chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED VACCINE THAT HAD BEEN PUNCTURED FOR 6 HOURS AND 25 MINUTES; VACCINE PUNCTURED FOR 6 HOURS AND 25 MINUTES; This spontaneous report received from a health care professional concerned a 31 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-JUL-2021, the subject experienced administered vaccine that had been punctured for 6 hours and 25 minutes. On 24-JUL-2021, the subject experienced vaccine punctured for 6 hours and 25 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine that had been punctured for 6 hours and 25 minutes and vaccine punctured for 6 hours and 25 minutes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210752694.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Myalgia, Pain, Skin discolouration
Clinical narrative: PAINFUL BRUISES WHEN TOUCHED/WHEN THE BRUISES COME OUT A LOT OF PAIN IN THE AREA; MUSCLE PAIN IN LEGS; LEFT LEG PURPLE AND BLACK; PURPLE AND GREEN BRUISES ON ABDMONEN/ON GOING BRUSING ON BODY; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included knee surgery, and blood clot. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced purple and green bruises on abdmonen/on going brusing on body. On 21-MAY-2021, the subject experienced left leg purple and black. On an unspecified date, the subject experienced painful bruises when touched/when the bruises come out a lot of pain in the area, and muscle pain in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from purple and green bruises on abdmonen/on going brusing on body, painful bruises when touched/when the bruises come out a lot of pain in the area, and muscle pain in legs, and the outcome of left leg purple and black was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OPENED YESTERDAY MORNING AT 9:00 AM AND STORED IN THE FRIDGE UNTIL ADMINISTRATION TODAY AT 12:00 PM; EXPIRED VACCINE ADMINISTRATED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 08-JUL-2021) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced expired vaccine administrated. On 27-JUL-2021, the subject experienced opened yesterday morning at 9:00 am and stored in the fridge until administration today at 12:00 pm. On an unspecified date, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administrated, incorrect product storage and opened yesterday morning at 9:00 am and stored in the fridge until administration today at 12:00 pm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Pain, Pyrexia
Clinical narrative: HEADACHE; FEELS NOT GOOD; FEVER; FELT  BAD; BODY ACHES/PAIN; This spontaneous report received from a patient concerned a 48 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: 204A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced felt bad. On 23-JUN-2021, the subject experienced body aches/pain. On 23-JUN-2021, the subject experienced fever. On 27-JUL-2021, the subject experienced feels not good. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, body aches/pain, felt bad and feels not good was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a parent concerned a 19 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 26-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-JUL-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms. This report was non-serious. This case, from the same reporter is linked to 20210757738.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: PAIN; SWELLING; 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. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the subject experienced pain, and swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and swelling. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Nasal congestion, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: CONGESTION; RUNNY NOSE; SORE THROAT; TENDER LYMPH NODES; 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: Unk) 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 20-JUL-2021, the subject experienced congestion. On 20-JUL-2021, the subject experienced runny nose. On 20-JUL-2021, the subject experienced sore throat. On 20-JUL-2021, the subject experienced tender lymph nodes. On 21-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the congestion, runny nose, sore throat and tender lymph nodes was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: STILL NOT FEELING WELL AFTER SHE GOT HER J&J VACCINE; This spontaneous report received from a consumer via a company representative concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, the subject experienced still not feeling well after she got her j&j vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still not feeling well after she got her j&j vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Scratch
Clinical narrative: BRUISING UNDERNEATH WATCH ON ARM OR OTHER EXTREMITIES WHERE THERE WAS PRESSURE; SCRATCHES GET A RED TRAIL LIKE BLOOD BLISTER AND ONE SCRATCH OPENED  UP AND BLED AND DID NOT SCAB OVER IN A NORMAL MANNER AND WAS SLOW TO STOP; This spontaneous report received from a consumer concerned a 7 decade old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was healthy with no comorbidities. 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 JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced bruising underneath watch on arm or other extremities where there was pressure, and scratches get a red trail like blood blister and one scratch opened up and bled and did not scab over in a normal manner and was slow to stop. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising underneath watch on arm or other extremities where there was pressure and scratches get a red trail like blood blister and one scratch opened up and bled and did not scab over in a normal manner and was slow to stop was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 15-SEP-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm at injection site was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram carotid, Asthenia, Blood test, Cardiac disorder, Dizziness
Clinical narrative: LESS ENERGY; FEELING LIGHT HEADED OFF AND ON; PRESSURE IN HEAD OR FEELING OF PRESSURE; NUMBNESS OF THE TONGUE; FELT THE CONDITION (HEART VALVE DISORDER) WORSENED SINCE RECEIVING THE VACCINE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hx heart valve disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced felt the condition (heart valve disorder) worsened since receiving the vaccine. On 08-APR-2021, the subject experienced numbness of the tongue. Treatment medications included: diphenhydramine hydrochloride. On 18-APR-2021, the subject experienced feeling light headed off and on. On 18-APR-2021, the subject experienced pressure in head or feeling of pressure. On 18-MAY-2021, the subject experienced less energy. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Carotid angiogram (NR: not provided) Unknown, Electrocardiogram (NR: not provided) Unknown, and Magnetic resonance imaging (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of the tongue on 08-JUL-2021, had not recovered from feeling light headed off and on, and the outcome of pressure in head or feeling of pressure, less energy and felt the condition (heart valve disorder) worsened since receiving the vaccine was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Head discomfort, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: LESS ENERGY; FEELING LIGHT HEADED OFF AND ON; PRESSURE IN HEAD OR FEELING OF PRESSURE; NUMBNESS OF THE TONGUE; FELT THE CONDITION (HEART VALVE DISORDER) WORSENED SINCE RECEIVING THE VACCINE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hx heart valve disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced felt the condition (heart valve disorder) worsened since receiving the vaccine. On 08-APR-2021, the subject experienced numbness of the tongue. Treatment medications included: diphenhydramine hydrochloride. On 18-APR-2021, the subject experienced feeling light headed off and on. On 18-APR-2021, the subject experienced pressure in head or feeling of pressure. On 18-MAY-2021, the subject experienced less energy. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Carotid angiogram (NR: not provided) Unknown, Electrocardiogram (NR: not provided) Unknown, and Magnetic resonance imaging (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of the tongue on 08-JUL-2021, had not recovered from feeling light headed off and on, and the outcome of pressure in head or feeling of pressure, less energy and felt the condition (heart valve disorder) worsened since receiving the vaccine was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FELT TIRED FOR 24 HOURS; This spontaneous report received from a patient concerned a 66 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: 18G5031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced felt tired for 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired for 24 hours on 18-MAR-2021. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Product dose omission issue
Clinical narrative: She was hospitalized before recieving 2nd dose due to underlying health conditions.; It is already more than 42 days after the first shot / Her specialist advised her not to receive her second dose at this time; This spontaneous case was reported by a pharmacist and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (She was hospitalized before recieving 2nd dose due to underlying health conditions.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (She was hospitalized before recieving 2nd dose due to underlying health conditions.) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (It is already more than 42 days after the first shot / Her specialist advised her not to receive her second dose at this time). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (She was hospitalized before recieving 2nd dose due to underlying health conditions.) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It is already more than 42 days after the first shot / Her specialist advised her not to receive her second dose at this time) 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.   No concomitant medications were provided by the reporter.  Treatment information was not provided.  Company Comment: Very limited information regarding this event/s has been provided at this time. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Additional information received- case upgraded to serious, new event added.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. However, more information is required for further assessment.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malabsorption, Myalgia, Myocarditis, Pharyngeal swelling
Clinical narrative: heart muscle inflammation; swelling in throat/sore throat; gaining weight faster; not metabolizing food; fever 99.4 progressed to 100.6F; sore throughout the body; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (heart muscle inflammation) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19 (Positive For Covid-19). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) for an unknown indication.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-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 MYOCARDITIS (heart muscle inflammation) (seriousness criterion medically significant), PHARYNGEAL SWELLING (swelling in throat/sore throat), WEIGHT INCREASED (gaining weight faster), MALABSORPTION (not metabolizing food), PYREXIA (fever 99.4 progressed to 100.6F) and MYALGIA (sore throughout the body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYOCARDITIS (heart muscle inflammation), WEIGHT INCREASED (gaining weight faster) and MALABSORPTION (not metabolizing food) outcome was unknown and PHARYNGEAL SWELLING (swelling in throat/sore throat), PYREXIA (fever 99.4 progressed to 100.6F) and MYALGIA (sore throughout the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 °f (High) mild fever of 99.4  °F progressed to 100.6.         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history of COVID-19could be a contributory factor.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: TCR document was received on 27-JUL-2021 and contained significant information. Events of heart muscle inflammation, no food metabolizing, and gaining weight faster were 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. However, the medical history of COVID-19could be a contributory factor.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Weight increased
Clinical narrative: heart muscle inflammation; swelling in throat/sore throat; gaining weight faster; not metabolizing food; fever 99.4 progressed to 100.6F; sore throughout the body; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (heart muscle inflammation) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19 (Positive For Covid-19). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) for an unknown indication.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-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 MYOCARDITIS (heart muscle inflammation) (seriousness criterion medically significant), PHARYNGEAL SWELLING (swelling in throat/sore throat), WEIGHT INCREASED (gaining weight faster), MALABSORPTION (not metabolizing food), PYREXIA (fever 99.4 progressed to 100.6F) and MYALGIA (sore throughout the body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYOCARDITIS (heart muscle inflammation), WEIGHT INCREASED (gaining weight faster) and MALABSORPTION (not metabolizing food) outcome was unknown and PHARYNGEAL SWELLING (swelling in throat/sore throat), PYREXIA (fever 99.4 progressed to 100.6F) and MYALGIA (sore throughout the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 °f (High) mild fever of 99.4  °F progressed to 100.6.         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history of COVID-19could be a contributory factor.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: TCR document was received on 27-JUL-2021 and contained significant information. Events of heart muscle inflammation, no food metabolizing, and gaining weight faster were 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. However, the medical history of COVID-19could be a contributory factor.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pain in extremity, Throat tightness
Clinical narrative: Anaphylactic reaction; Tight in my throat; Little bit of pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) from 01-Sep-1995 to an unknown date, BUSPIRONE HYDROCHLORIDE (BUSPAR) from 01-May-2015 to an unknown date and LAMOTRIGINE (LAMICTAL) from 01-Jun-2018 to an unknown date for Depression.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), THROAT TIGHTNESS (Tight in my throat) and PAIN IN EXTREMITY (Little bit of pain in my arm). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and THROAT TIGHTNESS (Tight in my throat) had not resolved and PAIN IN EXTREMITY (Little bit of pain in my arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.  It was reported that patient was diagnosed with Anaphylactic reaction symptoms included sensation of throat closing.  Throat tightening occurred 6-7hours a day which started at morning and lasted up to lunch time.   This case was linked to MOD-2021-240799 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information received on 26-Jul-2021 and included Newreporter details were added, New event Anaphylactic reaction was added, patient demographics updated, concomitant medications indications and dosage details were added, outcome of the event Throat tightness was updated from unknown to recovered and Case was upgraded from non-serious to serious.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information is requested.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Amenorrhoea, Asthenia, Heavy menstrual bleeding, Illness, Oropharyngeal pain
Clinical narrative: started her Periods again on July 13th, 2021 to Still going on which is not normal at all; weakness; sick; Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine; Sore Throat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MEDROXYPROGESTERONE for Menses lack of.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 started MEDROXYPROGESTERONE (unknown route) 10 milligram. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever). In May 2021, the patient experienced AMENORRHOEA (Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine). On 13-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHENIA (weakness) and ILLNESS (sick). The patient was hospitalized on 07-Jul-2021 due to HEAVY MENSTRUAL BLEEDING. On 16-Apr-2021, OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever) had resolved. At the time of the report, HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) had not resolved and AMENORRHOEA (Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine), ASTHENIA (weakness) and ILLNESS (sick) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received on 24 Jul 2021. Patient race added and additional events included.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: started her Periods again on July 13th, 2021 to Still going on which is not normal at all; weakness; sick; Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine; Sore Throat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MEDROXYPROGESTERONE for Menses lack of.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 started MEDROXYPROGESTERONE (unknown route) 10 milligram. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever). In May 2021, the patient experienced AMENORRHOEA (Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine). On 13-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHENIA (weakness) and ILLNESS (sick). The patient was hospitalized on 07-Jul-2021 due to HEAVY MENSTRUAL BLEEDING. On 16-Apr-2021, OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever) had resolved. At the time of the report, HEAVY MENSTRUAL BLEEDING (started her Periods again on July 13th, 2021 to Still going on which is not normal at all) had not resolved and AMENORRHOEA (Patient has not had a menstrual period since her second Moderna Covid-19 Vaccine), ASTHENIA (weakness) and ILLNESS (sick) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received on 24 Jul 2021. Patient race added and additional events included.; 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: Back pain, Blood test, Myocardial infarction
Clinical narrative: Heart Attack; Somebody stab me in the back; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Diabetic (Some members of his family are Diabetic, but he is not.) since an unknown date. Concomitant products included PANTOPRAZOLE, METOPROLOL SUCCINATE (TOPROL), ATORVASTATIN CALCIUM (LIPITROL [ATORVASTATIN CALCIUM]) and TICAGRELOR (BRILINTA) for an unknown indication.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization and medically significant) and BACK PAIN (Somebody stab me in the back). The patient was hospitalized from 14-May-2021 to 16-May-2021 due to MYOCARDIAL INFARCTION. The patient was treated with Surgery (Operation on 14-May-2021) for Myocardial infarction. On 14-May-2021, MYOCARDIAL INFARCTION (Heart Attack) and BACK PAIN (Somebody stab me in the back) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: an enzyme was high (abnormal) An Enzyme was high normal value is around 0.01 and he had it on 2.         Concomitant medications included one additional unspecified medication.  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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Product dose omission issue
Clinical narrative: 2 weeks after getting the 1st dose, he had a stroke; He did not get the 2nd dose because of medical problems; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (2 weeks after getting the 1st dose, he had a stroke) in a 74-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.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), TAMSULOSIN, ATORVASTATIN CALCIUM (LIPITOR) and RIVAROXABAN (XARELTO) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose because of medical problems). In February 2021, the patient experienced CEREBROVASCULAR ACCIDENT (2 weeks after getting the 1st dose, he had a stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (2 weeks after getting the 1st dose, he had a stroke) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose because of medical problems) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included OTC preservision. No treatment information was reported.  Caller was a Pharmacist who has a patient debating whether or not to receive his 2nd dose of the Moderna COVID-19 vaccine. The patient received the 1st dose of the Moderna COVID-19 vaccine on 14-FEB-2021. He did not get the 2nd dose because of medical problems. Per the Pharmacist, 2 weeks after receiving the 1st dose, the patient experienced a stroke and was hospitalized. The caller did not know the details of patient's experience after the 1st dose.  It has been 5 months since the patient received his 1st dose.  This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknow) with AE reported of CVA. Based on the current available information and temporal association between the use of the product and the start date of the event, CVA, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknow) with AE reported of CVA. Based on the current available information and temporal association between the use of the product and the start date of the event, CVA, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Staphylococcal infection
Clinical narrative: developed a staph infection same location of body and worse on backside and face; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (developed a staph infection same location of body and worse on backside and face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-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 STAPHYLOCOCCAL INFECTION (developed a staph infection same location of body and worse on backside and face) (seriousness criterion medically significant), FATIGUE (tired) and HEADACHE (headache). The patient was treated with CEFAZOLIN for Staphylococcal infection, at an unspecified dose and frequency and DOXYCYCLINE for Staphylococcal infection, at an unspecified dose and frequency. At the time of the report, STAPHYLOCOCCAL INFECTION (developed a staph infection same location of body and worse on backside and face), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.            Concomitant medication information included "prescribed medications" that were not specified.   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-2021-265793 (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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Haemorrhage, Hypoaesthesia, Ultrasound scan
Clinical narrative: Superficial bleeding left leg; Numbness in l. arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Superficial bleeding left leg) in a 77-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 Rheumatoid arthritis (gradual improvement) since 1996 and Hypertension (stable) since 2018. Concomitant products included METOPROLOL from 2018 to an unknown date for Hypertension, METHOTREXATE from 1996 to an unknown date and HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) from 1996 to an unknown date for Rheumatoid arthritis.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness in l. arm). On 16-Jun-2021, the patient experienced HAEMORRHAGE (Superficial bleeding left leg) (seriousness criterion medically significant). On 05-Jul-2021, HYPOAESTHESIA (Numbness in l. arm) had resolved. At the time of the report, HAEMORRHAGE (Superficial bleeding left leg) had resolved with sequelae. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: elevated (High) Elevated. In 2021, Ultrasound scan: normal (normal) Normal.         The patient reported that signs of bleeding were still present .Ten days later bleeding in left leg, area 4 in. x 8 in.  Treatment information was 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-2021-163325 (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: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death after vaccination) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.            Concomitant medication and treatment information were not reported.  Company Comment:  Very limited information regarding this event has been provided at this time.   Further information is not expected (Follow up contact denied)   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.   Further information is not expected (Follow up contact denied); Reported Cause(s) of Death: unknown cause of death
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: He passed in his sleep that night.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He passed in his sleep that night.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 22-Jul-2021 The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was given. No treatment information was given. Patient received the 1st dose of the Moderna Covid-19 vaccine. He died in his sleep that night.  This a report of dead one day after the first dose of the product in an 52-year-old patient with no comorbidities. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Sender's Comments: This a report of dead one day after the first dose of the product in an 52-year-old patient with no comorbidities. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death: unknown
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Hypokinesia, Lung disorder, Neuromyelitis optica spectrum disorder
Clinical narrative: weakness; difficulty breathing; unable to move his legs; Lung problem; neuromyletis optica; This spontaneous case was reported by a consumer and describes the occurrence of NEUROMYELITIS OPTICA SPECTRUM DISORDER (neuromyletis optica), ASTHENIA (weakness), DYSPNOEA (difficulty breathing), HYPOKINESIA (unable to move his legs) and LUNG DISORDER (Lung problem) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROMYELITIS OPTICA SPECTRUM DISORDER (neuromyletis optica) (seriousness criteria death, hospitalization and medically significant), ASTHENIA (weakness) (seriousness criteria death and hospitalization), DYSPNOEA (difficulty breathing) (seriousness criteria death and hospitalization), HYPOKINESIA (unable to move his legs) (seriousness criteria death and hospitalization) and LUNG DISORDER (Lung problem) (seriousness criteria death and hospitalization). The patient was hospitalized on 09-Jun-2021 due to ASTHENIA, DYSPNOEA, HYPOKINESIA, LUNG DISORDER and NEUROMYELITIS OPTICA SPECTRUM DISORDER. The patient died on 08-Jul-2021. The reported cause of death was Neuromyelitis optica. It is unknown if an autopsy was performed.            No concomitant medication was reported.  The patient was placed on ventilator and had a tracheotomy tube.  No treatment information was provided.   No laboratory data was provided.  Very limited information regarding the events has been provided at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: Neuromyelitis optica
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast enlargement, Breast swelling, Breast tenderness, Chills
Clinical narrative: breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; breasts enlarged and swollen as well as tender; body and joint pain; Fatigue; body and joint pain; headache; fever; pain at injection site; chills; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EW0217 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 09Jun2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation in Pharmacy or Drug Store. Medical history included COVID-19. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. The patient experienced fatigue, body and joint pain, headache, fever, pain at injection site, chills, swollen lymph nodes, breasts enlarged and swollen as well as tender on 10Jun2021 04:00. Reporter considered the events as non-serious. The patient underwent lab tests and procedures which included COVID-19 antigen test via nasal swab: negative on 07Jul2021. Patient visited Doctor or other healthcare professional office/clinic visit due to the events. Patient did not receive any treatment for the events. The outcome for the events was not recovered. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number ER8730 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 30Jun2021 13:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation.