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT STORAGE ERROR (30 people were administered the vaccines for past 24hours (stored in between  8° to 25°C)). On 27-May-2021, PRODUCT STORAGE ERROR (30 people were administered the vaccines for past 24hours (stored in between  8° to 25°C)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Followup received included no new significant information. The reported confirmed no adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: heartrate went up to 153 BPM; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heartrate went up to 153 BPM) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (heartrate went up to 153 BPM). On 27-May-2021, TACHYCARDIA (heartrate went up to 153 BPM) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 153 (High) 153 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown.  Patient stated that after she read a brochure about what an allergic reaction to the vaccine could look like, she mentions that she had a similar reaction to MRI scan dye at hospital several years ago.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR : Patient added she is feeling well.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (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 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Somnolence
Clinical narrative: Just wanted to sleep; Labored breathing; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Just wanted to sleep) and DYSPNOEA (Labored breathing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, 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 SOMNOLENCE (Just wanted to sleep) and DYSPNOEA (Labored breathing). At the time of the report, SOMNOLENCE (Just wanted to sleep) and DYSPNOEA (Labored breathing) outcome was unknown.            The concomitant medications were not provided. The Treatment information was not provided.   This case was linked to MOD-2021-182488 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PAIN (pain) 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 provided by reporter.    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 CHILLS (Chills) and PAIN (pain). At the time of the report, CHILLS (Chills) and PAIN (pain) outcome was unknown.            No concomitant and treatment medications were provided by reporter.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Felt a little tired; pain in arm in injection area maybe on the day or the day after he received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt a little tired) and VACCINATION SITE PAIN (pain in arm in injection area maybe on the day or the day after he received the vaccine) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (ZYBAN) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt a little tired) and VACCINATION SITE PAIN (pain in arm in injection area maybe on the day or the day after he received the vaccine). At the time of the report, FATIGUE (Felt a little tired) and VACCINATION SITE PAIN (pain in arm in injection area maybe on the day or the day after he received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-182839 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased
Clinical narrative: Elevated creatinine Kinase levels; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CREATINE PHOSPHOKINASE INCREASED (Elevated creatinine Kinase levels) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD CREATINE PHOSPHOKINASE INCREASED (Elevated creatinine Kinase levels). At the time of the report, BLOOD CREATINE PHOSPHOKINASE INCREASED (Elevated creatinine Kinase levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: ear pain in both ears; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear pain in both ears) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR PAIN (ear pain in both ears). At the time of the report, EAR PAIN (ear pain in both ears) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Jaundice, Ocular icterus
Clinical narrative: Is jaundiced eyes a side effect,Is jaundice a side effect; now my eyes are yellow; This spontaneous case was reported by a consumer and describes the occurrence of JAUNDICE (Is jaundiced eyes a side effect,Is jaundice a side effect) and OCULAR ICTERUS (now my eyes are yellow) 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 JAUNDICE (Is jaundiced eyes a side effect,Is jaundice a side effect) and OCULAR ICTERUS (now my eyes are yellow). At the time of the report, JAUNDICE (Is jaundiced eyes a side effect,Is jaundice a side effect) and OCULAR ICTERUS (now my eyes are yellow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Malaise
Clinical narrative: Very sick; Painful stomach/belly; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Very sick) and ABDOMINAL PAIN UPPER (Painful stomach/belly) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Very sick) and ABDOMINAL PAIN UPPER (Painful stomach/belly). At the time of the report, MALAISE (Very sick) and ABDOMINAL PAIN UPPER (Painful stomach/belly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: been in bed for two days after second dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (been in bed for two days after second dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 BEDRIDDEN (been in bed for two days after second dose of vaccine). At the time of the report, BEDRIDDEN (been in bed for two days after second dose of vaccine) outcome was unknown.            No concomitant medication provided by the reporter no treatment information reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I have lot of pain after taking first shot of vaccine and I took; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (I have lot of pain after taking first shot of vaccine and I took) 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 provided by the reporter.     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 (I have lot of pain after taking first shot of vaccine and I took). At the time of the report, PAIN (I have lot of pain after taking first shot of vaccine and I took) 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 was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Hypertension; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of HYPERTENSION (Hypertension) 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 HYPERTENSION (Hypertension). At the time of the report, HYPERTENSION (Hypertension) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received vaccine on Jan and said that hypertension was a reaction to the shot.  Treatment information was not provided.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Vaccination site pain
Clinical narrative: pain on injection side of body; head pain; difficulty taking a deep breath; injection arm ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on injection side of body), DYSPNOEA (difficulty taking a deep breath), VACCINATION SITE PAIN (injection arm ache) and HEADACHE (head pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced DYSPNOEA (difficulty taking a deep breath) and VACCINATION SITE PAIN (injection arm ache). On 26-May-2021, the patient experienced PAIN (pain on injection side of body) and HEADACHE (head pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain on injection side of body), DYSPNOEA (difficulty taking a deep breath), VACCINATION SITE PAIN (injection arm ache) and HEADACHE (head pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product include inhaler.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered to a 17 years old patient; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered to a 17 years old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concomitant products included DESVENLAFAXINE for an unknown indication.    On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered to a 17 years old patient). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered to a 17 years old patient) 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 treatment medications provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non significant follow up accepted on 15-06-21
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient; Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient) and UNDERDOSE (Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DEVICE CONNECTION ISSUE (Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient). On an unknown date, the patient experienced UNDERDOSE (Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient). At the time of the report, DEVICE CONNECTION ISSUE (Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient) and UNDERDOSE (Receiving moderna covid 19 vaccine and syringe leaked on floor and on patient) 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 medicines were reported. No treatment information were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Foot prosthesis user, Gait disturbance, Headache, Insomnia
Clinical narrative: swollen legs from the knee down to the feet; painful swollen hands; swell and pain at the knee joint; struggles to walk; muscle cramps; spasm; Not able to sleep; Unable to wear their shoes; swell and pain at the knee joint; sore ankles; Pain at the shoulder blade; pain at the top of the head; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk) and MUSCLE SPASMS (muscle cramps) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A211(4 or A)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ARTHRALGIA (Pain at the shoulder blade) and HEADACHE (pain at the top of the head). On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps), MUSCLE SPASMS (spasm), INSOMNIA (Not able to sleep), FOOT PROSTHESIS USER (Unable to wear their shoes), ARTHRALGIA (swell and pain at the knee joint) and ARTHRALGIA (sore ankles). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK UNK, qd; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK, qd; IBUPROFEN ongoing since an unknown date at a dose of UNK, qd and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of UNK, qd. At the time of the report, PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps), MUSCLE SPASMS (spasm), INSOMNIA (Not able to sleep), FOOT PROSTHESIS USER (Unable to wear their shoes), ARTHRALGIA (swell and pain at the knee joint), ARTHRALGIA (sore ankles), ARTHRALGIA (Pain at the shoulder blade) and HEADACHE (pain at the top of the head) 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 medications were reported.   This case was linked to MOD-2021-182438, MOD-2021-181936 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Muscle spasms, Peripheral swelling
Clinical narrative: swollen legs from the knee down to the feet; painful swollen hands; swell and pain at the knee joint; struggles to walk; muscle cramps; spasm; Not able to sleep; Unable to wear their shoes; swell and pain at the knee joint; sore ankles; Pain at the shoulder blade; pain at the top of the head; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk) and MUSCLE SPASMS (muscle cramps) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A211(4 or A)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ARTHRALGIA (Pain at the shoulder blade) and HEADACHE (pain at the top of the head). On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps), MUSCLE SPASMS (spasm), INSOMNIA (Not able to sleep), FOOT PROSTHESIS USER (Unable to wear their shoes), ARTHRALGIA (swell and pain at the knee joint) and ARTHRALGIA (sore ankles). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK UNK, qd; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK, qd; IBUPROFEN ongoing since an unknown date at a dose of UNK, qd and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of UNK, qd. At the time of the report, PERIPHERAL SWELLING (swollen legs from the knee down to the feet), PERIPHERAL SWELLING (painful swollen hands), JOINT SWELLING (swell and pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps), MUSCLE SPASMS (spasm), INSOMNIA (Not able to sleep), FOOT PROSTHESIS USER (Unable to wear their shoes), ARTHRALGIA (swell and pain at the knee joint), ARTHRALGIA (sore ankles), ARTHRALGIA (Pain at the shoulder blade) and HEADACHE (pain at the top of the head) 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 medications were reported.   This case was linked to MOD-2021-182438, MOD-2021-181936 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: super sick since second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (super sick since second dose) 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 24-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced ILLNESS (super sick since second dose). At the time of the report, ILLNESS (super sick since second dose) outcome was unknown.            No concomitant and treatment information provided.    AE submitted via chatbot I got my second shot (maderna) on Monday.. I've been super sick ever since. What can I do?
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: upper back discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (upper back discomfort) 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 provided by the reporter.     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 DISCOMFORT (upper back discomfort). At the time of the report, MUSCULOSKELETAL DISCOMFORT (upper back discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  patient reported having vaccinated a week before event.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provide. treatment to the events not reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up information received on 26-may-2021, it does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Fever; Bodyaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Bodyaches) and HEADACHE (Headache) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (Bodyaches) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and MYALGIA (Bodyaches) had resolved and HEADACHE (Headache) had not resolved.            No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Fatigue; Nausea; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: 2ndo dose yesterday and now i have  fever 100.7; My arm is so sore; my arm is red; headache; feel nauseous; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (2ndo dose yesterday and now i have  fever 100.7), VACCINATION SITE PAIN (My arm is so sore), ERYTHEMA (my arm is red), HEADACHE (headache) and NAUSEA (feel nauseous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     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 (2ndo dose yesterday and now i have  fever 100.7), VACCINATION SITE PAIN (My arm is so sore), ERYTHEMA (my arm is red), HEADACHE (headache) and NAUSEA (feel nauseous). At the time of the report, PYREXIA (2ndo dose yesterday and now i have  fever 100.7), VACCINATION SITE PAIN (My arm is so sore), ERYTHEMA (my arm is red), HEADACHE (headache) and NAUSEA (feel nauseous) outcome was unknown.            No concomitant medications were provided.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: patint potentially experience unspecified side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patint potentially experience unspecified side effect) 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 provided by reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (patint potentially experience unspecified side effect). At the time of the report, VACCINATION COMPLICATION (patint potentially experience unspecified side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt fatigue). At the time of the report, FATIGUE (Felt fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: chronic fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (chronic 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 FATIGUE (chronic fatigue). At the time of the report, FATIGUE (chronic fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid Arm 3 times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm 3 times) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm 3 times). At the time of the report, VACCINATION SITE REACTION (Covid Arm 3 times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. The patient had second dose on March 2021.   This case was linked to MOD-2021-182746 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Patient missed her 2nd dose, more than 42 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient missed her 2nd dose, more than 42 days after the 1st dose) 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 Surgery in April 2021.    On 31-Mar-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 INTENTIONAL PRODUCT USE ISSUE (Patient missed her 2nd dose, more than 42 days after the 1st dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient missed her 2nd dose, more than 42 days after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: body ache; chills; low grade fever/102.5 fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), PYREXIA (low grade fever/102.5 fever) and CHILLS (chills) 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 provided by the reporter.     On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (low grade fever/102.5 fever). On 09-May-2021, the patient experienced MYALGIA (body ache) and CHILLS (chills). On 11-May-2021, MYALGIA (body ache), PYREXIA (low grade fever/102.5 fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Body temperature: 102.5 (Inconclusive) 102.5.         No information regarding treatment medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long can the side effcts last; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long can the side effcts last) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long can the side effcts last). At the time of the report, VACCINATION COMPLICATION (How long can the side effcts last) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid Arm 3 times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm 3 times) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm 3 times). At the time of the report, VACCINATION SITE REACTION (Covid Arm 3 times) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was reported. No concomitant medication was reported.   This case was linked to MOD-2021-182721 (Patient Link).