chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Blood pressure fluctuation, Hypertension, Night sweats, Vaccination complication
Clinical narrative: fluttering heart beat; night sweats (more common in the morning); blood pressure shot up and it took 6-7 hours to calm it back down.; since been having episodes of blood pressure changes that go up and down.; usual vaccine reactions which were slightly more severe than the first dose; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FLUTTER (fluttering heart beat), NIGHT SWEATS (night sweats (more common in the morning)), VACCINATION COMPLICATION (usual vaccine reactions which were slightly more severe than the first dose), HYPERTENSION (blood pressure shot up and it took 6-7 hours to calm it back down.) and BLOOD PRESSURE FLUCTUATION (since been having episodes of blood pressure changes that go up and down.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION COMPLICATION (usual vaccine reactions which were slightly more severe than the first dose). On 08-Mar-2021, the patient experienced HYPERTENSION (blood pressure shot up and it took 6-7 hours to calm it back down.) and BLOOD PRESSURE FLUCTUATION (since been having episodes of blood pressure changes that go up and down.). On 12-Mar-2021, the patient experienced ATRIAL FLUTTER (fluttering heart beat) and NIGHT SWEATS (night sweats (more common in the morning)). At the time of the report, ATRIAL FLUTTER (fluttering heart beat), NIGHT SWEATS (night sweats (more common in the morning)) and BLOOD PRESSURE FLUCTUATION (since been having episodes of blood pressure changes that go up and down.) had not resolved and VACCINATION COMPLICATION (usual vaccine reactions which were slightly more severe than the first dose) and HYPERTENSION (blood pressure shot up and it took 6-7 hours to calm it back down.) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.  On 27-MAY-2021 patient still suffers from the fluttering heart rate, blood pressure, and night sweats occasionally.   This case was linked to MOD-2021-183202 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    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) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a lot of pain in his whole body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a lot of pain in his whole body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 24-May-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 PAIN (a lot of pain in his whole body). At the time of the report, PAIN (a lot of pain in his whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information were not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Tenderness, Urticaria
Clinical narrative: arm swelling; broke out in hives all over; arm was tender; arm got red; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (arm swelling), URTICARIA (broke out in hives all over), TENDERNESS (arm was tender) and ERYTHEMA (arm got red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune deficiency syndrome, Bipolar disorder, Fatty liver, Barrett's esophagus, Osteoporosis, Allergy, Sinus disorder NOS, Gastrooesophageal reflux disease and Hives (bad). Concomitant products included OMALIZUMAB (XOLAIR), PREDNISONE, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), FAMOTIDINE (PEPCID AC) and HYDROXYZINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (arm swelling), URTICARIA (broke out in hives all over), TENDERNESS (arm was tender) and ERYTHEMA (arm got red). At the time of the report, PERIPHERAL SWELLING (arm swelling), URTICARIA (broke out in hives all over), TENDERNESS (arm was tender) and ERYTHEMA (arm got red) 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 medication included.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: my arm start to pain after 7 days of second dose and its worse; 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 MYALGIA (my arm start to pain after 7 days of second dose and its worse) 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 MYALGIA (my arm start to pain after 7 days of second dose and its worse). At the time of the report, MYALGIA (my arm start to pain after 7 days of second dose and its worse) outcome was unknown. Not Provided          No treatment medications were provided. No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Get so tired; 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 (Get so tired) 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 FATIGUE (Get so tired). At the time of the report, FATIGUE (Get so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history and concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: period lasting long from first shot; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (period lasting long from first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OLIGOMENORRHOEA (period lasting long from first shot). At the time of the report, OLIGOMENORRHOEA (period lasting long from first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    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) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided          Concomitant product use was not provided. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: lungs problems; 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 LUNG DISORDER (lungs problems) 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 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 LUNG DISORDER (lungs problems). At the time of the report, LUNG DISORDER (lungs problems) outcome was unknown.            no treatment information was provided no concomitant medication were reported   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Muscle spasms, Pain in extremity, Ultrasound scan
Clinical narrative: Leg cramps in my calve; Inflammation; Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh; She reported the side effect; Leg pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She reported the side effect), PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Leg cramps in my calve), INFLAMMATION (Inflammation) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts, Allergy to antibiotic, Penicillin allergy and Drug allergy. Concomitant products included FENOFIBRATE from an unknown date to 11-May-2021 for Hypertriglyceridemia, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION COMPLICATION (She reported the side effect), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh). On an unknown date, the patient experienced MUSCLE SPASMS (Leg cramps in my calve) and INFLAMMATION (Inflammation). At the time of the report, VACCINATION COMPLICATION (She reported the side effect) outcome was unknown and PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Leg cramps in my calve), INFLAMMATION (Inflammation) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, Ultrasound scan: no blood clots (Inconclusive) No blood clots. On 05-Sep-2021, Ultrasound scan: no blood clots (Inconclusive) Blood clots- none were found.     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.   Patient experienced leg cramps in calve, pain behind knee, radiates to thigh and inflammation.  Treatment for inflammation will start from next day included steroid pack and natural massage.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16 Jun 2021 included details on: patient demographics(height, weight and ethnicity), relevant medical history, details on concomitant medication, and event outcome.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Leg cramps in my calve; Inflammation; Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh; She reported the side effect; Leg pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She reported the side effect), PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Leg cramps in my calve), INFLAMMATION (Inflammation) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts, Allergy to antibiotic, Penicillin allergy and Drug allergy. Concomitant products included FENOFIBRATE from an unknown date to 11-May-2021 for Hypertriglyceridemia, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION COMPLICATION (She reported the side effect), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh). On an unknown date, the patient experienced MUSCLE SPASMS (Leg cramps in my calve) and INFLAMMATION (Inflammation). At the time of the report, VACCINATION COMPLICATION (She reported the side effect) outcome was unknown and PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Leg cramps in my calve), INFLAMMATION (Inflammation) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, Ultrasound scan: no blood clots (Inconclusive) No blood clots. On 05-Sep-2021, Ultrasound scan: no blood clots (Inconclusive) Blood clots- none were found.     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.   Patient experienced leg cramps in calve, pain behind knee, radiates to thigh and inflammation.  Treatment for inflammation will start from next day included steroid pack and natural massage.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16 Jun 2021 included details on: patient demographics(height, weight and ethnicity), relevant medical history, details on concomitant medication, and event outcome.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: After second shot I had Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After second shot I had Flu like symptoms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 625C21A) for COVID-19 vaccination.     The patient's past medical history included COPD and Upper respiratory tract infection. Concomitant products included IBUPROFEN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (After second shot I had Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (After second shot I had Flu like symptoms) outcome was unknown. Not Provided          doctor advice patient to take dicyclomine 10mg, IB Guard before second short. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-068595 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Elevated heart rate 100 beats per minute; chills; fever over 100ºF; Bunch of muscle soreness.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate 100 beats per minute), CHILLS (chills), PYREXIA (fever over 100ºF) and MYALGIA (Bunch of muscle soreness.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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 HEART RATE INCREASED (Elevated heart rate 100 beats per minute), CHILLS (chills), PYREXIA (fever over 100ºF) and MYALGIA (Bunch of muscle soreness.). At the time of the report, HEART RATE INCREASED (Elevated heart rate 100 beats per minute), CHILLS (chills), PYREXIA (fever over 100ºF) and MYALGIA (Bunch of muscle soreness.) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: muscle weakness; 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 MUSCULAR WEAKNESS (muscle weakness) 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness). At the time of the report, MUSCULAR WEAKNESS (muscle weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment products were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Bad redness after a week taking the 1st 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 ERYTHEMA (Bad redness after a week taking the 1st 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, the patient experienced ERYTHEMA (Bad redness after a week taking the 1st dose). At the time of the report, ERYTHEMA (Bad redness after a week taking the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    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 OROPHARYNGEAL PAIN (sore throat) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site vesicles
Clinical narrative: Blister at the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (Blister at the injection site) and PYREXIA (Fever) 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) (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 VACCINATION SITE VESICLES (Blister at the injection site) and PYREXIA (Fever). At the time of the report, VACCINATION SITE VESICLES (Blister at the injection site) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: red swelling; red swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red swelling) and SWELLING (red swelling) 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 23-May-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 ERYTHEMA (red swelling) and SWELLING (red swelling). At the time of the report, ERYTHEMA (red swelling) and SWELLING (red swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Skin mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Knots under my under arm; Warm to touch; swelling up; 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 SKIN MASS (Knots under my under arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (swelling up) and 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 SKIN MASS (Knots under my under arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (swelling up) and HEADACHE (Headache). At the time of the report, SKIN MASS (Knots under my under arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (swelling up) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.  Patient stated that he got his shot a week ago.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: my fingers "fell asleep"; 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 HYPOAESTHESIA (my fingers "fell asleep") 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 HYPOAESTHESIA (my fingers "fell asleep"). At the time of the report, HYPOAESTHESIA (my fingers "fell asleep") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Twice overnight patient's fingers "fell asleep", it went away quickly when patient shook hand around. No concomitant and treatment medications were provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt a pinch for second shot but that was it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt a pinch for second shot but that was it) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included FOCUSFACTOR, ACETYLCARNITINE HYDROCHLORIDE, BIOTIN, CALCIUM, PHOSPHORUS, THIOCTIC ACID (JUVENON) and GINKGO BILOBA for an unknown indication.   On 13-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 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (felt a pinch for second shot but that was it). At the time of the report, PAIN (felt a pinch for second shot but that was it) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Additional concomitant medications  included Blood Flow 7. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (sinus infection) 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-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 SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-076339 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: This spontaneous case reported by a pharmacist (subsequently medically confirmed), describes the occurrence of device connection issue (needle came loose from the syringe and the vaccine ran down the patient's arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037C21A and 003C21A) for COVID-19 vaccination. No medical history reported. On May 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient experienced device connection issue (needle came loose from the syringe and the vaccine ran down the patient's arm). On May 27, 2021, device connection issue (needle came loose from the syringe and the vaccine ran down the patient's arm) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The action taken with mRNA-1273 in response to the event: not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Delayed 2 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 PRODUCT DOSE OMISSION ISSUE (Delayed 2 dose of vaccine) 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 PRODUCT DOSE OMISSION ISSUE (Delayed 2 dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Delayed 2 dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first shot but didn't go back for the second one like two weeks ago.  No relevant concomitant medications reported.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dehydration, Insomnia, Nausea, Urine output increased
Clinical narrative: Awake every hour going to the bathroom after 2nd dose; Vertigo after the 2nd dose; Staggering to bathroom like had been drinking after 2nd dose; Dehydrated from going to the bathroom after 2nd dose; Losing balance and hitting the walls after 2nd dose; Puncture area very hard and felt like vaccine stayed there after 2nd dose; Nauseous after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose) and BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-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 INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose), BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose), VACCINATION SITE INDURATION (Puncture area very hard and felt like vaccine stayed there after 2nd dose) and NAUSEA (Nauseous after 2nd dose). At the time of the report, INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose), BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose), VACCINATION SITE INDURATION (Puncture area very hard and felt like vaccine stayed there after 2nd dose) and NAUSEA (Nauseous after 2nd dose) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-022025 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vertigo
Clinical narrative: Awake every hour going to the bathroom after 2nd dose; Vertigo after the 2nd dose; Staggering to bathroom like had been drinking after 2nd dose; Dehydrated from going to the bathroom after 2nd dose; Losing balance and hitting the walls after 2nd dose; Puncture area very hard and felt like vaccine stayed there after 2nd dose; Nauseous after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose) and BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-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 INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose), BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose), VACCINATION SITE INDURATION (Puncture area very hard and felt like vaccine stayed there after 2nd dose) and NAUSEA (Nauseous after 2nd dose). At the time of the report, INSOMNIA (Awake every hour going to the bathroom after 2nd dose), VERTIGO (Vertigo after the 2nd dose), URINE OUTPUT INCREASED (Staggering to bathroom like had been drinking after 2nd dose), DEHYDRATION (Dehydrated from going to the bathroom after 2nd dose), BALANCE DISORDER (Losing balance and hitting the walls after 2nd dose), VACCINATION SITE INDURATION (Puncture area very hard and felt like vaccine stayed there after 2nd dose) and NAUSEA (Nauseous after 2nd dose) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-022025 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long are the side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    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 are the side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long are the side effects). At the time of the report, VACCINATION COMPLICATION (How long are the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Malaise
Clinical narrative: sweats; Nausea; Stayed on  bed all day; Arm was sore; No fever but warm; Muscle aches all over body; Injection site pretty sore; Chills; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), HYPERHIDROSIS (sweats) and MYALGIA (Muscle aches all over body) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV disease since 27-Oct-1987. Concomitant products included TENOFOVIR and EMTRICITABINE for HIV disease.   On 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), MYALGIA (Muscle aches all over body), VACCINATION SITE PAIN (Injection site pretty sore), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERHIDROSIS (sweats) and NAUSEA (Nausea). At the time of the report, MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), HYPERHIDROSIS (sweats), MYALGIA (Muscle aches all over body), VACCINATION SITE PAIN (Injection site pretty sore), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information received on 11-JUN-2021 Added reporter information. Added concomitant medications. and New events updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: sweats; Nausea; Stayed on  bed all day; Arm was sore; No fever but warm; Muscle aches all over body; Injection site pretty sore; Chills; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), HYPERHIDROSIS (sweats) and MYALGIA (Muscle aches all over body) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV disease since 27-Oct-1987. Concomitant products included TENOFOVIR and EMTRICITABINE for HIV disease.   On 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), MYALGIA (Muscle aches all over body), VACCINATION SITE PAIN (Injection site pretty sore), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERHIDROSIS (sweats) and NAUSEA (Nausea). At the time of the report, MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), HYPERHIDROSIS (sweats), MYALGIA (Muscle aches all over body), VACCINATION SITE PAIN (Injection site pretty sore), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information received on 11-JUN-2021 Added reporter information. Added concomitant medications. and New events updated.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Shoulder tightness; chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 28-May-2021.    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 CHEST DISCOMFORT (Shoulder tightness) and CHEST PAIN (chest 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 information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Shoulder tightness) and CHEST PAIN (chest pain). At the time of the report, CHEST DISCOMFORT (Shoulder tightness) and CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of vaccine as far out as 3 months after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine as far out as 3 months after the first 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine as far out as 3 months after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine as far out as 3 months after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Muscle spasms, Nausea
Clinical narrative: upper stomach pain; cramping feeling; extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (upper stomach pain), MUSCLE SPASMS (cramping feeling) and NAUSEA (extreme nausea) in a 20-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (upper stomach pain), MUSCLE SPASMS (cramping feeling) and NAUSEA (extreme nausea). At the time of the report, ABDOMINAL PAIN UPPER (upper stomach pain), MUSCLE SPASMS (cramping feeling) and NAUSEA (extreme nausea) outcome was unknown.            No concomitant medications were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: Bm in black; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (Bm in black) in a 25-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced FAECES DISCOLOURED (Bm in black). At the time of the report, FAECES DISCOLOURED (Bm in black) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The texter confirmed that they received moderna COVID-19 vaccine and had side effects.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The texter confirmed that they received moderna COVID-19 vaccine and had side effects.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The texter confirmed that they received moderna COVID-19 vaccine and had side effects.). At the time of the report, VACCINATION COMPLICATION (The texter confirmed that they received moderna COVID-19 vaccine and had side effects.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: mild chills; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (mild chills) and HEADACHE (slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 immunisation.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced CHILLS (mild chills) and HEADACHE (slight headache). At the time of the report, CHILLS (mild chills) and HEADACHE (slight headache) had resolved.            Concomitant products were not provided. Treatment products were not provided.