chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; EYES ARE BURNING; ARMS ARE VERY SORE; EXTREME TIREDNESS; FEVER; MASSIVE HEADACHES; ARMS ARE VERY COLD; SHORTNESS OF BREATH; CHEST PAIN; BODY IS VERY HOT; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included had a surgery on the finger, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with paracetamol for surgery on the finger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shortness of breath. On 21-JUL-2021, the subject experienced chest pain. On 21-JUL-2021, the subject experienced body is very hot. On 21-JUL-2021, the subject experienced arms are very cold. On 21-JUL-2021, the subject experienced eyes are burning. On 21-JUL-2021, the subject experienced arms are very sore. On 21-JUL-2021, the subject experienced extreme tiredness. On 21-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced massive headaches. On 22-JUL-2021, the subject experienced loss of taste. On 22-JUL-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chest pain, body is very hot, arms are very cold, eyes are burning, extreme tiredness, fever, and massive headaches on 21-JUL-2021, was recovering from arms are very sore, and had not recovered from loss of taste, and loss of smell. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine spasm
Clinical narrative: INTERMITTENT UTERAL CRAMPING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced intermittent uteral cramping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent uteral cramping on 16-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Pain in extremity, SARS-CoV-2 test
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included immunocompromised, infections, and flare up.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. Laboratory data (dates unspecified) included: Blood culture (NR: not provided) not reported, and COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysarthria, Hypoaesthesia, Hypokinesia, Joint noise
Clinical narrative: NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURRED SPEECH; STRAIN; LOSS OF SENSATION IN LEFT ARM; CRACK JOINT; UNABLE TO TURN ARM AT 360 DEGREE; PAIN GOES TO LEFT SHOULDER; SORENESS AND PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200095, and expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced soreness and pain in left arm. On JUL-2021, the subject experienced numbness in the left side of neck. On JUL-2021, the subject experienced tingling sensation in the left side of neck and in fingers. On JUL-2021, the subject experienced slurred speech. On JUL-2021, the subject experienced strain. On JUL-2021, the subject experienced loss of sensation in left arm. On JUL-2021, the subject experienced crack joint. On JUL-2021, the subject experienced unable to turn arm at 360 degree. On JUL-2021, the subject experienced pain goes to left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and pain in left arm, numbness in the left side of neck, and slurred speech, and the outcome of tingling sensation in the left side of neck and in fingers, strain, loss of sensation in left arm, crack joint, unable to turn arm at 360 degree and pain goes to left shoulder was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURRED SPEECH; STRAIN; LOSS OF SENSATION IN LEFT ARM; CRACK JOINT; UNABLE TO TURN ARM AT 360 DEGREE; PAIN GOES TO LEFT SHOULDER; SORENESS AND PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200095, and expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced soreness and pain in left arm. On JUL-2021, the subject experienced numbness in the left side of neck. On JUL-2021, the subject experienced tingling sensation in the left side of neck and in fingers. On JUL-2021, the subject experienced slurred speech. On JUL-2021, the subject experienced strain. On JUL-2021, the subject experienced loss of sensation in left arm. On JUL-2021, the subject experienced crack joint. On JUL-2021, the subject experienced unable to turn arm at 360 degree. On JUL-2021, the subject experienced pain goes to left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and pain in left arm, numbness in the left side of neck, and slurred speech, and the outcome of tingling sensation in the left side of neck and in fingers, strain, loss of sensation in left arm, crack joint, unable to turn arm at 360 degree and pain goes to left shoulder was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Injection site erythema, Injection site pruritus, Pyrexia, Rash
Clinical narrative: PAINFUL RED BUMPS ON LEGS AND ARMS STARTED OFF SMALL AND THEN GETTING LARGER AS NICKEL TO QUARTER SIZED; INJECTION SITE REDNESS; FEVER; INJECTION SITE ITCHINESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included not taking any medications no medical diagnosis, and other pre-existing medical conditions included the patient was not taking any concomitant medications at the time of this report. The patient had no medical diagnosis. the patient had no known allergies.  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 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced injection site itchiness. On 09-JUL-2021, the subject experienced injection site redness. On 09-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 19-JUL-2021, the subject experienced painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site itchiness, injection site redness on 16-JUL-2021, and fever on 11-JUL-2021, and had not recovered from painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VERY AFFECTED BY JANSSEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very affected by Janssen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very affected by Janssen was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Vision blurred
Clinical narrative: BLURRY AND DIVIDED VISION; TROUBLE WITH MOBILITY; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke. 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 MAR-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 blurry and divided vision, and trouble with mobility. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurry and divided vision, and trouble with mobility. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Paraesthesia
Clinical narrative: BACK PAIN WHICH HAS RADIATED TO THE LEGS; LEGS FEEL LIKE THEY ARE SLEEPING; This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, and other pre-existing medical conditions included the patient is not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802012, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced back pain which has radiated to the legs. On 10-MAY-2021, the subject experienced legs feel like they are sleeping. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain which has radiated to the legs, and legs feel like they are sleeping. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 22-JUL-2021, the subject experienced off label use. On 22-JUL-2021, the subject experienced drug administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and drug administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pain in extremity
Clinical narrative: Cold; Painful right arm; Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful right arm), MYALGIA (Sore right arm) and NASOPHARYNGITIS (Cold) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LITHIUM CARBONATE, INSULIN GLARGINE, BENZTROPINE [BENZATROPINE], VITAMIN C [ASCORBIC ACID], ZINC and MELATONIN for an unknown indication, DOCUSATE.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful right arm) (seriousness criterion medically significant) and MYALGIA (Sore right arm) (seriousness criterion medically significant). On 26-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold) (seriousness criterion medically significant). On 01-Mar-2021, NASOPHARYNGITIS (Cold) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful right arm) and MYALGIA (Sore right arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included Insulin Novolog and antibiotic.  Treatment information was not provided.  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.   This case was linked to MOD-2021-024406, MOD-2021-024406 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 included updated Adverse event and concomitant drugs.; 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Gastrointestinal haemorrhage, Influenza
Clinical narrative: Stomach Bleed; Flu symptoms; From that week on I've had no energy/ Ive felt weak; Dizzy; Short of breath / anything I do I feel out of breath.; Fever for a week.; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (Flu symptoms), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy), DYSPNOEA (Short of breath / anything I do I feel out of breath.) and PYREXIA (Fever for a week.). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) (seriousness criterion medically significant). On 11-Mar-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever for a week.) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy) and DYSPNOEA (Short of breath / anything I do I feel out of breath.) had resolved.            No concomitant medication was reported. The patient stated that per his doctor, his chest, heart and veins were all tested (type of tests were not specified) and all tests were negative. No treatment medication was reported.  Patient reported that later found out it was a stomach bleed but said not related to vaccine. Is all fine now and does not want to be contacted for follow up.  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 to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up added. Added event and upgraded case to serious. Outcome of case updated to recovered.; 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 to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Stomach Bleed; Flu symptoms; From that week on I've had no energy/ Ive felt weak; Dizzy; Short of breath / anything I do I feel out of breath.; Fever for a week.; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (Flu symptoms), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy), DYSPNOEA (Short of breath / anything I do I feel out of breath.) and PYREXIA (Fever for a week.). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) (seriousness criterion medically significant). On 11-Mar-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever for a week.) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy) and DYSPNOEA (Short of breath / anything I do I feel out of breath.) had resolved.            No concomitant medication was reported. The patient stated that per his doctor, his chest, heart and veins were all tested (type of tests were not specified) and all tests were negative. No treatment medication was reported.  Patient reported that later found out it was a stomach bleed but said not related to vaccine. Is all fine now and does not want to be contacted for follow up.  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 to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up added. Added event and upgraded case to serious. Outcome of case updated to recovered.; 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 to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: The doctors at the hospital diagnosed as a stroke/She was discharged the next day; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03B21A and 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), QUINAPRIL and ATORVASTATIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.  On 13May2021, she had started with numbness on fingertip of right side of the hand and it progressed to the whole right side. She called 911 and she ended up in hospital on 13May2021. The doctors at the hospital diagnosed as a stroke. She was discharged the next day (14May2021).  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Gait inability, Hemiplegia, Thrombosis
Clinical narrative: a large blood clot, which has been removed from her leg; Right side paralysis; No speaking; Unable to walk, due to her paralysis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a large blood clot, which has been removed from her leg) (seriousness criteria hospitalization and medically significant), HEMIPLEGIA (Right side paralysis) (seriousness criteria hospitalization and medically significant), APHASIA (No speaking) (seriousness criterion hospitalization) and GAIT INABILITY (Unable to walk, due to her paralysis) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. No concomitant medications were mentioned.  On an unknown date, the patient was hospitalized due to a large blood clot which was removed from the patient's leg. The patient, at the time of this report, was hospitalized in the stroke center. The patient had right sided paralysis and was unable to speak or walk.  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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Gait disturbance
Clinical narrative: Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) outcome was unknown.            No concomitant medications were reported. The patient reports that his doctor prescribed an inhaler for his breathing issues but the medication name is unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up: Date and batch no added for dose 1 and dose 2; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-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.     Concurrent medical conditions included Allergy NOS (The patient stated she has a lot of allergies).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown.            No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  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.  However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.   This case was linked to MOD-2021-035954 (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.  However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Dyspnoea
Clinical narrative: Heart Failure; troubled breathing; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD since an unknown date and Arteriosclerosis since an unknown date.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DYSPNOEA (troubled breathing). On an unknown date, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criteria death and medically significant). The patient died on 29-May-2021. The reported cause of death was Chronic obstructive pulmonary disease, Heart failure and Atherosclerosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (troubled breathing) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant product information was provided.  No treatment information was provided.  This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS.  It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS.  It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Chronic Obstructive Pulmonary Disease; Heart Failure; Atherosclerosis
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: Hospitalized, She was in the hospital 9 days later for 5 days; It will be about 6 months after 1st,It has been 6 months and she wants to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalized, She was in the hospital 9 days later for 5 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (The patient has rheumatoid arthritis since she was a child, for almost 60 years now.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HOSPITALISATION (Hospitalized, She was in the hospital 9 days later for 5 days) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It will be about 6 months after 1st,It has been 6 months and she wants to get the second dose). The patient was hospitalized from 12-Feb-2021 to 17-Feb-2021 due to HOSPITALISATION. On 17-Feb-2021, HOSPITALISATION (Hospitalized, She was in the hospital 9 days later for 5 days) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (It will be about 6 months after 1st,It has been 6 months and she wants to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. 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. Very limited information has been reported at this time. Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Non significant follow up-address, phone number added; 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. Very limited information has been reported at this time. Further information is not expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report from a contactable consumer.  A 39-years-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 at  09:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included allergies to Pennicilin. The patient's concomitant medications were none in two weeks, no other vaccine in four weeks. On 10Jul2021 the patient started experiencing Covid-19 symptoms such as cough, loss of taste and smell, fatigue, headache, congestion. On 20Jul2021 the patient tested positive for COVID-19 via Nasal Swab test. No treatment was received. The outcome of the event was recovering.  Information about lot/batch has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Flushing, Nausea
Clinical narrative: NVD/ emesis; nausea/ NVD; NVD; Visual/Neuro concerns; Visual/Neuro concerns; SOB; lightheadedness; funny taste in mouth; Tachycardia; flushed; This is a spontaneous report from a non-contactable other healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7534) via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 originally but ended up for 30 due to how she was feeling waiting period after the injection, the patient began to experience lightheadedness and nausea with brief "funny taste in mouth". She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling. + Nausea: + Lightheaded Tachycardia present. Flushed. Treatment included: water and Pepcid, Zofran. Follow up response to treatment. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). Patient was unable to tolerate PO fluids. Emesis frequency not changed. Discussed with patient about options, she wished to be taken to ED. Husband and daughter will meet her there. ED manager updated. Outcome of the event vomiting was not recovered while unknown for the other events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is a reasonable possibility that the event vomiting was related to BNT162b2 based on known drug safety profile.  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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Tachycardia, Taste disorder, Visual impairment, Vomiting
Clinical narrative: NVD/ emesis; nausea/ NVD; NVD; Visual/Neuro concerns; Visual/Neuro concerns; SOB; lightheadedness; funny taste in mouth; Tachycardia; flushed; This is a spontaneous report from a non-contactable other healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7534) via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 originally but ended up for 30 due to how she was feeling waiting period after the injection, the patient began to experience lightheadedness and nausea with brief "funny taste in mouth". She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling. + Nausea: + Lightheaded Tachycardia present. Flushed. Treatment included: water and Pepcid, Zofran. Follow up response to treatment. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). Patient was unable to tolerate PO fluids. Emesis frequency not changed. Discussed with patient about options, she wished to be taken to ED. Husband and daughter will meet her there. ED manager updated. Outcome of the event vomiting was not recovered while unknown for the other events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is a reasonable possibility that the event vomiting was related to BNT162b2 based on known drug safety profile.  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.
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: lump on her left clavicle and posterior cervicle; This is a spontaneous report from a contactable pharmacist (reported for herself). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reported stated that the patient experienced a lump on her left clavicle and posterior cervicle. No other symptoms experienced. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis microscopic, Colonoscopy, Culture stool
Clinical narrative: diagnosed with a microscopic/colitis/drastic change in bowel habits/ function /always loose and excessive bowel movements 3 to 6 times a day; This is a spontaneous report from a contactable other nurse (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Dec2020 12:00 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunisation at workplace clinic. The patient medical history and concomitant medications were not reported. No structured information. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jan2021 04:00, within 24 hours (as reported), the patient had a drastic change in bowel habits/function even had an accident in his sleep and woke up not knowing what happend. The patient had abnormal and always loose and excessive bowel movements 3 to 6 times a day. Immodium helps on his Drs advice. Patient had had a colonoscopy and was diagnosed with a microscopic/colitis. Patient will soon start a course of entocort (Budesonide). The patient had not taken or was he taking any medications during or prior to vaccination except the immodium when this all began. The patient was certain this was an adverse event from the vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included immodium, stool culture, colonoscopy and entocort. The event did not prolonged hospitalization. Outcome of event at the time of last observation was recovering/resolving.  Information on the lot/batch number has been requested.; Sender's Comments: Based on possible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported event of colitis microscopic. 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
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Contracted COVID-19 symptomatically; contracted the COVID-19 virus and its symptomatic with the virus now; Contracted COVID-19 symptomatically; contracted the COVID-19 virus and its symptomatic with the virus now; Fever; Congestion; Shortness of breath; Lost sense of smell; This is a spontaneous report from a contactable consumer.  A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Lot Number: EL3247, Expiration date: 31May2021) at the age of 26 years as single dose, and dose 1 via an unspecified route of administration, administered in Arm Left on 29Dec2020 (Lot Number: EH9899, Expiration date: 31Mar2021) at the age of 26 years as single dose,  for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included multivitamin like is generic multivitamin of men, a chewable Vitamin D3, and L-Lysine. On unspecified date the patient contracted covid-19 symptomatically; contracted the covid-19 virus and its symptomatic with the virus now, experienced fever, congestion, shortness of breath, lost sense of smell. Therapeutic measures taken as a result of the event contracted covid-19 symptomatically, included Sudafed 120 mg once a day and Ibuprofen 400 mg twice a day first 3 days. The outcome of the events was unknown. Subsequently Product Quality Complaint Group provided the following conclusions: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EH9899 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EH9899, fill lot EH9783, and the formulated drug product lot EH9782. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.