chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Foot fracture, Headache, Loss of consciousness
Clinical narrative: Passed out and broke foot; broke foot; lightheaded; Massive headache and couldn't lift her head up; Not feel good; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out and broke foot) in a 65-year-old female patient who received mRNA-1273  (batch nos. 025B21A and 036A21A) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced FEELING ABNORMAL (Not feel good). On 06-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out and broke foot) (seriousness criteria medically significant), FOOT FRACTURE (broke foot), DIZZINESS (lightheaded) and HEADACHE (Massive headache and couldn't lift her head up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out and broke foot), FOOT FRACTURE (broke foot), DIZZINESS (lightheaded) and HEADACHE (Massive headache and couldn't lift her head up) had not resolved and FEELING ABNORMAL (Not feel good) outcome was unknown. Not Provided      For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included medication for thyroid. Treatment information included for an events Advil and Aleve.  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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Loss of consciousness
Clinical narrative: Unconscious in shower/Eyes rolled back in head; Hot and sweaty; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious in shower/Eyes rolled back in head) in a 32-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.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious in shower/Eyes rolled back in head) (seriousness criterion medically significant), FEELING HOT (Hot and sweaty) and EYE MOVEMENT DISORDER (Eyes rolled back in head). At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious in shower/Eyes rolled back in head), FEELING HOT (Hot and sweaty) and EYE MOVEMENT DISORDER (Eyes rolled back in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clotting; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clotting) in a 59-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Feb-2021, the patient received first dose of mRNA-1273 ) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced THROMBOSIS (Blood Clotting) (seriousness criteria medically significant). At the time of the report, THROMBOSIS (Blood Clotting) had resolved. Not Provided.  The action taken with mRNA-1273 (Intramuscular) was unknown. Treatment information was not provided. Concomitant medications were not reported. Company Comment: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea
Clinical narrative: A minute "gray out"and could not see; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) in a 74-year-old female patient who received mRNA-1273  (batch nos. 046A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LOSARTAN for Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273  (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 12:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) and NAUSEA (Nausea) was resolving. Not Provided          Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sensitive skin, Skin burning sensation, Vaccination site pain
Clinical narrative: Area of burning moved to upper arm, shoulder, neck, and scapula; Burning at the injection site; Area was hot to the touch; painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula) and VACCINATION SITE PAIN (Burning at the injection site) in a 79-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.     The patient's past medical history included No adverse event (No historical condition reported.).    On 05-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 SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula) (seriousness criterion hospitalization prolonged), VACCINATION SITE PAIN (Burning at the injection site) (seriousness criterion hospitalization prolonged), SENSITIVE SKIN (Area was hot to the touch) and MYALGIA (painful). At the time of the report, SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula), VACCINATION SITE PAIN (Burning at the injection site), SENSITIVE SKIN (Area was hot to the touch) and MYALGIA (painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not 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: Herpes zoster, Pyrexia, Rash, Staphylococcal infection
Clinical narrative: Staff infection; Shingles; Rash; Fever; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Staff infection) 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 No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Staff infection) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), RASH (Rash) and PYREXIA (Fever). On 05-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, STAPHYLOCOCCAL INFECTION (Staff infection) had not resolved and HERPES ZOSTER (Shingles) and RASH (Rash) 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.  On 23 Apr 2021, second dose was scheduled.  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. 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.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Complication associated with device, Myocardial infarction, Product dose omission issue
Clinical narrative: possible heart attack; possible stroke; pacemaker was not working; overdue 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (possible heart attack), CEREBROVASCULAR ACCIDENT (possible stroke) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) in an 83-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.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Pre-existing disease.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (overdue 2nd dose). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (possible heart attack) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (possible stroke) (seriousness criteria hospitalization and medically significant) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (possible heart attack), CEREBROVASCULAR ACCIDENT (possible stroke), COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) and PRODUCT DOSE OMISSION ISSUE (overdue 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information available.  The reporter mentioned that patient has lot of pre-existing medical conditions.She does not know name of current medications he is taking which is tons of them. Patient is currently in rehab center and Hospital where he is admitted did not give him vaccine since he received his 1st dose at Rite aid. Rehab center does not have vaccine in stock.  Limited information regarding the possible MI  and CVA and pacemaker problems have been provided at this time and a causal relationship cannot be excluded.  This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the possible MI  and CVA and pacemaker problems have been provided at this time and a causal relationship cannot be excluded.  This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Loss of consciousness, Pain
Clinical narrative: knocked out very well for 3 days,; felt lack of energy; aches; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (knocked out very well for 3 days,) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) 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 reported.).   On 17-Feb-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 an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (knocked out very well for 3 days,) (seriousness criterion medically significant), ASTHENIA (felt lack of energy) and PAIN (aches). At the time of the report, LOSS OF CONSCIOUSNESS (knocked out very well for 3 days,), ASTHENIA (felt lack of energy) and PAIN (aches) had resolved. Not Provided    Treatment information was not 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. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: bleeding of the rectum; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding of the rectum) in a 74-year-old female patient who received mRNA-1273 (batch no. 006M20A) 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 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (bleeding of the rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (bleeding of the rectum) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Intramuscular) was unknown.  Concomitant product use was not provided. Treatment information was not provided.  The caller did not report if she received the IM dose into her left or right arm. She stated that she has called her HCP and is waiting for an appointment. She reported that her second dose in the series is scheduled for 15-Apr-2021.  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.      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.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Fatigue, Penile haemorrhage
Clinical narrative: discharge of blood from penis; heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating; felt fatigued and felt like he was ready to go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PENILE HAEMORRHAGE (discharge of blood from penis) and ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia and Cardiac ablation.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PENILE HAEMORRHAGE (discharge of blood from penis) (seriousness criterion medically significant), ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) (seriousness criterion medically significant) and FATIGUE (felt fatigued and felt like he was ready to go to sleep). On 12-Mar-2021, FATIGUE (felt fatigued and felt like he was ready to go to sleep) had resolved. At the time of the report, PENILE HAEMORRHAGE (discharge of blood from penis) outcome was unknown and ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Myalgia, Nausea, Presyncope
Clinical narrative: Dizzy; Fever 101 degrees Fahrenheit; Nausea; Body aches; Seizure; Symptoms like the flu; Felt like she was going to faint; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 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 provided.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Symptoms like the flu), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches). On an unknown date, the patient experienced PRESYNCOPE (Felt like she was going to faint). At the time of the report, SEIZURE (Seizure), INFLUENZA LIKE ILLNESS (Symptoms like the flu), PRESYNCOPE (Felt like she was going to faint), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.            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.   This case was linked to US-MODERNATX, INC.-MOD-2021-054366 (E2B Linked Report). This case was linked to MOD-2021-077998, MOD-2021-077998 (Patient Link).; 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. US-MODERNATX, INC.-MOD-2021-054366:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: Dizzy; Fever 101 degrees Fahrenheit; Nausea; Body aches; Seizure; Symptoms like the flu; Felt like she was going to faint; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 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 provided.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Symptoms like the flu), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches). On an unknown date, the patient experienced PRESYNCOPE (Felt like she was going to faint). At the time of the report, SEIZURE (Seizure), INFLUENZA LIKE ILLNESS (Symptoms like the flu), PRESYNCOPE (Felt like she was going to faint), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.            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.   This case was linked to US-MODERNATX, INC.-MOD-2021-054366 (E2B Linked Report). This case was linked to MOD-2021-077998, MOD-2021-077998 (Patient Link).; 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. US-MODERNATX, INC.-MOD-2021-054366:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness bilateral
Clinical narrative: Hearing loss in both ears, worse in left; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS BILATERAL (Hearing loss in both ears, worse in left) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided). Concomitant products included PROBIOTICS NOS, VITAMIN D3, VITAMIN B12 NOS and BIOTIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On 07-Apr-2021, the patient experienced DEAFNESS BILATERAL (Hearing loss in both ears, worse in left) (seriousness criteria disability and medically significant). At the time of the report, DEAFNESS BILATERAL (Hearing loss in both ears, worse in left) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Acoustic stimulation tests: hearing loss (abnormal) Hearing loss.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Thyroid medicine. Patient experienced hearing down on the right side of the ear. It was buzzing at first. Patient started taking Prednisone on 13-Apr-2021 and had to take it for 18 days.  Company comment: 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.; 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: Crohn's disease, Influenza like illness
Clinical narrative: Her Crohn's disease got really bad; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Her Crohn's disease got really bad) 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.     Concurrent medical conditions included Crohn's disease. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), ATORVASTATIN CALCIUM (LIPITOR), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and ALPRAZOLAM (XANAX) for an unknown indication.   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 CROHN'S DISEASE (Her Crohn's disease got really bad) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, CROHN'S DISEASE (Her Crohn's disease got really bad) and INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving.      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  Description: The patient experienced flu like symptoms and her Crohn's disease (medically significant) got really bad after receiving her first shot of the Moderna COVID-19 vaccine. The symptoms were better, but they were still there at the time of the call.  The patient took acetaminophen to help with the symptoms.; 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Pregnancy test, Pruritus, Thrombosis
Clinical narrative: Blood clots; Kind of bleeding; arm began being extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and HAEMORRHAGE (Kind of bleeding) in a 40-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.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (arm began being extremely itchy). On 05-Apr-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and HAEMORRHAGE (Kind of bleeding) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) and HAEMORRHAGE (Kind of bleeding) outcome was unknown and PRURITUS (arm began being extremely itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Pregnancy test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Joint dislocation, Rhabdomyolysis
Clinical narrative: Diagnosed with rhabdomyolysis; Found on floor with knee in an awkward position; Strength has not come back in legs and now needs a walker; Did not have strength to lift legs to go to bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) and JOINT DISLOCATION (Found on floor with knee in an awkward position) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included LEVOTHYROXINE and ROSUVASTATIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Did not have strength to lift legs to go to bed). On 12-Mar-2021, the patient experienced RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) (seriousness criteria hospitalization and medically significant), JOINT DISLOCATION (Found on floor with knee in an awkward position) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker). The patient was hospitalized from 12-Mar-2021 to 18-Mar-2021 due to JOINT DISLOCATION and RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis), JOINT DISLOCATION (Found on floor with knee in an awkward position) and ASTHENIA (Did not have strength to lift legs to go to bed) outcome was unknown and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker) had not resolved.            Treatment for events included  fluids and shots in knee.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is 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 the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blepharospasm, Pain in jaw
Clinical narrative: super mild bell's palsy; eye twitching; jaw pain; This spontaneous case was reported by a pharmacist and describes the occurrence of FACIAL PARALYSIS (super mild bell's palsy) 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 reported medical history.).  On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN JAW (jaw pain). On an unknown date, the patient experienced FACIAL PARALYSIS (super mild bell's palsy) (seriousness criterion medically significant) and BLEPHAROSPASM (eye twitching). At the time of the report, FACIAL PARALYSIS (super mild bell's palsy) outcome was unknown and PAIN IN JAW (jaw pain) and BLEPHAROSPASM (eye twitching) had not resolved. Not Provided   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.  Patient experienced super mild case of Bell's palsy. Within an hour of receiving the injection he developed jaw pain. There was no dropping of the jaw. He still has residual jaw pain and some eye twitching. He is scheduled for his second injection and would like to know if the reaction to the second dose could be worse. Also, would like to know if he should administer the injection in the opposite arm. No treatment information was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: could hardly turn her head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (could hardly turn her head) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04HA21A) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No reported medical history).  On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (could hardly turn her head) (seriousness criterion hospitalization). The patient was hospitalized from 22-Mar-2021 to 23-Mar-2021 due to MUSCULOSKELETAL STIFFNESS. At the time of the report, MUSCULOSKELETAL STIFFNESS (could hardly turn her head) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications were not provided. Treatment information was not reported. The patient was hospitalized for 2 days where the doctors ran many tests which included electrocardiogram, blood tests conducted among other things. The Healthcare professional assessed the causality between the event was considered as possibly related to the mRNA-1273.  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.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: some places in the back of her throat; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 06Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient lived in an assisted living community and received dose 1 of BNT162B2 on 06Feb2021. She was scheduled to receive her second dose of BNT162B2 three weeks after her first dose but the assisted living would not let her receive her second dose at that time because she had "some places in the back of her throat." She felt fine and had no symptoms. The patient underwent lab tests and procedures which included a COVID-19 test on an unspecified date with the result of negative. The patient received dose 2 of BNT162B2 on 20Mar2021. The outcome of "some places in the back of her throat" was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: She developed swollen lymph nodes in her neck about a week later and still is swollen; This is a spontaneous report received from a contactable consumer (patient). This 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 09Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Mar2021, the patient developed swollen lymph nodes in her neck about a week after receiving BNT162B2 and was still swollen. The outcome of swollen lymph nodes was not recovered.   Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This is a spontaneous report from a contactable consumer, reporting for herself, from a Pfizer sponsored program. A female patient of an unspecified age received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The medical history was not reported.  There were no concomitant medications. The patient experienced urinary tract infection on an unspecified date. The patient was prescribed an antibiotic but has not taken the antibiotic yet. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Raging bilateral tinnitus; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0150), via an unspecified route of administration administered in right arm on 31Mar2021 at 12:00 PM (at the age of 37-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took tetracycline and experienced allergies to it. On 01Apr2021 at 12:00 AM, the patient experienced raging bilateral tinnitus. The event was considered as serious as it was disabling/incapacitating. There was not treatment given for the event. Since the vaccination, the patient has been tested for COVID-19 (nasal swab, PCR) on 02Apr2021 which was negative. The patient had not yet recovered from the event.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Feeding disorder, Gait inability, Hypoacusis, Impaired driving ability
Clinical narrative: Raging bilateral tinnitus; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0150), via an unspecified route of administration administered in right arm on 31Mar2021 at 12:00 PM (at the age of 37-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took tetracycline and experienced allergies to it. On 01Apr2021 at 12:00 AM, the patient experienced raging bilateral tinnitus. The event was considered as serious as it was disabling/incapacitating. There was not treatment given for the event. Since the vaccination, the patient has been tested for COVID-19 (nasal swab, PCR) on 02Apr2021 which was negative. The patient had not yet recovered from the event.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Neuropathy peripheral, Seizure, Tinnitus, Troponin increased
Clinical narrative: Raging bilateral tinnitus; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0150), via an unspecified route of administration administered in right arm on 31Mar2021 at 12:00 PM (at the age of 37-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took tetracycline and experienced allergies to it. On 01Apr2021 at 12:00 AM, the patient experienced raging bilateral tinnitus. The event was considered as serious as it was disabling/incapacitating. There was not treatment given for the event. Since the vaccination, the patient has been tested for COVID-19 (nasal swab, PCR) on 02Apr2021 which was negative. The patient had not yet recovered from the event.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: Raging bilateral tinnitus; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0150), via an unspecified route of administration administered in right arm on 31Mar2021 at 12:00 PM (at the age of 37-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took tetracycline and experienced allergies to it. On 01Apr2021 at 12:00 AM, the patient experienced raging bilateral tinnitus. The event was considered as serious as it was disabling/incapacitating. There was not treatment given for the event. Since the vaccination, the patient has been tested for COVID-19 (nasal swab, PCR) on 02Apr2021 which was negative. The patient had not yet recovered from the event.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Inappropriate schedule of product administration
Clinical narrative: Blood in stool; PFIZER-BIONTECH COVID-19 VACCINE First dose on 30Mar2021 08:00 and Second dose on 30Mar2021 12:00; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 30Mar2021 08:00 (Batch/Lot number was not reported) and 2nd dose on 30Mar2021 12:00 (Batch/Lot number was not reported) both given via an unspecified route of administration administered on Arm Left as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history was not reported. Concomitant medication included phentermine (PHENTERMINE) taken for an unspecified indication and therapy dates.  On 05Apr2021 03:00, the patient had blood in stool and not yet recovered.  The patient did not receive any treatment for the event of blood in stool . The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Retinal detachment, Retinal tear
Clinical narrative: Retinal tears/detachment; Retinal tears/detachment; Severe swelling of knee; This is a spontaneous report from a contactable consumer (patient).   A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 26Feb2021 08:45 (Batch/Lot Number: EN6203) at a single dose for covid-19 immunization.  The patient's medical history concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine neither received any other medications within 2 weeks of vaccination. He was also not diagnosed with COVID-19 prior vaccination and has not been tested since the vaccination.  The patient experienced retinal tears/detachment and severe swelling of knee on 27Feb2021 07:30 am; all with outcome of recovered with sequelae (recovered with lasting effects).  Therapeutic measures were taken as a result of retinal tears/detachment and severe swelling of knee. Patient received multiple laser treatments. The events were assessed serious- disabling/Incapacitating.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Dyspnoea, Hypoxia, Lung opacity
Clinical narrative: hypoxic; shortness of breath; opacity in the mid and lower L lung; tachypnoea; tachycardia; This is a spontaneous report from a non-contactable other healthcare professional. A 65-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29Mar2021 (Lot Number: ER8734) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2), dose 2 on an unspecified date for covid-19 immunization but reported to have had DOE for the past 3-4 days, has felt fatigued for the past week and his taste seems different over the past couple of days. It was reported that during the 15-minute waiting period after the injection, the patient began to experience shortness of breath as he was walking out to the front. He reports no issues with the vaccine as he was waiting. He denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient complaints of shortness of breath. There was no treatment therapy provided. Follow up response to treatment was excellent (also reported as no treatment provided). The patient was discharged as stable to go home and follow up with PCP (primary care physician). He completed his second dose of Covid vaccine yesterday (29Mar2021). He presented to respiratory clinic earlier today (30Mar2021) and was noted to be hypoxic and was sent to ED. He reported DOE (dyspnea on exertion) for the past 3-4 days and has felt fatigued for the past week. He notes that his taste seems different over the past couple of days. CXR (chest x-ray) on an unspecified date in 2021 shows opacity in the mid and lower left lung. He is tachypnea, tachycardia, high normal WBC and afebrile on an unspecified date in 2021. The patient underwent lab tests and procedures which included chest x-ray showed opacity in the mid and lower L lung and white blood cell count was high normal on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further Information is expected.; Sender's Comments: Based on the close temporal association, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of hypoxic cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.