chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Member was given the J&J Covid vaccine.  Should have been scheduled at other facility for the Pfizer.  Staff was having technical difficulty with mobile device that is used when scanning and entering member vaccine information.  Instead of waiting and taking time to figure out what the problem was and then administering vaccine, the vaccine wrong was given.  It was afterwards while member was sitting during the waiting period that the issue was taken to the supervisor to help figure out.  This is when it was discovered that this was an immunization error and not the device.  Supervisor immediately consulted with the pediatrician in office and building manager. Member was asked to wait an additional 15 minutes for observation.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dry mouth, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: NUMBNESS IN RIGHT HAND AND FINGERTIPS; TINGLING IN RIGHT ARM AND FINGERTIPS; TINGLING IN LEFT ARM AND FINGERS; DRY MOUTH; COULD NOT EAT MUCH; FELT LIKE A TRUCK HIT; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; BAD HEADACHE; NAUSEA; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; WHOLE BODY ITCHED; INJECTION SITE WAS ITCHY; BIG HARD LUMP AT INJECTION SITE LIKE A MOSQUITO HAD BITTEN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced big hard lump at injection site like a mosquito had bitten. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced whole body itched. On 02-JUL-2021, the subject experienced injection site was itchy. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced bad headache. On 02-JUL-2021, the subject experienced nausea. On 04-JUL-2021, the subject experienced tingling in right arm and fingertips. On 04-JUL-2021, the subject experienced tingling in left arm and fingers. On 04-JUL-2021, the subject experienced dry mouth. On 04-JUL-2021, the subject experienced could not eat much. On 04-JUL-2021, the subject experienced felt like a truck hit. On 05-JUL-2021, the subject experienced numbness in right hand and fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site was red and raised for 3-4 days, injection site was red and raised for 3-4 days, bad headache, and nausea on 04-JUL-2021, and tingling in left arm and fingers on 07-JUL-2021, was recovering from whole body itched, and injection site was itchy, had not recovered from big hard lump at injection site like a mosquito had bitten, numbness in right hand and fingertips, and tingling in right arm and fingertips, and the outcome of dry mouth, could not eat much and felt like a truck hit was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site nodule, Injection site pruritus, Nausea, Paraesthesia
Clinical narrative: NUMBNESS IN RIGHT HAND AND FINGERTIPS; TINGLING IN RIGHT ARM AND FINGERTIPS; TINGLING IN LEFT ARM AND FINGERS; DRY MOUTH; COULD NOT EAT MUCH; FELT LIKE A TRUCK HIT; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; BAD HEADACHE; NAUSEA; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; WHOLE BODY ITCHED; INJECTION SITE WAS ITCHY; BIG HARD LUMP AT INJECTION SITE LIKE A MOSQUITO HAD BITTEN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced big hard lump at injection site like a mosquito had bitten. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced whole body itched. On 02-JUL-2021, the subject experienced injection site was itchy. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced bad headache. On 02-JUL-2021, the subject experienced nausea. On 04-JUL-2021, the subject experienced tingling in right arm and fingertips. On 04-JUL-2021, the subject experienced tingling in left arm and fingers. On 04-JUL-2021, the subject experienced dry mouth. On 04-JUL-2021, the subject experienced could not eat much. On 04-JUL-2021, the subject experienced felt like a truck hit. On 05-JUL-2021, the subject experienced numbness in right hand and fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site was red and raised for 3-4 days, injection site was red and raised for 3-4 days, bad headache, and nausea on 04-JUL-2021, and tingling in left arm and fingers on 07-JUL-2021, was recovering from whole body itched, and injection site was itchy, had not recovered from big hard lump at injection site like a mosquito had bitten, numbness in right hand and fingertips, and tingling in right arm and fingertips, and the outcome of dry mouth, could not eat much and felt like a truck hit was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensory disturbance
Clinical narrative: NUMBNESS IN RIGHT HAND AND FINGERTIPS; TINGLING IN RIGHT ARM AND FINGERTIPS; TINGLING IN LEFT ARM AND FINGERS; DRY MOUTH; COULD NOT EAT MUCH; FELT LIKE A TRUCK HIT; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; BAD HEADACHE; NAUSEA; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; WHOLE BODY ITCHED; INJECTION SITE WAS ITCHY; BIG HARD LUMP AT INJECTION SITE LIKE A MOSQUITO HAD BITTEN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced big hard lump at injection site like a mosquito had bitten. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced whole body itched. On 02-JUL-2021, the subject experienced injection site was itchy. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced bad headache. On 02-JUL-2021, the subject experienced nausea. On 04-JUL-2021, the subject experienced tingling in right arm and fingertips. On 04-JUL-2021, the subject experienced tingling in left arm and fingers. On 04-JUL-2021, the subject experienced dry mouth. On 04-JUL-2021, the subject experienced could not eat much. On 04-JUL-2021, the subject experienced felt like a truck hit. On 05-JUL-2021, the subject experienced numbness in right hand and fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site was red and raised for 3-4 days, injection site was red and raised for 3-4 days, bad headache, and nausea on 04-JUL-2021, and tingling in left arm and fingers on 07-JUL-2021, was recovering from whole body itched, and injection site was itchy, had not recovered from big hard lump at injection site like a mosquito had bitten, numbness in right hand and fingertips, and tingling in right arm and fingertips, and the outcome of dry mouth, could not eat much and felt like a truck hit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysuria, Headache, Nausea, Urticaria
Clinical narrative: BURNING SENSATION WHEN URINATING; CHILLS; HIVES; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned an 18 year old male. The patient's weight was 168 pounds, and height was 68 inches. The patient's concurrent conditions included food allergy, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies, patient is very healthy (athlete).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the subject experienced burning sensation when urinating. On 17-JUL-2021, the subject experienced chills. On 17-JUL-2021, the subject experienced hives. On 17-JUL-2021, the subject experienced headache. On 17-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 17-JUL-2021, and had not recovered from hives, headache, burning sensation when urinating, and chills. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: FEVER; FEELING VERY TIRED; This spontaneous report received from a patient via a company representative concerned a 21 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: Unknown) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) POSITIVE. On 16-JUL-2021, the subject experienced fever. On 16-JUL-2021, the subject experienced feeling very tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-JUL-2021, and had not recovered from feeling very tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: FELT THROAT TIGHTEN; This spontaneous report received from a parent 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 15-JUL-2021 11:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-JUL-2021, the subject experienced felt throat tighten. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt throat tighten on 15-JUL-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: SUPER WEAK; SORENESS FELT ALL OVER THE ENTIRE BODY; RIGHT ARM IS VERY VERY SORE; 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: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced soreness felt all over the entire body. On 24-JUN-2021, the subject experienced right arm is very very sore. On an unspecified date, the subject experienced super weak. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness felt all over the entire body, and right arm is very very sore, and the outcome of super weak was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: WALKING AROUND LIKE A WOUNDED DOE; 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 walking around like a wounded doe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of walking around like a wounded doe was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES IN ARMPIT, BACK, AND CHEST; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shingles in armpit, back, and chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles in armpit, back, and chest was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Oxygenation index, Palpitations
Clinical narrative: HEART PALPITATIONS LASTING 1 TO 2 SECONDS WHICH OCCURRED AS MUCH AS 10 TO 20 TIMES A DAY OR MORE FREQUENT OR NOT AT ALL IN SOME DAYS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient never had consistent heart palpitations in the past. 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 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-APR-2021, the subject experienced heart palpitations lasting 1 to 2 seconds which occurred as much as 10 to 20 times a day or more frequent or not at all in some days. Laboratory data (dates unspecified) included: Oxygenation index (NR: not provided) oxygenation normal via pulse oximeter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations lasting 1 to 2 seconds which occurred as much as 10 to 20 times a day or more frequent or not at all in some days. This report was non-serious.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 15 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: Unknown) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-JUL-2021, the subject experienced product administered to subject of inappropriate age. On 12-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Neuralgia, Pain
Clinical narrative: NUMB IN HANDS; SHOCKING PAIN/EXTREME PAIN; NEUROPATHY PAIN; CRAMP IN HANDS AT NIGHT; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 240 pounds, and height was 76 inches. The patient's concurrent conditions included diabetes, high dose penicillin allergy, adhesive tape allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had otc drug allergy. the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and pseudoephedrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 21-MAR-2021, the subject experienced shocking pain/extreme pain. On 21-MAR-2021, the subject experienced neuropathy pain. On 21-MAR-2021, the subject experienced cramp in hands at night. On 02-JUL-2021, the subject experienced numb in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy pain, shocking pain/extreme pain, cramp in hands at night, and numb in hands. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SEVERE BODY ACHES/STARTED IN NECK AND EXPANDED FROM HEAD TO TOE AND EVEN TEETH; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 110 pounds, and height was 60 inches. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. the patient was otherwise healthy adult.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the subject experienced severe body aches/started in neck and expanded from head to toe and even teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe body aches/started in neck and expanded from head to toe and even teeth. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Multiple sclerosis, Pyrexia
Clinical narrative: multiple sclerosis; Back pain; started having fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (multiple sclerosis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (started having fever) and FATIGUE (tiredness). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis) (seriousness criterion medically significant) and BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Back pain, at an unspecified dose and frequency. At the time of the report, MULTIPLE SCLEROSIS (multiple sclerosis) outcome was unknown and BACK PAIN (Back pain), PYREXIA (started having fever) and FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (High) 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking steroids for multiple sclerosis.  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 15-Jul-2021: Significant Follow up received on 15 Jul 2021: Event information updated.; 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: Hospitalisation
Clinical narrative: 1 week at the hospital; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (1 week at the hospital) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (1 week at the hospital) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (1 week at the hospital) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was unknown.  It was reported that the patient stayed at hospital for 1 week. Patient received the first vaccine last month.  Company comment: Very limited information regarding the hospitalization event has been provided at this time.  Further information is required.; Sender's Comments: Very limited information regarding the hospitalization event has been provided at this time.  Further information is required.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dementia, Malaise, Memory impairment
Clinical narrative: dementia flared up; Friend got worse / dementia flared up; Feel lousy; Starting to forget more and more after the shot/friend got worse and is starting to not remember things; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia flared up) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (dementia flared up) (seriousness criterion medically significant), CONDITION AGGRAVATED (Friend got worse / dementia flared up), MALAISE (Feel lousy) and MEMORY IMPAIRMENT (Starting to forget more and more after the shot/friend got worse and is starting to not remember things). At the time of the report, DEMENTIA (dementia flared up), CONDITION AGGRAVATED (Friend got worse / dementia flared up), MALAISE (Feel lousy) and MEMORY IMPAIRMENT (Starting to forget more and more after the shot/friend got worse and is starting to not remember things) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was provided.  No Treatment drug information was provided.  Company Comment An alternative explanation is that the event Dementia was more consistent with the advanced age and the event Malaise was more consistent with the underlying comorbidities.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 wherein events were added and case was upgraded to serious.; Sender's Comments: An alternative explanation is that the event Dementia was more consistent with the advanced age and the event Malaise was more consistent with the underlying comorbidities.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Felt like fainting; Nervous after the second shot; Dizzy after first and second shot; Rhabdomyolysis; heart rate increased; Malaise; Tired with normal activity after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Emotional distress (upset about his parents) on 27-Apr-2021.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizzy after first and second shot) and FATIGUE (Tired with normal activity after the second shot). April 2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), HEART RATE INCREASED (heart rate increased) and MALAISE (Malaise). On 27-Apr-2021, the patient experienced PRESYNCOPE (Felt like fainting) and NERVOUSNESS (Nervous after the second shot). The patient was treated with ALPRAZOLAM on 27-Apr-2021 for Anxiety, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like fainting), NERVOUSNESS (Nervous after the second shot), DIZZINESS (Dizzy after first and second shot), RHABDOMYOLYSIS (Rhabdomyolysis), HEART RATE INCREASED (heart rate increased), MALAISE (Malaise) and FATIGUE (Tired with normal activity after the second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 148/90 (High) Blood pressure at rest was 148/90 for the entire day. On 27-Apr-2021, Heart rate: 140 (High) Felt his heart  in chest beating fast 140.        Concomitant product information was not provided.  On 27-Apr-2021, the patient visited an emergency room (ER) where he was prescribed an anxiety medication.   The patient reported he thought he might have myocarditis after hearing about it on the news.  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-2021-243062 (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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nervousness, Presyncope
Clinical narrative: Felt like fainting; Nervous after the second shot; Dizzy after first and second shot; Rhabdomyolysis; heart rate increased; Malaise; Tired with normal activity after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Emotional distress (upset about his parents) on 27-Apr-2021.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizzy after first and second shot) and FATIGUE (Tired with normal activity after the second shot). April 2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), HEART RATE INCREASED (heart rate increased) and MALAISE (Malaise). On 27-Apr-2021, the patient experienced PRESYNCOPE (Felt like fainting) and NERVOUSNESS (Nervous after the second shot). The patient was treated with ALPRAZOLAM on 27-Apr-2021 for Anxiety, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like fainting), NERVOUSNESS (Nervous after the second shot), DIZZINESS (Dizzy after first and second shot), RHABDOMYOLYSIS (Rhabdomyolysis), HEART RATE INCREASED (heart rate increased), MALAISE (Malaise) and FATIGUE (Tired with normal activity after the second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 148/90 (High) Blood pressure at rest was 148/90 for the entire day. On 27-Apr-2021, Heart rate: 140 (High) Felt his heart  in chest beating fast 140.        Concomitant product information was not provided.  On 27-Apr-2021, the patient visited an emergency room (ER) where he was prescribed an anxiety medication.   The patient reported he thought he might have myocarditis after hearing about it on the news.  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-2021-243062 (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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After the first dose, his arm was sore at the site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (After the first dose, his arm was sore at the site) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-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 VACCINATION SITE PAIN (After the first dose, his arm was sore at the site) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE PAIN (After the first dose, his arm was sore at the site) had resolved.        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.   This case was linked to MOD-2021-249074 (Patient Link).; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient
Clinical narrative: Temporary blindness; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Temporary blindness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced BLINDNESS TRANSIENT (Temporary blindness) (seriousness criterion medically significant). At the time of the report, BLINDNESS TRANSIENT (Temporary blindness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart problem; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problem) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart problem) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Heart problem) outcome was unknown.            No concomitant medication were reported. Treatment information was unknown.  Very limited information regarding this event  has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event  has been provided at this time.  Further information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood disorder, Headache, Swelling face
Clinical narrative: thrombocytopenia; has a continued stomach problem that she went to the emergency room for; headache; her face was swollen a little bit/looked a bit different/still had her swelling; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (thrombocytopenia) 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.     No Medical History information was reported.   In May 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) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced SWELLING FACE (her face was swollen a little bit/looked a bit different/still had her swelling). On an unknown date, the patient experienced BLOOD DISORDER (thrombocytopenia) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (has a continued stomach problem that she went to the emergency room for) and HEADACHE (headache). At the time of the report, BLOOD DISORDER (thrombocytopenia) and SWELLING FACE (her face was swollen a little bit/looked a bit different/still had her swelling) had not resolved and ABDOMINAL DISCOMFORT (has a continued stomach problem that she went to the emergency room for) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.   Treatment included a blood transfusion.  On 14 Jun 2021, the patient had a swollen face and looked a bit different. Two weeks later, the patient had stomach problems which resulted in a visit to the emergency room (ER). While in the ER, the patient had unspecified blood work performed, which revealed her blood counts were dropping. The patient was released home and was to follow-up with their family doctor. A week later, the patient complained of a headache and still had swelling in the face. The patient's red blood cells (RBCs) were down below normal. The hospital gave the patient a blood transfusion and had a bone marrow biopsy performed, results not provided. At the time of this report, the patient was hospitalized.  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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Confusional state, Death, Dizziness, Dyspnoea
Clinical narrative: Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (20 years ago).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown.            Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Myasthenia gravis
Clinical narrative: Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (20 years ago).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown.            Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Product dose omission issue, Transient ischaemic attack
Clinical narrative: Transient heart attack; Chest pain; Patient did not receive the second dose with 36 days from the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient heart attack) (seriousness criterion medically significant), CHEST PAIN (Chest pain) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose with 36 days from the first dose). The patient was treated with Surgery (Stent placement in heart) for Transient ischaemic attack. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient heart attack), CHEST PAIN (Chest pain) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose with 36 days from the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment medications reported.  Caller who is a Pharmacy intern states that she had a patient who has Congestive Heart Failure who came in yesterday to receive the second dose of the Moderna Covid-19 vaccine. The patient received the first dose back in March in a different location and had a heart attack after fours hours of receiving the first dose. Caller states that the patient had chest pain and he went to the Emergency Room and he was told he had a transient heart attack; the patient has a stent put into his heart.  Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: Diabetes went to the roof, ended in the hospital; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes went to the roof, ended in the hospital) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS (Diabetes went to the roof, ended in the hospital) (seriousness criteria hospitalization and medically significant). At the time of the report, DIABETES MELLITUS (Diabetes went to the roof, ended in the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: had sore; Dizziness; swollen glands in the neck and back of her head; Extreme fatigue; She had nausea; Rectal bleeding; had a hard time walking; she was stiff; Wheezing; was short of breath; felt a vibration inside her body; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome (takes IGG replacement therapy) and Graves' disease (takes IGG replacement therapy).    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After the first dose, the patient had extreme fatigue, rectal bleeding, had a hard time walking, she was stiff, had sore and swollen glands in the neck and back of her head. She had nausea, dizziness, wheezing, was short of breath and felt a vibration inside her body. This continued for 30 days after 1st shot and into 2nd shot. Mentioned that the patient has a pre-existing condition of primary immunodeficiency, autoimmune graves disease and for that patient was taking IGG replacement therapy. Concomitant medications were not reported. Treatment included steroids.  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-2021-255830 (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.