chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Sinus congestion
Clinical narrative: CONGESTION; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced congestion. On 23-JUN-2021, the subject experienced chills. On 23-JUN-2021, the subject experienced fatigue. On 23-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the congestion, chills, fatigue and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 30-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POTENTIALLY EXPIRED VACCINE ADMINISTERED; INCORRECT PRODUCT STORAGE; This case, from the same reporter is linked to 20210704358. This spontaneous report received from a pharmacist concerned a 64 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: 1816022 expiry: 15-AUG-2021) dose was not reported, administered on 01-JUL-2021 11:50:00 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced potentially expired vaccine administered. On 01-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potentially expired vaccine administered and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210704358.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 56 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: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SECONDARY EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced secondary effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of secondary effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Fear
Clinical narrative: HORRIBLE REACTION TO J AND J FOR AN ACQUAINTANCE OF MINE; SCARY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced horrible reaction to j and j for an acquaintance of mine, and scary. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible reaction to j and j for an acquaintance of mine and scary was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: SORES IN MOUTH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sores in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sores in mouth was not reported. This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Computerised tomogram
Clinical narrative: temperarily lost sight in left eye; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS TRANSIENT (temperarily lost sight in left eye) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Right knee replacement surgery) in 2017. Concurrent medical conditions included Blood pressure high since 2014 and Benign prostatic hypertrophy since 2000. Concomitant products included TAMSULOSIN, LOSARTAN and NIFEDIPINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021 at 2:30 AM, the patient experienced BLINDNESS TRANSIENT (temperarily lost sight in left eye) (seriousness criterion medically significant). On 12-Jun-2021, BLINDNESS TRANSIENT (temperarily lost sight in left eye) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Computerised tomogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BLINDNESS TRANSIENT (temperarily lost sight in left eye) to be possibly related.    Patient's treatment product details not provided. It was ambiguously reported that outcome of the event was resolved on 12-Jun-2021 and unknown.  The first event occurred the day after the first vaccine shot the left toe swelled and the swelling and pain worked its way into the lower leg.  Required a doctor visit, ultra sound and xray did not show any damage to the toe, foot or leg.  Blood tests showed uric acid levels in the high end of the normal range.  After treatment in office with an injection the pain and swelling subsided.  No long term effects from this event. The second event occurred after the second vaccine shot.  Two weeks after the second shot was administered (Saturday 6/12/21), temporarily lost sight in my left eye while driving. Went to the ER for treatment. Assement showed no retinal detachment. On Monday visited family doctor and she recommended that patient see by an eye doctor and ordered some additional blood tests blood tests.  Family doctor appointment for follow up visit scheduled for 7/28/21. Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-040178, MOD-2021-245133 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Intermenstrual bleeding, Progesterone
Clinical narrative: I had bleeding for my period 5 days earlier the month of my second vaccine. I subsequently got pregnant that month and miscarried at 5 weeks.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Facial paralysis, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Swelling in arm, fever up to 39C, no appetite, decline and pain all over body, partial paralysis of face right side.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blood glucose normal, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received pfizer covid vaccine in left deltoid. 5 minutes after shot he complained of visual changes. He sat down and said he could not see then lost conciousness and had mild convulsions for about 10 seconds. He regained counciousness but still could not see. pupals very dialated. 911 was called. Patient had temp of 97.8 and osat of 99. vision loss continued for 10-15 minutes but patient was concious. EMTs arrived on scene. blood glucose 102, BP 92/46. very low. recommended he go to ER.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness, Mydriasis, Seizure, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received pfizer covid vaccine in left deltoid. 5 minutes after shot he complained of visual changes. He sat down and said he could not see then lost conciousness and had mild convulsions for about 10 seconds. He regained counciousness but still could not see. pupals very dialated. 911 was called. Patient had temp of 97.8 and osat of 99. vision loss continued for 10-15 minutes but patient was concious. EMTs arrived on scene. blood glucose 102, BP 92/46. very low. recommended he go to ER.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received pfizer covid vaccine in left deltoid. 5 minutes after shot he complained of visual changes. He sat down and said he could not see then lost conciousness and had mild convulsions for about 10 seconds. He regained counciousness but still could not see. pupals very dialated. 911 was called. Patient had temp of 97.8 and osat of 99. vision loss continued for 10-15 minutes but patient was concious. EMTs arrived on scene. blood glucose 102, BP 92/46. very low. recommended he go to ER.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles developed after the first round of vaccine.  I was treated with anti-virals.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Depression, Family stress, Gait disturbance, Loss of personal independence in daily activities, Rheumatoid arthritis
Clinical narrative: family stress; depression; drug effect decreased; Walking difficulty; Rheumatoid arthritis flare up; Activities of daily living impaired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. In May 2021, the patient experienced FAMILY STRESS (family stress) and DEPRESSION (depression). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty). The patient was treated with METHOTREXATE at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty) had not resolved and FAMILY STRESS (family stress) and DEPRESSION (depression) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Therapeutic product effect decreased
Clinical narrative: family stress; depression; drug effect decreased; Walking difficulty; Rheumatoid arthritis flare up; Activities of daily living impaired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. In May 2021, the patient experienced FAMILY STRESS (family stress) and DEPRESSION (depression). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty). The patient was treated with METHOTREXATE at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty) had not resolved and FAMILY STRESS (family stress) and DEPRESSION (depression) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient is still experiencing severe pain on injection site area. "COVID ARM" symptoms.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Pharmacy administered vaccine & followed normal routine, including keeping a hand on pt the whole time until finished pt slumped over & rolled to his left & rolled out of chair onto the ground, on his stomach. He didnt hit the wall or the chair.  Father & I both knelt to ground to roll him to his side and he immediately came to & sat up against wall. Dad said he had not had anything to eat any time recently, unconcerned & proceded to move to the next child, who was too scared to do it.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Upper respiratory tract infection
Clinical narrative: pneumonia; upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). At the time of the report, PNEUMONIA (pneumonia) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) outcome was unknown.            Treatment medication used as Steroids and Antibiotics. Concomitant medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, Hypoaesthesia, Lymphadenopathy, Malaise, Muscle spasms
Clinical narrative: Admitted to the hospital for low sodium; Malaise; Night sweats; fever; Swollen glands; Numb fingers and toes; Cramp to right lower leg; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium), MALAISE (Malaise), NIGHT SWEATS (Night sweats), PYREXIA (fever) and LYMPHADENOPATHY (Swollen glands) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium) (seriousness criterion hospitalization prolonged), MALAISE (Malaise) (seriousness criterion hospitalization prolonged), NIGHT SWEATS (Night sweats) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged), LYMPHADENOPATHY (Swollen glands) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (Numb fingers and toes) and MUSCLE SPASMS (Cramp to right lower leg). The patient was hospitalized on 15-May-2021 due to BLOOD SODIUM DECREASED, LYMPHADENOPATHY, MALAISE, NIGHT SWEATS and PYREXIA. The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 1 dosage form and SODIUM CHLORIDE at a dose of 1 dosage form. At the time of the report, BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium), MALAISE (Malaise), NIGHT SWEATS (Night sweats), PYREXIA (fever), LYMPHADENOPATHY (Swollen glands), HYPOAESTHESIA (Numb fingers and toes) and MUSCLE SPASMS (Cramp to right lower leg) outcome was unknown.            Concomitant medication was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: Admitted to the hospital for low sodium; Malaise; Night sweats; fever; Swollen glands; Numb fingers and toes; Cramp to right lower leg; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium), MALAISE (Malaise), NIGHT SWEATS (Night sweats), PYREXIA (fever) and LYMPHADENOPATHY (Swollen glands) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium) (seriousness criterion hospitalization prolonged), MALAISE (Malaise) (seriousness criterion hospitalization prolonged), NIGHT SWEATS (Night sweats) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged), LYMPHADENOPATHY (Swollen glands) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (Numb fingers and toes) and MUSCLE SPASMS (Cramp to right lower leg). The patient was hospitalized on 15-May-2021 due to BLOOD SODIUM DECREASED, LYMPHADENOPATHY, MALAISE, NIGHT SWEATS and PYREXIA. The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 1 dosage form and SODIUM CHLORIDE at a dose of 1 dosage form. At the time of the report, BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium), MALAISE (Malaise), NIGHT SWEATS (Night sweats), PYREXIA (fever), LYMPHADENOPATHY (Swollen glands), HYPOAESTHESIA (Numb fingers and toes) and MUSCLE SPASMS (Cramp to right lower leg) outcome was unknown.            Concomitant medication was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Vaccination complication
Clinical narrative: Convulsions; Patient is experiencing a possible vaccine reaction; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (Convulsions) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant). 25-Jun-2021, the patient experienced VACCINATION COMPLICATION (Patient is experiencing a possible vaccine reaction). The patient was treated with LORAZEPAM (ATIVAN) 25-Jun-2021 for Convulsion, at a dose of 2 mg. At the time of the report, SEIZURE (Convulsions) was resolving and VACCINATION COMPLICATION (Patient is experiencing a possible vaccine reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Lab Data: results pending. It was reported that in the emergency room they have treated the patient with 2mg of Ativan, with improving results, from convulsing to subtle shakes.  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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Malaise, Muscle spasms, Thrombosis
Clinical narrative: black blood cloth on the left foot; legs numbed/from the head half the body was numb; after the vaccine felt very sick; head feels like it explodes,it hurts daily; has Cramps on the left foot, all the night; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (black blood cloth on the left foot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (black blood cloth on the left foot) (seriousness criterion medically significant), HYPOAESTHESIA (legs numbed/from the head half the body was numb), MALAISE (after the vaccine felt very sick), HEADACHE (head feels like it explodes,it hurts daily) and MUSCLE SPASMS (has Cramps on the left foot, all the night). At the time of the report, THROMBOSIS (black blood cloth on the left foot), HYPOAESTHESIA (legs numbed/from the head half the body was numb), MALAISE (after the vaccine felt very sick), HEADACHE (head feels like it explodes,it hurts daily) and MUSCLE SPASMS (has Cramps on the left foot, all the night) outcome was unknown.            No concomitant product information was provided. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested   This case was linked to MOD-2021-237381 (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.  Further information has been requested
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymph node pain
Clinical narrative: Abnormal looking lymph nodes with necrosis; Tenderness and itchiness on the lymph nodes that went away but "came back"; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NECROSIS (Abnormal looking lymph nodes with necrosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back"). In March 2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 18-Mar-2021, the patient experienced NECROSIS (Abnormal looking lymph nodes with necrosis) (seriousness criterion medically significant). In March 2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, NECROSIS (Abnormal looking lymph nodes with necrosis) and LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Mammogram: negative (Negative) Negative.   Patient had a biopsy and magnetic resonance imaging done on her breast tissue. The biopsy results were inconclusive. No treatment information was provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.   This case was linked to MOD-2021-237379 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Myalgia, Nausea, Necrosis, Pyrexia
Clinical narrative: Abnormal looking lymph nodes with necrosis; Tenderness and itchiness on the lymph nodes that went away but "came back"; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NECROSIS (Abnormal looking lymph nodes with necrosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back"). In March 2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 18-Mar-2021, the patient experienced NECROSIS (Abnormal looking lymph nodes with necrosis) (seriousness criterion medically significant). In March 2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, NECROSIS (Abnormal looking lymph nodes with necrosis) and LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Mammogram: negative (Negative) Negative.   Patient had a biopsy and magnetic resonance imaging done on her breast tissue. The biopsy results were inconclusive. No treatment information was provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.   This case was linked to MOD-2021-237379 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Abnormal looking lymph nodes with necrosis; Tenderness and itchiness on the lymph nodes that went away but "came back"; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NECROSIS (Abnormal looking lymph nodes with necrosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back"). In March 2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 18-Mar-2021, the patient experienced NECROSIS (Abnormal looking lymph nodes with necrosis) (seriousness criterion medically significant). In March 2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, NECROSIS (Abnormal looking lymph nodes with necrosis) and LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Mammogram: negative (Negative) Negative.   Patient had a biopsy and magnetic resonance imaging done on her breast tissue. The biopsy results were inconclusive. No treatment information was provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.   This case was linked to MOD-2021-237379 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Inappropriate schedule of product administration, Myocarditis, Vaccination site dysaesthesia
Clinical narrative: myocarditis; Patient received 2nd dose 23 days after the first; a little sensitivity if she touched the injection site; heavy pressured feeling on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHEST DISCOMFORT (heavy pressured feeling on her chest). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first) and VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site). At the time of the report, MYOCARDITIS (myocarditis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first), VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site) and CHEST DISCOMFORT (heavy pressured feeling on her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was given. Patient had on allergy pills as concomitant medication.  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-2021-237410 (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.
Sex: U
Vaccine: COVID19
Symptoms: Syncope, Vertigo
Clinical narrative: fainting; Severe vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant) and VERTIGO (Severe vertigo). At the time of the report, SYNCOPE (fainting) and VERTIGO (Severe vertigo) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported. Lab details were not provided. Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Seizure
Clinical narrative: convulsion; aches; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (convulsion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (convulsion) (seriousness criterion medically significant). an unknown date, the patient experienced MYALGIA (aches). The patient was treated with Surgery (Heart Surgery) for Seizure. At the time of the report, SEIZURE (convulsion) and MYALGIA (aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment for the events included was heart surgery, received 3 stents and physical therapy. The patient was taken to the hospital. 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-2021-237450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 contains non-significant information. Batch number /Lot 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
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Fatigue, Myalgia, Myocardial necrosis marker increased
Clinical narrative: Heart enzyme elevated; Small blood clot; Chest pain; Soreness; Low grade fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) and THROMBOSIS (Small blood clot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided.  Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) (seriousness criterion medically significant), THROMBOSIS (Small blood clot) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with APIXABAN (ELIQUIS) for Thrombosis, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated), THROMBOSIS (Small blood clot), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) found a clot in his right lung.. On an unknown date, Myocardial necrosis marker increased: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Labs include ultrasound, chest x-ray ,strep tests whose results are not provided.  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-2021-237494 (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.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thrombosis
Clinical narrative: Heart enzyme elevated; Small blood clot; Chest pain; Soreness; Low grade fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) and THROMBOSIS (Small blood clot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided.  Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) (seriousness criterion medically significant), THROMBOSIS (Small blood clot) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with APIXABAN (ELIQUIS) for Thrombosis, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated), THROMBOSIS (Small blood clot), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) found a clot in his right lung.. On an unknown date, Myocardial necrosis marker increased: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Labs include ultrasound, chest x-ray ,strep tests whose results are not provided.  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-2021-237494 (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.