chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Antibody test, Blepharitis, Fatigue, General physical condition
Clinical narrative: EYELIDS WERE INFLAMED; DIFFICULTY SLEEPING; FATIGUE; HEAD TINGLING; PERIPHERAL NEUROPATHY; ADVERSE EVENT; This spontaneous report received from a patient concerned a 55 year old adult female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in JUN-2020, and concurrent conditions included: non-smoker. The patient had no history of drug abuse or illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A expiry: unknown) dose was not reported, 01 total administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient mentioned that, she had already contracted covid in JUN-2020, but took the shot for preventive purposes even though she had antibodies in December 2020. On 04-MAY-2021, the patient experienced adverse event. On 04-MAY-2021 patient had her wellness exam and she told the doctor that her head, feet and hands were tingling. She was told to give it 6-8 weeks to see if symptoms subside. The symptoms did not go away after 6 weeks and were getting worse. Her obstetrician-gynecologists (OBGYN) sent her to the primary care physician (PCP) and they did not give her much to help. In JUL-2021 patient went to a neurologist because her symptoms were getting progressively worse. Patient was going to a neurologist, acupuncturist and even an ophthalmologist because her eye lids were inflamed. She has had 3 magnetic resonance imaging tests (MRIs), a spinal tap, and among other tests with nothing was coming back positive. The patient was told that she is suffering from peripheral neuropathy. While she was getting better, it was still a struggle and it took an emotional and financial toll on her. The patient was treated with Gabapentin and Cymbalta. She had difficulty sleeping, and was fatigued.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping, and was recovering from adverse event, peripheral neuropathy, eyelids were inflamed, fatigue, and head tingling. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211136843- COVID-19 VACCINE AD26.COV2.S-peripheral neuropathy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Laboratory test, Lumbar puncture, Magnetic resonance imaging, Neuropathy peripheral
Clinical narrative: EYELIDS WERE INFLAMED; DIFFICULTY SLEEPING; FATIGUE; HEAD TINGLING; PERIPHERAL NEUROPATHY; ADVERSE EVENT; This spontaneous report received from a patient concerned a 55 year old adult female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in JUN-2020, and concurrent conditions included: non-smoker. The patient had no history of drug abuse or illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A expiry: unknown) dose was not reported, 01 total administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient mentioned that, she had already contracted covid in JUN-2020, but took the shot for preventive purposes even though she had antibodies in December 2020. On 04-MAY-2021, the patient experienced adverse event. On 04-MAY-2021 patient had her wellness exam and she told the doctor that her head, feet and hands were tingling. She was told to give it 6-8 weeks to see if symptoms subside. The symptoms did not go away after 6 weeks and were getting worse. Her obstetrician-gynecologists (OBGYN) sent her to the primary care physician (PCP) and they did not give her much to help. In JUL-2021 patient went to a neurologist because her symptoms were getting progressively worse. Patient was going to a neurologist, acupuncturist and even an ophthalmologist because her eye lids were inflamed. She has had 3 magnetic resonance imaging tests (MRIs), a spinal tap, and among other tests with nothing was coming back positive. The patient was told that she is suffering from peripheral neuropathy. While she was getting better, it was still a struggle and it took an emotional and financial toll on her. The patient was treated with Gabapentin and Cymbalta. She had difficulty sleeping, and was fatigued.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping, and was recovering from adverse event, peripheral neuropathy, eyelids were inflamed, fatigue, and head tingling. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211136843- COVID-19 VACCINE AD26.COV2.S-peripheral neuropathy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: EYELIDS WERE INFLAMED; DIFFICULTY SLEEPING; FATIGUE; HEAD TINGLING; PERIPHERAL NEUROPATHY; ADVERSE EVENT; This spontaneous report received from a patient concerned a 55 year old adult female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in JUN-2020, and concurrent conditions included: non-smoker. The patient had no history of drug abuse or illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A expiry: unknown) dose was not reported, 01 total administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient mentioned that, she had already contracted covid in JUN-2020, but took the shot for preventive purposes even though she had antibodies in December 2020. On 04-MAY-2021, the patient experienced adverse event. On 04-MAY-2021 patient had her wellness exam and she told the doctor that her head, feet and hands were tingling. She was told to give it 6-8 weeks to see if symptoms subside. The symptoms did not go away after 6 weeks and were getting worse. Her obstetrician-gynecologists (OBGYN) sent her to the primary care physician (PCP) and they did not give her much to help. In JUL-2021 patient went to a neurologist because her symptoms were getting progressively worse. Patient was going to a neurologist, acupuncturist and even an ophthalmologist because her eye lids were inflamed. She has had 3 magnetic resonance imaging tests (MRIs), a spinal tap, and among other tests with nothing was coming back positive. The patient was told that she is suffering from peripheral neuropathy. While she was getting better, it was still a struggle and it took an emotional and financial toll on her. The patient was treated with Gabapentin and Cymbalta. She had difficulty sleeping, and was fatigued.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping, and was recovering from adverse event, peripheral neuropathy, eyelids were inflamed, fatigue, and head tingling. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211136843- COVID-19 VACCINE AD26.COV2.S-peripheral neuropathy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, smoker, drug abuse, and asthma, and other pre-existing medical conditions included: she is neither pregnant at time of vaccination nor on breastfeeding and unknown for acute illness or hospitalization 30 days prior to vaccination. No risk factors and no family history of any disease (relevant to vaccination). The patient had no illness at time of vaccination and no past history of similar event. She did not have adverse event after any previous vaccination. The patient experienced hives when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 21-SEP-2021) 0.5 ml, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211137983 and 20210955494.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Adverse event, Panic attack
Clinical narrative: TOTALLY PANIC STRICKEN; OTHER SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: active cancer. 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. Non-company suspect vaccine included: bnt 162 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced totally panic stricken, and other symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the totally panic stricken and other symptoms was not reported. This report was non-serious. This report was associated with product quality complaint.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: INTERMITTENT STOMACH PAIN/STOMACH PAIN ON AND OFF; DIARRHEA; SWEATING; GONE TO THE WORLD; CHILLS; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: stomach ulcer, and bee stings allergy. The patient experienced drug allergy when treated with cefaclor for bee stings allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-NOV-2021, the patient experienced sweating. On 12-NOV-2021, the patient experienced gone to the world. On 12-NOV-2021, the patient experienced chills. On 12-NOV-2021, the patient experienced fatigue. On 12-NOV-2021, the patient experienced fever. On 15-NOV-2021, the patient experienced diarrhea. On 16-NOV-2021, the patient experienced intermittent stomach pain/stomach pain on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, gone to the world, chills, fatigue, and fever on 14-NOV-2021, was recovering from diarrhea, and had not recovered from intermittent stomach pain/stomach pain on and off. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: INTERMITTENT STOMACH PAIN/STOMACH PAIN ON AND OFF; DIARRHEA; SWEATING; GONE TO THE WORLD; CHILLS; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: stomach ulcer, and bee stings allergy. The patient experienced drug allergy when treated with cefaclor for bee stings allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-NOV-2021, the patient experienced sweating. On 12-NOV-2021, the patient experienced gone to the world. On 12-NOV-2021, the patient experienced chills. On 12-NOV-2021, the patient experienced fatigue. On 12-NOV-2021, the patient experienced fever. On 15-NOV-2021, the patient experienced diarrhea. On 16-NOV-2021, the patient experienced intermittent stomach pain/stomach pain on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, gone to the world, chills, fatigue, and fever on 14-NOV-2021, was recovering from diarrhea, and had not recovered from intermittent stomach pain/stomach pain on and off. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Bursitis, Fatigue, Hypersomnia
Clinical narrative: LETHARGIC; BURSITIS IN LEFT SHOULDER; FALLS ASLEEP A LOT WHEN SITTING DOWN AND WATCHING TV; PAIN IN ARM; PAIN AT INJECTION SITE; FEELS OVERALL MUCH WEAKER AND CAN NO LONGER DO A PUSHUP; TIRED; ANXIETY; HEART PALPITATIONS/POUNDING; LOST 10 POUNDS; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 158 pounds, and height was 70 inches. The patient's concurrent conditions included: no alcohol use, and smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the patient experienced lost 10 pounds. On 08-APR-2021, the patient experienced anxiety. On 08-APR-2021, the patient experienced heart palpitations/pounding. On an unspecified date, the patient experienced lethargic, bursitis in left shoulder, falls asleep a lot when sitting down and watching tv, pain in arm, pain at injection site, feels overall much weaker and can no longer do a pushup, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anxiety, and heart palpitations/pounding, had not recovered from lethargic, lost 10 pounds, bursitis in left shoulder, pain at injection site, feels overall much weaker and can no longer do a pushup, and pain in arm, and the outcome of tired and falls asleep a lot when sitting down and watching tv was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Pain in extremity, Palpitations, Weight decreased
Clinical narrative: LETHARGIC; BURSITIS IN LEFT SHOULDER; FALLS ASLEEP A LOT WHEN SITTING DOWN AND WATCHING TV; PAIN IN ARM; PAIN AT INJECTION SITE; FEELS OVERALL MUCH WEAKER AND CAN NO LONGER DO A PUSHUP; TIRED; ANXIETY; HEART PALPITATIONS/POUNDING; LOST 10 POUNDS; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 158 pounds, and height was 70 inches. The patient's concurrent conditions included: no alcohol use, and smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the patient experienced lost 10 pounds. On 08-APR-2021, the patient experienced anxiety. On 08-APR-2021, the patient experienced heart palpitations/pounding. On an unspecified date, the patient experienced lethargic, bursitis in left shoulder, falls asleep a lot when sitting down and watching tv, pain in arm, pain at injection site, feels overall much weaker and can no longer do a pushup, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anxiety, and heart palpitations/pounding, had not recovered from lethargic, lost 10 pounds, bursitis in left shoulder, pain at injection site, feels overall much weaker and can no longer do a pushup, and pain in arm, and the outcome of tired and falls asleep a lot when sitting down and watching tv was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: EXTREMELY SICK FOR ALMOST THREE DAYS; HEADACHE FOR 6; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced extremely sick for almost three days, and headache for 6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely sick for almost three days, and headache for 6. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 28-OCT-2021) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211139710.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOT; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced clot after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211139236 -covid-19 vaccine ad26.cov2.s- clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART DAMAGE; This spontaneous report received from a patient via a company representative via a social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart damage was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Headache, Pyrexia
Clinical narrative: CHEST PAIN; PRETTY BAD HEADACHE; FEVER AS HIGH AS 103 DEGREES; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no medical history. Patient had no known allergies and no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced fever as high as 103 degrees. On 15-NOV-2021, the patient experienced pretty bad headache. Laboratory data included: Body temperature (NR: not provided) 103 degrees. On 17-NOV-2021, the patient experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever as high as 103 degrees, and pretty bad headache on NOV-2021, and had not recovered from chest pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT LIKE POO FOR 2 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. 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. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt like poo for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like poo for 2 days. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED FOR A DAY; This spontaneous report received from a patient via a company representative (via social media) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced tired for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired for a day. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Catheterisation cardiac, Coronary artery disease, Echocardiogram, Ejection fraction
Clinical narrative: NONOBSTRUCTIVE CORONARY ARTERY DISEASE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: leaky valve (mild), non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient did not have any no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1052068 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the patient experienced nonobstructive coronary artery disease. Laboratory data included: Echocardiogram (NR: not provided) low HR in the upper 40's low EF. On 11-MAY-2021, Laboratory data included: Stress test (NR: not provided) ejection fraction back mid 60's. On 02-JUN-2021, Laboratory data included: Cardiac catheterization (NR: not provided) detect no any issues with heart. Laboratory data (dates unspecified) included: Cardiac catheterization (NR: not provided) nonobstructive CAD, Echocardiogram (NR: not provided) Leaky valve (mild), and Ejection fraction (NR: not provided) normal rate in the mid 60's. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nonobstructive coronary artery disease was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: TEMPERATURE EXCURSION BETWEEN 49.82  TO 51.26 DEGREES FOR 48 HOURS; ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-NOV-2021, the patient experienced temperature excursion between 49.82 to 51.26 degrees for 48 hours. On 16-NOV-2021, the patient experienced administration of vaccine stored outside of the recommended storage condition. On 16-NOV-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion between 49.82 to 51.26 degrees for 48 hours, administration of vaccine stored outside of the recommended storage condition and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20211139517.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITION; TEMPERATURE EXCURSION BETWEEN 46.04 TO 49 DEGREES FOR 24 HOURS AND THEN PUT IN REFRIGERATOR; This spontaneous report received from a health care professional concerned multiple patients.  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: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 15-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-NOV-2021, the patient experienced administration of vaccine stored outside of the recommended storage condition, and temperature excursion between 46.04 to 49 degrees for 24 hours and then put in refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine stored outside of the recommended storage condition and temperature excursion between 46.04 to 49 degrees for 24 hours and then put in refrigerator was not reported. This report was non-serious. This case, from the same reporter is linked to 20211139494.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: ARM HURT; FELT TIRED; LITTLE NAUSEA; 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: Unk) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced arm hurt, felt tired, and little nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and felt tired, and the outcome of little nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had been tested months before and was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED (PUNCTURED VIAL OF VACCINE WAS EXPIRED FOR 6 HOURS PRIOR TO BEING ADMINISTERED); This spontaneous report received from a consumer concerned an 83 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 28-OCT-2021) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-OCT-2021, the patient experienced expired vaccine administered (punctured vial of vaccine was expired for 6 hours prior to being administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (punctured vial of vaccine was expired for 6 hours prior to being administered) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211139224.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: DON'T HAVE FEELING IN 2 FINGERS OF SAME ARM; 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 was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced don't have feeling in 2 fingers of same arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from don't have feeling in 2 fingers of same arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER; BARFED; 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. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, and barfed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and barfed was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE OUTSIDE OF THE RECOMMENDED HOLD TIME; This spontaneous report received from a pharmacist concerned multiple patients. 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-NOV-2021, the patient experienced administration of vaccine outside of the recommended hold time. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine outside of the recommended hold time and incorrect product storage was not reported. This report was non-serious. .
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Gait inability, Vomiting
Clinical narrative: CANT WALK; BURNING WITH FEVER; CANT KEEP FOOD DOWN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced cant walk, burning with fever, and cant keep food down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cant walk, burning with fever, and cant keep food down. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Blood test, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: MUSCLE/SKELETON INFLAMMATION; SEVERE REACTION; SEVERE CHEST PAIN; BAD LEG CRAMPS IN LEFT LEG; SHARP PAIN IN UPPER RIGHT SIDE CLOSE TO LIVER; SHARP PAIN IN UPPER RIGHT SIDE CLOSE TO RIB; THREW UP; SPEECH ISSUES; TIREDNESS; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 44 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: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced sore arm. On 29-SEP-2021, the patient experienced headache. On 30-SEP-2021, the patient experienced tiredness. On 01-OCT-2021, the patient experienced speech issues. On 04-OCT-2021, the patient experienced bad leg cramps in left leg. On 04-OCT-2021, the patient experienced sharp pain in upper right side close to liver. On 04-OCT-2021, the patient experienced sharp pain in upper right side close to rib. On 04-OCT-2021, the patient experienced threw up. On 05-OCT-2021, the patient experienced severe chest pain. On 05-OCT-2021, the patient experienced severe reaction. On an unspecified date, the patient experienced muscle/skeleton inflammation. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, Echocardiogram (NR: not provided) Normal, Electrocardiogram (NR: not provided) Normal, and Fibrin D dimer (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from speech issues, bad leg cramps in left leg, and tiredness, sore arm on 29-SEP-2021, and headache on 01-OCT-2021, was recovering from severe chest pain, had not recovered from sharp pain in upper right side close to liver, and sharp pain in upper right side close to rib, and the outcome of threw up, severe reaction and muscle/skeleton inflammation was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer, Headache, Hepatic pain, Muscle spasms
Clinical narrative: MUSCLE/SKELETON INFLAMMATION; SEVERE REACTION; SEVERE CHEST PAIN; BAD LEG CRAMPS IN LEFT LEG; SHARP PAIN IN UPPER RIGHT SIDE CLOSE TO LIVER; SHARP PAIN IN UPPER RIGHT SIDE CLOSE TO RIB; THREW UP; SPEECH ISSUES; TIREDNESS; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 44 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: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced sore arm. On 29-SEP-2021, the patient experienced headache. On 30-SEP-2021, the patient experienced tiredness. On 01-OCT-2021, the patient experienced speech issues. On 04-OCT-2021, the patient experienced bad leg cramps in left leg. On 04-OCT-2021, the patient experienced sharp pain in upper right side close to liver. On 04-OCT-2021, the patient experienced sharp pain in upper right side close to rib. On 04-OCT-2021, the patient experienced threw up. On 05-OCT-2021, the patient experienced severe chest pain. On 05-OCT-2021, the patient experienced severe reaction. On an unspecified date, the patient experienced muscle/skeleton inflammation. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, Echocardiogram (NR: not provided) Normal, Electrocardiogram (NR: not provided) Normal, and Fibrin D dimer (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from speech issues, bad leg cramps in left leg, and tiredness, sore arm on 29-SEP-2021, and headache on 01-OCT-2021, was recovering from severe chest pain, had not recovered from sharp pain in upper right side close to liver, and sharp pain in upper right side close to rib, and the outcome of threw up, severe reaction and muscle/skeleton inflammation was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Musculoskeletal disorder, Pain in extremity, Speech disorder, Vomiting
Clinical narrative: MUSCLE/SKELETON INFLAMMATION; SEVERE REACTION; SEVERE CHEST PAIN; BAD LEG CRAMPS IN LEFT LEG; SHARP PAIN IN UPPER RIGHT SIDE CLOSE TO LIVER; SHARP PAIN IN UPPER RIGHT SIDE CLOSE TO RIB; THREW UP; SPEECH ISSUES; TIREDNESS; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 44 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: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced sore arm. On 29-SEP-2021, the patient experienced headache. On 30-SEP-2021, the patient experienced tiredness. On 01-OCT-2021, the patient experienced speech issues. On 04-OCT-2021, the patient experienced bad leg cramps in left leg. On 04-OCT-2021, the patient experienced sharp pain in upper right side close to liver. On 04-OCT-2021, the patient experienced sharp pain in upper right side close to rib. On 04-OCT-2021, the patient experienced threw up. On 05-OCT-2021, the patient experienced severe chest pain. On 05-OCT-2021, the patient experienced severe reaction. On an unspecified date, the patient experienced muscle/skeleton inflammation. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, Echocardiogram (NR: not provided) Normal, Electrocardiogram (NR: not provided) Normal, and Fibrin D dimer (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from speech issues, bad leg cramps in left leg, and tiredness, sore arm on 29-SEP-2021, and headache on 01-OCT-2021, was recovering from severe chest pain, had not recovered from sharp pain in upper right side close to liver, and sharp pain in upper right side close to rib, and the outcome of threw up, severe reaction and muscle/skeleton inflammation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: can you get the vaccine while pregnant?; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (can you get the vaccine while pregnant?) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (can you get the vaccine while pregnant?). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (can you get the vaccine while pregnant?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon internal review on 17-Nov-2021 Gender should be female, pregnancy type, Birth type and Fetal outcome are Corrected
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Myalgia
Clinical narrative: back pain; trouble walking; Had a severe, severe, severe muscle pain across her back and is on going; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), GAIT DISTURBANCE (trouble walking) and MYALGIA (Had a severe, severe, severe muscle pain across her back and is on going) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 003A21A and 031L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLULAVAL QUADRIVALENT and SHINGRIX. Concurrent medical conditions included Blood pressure high (not sure when first diagnosed.), Reflux gastritis, Penicillin allergy and Drug allergy (Septra). Concomitant products included LISINOPRIL for Blood pressure high, PANTOPRAZOLE SODIUM for Gastroesophageal reflux.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced BACK PAIN (back pain), GAIT DISTURBANCE (trouble walking) and MYALGIA (Had a severe, severe, severe muscle pain across her back and is on going). The patient was treated with PARACETAMOL (TYLENOL A) for Pain, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain), GAIT DISTURBANCE (trouble walking) and MYALGIA (Had a severe, severe, severe muscle pain across her back and is on going) had not resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-161898, US-MODERNATX, INC.-MOD-2021-161897 (E2B Linked Report). This case was linked to MOD-2021-377102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up received (information regarding seriousness, concomitant and treatment medication included).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-161898:(No subject)  US-MODERNATX, INC.-MOD-2021-161897: