chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vision blurred, Visual impairment, Vitreous degeneration
Clinical narrative: light that can be seen in the right side of the eye; eye pain; little dots and floaters in vision; pressure in eye; pressure in head; pain on roof of head; slight fever; headache; vitreous degeneration; blurred dark circles in vision which were darkest on outside; noticeably different vision; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS DEGENERATION (vitreous degeneration) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (acetaminophen with codein). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and MULTIVITAMINS;MINERALS for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VISUAL IMPAIRMENT (noticeably different vision). On 25-Apr-2021, the patient experienced VITREOUS DEGENERATION (vitreous degeneration) (seriousness criterion medically significant), VISION BLURRED (blurred dark circles in vision which were darkest on outside), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, VITREOUS DEGENERATION (vitreous degeneration), VISION BLURRED (blurred dark circles in vision which were darkest on outside), VISUAL IMPAIRMENT (noticeably different vision), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: light that can be seen in the right side of the eye; eye pain; little dots and floaters in vision; pressure in eye; pressure in head; pain on roof of head; slight fever; headache; vitreous degeneration; blurred dark circles in vision which were darkest on outside; noticeably different vision; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS DEGENERATION (vitreous degeneration) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (acetaminophen with codein). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and MULTIVITAMINS;MINERALS for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VISUAL IMPAIRMENT (noticeably different vision). On 25-Apr-2021, the patient experienced VITREOUS DEGENERATION (vitreous degeneration) (seriousness criterion medically significant), VISION BLURRED (blurred dark circles in vision which were darkest on outside), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, VITREOUS DEGENERATION (vitreous degeneration), VISION BLURRED (blurred dark circles in vision which were darkest on outside), VISUAL IMPAIRMENT (noticeably different vision), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Brain stem stroke, Gait disturbance, Pneumonia, Speech disorder, Thrombosis
Clinical narrative: Blood clots around the heart, 70% blockage; Pneumonia; Can barely walk, need walker or somebody need to hold; Hardly talk; Barely sees; Brain stem stroke; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM STROKE (Brain stem stroke), THROMBOSIS (Blood clots around the heart, 70% blockage) and PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement on 29-Apr-2021.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BRAIN STEM STROKE (Brain stem stroke) (seriousness criterion medically significant). On 29-Apr-2021, the patient experienced THROMBOSIS (Blood clots around the heart, 70% blockage) (seriousness criterion medically significant), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), GAIT DISTURBANCE (Can barely walk, need walker or somebody need to hold), SPEECH DISORDER (Hardly talk) and VISION BLURRED (Barely sees). At the time of the report, BRAIN STEM STROKE (Brain stem stroke), THROMBOSIS (Blood clots around the heart, 70% blockage), PNEUMONIA (Pneumonia), GAIT DISTURBANCE (Can barely walk, need walker or somebody need to hold), SPEECH DISORDER (Hardly talk) and VISION BLURRED (Barely sees) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication, No treatment information provided. The patient had brain stem stroke after 5 hours of the vaccination. The next day, on 20Apr2021, the doctor found that patient had 70% blockage, blood clot around the heart and they have to put stent.  Company comment: The event of pneumonia is of an infective etiology, hence a causal association is unlikely. However, based on strong temporal association between the remaining events and the administration of mRNA-1273, a causal relationship cannot be excluded.; Sender's Comments: The event of pneumonia is of an infective etiology, hence a causal association is unlikely. However, based on strong temporal association between the remaining events and the administration of mRNA-1273, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blood clots around the heart, 70% blockage; Pneumonia; Can barely walk, need walker or somebody need to hold; Hardly talk; Barely sees; Brain stem stroke; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM STROKE (Brain stem stroke), THROMBOSIS (Blood clots around the heart, 70% blockage) and PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement on 29-Apr-2021.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BRAIN STEM STROKE (Brain stem stroke) (seriousness criterion medically significant). On 29-Apr-2021, the patient experienced THROMBOSIS (Blood clots around the heart, 70% blockage) (seriousness criterion medically significant), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), GAIT DISTURBANCE (Can barely walk, need walker or somebody need to hold), SPEECH DISORDER (Hardly talk) and VISION BLURRED (Barely sees). At the time of the report, BRAIN STEM STROKE (Brain stem stroke), THROMBOSIS (Blood clots around the heart, 70% blockage), PNEUMONIA (Pneumonia), GAIT DISTURBANCE (Can barely walk, need walker or somebody need to hold), SPEECH DISORDER (Hardly talk) and VISION BLURRED (Barely sees) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication, No treatment information provided. The patient had brain stem stroke after 5 hours of the vaccination. The next day, on 20Apr2021, the doctor found that patient had 70% blockage, blood clot around the heart and they have to put stent.  Company comment: The event of pneumonia is of an infective etiology, hence a causal association is unlikely. However, based on strong temporal association between the remaining events and the administration of mRNA-1273, a causal relationship cannot be excluded.; Sender's Comments: The event of pneumonia is of an infective etiology, hence a causal association is unlikely. However, based on strong temporal association between the remaining events and the administration of mRNA-1273, a causal relationship cannot be excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Computerised tomogram, Dyspnoea, Headache
Clinical narrative: chest pain; Difficult breathing; fever; chills; body aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pain) and DYSPNOEA (Difficult breathing) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, 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 PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (Headache). On 06-May-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization) and DYSPNOEA (Difficult breathing) (seriousness criterion hospitalization). The patient was hospitalized on 06-May-2021 due to CHEST PAIN and DYSPNOEA. At the time of the report, CHEST PAIN (chest pain) and DYSPNOEA (Difficult breathing) was resolving and PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerized tomogram: negative (Negative) negative for presumed pneumonia. On an unknown date, Ultrasound chest: negative (Negative) negative for presumed pneumonia.         No concomitant medication. Treatment medication were reported as prednisone and Aztec.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information have been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information have been requested
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Ultrasound chest
Clinical narrative: chest pain; Difficult breathing; fever; chills; body aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pain) and DYSPNOEA (Difficult breathing) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, 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 PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (Headache). On 06-May-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization) and DYSPNOEA (Difficult breathing) (seriousness criterion hospitalization). The patient was hospitalized on 06-May-2021 due to CHEST PAIN and DYSPNOEA. At the time of the report, CHEST PAIN (chest pain) and DYSPNOEA (Difficult breathing) was resolving and PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerized tomogram: negative (Negative) negative for presumed pneumonia. On an unknown date, Ultrasound chest: negative (Negative) negative for presumed pneumonia.         No concomitant medication. Treatment medication were reported as prednisone and Aztec.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information have been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information have been requested
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chills, Dyspnoea, Headache
Clinical narrative: back pain; Pneumonia in right lung; Shortness of breath and couldn't breath; Malaise; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia in right lung) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020 and Pneumonia (Patient had Covid about an year ago and it gave them pneumonia.) in 2020. Concomitant products included THYROID for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache). On 07-May-2021, the patient experienced PNEUMONIA (Pneumonia in right lung) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath and couldn't breath). On an unknown date, the patient experienced BACK PAIN (back pain). On 06-May-2021, MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, PNEUMONIA (Pneumonia in right lung), DYSPNOEA (Shortness of breath and couldn't breath) and BACK PAIN (back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Blood analysis were good. On an unknown date, Scan: abnormal (abnormal) Found pneumonia in right lung.         The patient was treated with doxycycline for five days and received antibiotics in the hospital.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  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: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pneumonia, Scan
Clinical narrative: back pain; Pneumonia in right lung; Shortness of breath and couldn't breath; Malaise; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia in right lung) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020 and Pneumonia (Patient had Covid about an year ago and it gave them pneumonia.) in 2020. Concomitant products included THYROID for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache). On 07-May-2021, the patient experienced PNEUMONIA (Pneumonia in right lung) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath and couldn't breath). On an unknown date, the patient experienced BACK PAIN (back pain). On 06-May-2021, MALAISE (Malaise), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, PNEUMONIA (Pneumonia in right lung), DYSPNOEA (Shortness of breath and couldn't breath) and BACK PAIN (back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Blood analysis were good. On an unknown date, Scan: abnormal (abnormal) Found pneumonia in right lung.         The patient was treated with doxycycline for five days and received antibiotics in the hospital.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chills, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Experienced a huge hot red lump/Hot lump on injection arm; Fever; Red lump on injection site; Chills; Angioedema to her face; swelling of tongue; hot red lump at vaccination site/Huge red lump on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema to her face) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Poison ivy rash. Concomitant products included PREDNISONE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ANGIOEDEMA (Angioedema to her face) (seriousness criterion medically significant), SWOLLEN TONGUE (swelling of tongue), VACCINATION SITE WARMTH (hot red lump at vaccination site/Huge red lump on injection arm), PYREXIA (Fever), INJECTION SITE ERYTHEMA (Red lump on injection site) and CHILLS (Chills). On 14-Apr-2021, the patient experienced INJECTION SITE INDURATION (Experienced a huge hot red lump/Hot lump on injection arm). On 13-Apr-2021, ANGIOEDEMA (Angioedema to her face), SWOLLEN TONGUE (swelling of tongue), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 27-Apr-2021, VACCINATION SITE WARMTH (hot red lump at vaccination site/Huge red lump on injection arm), INJECTION SITE INDURATION (Experienced a huge hot red lump/Hot lump on injection arm) and INJECTION SITE ERYTHEMA (Red lump on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not reported.  It was noted swelling started 45 minutes after vaccination and went down one hour after. Additionally, the event huge, red, hot lump came and went for two weeks on and off.  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.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received included update to event outcome; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Vaccination site warmth
Clinical narrative: Experienced a huge hot red lump/Hot lump on injection arm; Fever; Red lump on injection site; Chills; Angioedema to her face; swelling of tongue; hot red lump at vaccination site/Huge red lump on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema to her face) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Poison ivy rash. Concomitant products included PREDNISONE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ANGIOEDEMA (Angioedema to her face) (seriousness criterion medically significant), SWOLLEN TONGUE (swelling of tongue), VACCINATION SITE WARMTH (hot red lump at vaccination site/Huge red lump on injection arm), PYREXIA (Fever), INJECTION SITE ERYTHEMA (Red lump on injection site) and CHILLS (Chills). On 14-Apr-2021, the patient experienced INJECTION SITE INDURATION (Experienced a huge hot red lump/Hot lump on injection arm). On 13-Apr-2021, ANGIOEDEMA (Angioedema to her face), SWOLLEN TONGUE (swelling of tongue), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 27-Apr-2021, VACCINATION SITE WARMTH (hot red lump at vaccination site/Huge red lump on injection arm), INJECTION SITE INDURATION (Experienced a huge hot red lump/Hot lump on injection arm) and INJECTION SITE ERYTHEMA (Red lump on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not reported.  It was noted swelling started 45 minutes after vaccination and went down one hour after. Additionally, the event huge, red, hot lump came and went for two weeks on and off.  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.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received included update to event outcome; 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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Malaise, Nausea, Palpitations
Clinical narrative: Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated blood pressures of "240 and 190/92"; "sick" ever since after first dose; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, CILOSTAZOL (CLAUDINE), MONTELUKAST and SITAGLIPTIN PHOSPHATE (JANUVIA).    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") (seriousness criterion medically significant), MALAISE ("sick" ever since after first dose), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92"), MALAISE ("sick" ever since after first dose), SLEEP DISORDER (can't sleep), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she was likely to travel to the Emergency Room at the time of the call. Her second dose of the vaccine was scheduled to take place on 17May2021.  Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Urinary incontinence
Clinical narrative: Heart racing; trouble holding her urine; throbbing on the right side of her head; Nausea; elevated blood pressures of "240 and 190/92"; "sick" ever since after first dose; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, CILOSTAZOL (CLAUDINE), MONTELUKAST and SITAGLIPTIN PHOSPHATE (JANUVIA).    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92") (seriousness criterion medically significant), MALAISE ("sick" ever since after first dose), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressures of "240 and 190/92"), MALAISE ("sick" ever since after first dose), SLEEP DISORDER (can't sleep), PALPITATIONS (Heart racing), URINARY INCONTINENCE (trouble holding her urine), HEADACHE (throbbing on the right side of her head) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she was likely to travel to the Emergency Room at the time of the call. Her second dose of the vaccine was scheduled to take place on 17May2021.  Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event of blood pressure increased retained as serious (MS) due to readings provided being significantly high
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: neuropathy; body tingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) and PARAESTHESIA (body tingles) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criteria hospitalization prolonged and medically significant). 12-Apr-2021, the patient experienced PARAESTHESIA (body tingles) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 12-Apr-2021 due to NEUROPATHY PERIPHERAL and PARAESTHESIA. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy) and PARAESTHESIA (body tingles) had not resolved. Not Provided          About four hours after her second shot, she experienced neuropathy and body tingles. The patient had to go to the hospital and stayed there for 5 days.   Treatment included gabapentin, methylprednisolone, migraine vasodilator and B-12 shots.  Company comment : Based on current available information and the temporal association between product use and the start date of the events a causal 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 cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bile duct stone, Cholelithiasis, Dyspnoea, Intestinal perforation
Clinical narrative: the surgeon accidentally punctured her bowel; A stone was stuck in her bile duct; gallstones; short of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTESTINAL PERFORATION (the surgeon accidentally punctured her bowel) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced INTESTINAL PERFORATION (the surgeon accidentally punctured her bowel) (seriousness criteria hospitalization and medically significant), BILE DUCT STONE (A stone was stuck in her bile duct), CHOLELITHIASIS (gallstones) and DYSPNOEA (short of breath). The patient was treated with Surgery for Bile duct stone and Surgery for Cholelithiasis. At the time of the report, INTESTINAL PERFORATION (the surgeon accidentally punctured her bowel), BILE DUCT STONE (A stone was stuck in her bile duct), CHOLELITHIASIS (gallstones) and DYSPNOEA (short of breath) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. After getting first dose of vaccine, by that afternoon, the patient was short of breath, had abdominal pain, and was found to have gallstones during ER visit.  A stone was stuck in her bile duct and while trying to remove the stone in her bile duct, the surgeon accidentally punctured her bowel. The patient was transferred to a different hospital. She had her gall bladder removed and was recovering at home. The patient was due for the second vaccine dose tomorrow, but was unable to get it due to her recovery process. Company Comment : 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 for the  events of Dyspnea. The events of Intestinal perforation, Bile duct stone, Cholelithiasis and Abdominal pain are Unlikely related.; 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 for the  events of Dyspnea. The events of Intestinal perforation, Bile duct stone, Cholelithiasis and Abdominal pain are Unlikely related.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: blood clot was discovered in the left leg; excruciating pain in the left leg below the knee; area is swollen; Area of the left leg below the knee is red; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot was discovered in the left leg) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (blood clot was discovered in the left leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red). At the time of the report, THROMBOSIS (blood clot was discovered in the left leg), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red) had not resolved.            The patient's concomitant medication was not reported. The information regarding the patient's treatment medication 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 these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-116642 (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 these events, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Chills, Dizziness, Extrasystoles
Clinical narrative: missed beats; become sensitive to light and cannot go outside without sunglasses; sweating more especially acidic and disgusting; splitting headaches; pain in the left arm at the vaccination site; arrhythmias; altered smell; heart rhythm, palpitations; tachycardia; joint pains; chills; mild fever; dizzy.; "feels like my body has been split into 1000 different microclimates; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmias) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue syndrome, Fibromyalgia and Neurocardiogenic syncope.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy.). On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (mild fever). In February 2021, the patient experienced FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates). On 18-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmias) (seriousness criterion medically significant), PAROSMIA (altered smell), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), HEADACHE (splitting headaches) and VACCINATION SITE PAIN (pain in the left arm at the vaccination site). On an unknown date, the patient experienced EXTRASYSTOLES (missed beats). On 14-Feb-2021, ARTHRALGIA (joint pains) and CHILLS (chills) had resolved. On 24-Feb-2021, HEADACHE (splitting headaches) had resolved. At the time of the report, ARRHYTHMIA (arrhythmias), PAROSMIA (altered smell), FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates), DIZZINESS (dizzy.), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), EXTRASYSTOLES (missed beats), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), VACCINATION SITE PAIN (pain in the left arm at the vaccination site) and PYREXIA (mild fever) outcome was unknown.            No concomitant medications were provided. Treatment taken were Diphenhydramine (Benadryl) , Ibuprofen (Advil), Prednisone and acupuncture to alleviate the symptoms experienced.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Palpitations, Parosmia
Clinical narrative: missed beats; become sensitive to light and cannot go outside without sunglasses; sweating more especially acidic and disgusting; splitting headaches; pain in the left arm at the vaccination site; arrhythmias; altered smell; heart rhythm, palpitations; tachycardia; joint pains; chills; mild fever; dizzy.; "feels like my body has been split into 1000 different microclimates; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmias) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue syndrome, Fibromyalgia and Neurocardiogenic syncope.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy.). On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (mild fever). In February 2021, the patient experienced FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates). On 18-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmias) (seriousness criterion medically significant), PAROSMIA (altered smell), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), HEADACHE (splitting headaches) and VACCINATION SITE PAIN (pain in the left arm at the vaccination site). On an unknown date, the patient experienced EXTRASYSTOLES (missed beats). On 14-Feb-2021, ARTHRALGIA (joint pains) and CHILLS (chills) had resolved. On 24-Feb-2021, HEADACHE (splitting headaches) had resolved. At the time of the report, ARRHYTHMIA (arrhythmias), PAROSMIA (altered smell), FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates), DIZZINESS (dizzy.), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), EXTRASYSTOLES (missed beats), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), VACCINATION SITE PAIN (pain in the left arm at the vaccination site) and PYREXIA (mild fever) outcome was unknown.            No concomitant medications were provided. Treatment taken were Diphenhydramine (Benadryl) , Ibuprofen (Advil), Prednisone and acupuncture to alleviate the symptoms experienced.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Pyrexia, Tachycardia, Vaccination site pain
Clinical narrative: missed beats; become sensitive to light and cannot go outside without sunglasses; sweating more especially acidic and disgusting; splitting headaches; pain in the left arm at the vaccination site; arrhythmias; altered smell; heart rhythm, palpitations; tachycardia; joint pains; chills; mild fever; dizzy.; "feels like my body has been split into 1000 different microclimates; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmias) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic fatigue syndrome, Fibromyalgia and Neurocardiogenic syncope.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy.). On 10-Feb-2021, the patient experienced ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (mild fever). In February 2021, the patient experienced FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates). On 18-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmias) (seriousness criterion medically significant), PAROSMIA (altered smell), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), HEADACHE (splitting headaches) and VACCINATION SITE PAIN (pain in the left arm at the vaccination site). On an unknown date, the patient experienced EXTRASYSTOLES (missed beats). On 14-Feb-2021, ARTHRALGIA (joint pains) and CHILLS (chills) had resolved. On 24-Feb-2021, HEADACHE (splitting headaches) had resolved. At the time of the report, ARRHYTHMIA (arrhythmias), PAROSMIA (altered smell), FEELING ABNORMAL ("feels like my body has been split into 1000 different microclimates), DIZZINESS (dizzy.), PALPITATIONS (heart rhythm, palpitations), TACHYCARDIA (tachycardia), EXTRASYSTOLES (missed beats), PHOTOSENSITIVITY REACTION (become sensitive to light and cannot go outside without sunglasses), HYPERHIDROSIS (sweating more especially acidic and disgusting), VACCINATION SITE PAIN (pain in the left arm at the vaccination site) and PYREXIA (mild fever) outcome was unknown.            No concomitant medications were provided. Treatment taken were Diphenhydramine (Benadryl) , Ibuprofen (Advil), Prednisone and acupuncture to alleviate the symptoms experienced.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue, Neoplasm malignant
Clinical narrative: patient was diagnosed with cancer; beyond 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (patient was diagnosed with cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (patient was diagnosed with cancer) (seriousness criteria hospitalization and medically significant) and INTENTIONAL PRODUCT USE ISSUE (beyond 42 days). At the time of the report, NEOPLASM MALIGNANT (patient was diagnosed with cancer) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (beyond 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and event treatment information were not provided by the reporter.  Company comment: Limited information regarding the reported cancer has been provided at this time and a causal relationship cannot be excluded although if the diagnosis was made after the first dose but before the second dose was due it is likely the cancer was present prior to first injection of Moderna vaccine.  Per report the patient was hospitalized and then diagnosed with cancer.  Query created to ascertain the reason for the hospitalization and new event may need to be added dependent on the response to that query.  The report also includes an event of missed second dose with no associated AEs; Sender's Comments: Limited information regarding the reported cancer has been provided at this time and a causal relationship cannot be excluded although if the diagnosis was made after the first dose but before the second dose was due it is likely the cancer was present prior to first injection of Moderna vaccine.  Per report the patient was hospitalized and then diagnosed with cancer.  Query created to ascertain the reason for the hospitalization and new event may need to be added dependent on the response to that query.  The report also includes an event of missed second dose with no associated AEs