chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Medication error, Pain in extremity
Clinical narrative: SORENESS REACTION IN ARM LASTED ABOUT THREE WEEKS; RECEIVED J&J VACCINE AS A  BOOSTER AFTER TWO DOSE OF PFIZER-BIONTECH COVID-19 VACCINE; This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type ii diabetes, and other pre-existing medical conditions included: The patient had particular health issues. 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 24-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On 24-JUL-2021, the patient experienced received j&j vaccine as a booster after two dose of pfizer-biontech covid-19 vaccine. On an unspecified date, the patient experienced soreness reaction in arm lasted about three weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness reaction in arm lasted about three weeks, and the outcome of received j&j vaccine as a booster after two dose of pfizer-biontech covid-19 vaccine was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 30 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 (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844, 20210931810, 20210931951, 20210931982, 20210932240, 20210932036, 20210932593, 20210932874, 20210933129 and 20210933076.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 41 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 (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931982, 20210932036, 20210932240, 20210931810, 20210932567, 20210931844, 20210931951, 20210932874, 20210933129 and 20210933076.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain assessment, Pain in extremity, Vision blurred
Clinical narrative: VISION BLURRY OUT IN SUN/VISION PROBLEMS; HEADACHE OVER RIGHT EYE AND MOVES TO BACK OF HEAD/  HEADACHE IS WORSENING; ARM WAS SORE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: bad nerves, high cholesterol, non-alcohol user, non-smoker, and bad back, and other pre-existing medical conditions included: Patient did not have known drug allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced arm was sore. On 28-AUG-2021, the patient experienced vision blurry out in sun/vision problems. On 28-AUG-2021, the patient experienced headache over right eye and moves to back of head/ headache is worsening. Laboratory data included: Pain scale (NR: not provided) 7 out of 10 (10 being the worst). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from arm was sore on 23-AUG-2021, and had not recovered from headache over right eye and moves to back of head/ headache is worsening, and vision blurry out in sun/vision problems. This report was non-serious. This case, from the same reporter is linked to 20210931789.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; JANSSEN COVID-19 VACCINE ADMINISTRATED TO A 15 YEARS OLD GIRL AS AN ACCIDENT; This spontaneous report received from a health care professional concerned a 15 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: 202A21A, and expiry: 31-OCT-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination.  On 16-SEP-2021, the patient experienced off label use. On 16-SEP-2021, the patient experienced janssen covid-19 vaccine administrated to a 15 years old girl as an accident. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and janssen covid-19 vaccine administrated to a 15 years old girl as an accident was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain assessment
Clinical narrative: EXTENDED SORENESS AT SITE OF  INJECTION; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: sleep apnea, cpap, and alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient experienced extended soreness at site of injection. Laboratory data included: Pain scale (NR: not provided) 2-3/10. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 1/10. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from extended soreness at site of injection. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hepatic enzyme increased
Clinical narrative: ELEVATED LIVER ENZYMES; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have any medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced elevated liver enzymes. Laboratory data included: Blood test (NR: not provided) Elevated liver enzymes (did not tell the exact number). The action taken with covid-19 vaccine was not applicable. The outcome of elevated liver enzymes was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE WHOSE EXPIRATION DATE WAS 24-AUG-2021; This spontaneous report received from a health care professional concerned a 25 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 (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced administration of expired vaccine whose expiration date was 24-aug-2021. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine whose expiration date was 24-aug-2021 was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Illness, Lethargy, Lymphadenopathy, Nausea
Clinical narrative: SORENESS IN THE ARM; SWOLLEN GLANDS IN THE NECK; REALLY NAUSEOUS; COULD NOT GET OUT OF BED FOR 3 DAYS; REALLY SICK; VERY LETHARGIC; 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 (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced could not get out of bed for 3 days. On 09-SEP-2021, the patient experienced really sick. On 09-SEP-2021, the patient experienced very lethargic. On 09-SEP-2021, the patient experienced swollen glands in the neck. On 09-SEP-2021, the patient experienced really nauseous. On 10-SEP-2021, the patient experienced soreness in the arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from could not get out of bed for 3 days, really sick, very lethargic, soreness in the arm, swollen glands in the neck, and really nauseous on SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20200314674.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN THE ARM; SWOLLEN GLANDS IN THE NECK; REALLY NAUSEOUS; COULD NOT GET OUT OF BED FOR 3 DAYS; REALLY SICK; VERY LETHARGIC; 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 (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced could not get out of bed for 3 days. On 09-SEP-2021, the patient experienced really sick. On 09-SEP-2021, the patient experienced very lethargic. On 09-SEP-2021, the patient experienced swollen glands in the neck. On 09-SEP-2021, the patient experienced really nauseous. On 10-SEP-2021, the patient experienced soreness in the arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from could not get out of bed for 3 days, really sick, very lethargic, soreness in the arm, swollen glands in the neck, and really nauseous on SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20200314674.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Alopecia, Biopsy skin, Blood test, Burning sensation
Clinical narrative: MORE SENSITIVE TO THE CHEMICAL METHYLISOTHIAZOLINONE AFTER RECEIVING THE VACCINE; LOSING HAIR (HAIR COMING OUT AS WELL); EXTREMELY DRY SKIN PEELS OFF DUE TO THE DRYNESS; CONTINUE BURNING SENSATION; RED BURNING ITCHY RASH ALL OVER ENTIRE BODY LOOKED LIKE IT HAD BEEN SUNBURNT WITH BLISTERS LIKE HAD BEEN IN A BUNCH OF POISON IVY; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies before. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced losing hair (hair coming out as well). On 06-APR-2021, the patient experienced extremely dry skin peels off due to the dryness. On 06-APR-2021, the patient experienced continue burning sensation. On 06-APR-2021, the patient experienced red burning itchy rash all over entire body looked like it had been sunburnt with blisters like had been in a bunch of poison ivy. On 12-JUL-2021, Laboratory data included: Allergy test (NR: not provided) Showed allergy to Methylisothiazolinone. On 14-JUL-2021, Laboratory data included: Allergy test (NR: not provided) Showed allergy to Methylisothiazolinone. On 16-JUL-2021, Laboratory data included: Allergy test (NR: not provided) Showed allergy to Methylisothiazolinone. On 15-SEP-2021, treatment medications included: dupilumab. On an unspecified date, the patient experienced more sensitive to the chemical methylisothiazolinone after receiving the vaccine. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Results not known, and Skin biopsy (NR: not provided) One of the biopsies came back as drug induced allergy. Additional treatment medications (dates unspecified) included: hydroxychloroquine, and prednisone. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from more sensitive to the chemical methylisothiazolinone after receiving the vaccine, losing hair (hair coming out as well), extremely dry skin peels off due to the dryness, continue burning sensation, and red burning itchy rash all over entire body looked like it had been sunburnt with blisters like had been in a bunch of poison ivy. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash pruritic, Reaction to preservatives
Clinical narrative: MORE SENSITIVE TO THE CHEMICAL METHYLISOTHIAZOLINONE AFTER RECEIVING THE VACCINE; LOSING HAIR (HAIR COMING OUT AS WELL); EXTREMELY DRY SKIN PEELS OFF DUE TO THE DRYNESS; CONTINUE BURNING SENSATION; RED BURNING ITCHY RASH ALL OVER ENTIRE BODY LOOKED LIKE IT HAD BEEN SUNBURNT WITH BLISTERS LIKE HAD BEEN IN A BUNCH OF POISON IVY; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergies before. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced losing hair (hair coming out as well). On 06-APR-2021, the patient experienced extremely dry skin peels off due to the dryness. On 06-APR-2021, the patient experienced continue burning sensation. On 06-APR-2021, the patient experienced red burning itchy rash all over entire body looked like it had been sunburnt with blisters like had been in a bunch of poison ivy. On 12-JUL-2021, Laboratory data included: Allergy test (NR: not provided) Showed allergy to Methylisothiazolinone. On 14-JUL-2021, Laboratory data included: Allergy test (NR: not provided) Showed allergy to Methylisothiazolinone. On 16-JUL-2021, Laboratory data included: Allergy test (NR: not provided) Showed allergy to Methylisothiazolinone. On 15-SEP-2021, treatment medications included: dupilumab. On an unspecified date, the patient experienced more sensitive to the chemical methylisothiazolinone after receiving the vaccine. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Results not known, and Skin biopsy (NR: not provided) One of the biopsies came back as drug induced allergy. Additional treatment medications (dates unspecified) included: hydroxychloroquine, and prednisone. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from more sensitive to the chemical methylisothiazolinone after receiving the vaccine, losing hair (hair coming out as well), extremely dry skin peels off due to the dryness, continue burning sensation, and red burning itchy rash all over entire body looked like it had been sunburnt with blisters like had been in a bunch of poison ivy. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 29 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 (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844, 20210932593, 20210932567, 20210932036, 20210932874, 20210933076, 20210931810, 20210931982, 20210931951 and 20210932240.
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness, Somnolence
Clinical narrative: FEELING SLEEPISH; SLUGGISH; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced feeling sleepish. On 16-SEP-2021, the patient experienced sluggish. The action taken with covid-19 vaccine was not applicable. The outcome of the feeling sleepish and sluggish was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931931.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: PREGNANT FOR ALMOST TWO WEEKS WHEN VACCINATED; This spontaneous pregnancy report received from a patient 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. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On AUG-2021, the patient experienced pregnant for almost two weeks when vaccinated. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pregnant for almost two weeks when vaccinated. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Energy increased, Fatigue, Hyperhidrosis
Clinical narrative: LOSS OF APPETITE; INSOMNIA; CONSTANT SWEATING; BURST OF ENERGY; LOST 12 POUNDS; CHILLS; WAVES OF FATIGUE; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced loss of appetite. On SEP-2021, the patient experienced insomnia. On SEP-2021, the patient experienced constant sweating. On SEP-2021, the patient experienced burst of energy. On SEP-2021, the patient experienced lost 12 pounds. On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced waves of fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills on SEP-2021, and had not recovered from loss of appetite, insomnia, constant sweating, burst of energy, lost 12 pounds, and waves of fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Weight decreased
Clinical narrative: LOSS OF APPETITE; INSOMNIA; CONSTANT SWEATING; BURST OF ENERGY; LOST 12 POUNDS; CHILLS; WAVES OF FATIGUE; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced loss of appetite. On SEP-2021, the patient experienced insomnia. On SEP-2021, the patient experienced constant sweating. On SEP-2021, the patient experienced burst of energy. On SEP-2021, the patient experienced lost 12 pounds. On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced waves of fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills on SEP-2021, and had not recovered from loss of appetite, insomnia, constant sweating, burst of energy, lost 12 pounds, and waves of fatigue. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Papule, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: itchy; light raxh appeared slowly on the top of both forearms; some bumps on chest/tops of his forearms had bumps; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (some bumps on chest/tops of his forearms had bumps), PRURITUS (itchy) and RASH (light raxh appeared slowly on the top of both forearms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy (Anti Fungal Creams).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PAPULE (some bumps on chest/tops of his forearms had bumps) and RASH (light raxh appeared slowly on the top of both forearms). On 10-Mar-2021, the patient experienced PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. On 14-Mar-2021, PAPULE (some bumps on chest/tops of his forearms had bumps) and RASH (light raxh appeared slowly on the top of both forearms) had resolved. At the time of the report, PRURITUS (itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jun-2020, SARS-CoV-2 test: positive (Positive) PCR(Twice).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Patient got second dose on 19-MAR-2021 on right arm, batch number was 044A21A.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter address, race, medical history, lab data were added. Second dose information, treatment medication, new event were added, outcome of the events were updated to resolved. Event start date and stop updated
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.  The patient was down in bed for 2 days.   This case was linked to MOD-2021-042782 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; 102 degree fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (102 degree fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (102 degree fever). At the time of the report, CHILLS (chills) and PYREXIA (102 degree fever) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm; the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm) and DEVICE CONNECTION ISSUE (the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm) and DEVICE CONNECTION ISSUE (the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm). At the time of the report, UNDERDOSE (the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm) and DEVICE CONNECTION ISSUE (the needle on the syringe was loose and as the vaccine was injected, the liquid could be seen dripping down the patient's arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication provided
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Cough, Illness, Pyrexia
Clinical narrative: start sick on Monday I deal sick; cofing; chase paint; with fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (start sick on Monday I deal sick), COUGH (cofing), CHEST PAIN (chase paint) and PYREXIA (with fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (start sick on Monday I deal sick), COUGH (cofing), CHEST PAIN (chase paint) and PYREXIA (with fever). At the time of the report, ILLNESS (start sick on Monday I deal sick), COUGH (cofing), CHEST PAIN (chase paint) and PYREXIA (with fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported; Sender's Comments: This case concerns a patient without identifiers, who experienced the expected  event of pyrexia and unexpected events of illness, cough and chest pain . The event occurred after a dose of of mRNA-1273 Moderna vaccine. (onset date of events were unknown)  The events was considered related to the product per the reporter´s assessment.  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Paralysis
Clinical narrative: paralysis; Excruating leg pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (paralysis) and PAIN IN EXTREMITY (Excruating leg pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (paralysis) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Excruating leg pain) (seriousness criterion medically significant). At the time of the report, PARALYSIS (paralysis) and PAIN IN EXTREMITY (Excruating leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       CONCOMITANT INFORMATION NOT PROVIDED  TREATMENT INFORMATION WERE NOT PROVIDED  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days from first vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days from first vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received contains no new information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Vaccination complication
Clinical narrative: Extremely weak; I was so weak that I actually fell; Reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely weak), FALL (I was so weak that I actually fell) and VACCINATION COMPLICATION (Reaction) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Extremely weak), FALL (I was so weak that I actually fell) and VACCINATION COMPLICATION (Reaction). At the time of the report, ASTHENIA (Extremely weak), FALL (I was so weak that I actually fell) and VACCINATION COMPLICATION (Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments medications was reported.   This case was linked to MOD-2021-250426 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021 contains: No new information regarding first dose On 10-Aug-2021: Follow up received and does not contain any new information. On 12-Aug-2021: Follow up included no new information On 25-Aug-2021: Follow up contains additional dose 2 events reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypertension, Irritable bowel syndrome, Neck pain
Clinical narrative: Severe lHBp; Pneck pain along with blood pressure; Fatigue; Irritable bowel syndrome; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Severe lHBp), IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome), NECK PAIN (Pneck pain along with blood pressure) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome). On an unknown date, the patient experienced HYPERTENSION (Severe lHBp), NECK PAIN (Pneck pain along with blood pressure) and FATIGUE (Fatigue). At the time of the report, HYPERTENSION (Severe lHBp), NECK PAIN (Pneck pain along with blood pressure) and FATIGUE (Fatigue) outcome was unknown and IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received added events.; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Difficulty breathing; patient experienced extreme dizziness; Chest discomfort; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), DIZZINESS (patient experienced extreme dizziness), CHEST DISCOMFORT (Chest discomfort) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004921A) for COVID-19 vaccination.     The patient's past medical history included Hives and Hay fever. Concurrent medical conditions included Asthma. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort) and FATIGUE (Tired). On 16-Jul-2021 at 10:30 AM, the patient experienced DIZZINESS (patient experienced extreme dizziness). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with PREDNISONE from 16-Jul-2021 to 14-Aug-2021 for Adverse event, at a dose of 5 milligram. On 16-Jul-2021, CHEST DISCOMFORT (Chest discomfort) and FATIGUE (Tired) had resolved. On 16-Jul-2021 at 11:00 AM, DIZZINESS (patient experienced extreme dizziness) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient 's allergic reactions included  Anaphylaxis.  The patient took an antihistamine before receiving the vaccine and drank a lot of water once at home after the vaccination.  Patient received the second dose of Moderna Vaccine on 14-AUG-2021 on the left arm.  Treatment medication included Prednisone in which the patient was continuing still on a dose of 5 milligram.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated the primary reporter's phone number, added the patient details (height, weight, ethnicity and race), medical history, concomitant medication, treatment medication, event (dyspnea), updated the events date and outcome and added information in I-narrative supplement.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Loosing feeling in my leg and feet; Tingli ness in leg/ tingly ness throughout my finger tips and legs and feet.; Loose feeling in it and my feet would randomly get cold cold; Tiredness; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Loosing feeling in my leg and feet), PARAESTHESIA (Tingli ness in leg/ tingly ness throughout my finger tips and legs and feet.), LIMB DISCOMFORT (Loose feeling in it and my feet would randomly get cold cold), FATIGUE (Tiredness) and ARTHRALGIA (joint pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Loosing feeling in my leg and feet), PARAESTHESIA (Tingli ness in leg/ tingly ness throughout my finger tips and legs and feet.), LIMB DISCOMFORT (Loose feeling in it and my feet would randomly get cold cold), FATIGUE (Tiredness) and ARTHRALGIA (joint pain). At the time of the report, HYPOAESTHESIA (Loosing feeling in my leg and feet), PARAESTHESIA (Tingli ness in leg/ tingly ness throughout my finger tips and legs and feet.), LIMB DISCOMFORT (Loose feeling in it and my feet would randomly get cold cold), FATIGUE (Tiredness) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant follow-up received. new events added (limb discomfort, Paraesthesia, fatigue).
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Heart rate went up and went back to normal; Went to sleep and his heart started pounding and it woke him up; This spontaneous case was reported by a consumer and describes the occurrence of Heart rate went up and went back to normal and PALPITATIONS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced Heart rate went up and went back to normal and PALPITATIONS. At the time of the report, Heart rate went up and went back to normal and PALPITATIONS was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient stated everything was fine now.   Most recent FOLLOW-UP information incorporated above included On 08-Sep-2021 AE Outcome updated.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Pain in his left sciatic nerve (on his left leg); This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Pain in his left sciatic nerve (on his left leg)) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Surgery (Surgery for left sciatic nerve) in 2015.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SCIATICA (Pain in his left sciatic nerve (on his left leg)). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, SCIATICA (Pain in his left sciatic nerve (on his left leg)) had resolved.            No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Non significant follow-up appended as there is no new information added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site Arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site Arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site Arm) outcome was unknown.            No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-265242 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow-up received on 14 Seo 2021  included no new information
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Methylenetetrahydrofolate reductase gene mutation, Pain in extremity, Product dose omission issue
Clinical narrative: she was diagnosed with MTHFR - a DNA condition; More than 35 days after the first dose without receiving the second dose; Pain in hand; discomfort in liver; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (discomfort in liver), PAIN IN EXTREMITY (Pain in hand), METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (she was diagnosed with MTHFR - a DNA condition) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (discomfort in liver). On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in hand). On an unknown date, the patient experienced METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (she was diagnosed with MTHFR - a DNA condition) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, ABDOMINAL DISCOMFORT (discomfort in liver), PAIN IN EXTREMITY (Pain in hand) and METHYLENETETRAHYDROFOLATE REDUCTASE GENE MUTATION (she was diagnosed with MTHFR - a DNA condition) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: follow up received added events More than 35 days after the first dose without receiving the second dose and she was diagnosed with MTHFR - a DNA condition
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient didn't receive the second dose; This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient didn't receive the second dose) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient didn't receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient didn't receive the second dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  The patient did not experience any adverse events/reactions after first dose. She states that she still has not received the second dose.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: follow up received: outcome of the event was updated to not recovered, narrative information was updated.