chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: PATIENT DOSED FROM A VIAL OPENED THE PREVIOUS DAY; This spontaneous report received from a health care professional 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: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAY-2021, the subject experienced subject dosed from a vial opened the previous day. The action taken with covid-19 vaccine was not applicable. The outcome of patient dosed from a vial opened the previous day was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, COVID-19, Dizziness
Clinical narrative: DIZZINESS; NAUSEA; LOSS OF SMELL; LOSS OF TASTE; JOINT PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid19, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies and had no breastfeeding. The patient had emergency room for an allergic reaction 10 years ago. The patient took an unspecified high blood pressure medication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095 and expiry: 04-JUL-2021) dose was not reported, administered on 28-MAY-2021 18:30 for prophylactic vaccination. No concomitant medications were reported.  On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 29-MAY-2021, the subject experienced loss of smell. On 29-MAY-2021, the subject experienced loss of taste. On 29-MAY-2021, the subject experienced joint pain. On 30-MAY-2021, the subject experienced dizziness. On 30-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of smell, loss of taste, and joint pain on 29-MAY-2021, and had not recovered from dizziness, and nausea. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: DIZZINESS; NAUSEA; LOSS OF SMELL; LOSS OF TASTE; JOINT PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid19, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies and had no breastfeeding. The patient had emergency room for an allergic reaction 10 years ago. The patient took an unspecified high blood pressure medication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095 and expiry: 04-JUL-2021) dose was not reported, administered on 28-MAY-2021 18:30 for prophylactic vaccination. No concomitant medications were reported.  On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 29-MAY-2021, the subject experienced loss of smell. On 29-MAY-2021, the subject experienced loss of taste. On 29-MAY-2021, the subject experienced joint pain. On 30-MAY-2021, the subject experienced dizziness. On 30-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of smell, loss of taste, and joint pain on 29-MAY-2021, and had not recovered from dizziness, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; 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  (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine  was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210557803.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included developmentally disabled. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000181533.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: RESIDENCE AND STAFF MEMBERS WERE ADMINISTERED VACCINE, WHICH WAS NOT VIABLE AT THE TIME; OUT OF COLD CHAIN/OUT OF TEMPERATURE RANGE; This spontaneous report received from a pharmacist concerned 56 patients.  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 expiry date: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced residence and staff members were administered vaccine, which was not viable at the time, and out of cold chain/out of temperature range. The action taken with covid-19 vaccine  was not applicable. The outcome of the residence and staff members were administered vaccine, which was not viable at the time and out of cold chain/out of temperature range was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: RECEIVED VACCINE WHICH MAY HAVE BEEN INCORRECTLY STORED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced incorrectly storage of vaccine. The action taken with covid-19 vaccine  was not applicable. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: ACHY LEGS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. 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 did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with guaifenesin for hyperactivity.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: LC1820095 expiry: 04-JUL-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced achy legs. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills on 02-JUN-2021, and had not recovered from headache, fever, and achy legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a 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: 1805031 expiry: 27-MAY-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  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 20210605676.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM REALLY HURTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205821A, and batch number: 205821A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: ibuprofen, and paracetamol. On 18-MAY-2021, the subject experienced arm really hurts. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm really hurts. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: MILD BODY ACHE; MILD FEVER; SWELLING THE SIZE OF A FIST ON LEFT ARMPIT/ SWELLING THE SIZE OF A GOLF BALL ON RIGHT ARMPIT; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 230 pounds, and height was 180.34 centimeters. The patient's pre-existing medical conditions included patient had no known drug allergies and no pre-existing conditions. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced swelling the size of a fist on left armpit/ swelling the size of a golf ball on right armpit. On 31-MAY-2021, the subject experienced mild body ache. On 31-MAY-2021, the subject experienced mild fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from mild body ache, and mild fever on 01-JUN-2021, and had not recovered from swelling the size of a fist on left armpit/ swelling the size of a golf ball on right armpit. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram, Headache, Magnetic resonance imaging, Pyrexia
Clinical narrative: HAVING ISSUES SPEAKING; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 24 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: Unk) dose was not reported, administered on 21-MAY-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 MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100/101 F, CT scan (NR: not provided) No blood clots, and MRI (NR: not provided) No blood clots. On 21-MAY-2021, the subject experienced having issues speaking. The action taken with covid-19 vaccine  was not applicable. The outcome of the having issues speaking, fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: HAVING ISSUES SPEAKING; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 24 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: Unk) dose was not reported, administered on 21-MAY-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 MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100/101 F, CT scan (NR: not provided) No blood clots, and MRI (NR: not provided) No blood clots. On 21-MAY-2021, the subject experienced having issues speaking. The action taken with covid-19 vaccine  was not applicable. The outcome of the having issues speaking, fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash
Clinical narrative: ITCHINESS; BODY RASH; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hives, and brown recluse spider bite. The patient was previously treated with diphenhydramine hydrochloride for hives, and dexamethasone for hives. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced headache. On 24-MAY-2021, the subject experienced itchiness. On 24-MAY-2021, the subject experienced body rash. Treatment medications (dates unspecified) included: dexamethasone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and was recovering from itchiness, and body rash. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: A LOT OF PAIN IN ARM; FEVER; This spontaneous report received from a parent concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. the patient had some allergies.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAY-2021, the subject experienced a lot of pain in arm. On 30-MAY-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 99.8 F. On 31-MAY-2021, Laboratory data included: Fever (NR: not provided) 101.8 F. On 02-JUN-2021, Laboratory data included: Fever (NR: not provided) 99.1 F, 101 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever, and a lot of pain in arm. This report was non-serious. This case, from the same reporter is linked to 20210604932.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Mononucleosis heterophile test
Clinical narrative: NECK ACHES; DIZZINESS; JOINT PAIN; HEADACHE; CHRONIC FATIGUE; NAUSEA; ACHINESS; FEVER; TIREDNESS/CHRONIC FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with cetirizine hydrochloride for drug used for unknown indication, and fluticasone propionate for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative, Diagnostic ultrasound (NR: not provided) Negative, Lung function tests (NR: not provided) Negative, and Mononucleosis heterophile test (NR: not provided) Negative. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness/chronic fatigue. On 15-APR-2021, the subject experienced neck aches. On 15-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced joint pain. On 15-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced chronic fatigue. On 15-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, tiredness/chronic fatigue, achiness, headache, neck aches, dizziness, joint pain, chronic fatigue and nausea was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pulmonary function test, Pyrexia
Clinical narrative: NECK ACHES; DIZZINESS; JOINT PAIN; HEADACHE; CHRONIC FATIGUE; NAUSEA; ACHINESS; FEVER; TIREDNESS/CHRONIC FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with cetirizine hydrochloride for drug used for unknown indication, and fluticasone propionate for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative, Diagnostic ultrasound (NR: not provided) Negative, Lung function tests (NR: not provided) Negative, and Mononucleosis heterophile test (NR: not provided) Negative. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness/chronic fatigue. On 15-APR-2021, the subject experienced neck aches. On 15-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced joint pain. On 15-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced chronic fatigue. On 15-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, tiredness/chronic fatigue, achiness, headache, neck aches, dizziness, joint pain, chronic fatigue and nausea was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Ultrasound scan
Clinical narrative: NECK ACHES; DIZZINESS; JOINT PAIN; HEADACHE; CHRONIC FATIGUE; NAUSEA; ACHINESS; FEVER; TIREDNESS/CHRONIC FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with cetirizine hydrochloride for drug used for unknown indication, and fluticasone propionate for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative, Diagnostic ultrasound (NR: not provided) Negative, Lung function tests (NR: not provided) Negative, and Mononucleosis heterophile test (NR: not provided) Negative. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness/chronic fatigue. On 15-APR-2021, the subject experienced neck aches. On 15-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced joint pain. On 15-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced chronic fatigue. On 15-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, tiredness/chronic fatigue, achiness, headache, neck aches, dizziness, joint pain, chronic fatigue and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: THE VACCINE WAS KEPT IN THE FREEZER AFTER DELIVERY AND THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION / DRUG STORED IN INAPPROPRIATE TEMPERATURE; This spontaneous report received from a pharmacist concerned a 57-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: 1821288 and expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination / drug stored in inappropriate temperature. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination / drug stored in inappropriate temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605120, 20210604703, 20210605010, 20210605028 and 20210605104.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE VACCINE WAS KEPT IN THE FREEZER AFTER DELIVERY AND THAWED OVERNIGHT AND KEPT IN THE FRIDGE TILL VACCINATION; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 28 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: 1821288 expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination. On 30-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of the the vaccine was kept in the freezer after delivery and thawed overnight and kept in the fridge till vaccination and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210605104, 20210605120 and 20210605009.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PATIENT RECEIVED THE VACCINE  AFTER 7HRS IN REFRIGERATOR AT 4C  INSTEAD OF 6HRS; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced subject received the vaccine after 7hrs in refrigerator at 4c instead of 6hrs, and poor quality drug administered. The action taken with covid-19 vaccine  was not applicable. The outcome of the patient received the vaccine after 7 hrs in refrigerator at 4c instead of 6hrs and poor quality drug administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-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 JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Influenza like illness, Insomnia
Clinical narrative: LOST LITTLE BIT WEIGHT; NIGHT SWEATS REALLY BAD; DID NOT HAVE SAME ENERGY (LOW ENERGY EACH DAY); CHILLS; TEMPERATURE WENT UP EVERY NIGHT CLOSE TO 100F (FEVER); FELT LIKE HAD FLU WITHOUT VOMITING; HARD TIME SLEEPING; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included copd (chronic obstructive pulmonary disease), hypertension, diabetes (undiagnosed), skin issues, and allergic to pneumonia vaccine (bad reaction from second dose).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 2038218, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced felt like had flu without vomiting. On 26-MAY-2021, the subject experienced hard time sleeping. On 26-MAY-2021, the subject experienced night sweats really bad. On 26-MAY-2021, the subject experienced did not have same energy (low energy each day). On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced temperature went up every night close to 100f (fever). Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 97.4 F. On an unspecified date, the subject experienced lost little bit weight. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from felt like had flu without vomiting, night sweats really bad, hard time sleeping, did not have same energy (low energy each day), lost little bit weight, temperature went up every night close to 100f (fever), and chills. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Weight decreased
Clinical narrative: LOST LITTLE BIT WEIGHT; NIGHT SWEATS REALLY BAD; DID NOT HAVE SAME ENERGY (LOW ENERGY EACH DAY); CHILLS; TEMPERATURE WENT UP EVERY NIGHT CLOSE TO 100F (FEVER); FELT LIKE HAD FLU WITHOUT VOMITING; HARD TIME SLEEPING; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included copd (chronic obstructive pulmonary disease), hypertension, diabetes (undiagnosed), skin issues, and allergic to pneumonia vaccine (bad reaction from second dose).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 2038218, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced felt like had flu without vomiting. On 26-MAY-2021, the subject experienced hard time sleeping. On 26-MAY-2021, the subject experienced night sweats really bad. On 26-MAY-2021, the subject experienced did not have same energy (low energy each day). On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced temperature went up every night close to 100f (fever). Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 97.4 F. On an unspecified date, the subject experienced lost little bit weight. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from felt like had flu without vomiting, night sweats really bad, hard time sleeping, did not have same energy (low energy each day), lost little bit weight, temperature went up every night close to 100f (fever), and chills. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODYACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 26 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 30-MAY-2021, the subject experienced bodyaches. On 30-MAY-2021, the subject experienced chills. On 30-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, chills, and bodyaches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a 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, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  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 20210604819.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; 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, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced urinary tract infection. The action taken with covid-19 vaccine  was not applicable. The outcome of urinary tract infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210603257.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: NUMBNESS IN BOTH ARMS; TINGLING IN ARM; PAIN IN RIGHT ARM ALL THE WAY TO THE WRIST; INJECTION SITE SORE; HEADACHE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included car accident, and concurrent conditions included cataract, teeth problems, nerve condition, penicillin allergy, marijuana abuse, non-alcohol user, and cigarette smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced numbness in both arms. On 30-MAY-2021, the subject experienced tingling in arm. On 30-MAY-2021, the subject experienced pain in right arm all the way to the wrist. On 30-MAY-2021, the subject experienced injection site sore. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache on MAY-2021, had not recovered from pain in right arm all the way to the wrist, tingling in arm, and numbness in both arms, and the outcome of injection site sore was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Nausea
Clinical narrative: The patient is deceased; Nausea while eating; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (The patient is deceased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Nausea while eating). The patient died on 11-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, NAUSEA (Nausea while eating) outcome was unknown.            No concomitant medications were reported.   It was reported that nausea would go away for a few hours and would come back while eating again. The patient was already in supplemental oxygen but was using more since he received the vaccine. The patient had been experiencing the events for four days.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be ruled out for the event of Nausea and is unlikely for the event of Death. The event of Oxygen therapy is invalid as it is a pre-existing condition.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 includes serious event death.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be ruled out for the event of Nausea and is unlikely for the event of Death. The event of Oxygen therapy is invalid as it is a pre-existing condition.; Reported Cause(s) of Death: unknown cause of death
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-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 PAIN IN EXTREMITY (arm soreness) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Patient had second dose on 14MAY2021, lot number- 008C21A, expiration Date- 21DEC2069. The vaccine was administered on her upper right arm.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-132180 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cough, Decreased appetite, Diarrhoea, Influenza, Pneumonia
Clinical narrative: flu symptoms; unable to eat; diarrhea; coughed hard; vomiting; Pneumonia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia), INFLUENZA (flu symptoms), DECREASED APPETITE (unable to eat), DIARRHOEA (diarrhea), COUGH (coughed hard) and VOMITING (vomiting) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. In January 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and DIARRHOEA (diarrhea) (seriousness criterion hospitalization). January 2021, the patient experienced INFLUENZA (flu symptoms) (seriousness criterion hospitalization), DECREASED APPETITE (unable to eat) (seriousness criterion hospitalization), COUGH (coughed hard) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 4 days due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), INFLUENZA (flu symptoms), DECREASED APPETITE (unable to eat), DIARRHOEA (diarrhea), COUGH (coughed hard) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In Jan 2021 patient had experienced immune system shut down and had several infections and was in the hospital for four days with pneumonia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication was not  provided.  Concomitant product use was not provided by the reporter.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vomiting
Clinical narrative: flu symptoms; unable to eat; diarrhea; coughed hard; vomiting; Pneumonia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia), INFLUENZA (flu symptoms), DECREASED APPETITE (unable to eat), DIARRHOEA (diarrhea), COUGH (coughed hard) and VOMITING (vomiting) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. In January 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and DIARRHOEA (diarrhea) (seriousness criterion hospitalization). January 2021, the patient experienced INFLUENZA (flu symptoms) (seriousness criterion hospitalization), DECREASED APPETITE (unable to eat) (seriousness criterion hospitalization), COUGH (coughed hard) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 4 days due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), INFLUENZA (flu symptoms), DECREASED APPETITE (unable to eat), DIARRHOEA (diarrhea), COUGH (coughed hard) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In Jan 2021 patient had experienced immune system shut down and had several infections and was in the hospital for four days with pneumonia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication was not  provided.  Concomitant product use was not provided by the reporter.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: Bad Reaction to Shot, Vaccination complication; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Bad Reaction to Shot, Vaccination complication) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TIPIRACIL HYDROCHLORIDE, TRIFLURIDINE (LONSURF) for Malignant neoplasm of colon.    Concurrent medical conditions included Malignant neoplasm of colon and Allergic reaction to drug. Concomitant products included PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS], MULTIVITAMIN [VITAMINS NOS], DOCUSATE SODIUM (COLACE), LISINOPRIL and REGORAFENIB (STIVARGA) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TIPIRACIL HYDROCHLORIDE, TRIFLURIDINE (LONSURF) (Oral) 45 milligram twice a day. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad Reaction to Shot, Vaccination complication) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Bad Reaction to Shot, Vaccination complication) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine; This spontaneous case was reported by an other health professional and describes the occurrence of RHEUMATOID ARTHRITIS (reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine) 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 not required.  Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment medications were not reported.  Company Comment : Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.