chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle discomfort, Night sweats, Pain in extremity
Clinical narrative: Partially lost smell; Partially lost taste; Headache; Short time "everything come black"/ short time "black down"; Sore arm; Night time sweat; Short time "lost control of muscle of neck"; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache). On 11-Apr-2021, the patient experienced HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste). On 10-Apr-2021, LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") had resolved. On 11-Apr-2021, NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications use was unknown.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nephrolithiasis, Sepsis, Urinary tract obstruction
Clinical narrative: kidney stones; kidney stone blocked the tube; Did not get second dose; sepsis; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (kidney stones), SEPSIS (sepsis) and URINARY TRACT OBSTRUCTION (kidney stone blocked the tube) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (kidney stones) (seriousness criterion hospitalization), SEPSIS (sepsis) (seriousness criterion hospitalization prolonged), URINARY TRACT OBSTRUCTION (kidney stone blocked the tube) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose). At the time of the report, NEPHROLITHIASIS (kidney stones), SEPSIS (sepsis), URINARY TRACT OBSTRUCTION (kidney stone blocked the tube) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included unspecific transfusion. No concomitant medications provided.   The patient reported that due to being hospitalized, she was unable to get the second dose of the Moderna COVID-19 vaccine.  This report refers to a case of incomplete course of vaccination (second dose) for mRNA-1273,  with associated AEs of Nephrolithiasis, sepsis and Urinary tract obstruction. Further information is requested.; Sender's Comments: This report refers to a case of incomplete course of vaccination (second dose) for mRNA-1273,  with associated AEs of Nephrolithiasis, sepsis and Urinary tract obstruction. Further information is requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: fainted in the bathroom; Dizziness; Headache; This spontaneous case was reported by a non-health professional and describes the occurrence of SYNCOPE (fainted in the bathroom) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported.).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced SYNCOPE (fainted in the bathroom) (seriousness criterion medically significant), DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, SYNCOPE (fainted in the bathroom), DIZZINESS (Dizziness) and HEADACHE (Headache) 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 reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (hospitalized with covid after first 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 No adverse event (No medical history was reported).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (hospitalized with covid after first dose) (seriousness criterion hospitalization). At the time of the report, COVID-19 (hospitalized with covid after first dose) 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 medication was reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rectal haemorrhage
Clinical narrative: Rectal Bleed; Exacerbation of psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal Bleed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis since an unknown date.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RECTAL HAEMORRHAGE (Rectal Bleed) (seriousness criterion medically significant) and PSORIASIS (Exacerbation of psoriasis). At the time of the report, RECTAL HAEMORRHAGE (Rectal Bleed) and PSORIASIS (Exacerbation of psoriasis) outcome was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Syncope
Clinical narrative: Fainted; Arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 08-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On 05-Apr-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, SYNCOPE (Fainted) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included Ibuprofen. On 08-APR-2021, patient fainted at the work place. Patient was seen by the HCP on the same day and they did some blood work and all the blood work reports came within normal limits. So the HCP mentioned that possibly it could be a delayed reaction to vaccine and suggested to call the manufacturer and report it.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Still very weak; Tired; Sweating; Hurting; Chest oppression; Fainted; Difficulty breathing; Fast Heartbeat; Arm Pain; Couldn't sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Unspecified). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HEART RATE INCREASED (Fast Heartbeat), PAIN IN EXTREMITY (Arm Pain) and INSOMNIA (Couldn't sleep). On 08-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing), HYPERHIDROSIS (Sweating), PAIN (Hurting), CHEST DISCOMFORT (Chest oppression) and FATIGUE (Tired). On an unknown date, the patient experienced ASTHENIA (Still very weak). On 08-Apr-2021, SYNCOPE (Fainted) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast Heartbeat), PAIN IN EXTREMITY (Arm Pain), HYPERHIDROSIS (Sweating), PAIN (Hurting), CHEST DISCOMFORT (Chest oppression) and FATIGUE (Tired) had resolved and INSOMNIA (Couldn't sleep) and ASTHENIA (Still very weak) had not resolved. Not Provided          The patient went to UC, where the doctors made an electrocardiogram (EKG), bloodwork (within normal limits), and said she should consult the vaccine providers. She is still very weak, and cannot sleep correctly. Treatment medications included Tylenol (acetaminophen) and Advil (ibuprofen).  This case concerns a 53-year-old female with a serious unexpected event of syncope and nonserious unexpected chest discomfort, heart rate increased, dyspnea, asthenia, hyperhidrosis, pain, pain in extremity, insomnia, and expected fatigue. Event onset 2 days after second dose mRNA-1273. Syncopal event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-073382 (Patient Link).; Sender's Comments: This case concerns a 53-year-old female with a serious unexpected event of syncope and nonserious unexpected chest discomfort, heart rate increased, dyspnea, asthenia, hyperhidrosis, pain, pain in extremity, insomnia, and expected fatigue. Event onset 2 days after second dose mRNA-1273. Syncopal event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Pain, Pain in extremity, Syncope
Clinical narrative: Still very weak; Tired; Sweating; Hurting; Chest oppression; Fainted; Difficulty breathing; Fast Heartbeat; Arm Pain; Couldn't sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Unspecified). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HEART RATE INCREASED (Fast Heartbeat), PAIN IN EXTREMITY (Arm Pain) and INSOMNIA (Couldn't sleep). On 08-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing), HYPERHIDROSIS (Sweating), PAIN (Hurting), CHEST DISCOMFORT (Chest oppression) and FATIGUE (Tired). On an unknown date, the patient experienced ASTHENIA (Still very weak). On 08-Apr-2021, SYNCOPE (Fainted) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast Heartbeat), PAIN IN EXTREMITY (Arm Pain), HYPERHIDROSIS (Sweating), PAIN (Hurting), CHEST DISCOMFORT (Chest oppression) and FATIGUE (Tired) had resolved and INSOMNIA (Couldn't sleep) and ASTHENIA (Still very weak) had not resolved. Not Provided          The patient went to UC, where the doctors made an electrocardiogram (EKG), bloodwork (within normal limits), and said she should consult the vaccine providers. She is still very weak, and cannot sleep correctly. Treatment medications included Tylenol (acetaminophen) and Advil (ibuprofen).  This case concerns a 53-year-old female with a serious unexpected event of syncope and nonserious unexpected chest discomfort, heart rate increased, dyspnea, asthenia, hyperhidrosis, pain, pain in extremity, insomnia, and expected fatigue. Event onset 2 days after second dose mRNA-1273. Syncopal event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-073382 (Patient Link).; Sender's Comments: This case concerns a 53-year-old female with a serious unexpected event of syncope and nonserious unexpected chest discomfort, heart rate increased, dyspnea, asthenia, hyperhidrosis, pain, pain in extremity, insomnia, and expected fatigue. Event onset 2 days after second dose mRNA-1273. Syncopal event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) 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 No adverse event. Concurrent medical conditions included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication list was not provided. Treatment information was not provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration, Swelling, Thrombosis
Clinical narrative: Blood clot; Left leg pain; Discoloration (blue-purple); Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Clot blood in 2010. Concurrent medical conditions included Drug allergy (Dalaudid, Ambien and Demerol) and Hypertension. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE (AMARYL), ACETYLCARNITINE HYDROCHLORIDE (NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]), COLECALCIFEROL (CALTRATE VITAMIN D DAILY), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and VITAMIN D NOS for an unknown indication.   On 11-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) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain) (seriousness criterion hospitalization), SKIN DISCOLOURATION (Discoloration (blue-purple)) (seriousness criterion hospitalization) and SWELLING (Swelling) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was sent to hospital to remove clots. The patient stated that the clot was 2/3 size of thigh.  The patient scheduled to have a second procedure in May to remove blockages from iliac.  Action taken with mRNA-1273 was not applicable.   Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Amnesia, Chills, Deafness, Diarrhoea
Clinical narrative: loss of hearing; Body aches; Diarrhea; shortness of breath; Loss of tastes; loss of attention; loss of memory; Breaking of the hair; Blurry vision; Nausea; chills Life Threatening; Fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (loss of hearing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DEAFNESS (loss of hearing) (seriousness criterion medically significant), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), VISION BLURRED (Blurry vision), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches). At the time of the report, DEAFNESS (loss of hearing), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches) had not resolved and VISION BLURRED (Blurry vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment included were, acetaminophen (Tylenol) and an inhaler.  Company comment:Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dyspnoea, Fatigue, Myalgia, Nausea
Clinical narrative: loss of hearing; Body aches; Diarrhea; shortness of breath; Loss of tastes; loss of attention; loss of memory; Breaking of the hair; Blurry vision; Nausea; chills Life Threatening; Fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (loss of hearing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DEAFNESS (loss of hearing) (seriousness criterion medically significant), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), VISION BLURRED (Blurry vision), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches). At the time of the report, DEAFNESS (loss of hearing), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches) had not resolved and VISION BLURRED (Blurry vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment included were, acetaminophen (Tylenol) and an inhaler.  Company comment:Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Trichorrhexis, Vision blurred
Clinical narrative: loss of hearing; Body aches; Diarrhea; shortness of breath; Loss of tastes; loss of attention; loss of memory; Breaking of the hair; Blurry vision; Nausea; chills Life Threatening; Fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (loss of hearing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DEAFNESS (loss of hearing) (seriousness criterion medically significant), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), VISION BLURRED (Blurry vision), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches). At the time of the report, DEAFNESS (loss of hearing), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches) had not resolved and VISION BLURRED (Blurry vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment included were, acetaminophen (Tylenol) and an inhaler.  Company comment:Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Feeling abnormal, Loss of consciousness
Clinical narrative: lose consciousness; Dizziness/felt faint; Breathing appeared mildly labored; feeling weird; Tachycardia; Shiver significantly; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (lose consciousness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 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 LOSS OF CONSCIOUSNESS (lose consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness/felt faint), DYSPNOEA (Breathing appeared mildly labored), FEELING ABNORMAL (feeling weird), TACHYCARDIA (Tachycardia) and CHILLS (Shiver significantly). At the time of the report, LOSS OF CONSCIOUSNESS (lose consciousness), DIZZINESS (Dizziness/felt faint), DYSPNOEA (Breathing appeared mildly labored), FEELING ABNORMAL (feeling weird), TACHYCARDIA (Tachycardia) and CHILLS (Shiver significantly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On unknown date, during the observation post vaccination, the patient opened the window to the car for air, reported to the nurse that she felt dizzy. The nurse practicioner arrived to the car with emergency supply cart. Patient was reclined in the passenger seat and stated she felt weird and felt. The patient then slumped down and appeared to have lost consciousness for a few seconds. The patient was breathing and began to shivery significantly. Blood pressure within normal limits, she was tachycardic with elevated respirations. At 1237, the nurse practicioner administered 0.3 milligrams intramuscular through the patient's jeans into the right thigh. Patient tolerated it well. Approximately 5 to 10 minutes post epinephrine, patient's vital signs were within normal limits. The patient stated, she felt much better. 911 was called, an ambulance arrived 3 to 4 minutes later. Patient declined to go to the hospital. Patient was driven home by her husband. The doctor called the patient at 1430 and reported being home with no further complaints.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: lose consciousness; Dizziness/felt faint; Breathing appeared mildly labored; feeling weird; Tachycardia; Shiver significantly; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (lose consciousness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 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 LOSS OF CONSCIOUSNESS (lose consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness/felt faint), DYSPNOEA (Breathing appeared mildly labored), FEELING ABNORMAL (feeling weird), TACHYCARDIA (Tachycardia) and CHILLS (Shiver significantly). At the time of the report, LOSS OF CONSCIOUSNESS (lose consciousness), DIZZINESS (Dizziness/felt faint), DYSPNOEA (Breathing appeared mildly labored), FEELING ABNORMAL (feeling weird), TACHYCARDIA (Tachycardia) and CHILLS (Shiver significantly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On unknown date, during the observation post vaccination, the patient opened the window to the car for air, reported to the nurse that she felt dizzy. The nurse practicioner arrived to the car with emergency supply cart. Patient was reclined in the passenger seat and stated she felt weird and felt. The patient then slumped down and appeared to have lost consciousness for a few seconds. The patient was breathing and began to shivery significantly. Blood pressure within normal limits, she was tachycardic with elevated respirations. At 1237, the nurse practicioner administered 0.3 milligrams intramuscular through the patient's jeans into the right thigh. Patient tolerated it well. Approximately 5 to 10 minutes post epinephrine, patient's vital signs were within normal limits. The patient stated, she felt much better. 911 was called, an ambulance arrived 3 to 4 minutes later. Patient declined to go to the hospital. Patient was driven home by her husband. The doctor called the patient at 1430 and reported being home with no further complaints.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication.     The patient's past medical history included Thrombectomy.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Computerised tomogram, Pneumonia bacterial
Clinical narrative: pain underneath her breast; chest hurt; bacterial pneumonia on left lower lobe; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA BACTERIAL (bacterial pneumonia on left lower lobe) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes, Asthma, Hypertension and High cholesterol. Family history included Heart disease, unspecified.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PNEUMONIA BACTERIAL (bacterial pneumonia on left lower lobe) (seriousness criterion medically significant). At the time of the report, PNEUMONIA BACTERIAL (bacterial pneumonia on left lower lobe) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Computerised tomogram: abnormal (abnormal) Pneumonia on left lower lobe..     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 reported. Treatment of the events included doxycycline.  She had a CAT scan on 05Apr2021 because she had been having pain underneath her breast and her chest hurt. She had to cancel her second dose scheduled for 08Apr2021 due to the pneumonia. She had not been able to find appointment for her second dose and was concerned she may not be able to get the second dose.  Company Comment: This case refers to a 65-year old female patient with relevant history of Diabetes, Asthma, Hypertension and High cholesterol who experienced Pneumonia bacterial, chest pain, and breast pain following the administration of Covid-19 vaccine and was assessed as Unlikely Related to study drug due to lack of temporal relationship.  The subject's underlying disease history can be strong confounding factors.  The pneumonia bacterial can be caused by bacterial infection and the immunocompromised system can allow the patient to higher risk for infections.; Sender's Comments: This case refers to a 65-year old female patient with relevant history of Diabetes, Asthma, Hypertension and High cholesterol who experienced Pneumonia bacterial, chest pain, and breast pain following the administration of Covid-19 vaccine and was assessed as Unlikely Related to study drug due to lack of temporal relationship.  The subject's underlying disease history can be strong confounding factors.  The pneumonia bacterial can be caused by bacterial infection and the immunocompromised system can allow the patient to higher risk for infections.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Seizure
Clinical narrative: 4 seizures; anaphylaxis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Seizures. Concomitant products included ACETAMINOPHEN, ATOMOXETINE HYDROCHLORIDE (STRATTERA), CLONIDINE, DIAZEPAM (VALIUM), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVETIRACETAM (KEPPRA), ONDANSETRON (ZOFRAN [ONDANSETRON]), OXYCODONE and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced SEIZURE (4 seizures) (seriousness criteria hospitalization and life threatening) and ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criteria hospitalization and life threatening). On 09-Apr-2021, SEIZURE (4 seizures) had resolved and ANAPHYLACTIC REACTION (anaphylaxis) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SEIZURE (4 seizures) and ANAPHYLACTIC REACTION (anaphylaxis) to be related.    Hospitalization unknown meds.  This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction  one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected   Reporter did not allow further contact; Sender's Comments: This is a 19 -year-old, male patient who received Moderna COVID-19 Vaccine) (batch no. 037B21A) and experienced seizures and anaphylactic reaction  one day after receiving second dose of vaccine. Medical hx includes seizures Some relevant conmeds atomoxetine, clonidine, diazepam, fluoxetine, levetiracetam, and oxycodone were provided. Very limited information has been reported at this time. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Product dose omission issue
Clinical narrative: Adverse event; did not receive second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chromaturia, Fatigue, Haemorrhage urinary tract, Headache
Clinical narrative: blood in her urine with clots; urine was dark like the color of syrup and it was a brown thick stream; sharp severe headache; chills; fatigue; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE URINARY TRACT (blood in her urine with clots) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (sharp severe headache), CHILLS (chills) and FATIGUE (fatigue). On 08-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (blood in her urine with clots) (seriousness criterion medically significant) and CHROMATURIA (urine was dark like the color of syrup and it was a brown thick stream). On 09-Apr-2021, HAEMORRHAGE URINARY TRACT (blood in her urine with clots) and CHROMATURIA (urine was dark like the color of syrup and it was a brown thick stream) had resolved. At the time of the report, HEADACHE (sharp severe headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided   No relevant concomitant medications were provided.   The patient received acetaminophen for symptoms. She is currently seeking help from her health care provider regarding this situation and is undergoing some tests in the meantime such as a renal ultrasound.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event (headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the events (Haemorrhage urinary tract, chromaturia) has been provided at this time. The subject's medical history and concomitant medications are required for analysis. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the events (Haemorrhage urinary tract, chromaturia) has been provided at this time. The subject's medical history and concomitant medications are required for analysis. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Chest discomfort, Chills, Cough, Headache
Clinical narrative: coughing; heaviness around chest; pink and itchy rash all over body; headache; pain at injection site; fever; confused consciousness; chills; This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (confused consciousness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (confused consciousness) (seriousness criterion medically significant), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (pain at injection site) and PYREXIA (fever). On 12-Apr-2021, the patient experienced COUGH (coughing), CHEST DISCOMFORT (heaviness around chest) and RASH (pink and itchy rash all over body). At the time of the report, ALTERED STATE OF CONSCIOUSNESS (confused consciousness), CHILLS (chills), COUGH (coughing), CHEST DISCOMFORT (heaviness around chest), RASH (pink and itchy rash all over body), HEADACHE (headache), VACCINATION SITE PAIN (pain at injection site) and PYREXIA (fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was not applicable. The treatment included paracetamol.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-073931 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: coughing; heaviness around chest; pink and itchy rash all over body; headache; pain at injection site; fever; confused consciousness; chills; This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (confused consciousness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (confused consciousness) (seriousness criterion medically significant), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (pain at injection site) and PYREXIA (fever). On 12-Apr-2021, the patient experienced COUGH (coughing), CHEST DISCOMFORT (heaviness around chest) and RASH (pink and itchy rash all over body). At the time of the report, ALTERED STATE OF CONSCIOUSNESS (confused consciousness), CHILLS (chills), COUGH (coughing), CHEST DISCOMFORT (heaviness around chest), RASH (pink and itchy rash all over body), HEADACHE (headache), VACCINATION SITE PAIN (pain at injection site) and PYREXIA (fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was not applicable. The treatment included paracetamol.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-073931 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.