chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Fibrin D dimer increased, Headache
Clinical narrative: BRAIN FOG; D-DIMER OF 32; STRONG HEADACHE; This spontaneous report received from a consumer concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-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 elevated d-dimer, brain fog, and strong headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, and Fibrin D dimer high (NR: not provided) 32. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache, brain fog and elevated d-dimer was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia
Clinical narrative: DIARRHEA; EXTREME FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 31-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced diarrhea. On 15-MAY-2021, the subject experienced extreme fatigue. On 15-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, extreme fatigue, and muscle ache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Eating disorder, Vomiting, Weight, Weight decreased
Clinical narrative: VOMITING; LOST SIX POUNDS; CANNOT EAT; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 14-MAY-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 14-MAY-2021, the subject experienced vomiting. On 14-MAY-2021, the subject experienced lost six pounds. On 14-MAY-2021, the subject experienced cannot eat. On 14-MAY-2021, the subject experienced weakness. Laboratory data included: Weight (NR: not provided) lost six pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and the outcome of vomiting, lost six pounds and cannot eat was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: GETTING KICKED IN THE CHEST BY A MULE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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. On an unspecified date, the subject experienced getting kicked in the chest by a mule. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of getting kicked in the chest by a mule was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dry mouth, Feeling abnormal, Headache
Clinical narrative: BAD REACTION; BRAIN FOG; BAD HEADACHE; BAD DRY MOUTH; SWEATING AND FREEZING ALL NIGHT LONG; HORRIBLE CHILLS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25/MAY/2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin. On 24-MAR-2021, the subject experienced sweating and freezing all night long. On 24-MAR-2021, the subject experienced horrible chills. On 25-MAR-2021, the subject experienced bad dry mouth. On 25-MAR-2021, the subject experienced bad headache. On 26-MAR-2021, the subject experienced brain fog. On an unspecified date, the subject experienced bad reaction. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating and freezing all night long, and horrible chills on 25-MAR-2021, and brain fog, had not recovered from bad dry mouth and bad headache, and the outcome of bad reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; BRAIN FOG; BAD HEADACHE; BAD DRY MOUTH; SWEATING AND FREEZING ALL NIGHT LONG; HORRIBLE CHILLS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25/MAY/2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin. On 24-MAR-2021, the subject experienced sweating and freezing all night long. On 24-MAR-2021, the subject experienced horrible chills. On 25-MAR-2021, the subject experienced bad dry mouth. On 25-MAR-2021, the subject experienced bad headache. On 26-MAR-2021, the subject experienced brain fog. On an unspecified date, the subject experienced bad reaction. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating and freezing all night long, and horrible chills on 25-MAR-2021, and brain fog, had not recovered from bad dry mouth and bad headache, and the outcome of bad reaction was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: SWOLLEN ANKLES/BOTH THE LEGS; PAIN IN ANKLES; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included bleeding after first baby, blood transfusion, dnc after a month for second baby, and heart surgery to get water out of heart, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. medical history include hormone pill ,thyroid pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride, loxapine, and quetiapine fumarate. On 15-MAY-2021, the subject experienced swollen ankles/both the legs. On 15-MAY-2021, the subject experienced pain in ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen ankles/both the legs, and pain in ankles. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Agitation
Clinical narrative: MEDICATION ERROR DUE TO ACCIDENTAL EXPOSURE INTO EYES; FREAKING OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 and has been requested. No concomitant medications were reported.  On 16-MAY-2021, the subject experienced medication error due to accidental exposure into eyes. On 16-MAY-2021, the subject experienced freaking out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error due to accidental exposure into eyes and freaking out was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Skin mass
Clinical narrative: LUMP IN ELBOW; CHILLS; JOINT PAIN; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergies or drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: 01-JUL-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine. On 16-MAY-2021, the subject experienced lump in elbow. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 17-MAY-2021, was recovering from joint pain, and had not recovered from lump in elbow. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE GIVEN OUTSIDE OF 6 HOUR APPROPRIATE STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa antibiotics.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dose given outside of 6 hour appropriate storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given outside of 6 hour appropriate storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210532044.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE GIVEN OUTSIDE OF 6 HOUR APPROPRIATE STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa antibiotics.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dose given outside of 6 hour appropriate storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given outside of 6 hour appropriate storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210532044.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis, Eye pain, Headache, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: haze in left eye; pain behind left eye, and pain above left eye; Headache/pain in left temporal area; told symptoms consistent with encephalitis; Within 30-36 hours after second dose, she had stiffness of neck; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ENCEPHALITIS (told symptoms consistent with encephalitis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ENCEPHALITIS (told symptoms consistent with encephalitis) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Within 30-36 hours after second dose, she had stiffness of neck) and HEADACHE (Headache/pain in left temporal area). On an unknown date, the patient experienced VISION BLURRED (haze in left eye) and EYE PAIN (pain behind left eye, and pain above left eye). At the time of the report, ENCEPHALITIS (told symptoms consistent with encephalitis), MUSCULOSKELETAL STIFFNESS (Within 30-36 hours after second dose, she had stiffness of neck), VISION BLURRED (haze in left eye), EYE PAIN (pain behind left eye, and pain above left eye) and HEADACHE (Headache/pain in left temporal area) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Magnetic resonance imaging: for most part appears normal (normal) for most part appears normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications included trigger point injections. The patient was evaluated in the ER for symptoms of stiffness of neck and headache and was told the symptoms are consistent with encephalitis, however, the diagnosis had not been confirmed.  She was also evaluated by her primary doctor on 22Mar2021, an ophthalmologist on 15Mar2021, 19Mar2021 and 03May2021, a retinal specialist on 03May2021 and is scheduled to see a neuro-ophthalmologist on 03Jun2021.  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.   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: Vision blurred
Clinical narrative: haze in left eye; pain behind left eye, and pain above left eye; Headache/pain in left temporal area; told symptoms consistent with encephalitis; Within 30-36 hours after second dose, she had stiffness of neck; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ENCEPHALITIS (told symptoms consistent with encephalitis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ENCEPHALITIS (told symptoms consistent with encephalitis) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Within 30-36 hours after second dose, she had stiffness of neck) and HEADACHE (Headache/pain in left temporal area). On an unknown date, the patient experienced VISION BLURRED (haze in left eye) and EYE PAIN (pain behind left eye, and pain above left eye). At the time of the report, ENCEPHALITIS (told symptoms consistent with encephalitis), MUSCULOSKELETAL STIFFNESS (Within 30-36 hours after second dose, she had stiffness of neck), VISION BLURRED (haze in left eye), EYE PAIN (pain behind left eye, and pain above left eye) and HEADACHE (Headache/pain in left temporal area) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Magnetic resonance imaging: for most part appears normal (normal) for most part appears normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications included trigger point injections. The patient was evaluated in the ER for symptoms of stiffness of neck and headache and was told the symptoms are consistent with encephalitis, however, the diagnosis had not been confirmed.  She was also evaluated by her primary doctor on 22Mar2021, an ophthalmologist on 15Mar2021, 19Mar2021 and 03May2021, a retinal specialist on 03May2021 and is scheduled to see a neuro-ophthalmologist on 03Jun2021.  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.   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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Emotional distress, Fatigue, Feeling abnormal, Feeling jittery
Clinical narrative: mentally overwhelmed; missed her 2nd dose; headache on and off; staggering fatigue/hard to stay awake where her eyes always wanted to close; felt uneasy; dizzy; she did not make it and urinated on the floor; passed out on the toilet; nervous; jittery feelings; Hands started to shake; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the toilet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Left knee). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), KETOROLAC and HYDROXYZINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings) and TREMOR (Hands started to shake). On 13-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the toilet) (seriousness criterion medically significant), DIZZINESS (dizzy), INCONTINENCE (she did not make it and urinated on the floor), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close). On an unknown date, the patient experienced EMOTIONAL DISTRESS (mentally overwhelmed) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose). On 12-Mar-2021, TREMOR (Hands started to shake) had resolved. On 13-Mar-2021, LOSS OF CONSCIOUSNESS (passed out on the toilet) and INCONTINENCE (she did not make it and urinated on the floor) had resolved. At the time of the report, NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings), DIZZINESS (dizzy), EMOTIONAL DISTRESS (mentally overwhelmed), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incontinence, Loss of consciousness, Nervousness, Product dose omission issue
Clinical narrative: mentally overwhelmed; missed her 2nd dose; headache on and off; staggering fatigue/hard to stay awake where her eyes always wanted to close; felt uneasy; dizzy; she did not make it and urinated on the floor; passed out on the toilet; nervous; jittery feelings; Hands started to shake; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the toilet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Left knee). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), KETOROLAC and HYDROXYZINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings) and TREMOR (Hands started to shake). On 13-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the toilet) (seriousness criterion medically significant), DIZZINESS (dizzy), INCONTINENCE (she did not make it and urinated on the floor), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close). On an unknown date, the patient experienced EMOTIONAL DISTRESS (mentally overwhelmed) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose). On 12-Mar-2021, TREMOR (Hands started to shake) had resolved. On 13-Mar-2021, LOSS OF CONSCIOUSNESS (passed out on the toilet) and INCONTINENCE (she did not make it and urinated on the floor) had resolved. At the time of the report, NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings), DIZZINESS (dizzy), EMOTIONAL DISTRESS (mentally overwhelmed), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: mentally overwhelmed; missed her 2nd dose; headache on and off; staggering fatigue/hard to stay awake where her eyes always wanted to close; felt uneasy; dizzy; she did not make it and urinated on the floor; passed out on the toilet; nervous; jittery feelings; Hands started to shake; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the toilet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Left knee). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), KETOROLAC and HYDROXYZINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings) and TREMOR (Hands started to shake). On 13-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the toilet) (seriousness criterion medically significant), DIZZINESS (dizzy), INCONTINENCE (she did not make it and urinated on the floor), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close). On an unknown date, the patient experienced EMOTIONAL DISTRESS (mentally overwhelmed) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose). On 12-Mar-2021, TREMOR (Hands started to shake) had resolved. On 13-Mar-2021, LOSS OF CONSCIOUSNESS (passed out on the toilet) and INCONTINENCE (she did not make it and urinated on the floor) had resolved. At the time of the report, NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings), DIZZINESS (dizzy), EMOTIONAL DISTRESS (mentally overwhelmed), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pulmonary embolism, Thrombosis
Clinical narrative: Small Pulmonary Embolism; blood clots in upper arm, arm pit, neck, across right side of chest; Opposite arm blew up like a baloon; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Small Pulmonary Embolism) and THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) in a 45-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 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PULMONARY EMBOLISM (Small Pulmonary Embolism) (seriousness criteria medically significant and life threatening), THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) (seriousness criteria medically significant and life threatening) and PERIPHERAL SWELLING (Opposite arm blew up like a baloon). At the time of the report, PULMONARY EMBOLISM (Small Pulmonary Embolism), THROMBOSIS (blood clots in upper arm, arm pit, neck, across right side of chest) and PERIPHERAL SWELLING (Opposite arm blew up like a baloon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  Treatment medications for the events included Xarelto (rivaroxaban).  Reporter states patient went to Urgent Care on 22-Apr-2021 due to the events and was then told to go to the Emergency Room.   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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Delirium, Dizziness, Fatigue, Influenza
Clinical narrative: cough; nightmares; delirium; it feels like a very violent flu; dizzy; fever for three days; Nausea; tiredness; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (delirium) in a 58-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 Confusion (occurred s/p first dose of mRNA-1273; lasted 4 days), Weakness (occurred s/p first dose of mRNA-1273; lasted 4 days) and Tiredness (occurred s/p first dose of mRNA-1273; lasted 4 days).   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (tiredness). On 03-May-2021, the patient experienced DELIRIUM (delirium) (seriousness criterion medically significant), INFLUENZA (it feels like a very violent flu), DIZZINESS (dizzy), NIGHTMARE (nightmares), PYREXIA (fever for three days) and NAUSEA (Nausea). On 05-May-2021, the patient experienced COUGH (cough). On 06-May-2021, DELIRIUM (delirium), INFLUENZA (it feels like a very violent flu), DIZZINESS (dizzy), NIGHTMARE (nightmares), FATIGUE (tiredness), PYREXIA (fever for three days) and NAUSEA (Nausea) had resolved. At the time of the report, COUGH (cough) had not resolved.            Concomitant product use was not provided by the reporter. Treatment medication included Advil.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nightmare, Pyrexia
Clinical narrative: cough; nightmares; delirium; it feels like a very violent flu; dizzy; fever for three days; Nausea; tiredness; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (delirium) in a 58-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 Confusion (occurred s/p first dose of mRNA-1273; lasted 4 days), Weakness (occurred s/p first dose of mRNA-1273; lasted 4 days) and Tiredness (occurred s/p first dose of mRNA-1273; lasted 4 days).   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (tiredness). On 03-May-2021, the patient experienced DELIRIUM (delirium) (seriousness criterion medically significant), INFLUENZA (it feels like a very violent flu), DIZZINESS (dizzy), NIGHTMARE (nightmares), PYREXIA (fever for three days) and NAUSEA (Nausea). On 05-May-2021, the patient experienced COUGH (cough). On 06-May-2021, DELIRIUM (delirium), INFLUENZA (it feels like a very violent flu), DIZZINESS (dizzy), NIGHTMARE (nightmares), FATIGUE (tiredness), PYREXIA (fever for three days) and NAUSEA (Nausea) had resolved. At the time of the report, COUGH (cough) had not resolved.            Concomitant product use was not provided by the reporter. Treatment medication included Advil.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked.; 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: Pulmonary embolism, Thrombosis
Clinical narrative: multiple subsegmental pulmonary emboli; blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (multiple subsegmental pulmonary emboli) and THROMBOSIS (blood clot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (multiple subsegmental pulmonary emboli) (seriousness criterion medically significant) and THROMBOSIS (blood clot) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (multiple subsegmental pulmonary emboli) and THROMBOSIS (blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were 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.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Postmenopausal bleeding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025b21a and 014m20a) for COVID-19 vaccination.     The patient's past medical history included Cervical os suture in 2004. Concurrent medical conditions included Penicillin allergy, Drug allergy (Opioids), Drug allergy (narcotics), Fruit allergy (mango, pineapple, avocado, watermelon, pomegranate, kiwi and cantaloupe) and Shellfish allergy.   On 12-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) outcome was unknown.            No treatment information was provided. Action taken with mRNA in respect to the events was not applicable.  Patient had a failed endometrial lining biopsy attempt on 21 Apr 2021 due to scar tissue from a previous cerclage placed in 2004. On 07-May-2021, patient was waiting on lab results from hysteroscopy and Dilatation and Curettage (D&C).  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.   This case was linked; 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: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Crohn's disease
Clinical narrative: full chrons symptoms; Joint pain; This spontaneous case was reported by a physician and describes the occurrence of CROHN'S DISEASE (full chrons symptoms) in a 55-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (moderate to severe).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (full chrons symptoms) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain). At the time of the report, CROHN'S DISEASE (full chrons symptoms) and ARTHRALGIA (Joint pain) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 (Moderna COVID-19 Vaccine); therefore, the action taken in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Severe joint pain; Body aches; Diarrhea; Headache; This is a spontaneous report from a contactable Other Health Care Professional (reported for him-self). A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 25Jan2021 15:45, (at the age of 33-years-old) as un-known, single for COVID-19 immunization. Medical history included post-traumatic stress disorder, hypertension both from an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT); amlodipine (AMLODIPINE) both taken for an unspecified indication, start and stop date were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 26Jan2021 06:00, patient experienced severe joint pain and body aches, diarrhea and headache. Patient did not received any treatment for the adverse event. The outcome of the events was recovering.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed; This is a spontaneous report from a contactable Consumer. This 53-year-old female Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown; 53-year age at the time of vaccination), via an unspecified route of administration on 25Jan2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. patient had the first dose of the Pfizer vaccine on 25Jan2021 and has reported having a nose bleed starting from 28Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Taste disorder
Clinical narrative: Chills; Sweats; Muscle pain; Joint pain; Slight less taste sensations; This is a spontaneous report from a contactable consumer or other non hcp.  A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date: unknown) dose 1 via an unspecified route of administration on 20Jan2021 (at the age of A 59-years-old),  as single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 27Jan2021, the patient had experienced some chills, sweats, muscle pain, joint pain, and slight less taste sensations.  The patient asked it would that still be from the first dose of the vaccine. Patient mentioned that he will call his doctor first then report online. No treatment was reported. The outcome of events was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm started to hurt sore arm /pain in right arm /right arm has the pain; This is a spontaneous report from a contactable consumer. This female consumer (patient) of unspecified age reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration into the left arm on 23Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021, this past Saturday, the patient reported that her arm started to hurt, pain in right arm sore arm, which was the opposite of the arm she received the vaccine in. She wanted to know if she could take Aleve for the pain. She did not want to take anything for pain if the COVID-19 Vaccine was still in her system and just wanted to find out if she could take a pain reliever. Outcome of the event was unknown.  Follow up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported which included event and product details.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site rash
Clinical narrative: A bad red rash larger than a quarter at injection site.; A bad red rash larger than a quarter at injection site.; This is a spontaneous report from a contactable other hcp. A 46-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9262) via intramuscular route administered on Arm Left on 22Jan2021 10:15 AM (Age at vaccination: 46 Years) as SINGLE DOSE for covid-19 immunisation at hospital. Medical history included hypertension. The patient had allergies to Aleve, Robaxin, Flexeril and Tramadol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The Concomitant medications included received within 2 weeks of vaccination included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported.  Patient did not receive other vaccine within four weeks of vaccination. The event had not resulted in death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. The patient did not receive treatment for adverse event. On 22Jan2021 the patient experienced A bad red rash larger than a quarter at injection site.  The outcome of the events was not recovered.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Oral pain, Vaccination site pain
Clinical narrative: Tightness and soreness at the injection site; Tightness and soreness at the injection site; Tenderness in the corner of the mouth; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Jan2021 as single dose for covid-19 immunisation. The patient medical history includes flu vaccine and shingles. Patients concomitant medications were not reported. The patient stated that when he got the flu vaccine and shingles he had tightness and soreness, but he did not feel anything after the covid shot. It was reported that he received pfizer covid vaccine 3 days ago and next dose is 15Feb. Patient experienced some side effects and he read that older people have severe side effects after the second dose. He experienced tightness and soreness at the injection site, tenderness in the corner of the mouth. He said it went away. He wanted to know about the severity of side effect and how effective the vaccine is. He also stated that he read that people are getting the infection after the first dose of the covid vaccine. he wanted to know if symptoms are going to be less severe after the vaccine and also wanted to know if he should be wearing double mask. Patient asked that is it true that you have about 50 % immunity after the 10 days of the first shot. On Jan2021, the patient experienced tightness and soreness at the injection site and tenderness in the corner of the mouth. Outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: due to the infection in her tooth she is taking penicillin. She wanted to know will that make the vaccine less effective; This is a spontaneous report from a contactable consumer(Patient). A 76 years female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that she is scheduled for the second dose of the Pfizer covid vaccine on Monday, but due to the infection in her tooth she is taking penicillin. She wanted to know will that make the vaccine less effective. The caller wanted to know if she can take Tylenol after the second dose if she experiences any side effects. Therapeutic measures were taken as a result of due to the infection in her tooth she is taking penicillin. The clinical outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: digestive discomfort and heart burn; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on an unknown date as 1ST SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient got the first dose of the vaccine and experienced digestive discomfort and heart burn. The outcome of the events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected