chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that on an unspecified date, the patient experienced a blood clot. There was no additional information provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210626844-COVID-19 VACCINE AD26.COV2.S-blood clot. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia
Clinical narrative: JUST WANT TO SINK INTO SOMETHING AND NEVER GET UP; CHILLS; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-JUN-2021, the subject experienced just want to sink into something and never get up. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and muscle aches, and the outcome of just want to sink into something and never get up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: SEVERE MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JUN-2021, the subject experienced severe muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe muscle aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a company representative via Social media concerned a 35-year-old female, unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. Post vaccination, after one week, on an unspecified date patient died, cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210626951- Covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphoedema
Clinical narrative: LEFT ARM UNDERNEATH THE ARMPIT AREA WAS SWOLLEN; LEFT ARMPIT AREA WAS PUFFY, FELT LIKE THE MEDICATION DRAINED INTO THE LYMPH NODES; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-JUN-2021, the subject experienced left arm underneath the armpit area was swollen. On 11-JUN-2021, the subject experienced left armpit area was puffy, felt like the medication drained into the lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm underneath the armpit area was swollen, and left armpit area was puffy, felt like the medication drained into the lymph nodes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: ELECTRICAL PULSES IN LEFT CALF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced electrical pulses in left calf. The action taken with covid-19 vaccine was not applicable. The outcome of electrical pulses in left calf was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED DOSE OF JANSSEN COVID-19 VACCINE WAS ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 16:33 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced expired dose of Janssen covid-19 vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of Janssen covid-19 vaccine was administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH AROUND FACE, NECK, CHEST; This spontaneous report received from a pharmacist concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced rash around face, neck, chest. Treatment medications (dates unspecified) included: calamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash around face, neck, chest. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Contusion, Dizziness, Fatigue, Musculoskeletal stiffness
Clinical narrative: UNABLE TO MOVE ARM AND NECK (COMPLETELY STIFF); BRUISES ALL OVER MY BODY FROM WHERE IT FELT LIKE VESSELS BURSTING; VOMITING; DIZZY; BACK PAIN; TIREDNESS; This spontaneous report received from a consumer via a company representative concerned a 5 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced unable to move arm and neck (completely stiff). On 10-JUN-2021, the subject experienced bruises all over my body from where it felt like vessels bursting. On 10-JUN-2021, the subject experienced vomiting. On 10-JUN-2021, the subject experienced dizzy. On 10-JUN-2021, the subject experienced back pain. On 10-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to move arm and neck (completely stiff), bruises all over my body from where it felt like vessels bursting, vomiting, dizzy, tiredness and back pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: UNABLE TO MOVE ARM AND NECK (COMPLETELY STIFF); BRUISES ALL OVER MY BODY FROM WHERE IT FELT LIKE VESSELS BURSTING; VOMITING; DIZZY; BACK PAIN; TIREDNESS; This spontaneous report received from a consumer via a company representative concerned a 5 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-JUN-2021, the subject experienced unable to move arm and neck (completely stiff). On 10-JUN-2021, the subject experienced bruises all over my body from where it felt like vessels bursting. On 10-JUN-2021, the subject experienced vomiting. On 10-JUN-2021, the subject experienced dizzy. On 10-JUN-2021, the subject experienced back pain. On 10-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to move arm and neck (completely stiff), bruises all over my body from where it felt like vessels bursting, vomiting, dizzy, tiredness and back pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: SHIVERS; BIT OF A FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shivers and bit of a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shivers and bit of a fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHES; A FEW DAYS WITH FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced aches, and a few days with fever. The action taken with covid-19 vaccine was not applicable. The outcome of the a few days with fever and aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210626803.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain
Clinical narrative: INCREDIBLE PAIN; PART OF HIS FACE WENT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced incredible pain, and part of his face went numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incredible pain and part of his face went numb was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: INTERMITTENT RAPID HEARTBEAT AND NOTICE MORE HEART BEATS WHILE SITTING; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. Patient was pretty health and does not take any medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced intermittent rapid heartbeat and notice more heart beats while sitting. Laboratory data included: Heart rate (NR: not provided) intermittent rapid heart beat. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from intermittent rapid heartbeat and notice more heart beats while sitting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Lymphadenopathy, Muscular weakness
Clinical narrative: SORE; SWOLLEN NECK LYMPH NODES AND UNDER ARM LYMPH NODES; CHILLS; COULD HARDLY LIFT ARM; FEVER; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sore, swollen neck lymph nodes and under arm lymph nodes, chills, could hardly lift arm, fever, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore, swollen neck lymph nodes and under arm lymph nodes, chills, could hardly lift arm, fever, and fatigued. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE; SWOLLEN NECK LYMPH NODES AND UNDER ARM LYMPH NODES; CHILLS; COULD HARDLY LIFT ARM; FEVER; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sore, swollen neck lymph nodes and under arm lymph nodes, chills, could hardly lift arm, fever, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore, swollen neck lymph nodes and under arm lymph nodes, chills, could hardly lift arm, fever, and fatigued. This report was non-serious.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Hunger
Clinical narrative: VERY HUNGRY; BODY ACHES; ORGANS FEEL LIKE THEY HAVE BEEN SITTING OUT IN THE DESERT EVEN THOUGH CONSTANTLY DRINKING WATER; CHILLS; OVERALL FATIGUE; FEVER; VERY NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a 2 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced very hungry. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced organs feel like they have been sitting out in the desert even though constantly drinking water. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced overall fatigue. On JUN-2021, the subject experienced fever. On JUN-2021, the subject experienced very nauseous. Laboratory data included: Body temperature (NR: not provided) High as 103.4 (Units were not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, chills, very hungry, overall fatigue, organs feel like they have been sitting out in the desert even though constantly drinking water and very nauseous was not reported. This report was non-serious.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: VERY HUNGRY; BODY ACHES; ORGANS FEEL LIKE THEY HAVE BEEN SITTING OUT IN THE DESERT EVEN THOUGH CONSTANTLY DRINKING WATER; CHILLS; OVERALL FATIGUE; FEVER; VERY NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a 2 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced very hungry. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced organs feel like they have been sitting out in the desert even though constantly drinking water. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced overall fatigue. On JUN-2021, the subject experienced fever. On JUN-2021, the subject experienced very nauseous. Laboratory data included: Body temperature (NR: not provided) High as 103.4 (Units were not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, chills, very hungry, overall fatigue, organs feel like they have been sitting out in the desert even though constantly drinking water and very nauseous was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: PAIN IN BOTH CALVES OF LEGS/LEGS SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain in both calves of legs/legs sore. Laboratory data (dates unspecified) included: Sonogram (NR: not provided) Did not have any clots. The action taken with covid-19 vaccine was not applicable. The outcome of pain in both calves of legs/legs sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.5 (Unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: IMPROVEMENT IN ASTHMA SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included asthma(excessive wheezing during strenuous activity).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced improvement in asthma symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of improvement in asthma symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Seizure
Clinical narrative: seizure; Rash on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced RASH (Rash on upper arm). The patient was hospitalized on 26-Feb-2021 due to SEIZURE. At the time of the report, SEIZURE (seizure) and RASH (Rash on upper arm) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-030292 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030292:2nd Dose Case - Serious
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis infective
Clinical narrative: Emergency hip replacement operation to correct an infection that was in the hip; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Emergency hip replacement operation) for Arthritis infective. At the time of the report, ARTHRITIS INFECTIVE (Emergency hip replacement operation to correct an infection that was in the hip) 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 relevant concomitant medications were provided.  Company Comment  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
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Hypertension, Pyrexia
Clinical narrative: Dehydration; High blood pressure; Fever 98.1 degrees fahrenheit); This spontaneous case was reported by an other caregiver and describes the occurrence of DEHYDRATION (Dehydration) and HYPERTENSION (High blood pressure) in a 63-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.     Concomitant products included VITAMIN D NOS for an unknown indication.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization prolonged) and HYPERTENSION (High blood pressure) (seriousness criterion hospitalization prolonged). On 01-Jun-2021, the patient experienced PYREXIA (Fever 98.1 degrees fahrenheit)   ). The patient was hospitalized for 3 days due to DEHYDRATION and HYPERTENSION. The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 tablet. At the time of the report, DEHYDRATION (Dehydration), HYPERTENSION (High blood pressure) and PYREXIA (Fever 98.1 degrees fahrenheit)   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment received while hospitalized was not reported.  Company 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Cardiac problems  after receiving either Pfizer or Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC DISORDER (Cardiac problems  after receiving either Pfizer or Moderna vaccine) in an elderly patient of an unknown 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 CARDIAC DISORDER (Cardiac problems  after receiving either Pfizer or Moderna vaccine) (seriousness criterion death). The reported cause of death was Cardiac disorder NOS. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: 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.; Reported Cause(s) of Death: Cardiac disorder NOS
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Loss of consciousness, Pyrexia, Vaccination site pain
Clinical narrative: When I stand up I feel like I am going to pass out; My arm is so painful I cannot raise it up; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out) (seriousness criterion medically significant), VACCINATION SITE PAIN (My arm is so painful I cannot raise it up), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LOSS OF CONSCIOUSNESS (When I stand up I feel like I am going to pass out), VACCINATION SITE PAIN (My arm is so painful I cannot raise it up), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment information was provided.  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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Diarrhoea, Insomnia, Mental disorder, Schizophrenia
Clinical narrative: Talking to imaginary man; Exacerbation of Mental health disorder; talking to himself (full conversation); Mild Angry outburst; Diarrhea; insomnia; Not communicating with family members; This spontaneous case was reported by a patient and describes the occurrence of SCHIZOPHRENIA (Talking to imaginary man) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disorder NOS.    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 SCHIZOPHRENIA (Talking to imaginary man) (seriousness criterion medically significant), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members). At the time of the report, SCHIZOPHRENIA (Talking to imaginary man), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided. Treatment information was not reported.  Company comment: 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.; 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Social avoidant behaviour, Soliloquy
Clinical narrative: Talking to imaginary man; Exacerbation of Mental health disorder; talking to himself (full conversation); Mild Angry outburst; Diarrhea; insomnia; Not communicating with family members; This spontaneous case was reported by a patient and describes the occurrence of SCHIZOPHRENIA (Talking to imaginary man) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disorder NOS.    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 SCHIZOPHRENIA (Talking to imaginary man) (seriousness criterion medically significant), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members). At the time of the report, SCHIZOPHRENIA (Talking to imaginary man), MENTAL DISORDER (Exacerbation of Mental health disorder), SOLILOQUY (talking to himself (full conversation)), ANGER (Mild Angry outburst), DIARRHOEA (Diarrhea), INSOMNIA (insomnia) and SOCIAL AVOIDANT BEHAVIOUR (Not communicating with family members) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided. Treatment information was not reported.  Company comment: 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.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Pulmonary embolism, Ultrasound scan
Clinical narrative: Saddle Pulmonary Embolism; DVT; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UBLITUXIMAB for an unknown indication, UMBRALISIB for an unknown indication and VENETOCLAX for an unknown indication.    Concurrent medical conditions included Hypertension, Mantle cell lymphoma, Leukemia (relapsed or refractory CLL/SLL) and Richter's syndrome.   On 28-May-2020, the patient started UBLITUXIMAB (Intravenous) 900 milligram and UMBRALISIB (Oral) 800 milligram. On 02-Sep-2020, the patient started VENETOCLAX (Oral) 400 milligram. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Saddle Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Apr-2021 to 26-Apr-2021 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with HEPARIN on 23-Apr-2021 for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: dvt (abnormal) Ultrasound of lower right extremity showed acute deep vein thrombosis, DVT.. On 24-Apr-2021, Computerised tomogram: saddle pulmonary embolism (abnormal) CT on chest with IV contrast showed a saddle pulmonary embolism ..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  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.; 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: Anaphylactic Shock about 1 hour post vaccination; Hives all over the body; Swollen Throat; Itching all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced URTICARIA (Hives all over the body), PHARYNGEAL SWELLING (Swollen Throat) and PRURITUS (Itching all over the body). On 04-Jun-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) (seriousness criteria hospitalization and medically significant). The patient was treated with EPINEPHRINE (EPIPEN) on 04-Jun-2021 for Anaphylactic shock, at a dose of 2 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Jun-2021 for Hives, at a dose of 25 milligram every six hours. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic Shock about 1 hour post vaccination) and PHARYNGEAL SWELLING (Swollen Throat) outcome was unknown and URTICARIA (Hives all over the body) and PRURITUS (Itching all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that as of 07 JUN 2021, the patient still had hives and itchiness.  Company comment: 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: M
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Severe thrombocytopenia; This spontaneous case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA (Severe thrombocytopenia) 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 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced THROMBOCYTOPENIA (Severe thrombocytopenia) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, THROMBOCYTOPENIA (Severe thrombocytopenia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient experienced the event after administration of the 2nd dose.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Loss of control of legs, Skin exfoliation
Clinical narrative: Lost control of right leg; Left thumb and index finger became red; Left thumb and index finger became scaly; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONTROL OF LEGS (Lost control of right leg) and ERYTHEMA (Left thumb and index finger became red) 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 Brain operation NOS (She has had operation on her left brain at the clinic in the past).   On 09-Mar-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 10-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (Lost control of right leg) (seriousness criteria hospitalization and medically significant) and ERYTHEMA (Left thumb and index finger became red) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced SKIN EXFOLIATION (Left thumb and index finger became scaly). The patient was hospitalized on 10-Mar-2021 due to ERYTHEMA and LOSS OF CONTROL OF LEGS. At the time of the report, LOSS OF CONTROL OF LEGS (Lost control of right leg), ERYTHEMA (Left thumb and index finger became red) and SKIN EXFOLIATION (Left thumb and index finger became scaly) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was unknown.   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 events, a causal relationship cannot be excluded.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Tourette's disorder
Clinical narrative: Exhibiting symptoms of Tourette Syndrome; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOURETTE'S DISORDER (Exhibiting symptoms of Tourette Syndrome) in a 17-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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced TOURETTE'S DISORDER (Exhibiting symptoms of Tourette Syndrome) (seriousness criterion medically significant) . At the time of the report, TOURETTE'S DISORDER (Exhibiting symptoms of Tourette Syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram head: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.; 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