chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included premenstrual syndrome, and other pre-existing medical conditions included the patient never had a reaction to a vaccine. she takes flu shot every year. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 04-MAY-2021, the subject experienced suspected covid-19 infection. On 11-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine  was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be management approval - confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. void: yes based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: ILLNESS; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced illness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from illness. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: FEELS LIKE SOMETHING CRAWLING IN RIGHT EAR; This spontaneous report received from a physician concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced feels like something crawling in right ear. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from feels like something crawling in right ear. This report was non-serious. The suspected product quality complaint has been confirmed to be confirmed no : PQC was identified within the reporter complaint reported. complaint is approved for void. based on the PQC investigation performed. This report was associated with product quality complaint:90000179264
Sex: F
Vaccine: COVID19
Symptoms: Rash, Thrombosis
Clinical narrative: BLOOD CLOT; MULTIPLE RED SPOTS ON NECK/RASH; This spontaneous report received from a patient concerned a 19 year old Asian and not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 11-MAY-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced symptoms of blood clot  and multiple red spots on neck. Patient reported that the red spots on neck might be a rash. The patient's father wanted to know about treatment of rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple red spots on neck/rash and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210524274- Covid-19 vaccine ad26.cov2.s- A 19- year old Asian and  not Hispanic or Latino female presents with Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYSIS ON BOTH SIDES OF HIS BODY; This spontaneous report received from a consumer via social media platform concerned a male of unspecified age.. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  The patient was paralyzed on both sides of body for a month and had no improvement. The patient had vaccine and on day 5 after vaccination issue had started. On day 9 after vaccination, the patient was paralyzed and still had at the time of this report. The patient's physician stated the patient was perfectly healthy no medical issues, it was the vaccine that caused it. The patient was not better at the time of this report. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis on both sides. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.  20210524291- Covid-19 vaccine ad26.cov2.s-Paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received covid-19 vaccine (suspension for injection, route of admin) and dose were not reported, administered on 2021 as prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included macitentan for pulmonary arterial hypertension. On APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine was not applicable. The outcome of shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Venous thrombosis
Clinical narrative: CENTRAL VEIN THROMBOSIS; This spontaneous report received from a patient concerned 14 female patients. The patient's weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the 14 out of 15 patients experienced central vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of central vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210524749-covid-19 vaccine ad26.cov2.s-Venous thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: SWOLLEN RIGHT LEG; PAIN AT CALF IN RIGHT LEG; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Diagnostic ultrasound (NR: not provided) Normal. On 15-APR-2021, the subject experienced swollen right leg. On 15-APR-2021, the subject experienced pain at calf in right leg. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from swollen right leg, and pain at calf in right leg on 2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Laryngitis, Nasal congestion, Pain
Clinical narrative: SUSPECTED COVID-19 INFECTION; LARYNGITIS; STUFFY NOSE; MINOR BODY ACHES; FEELING CLAMMY AND COLD SWEATS; REALLY THIRSTY; MINOR HEADACHE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the patient experienced other symptoms like suspected clinical vaccination failure, laryngitis, stuffy nose, minor body aches, feeling of clammy and cold sweats, really thirsty and minor headache. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, laryngitis, minor headache, stuffy nose, minor body aches, feeling clammy and cold sweats and really thirsty was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210523526-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Thirst, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; LARYNGITIS; STUFFY NOSE; MINOR BODY ACHES; FEELING CLAMMY AND COLD SWEATS; REALLY THIRSTY; MINOR HEADACHE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the patient experienced other symptoms like suspected clinical vaccination failure, laryngitis, stuffy nose, minor body aches, feeling of clammy and cold sweats, really thirsty and minor headache. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, laryngitis, minor headache, stuffy nose, minor body aches, feeling clammy and cold sweats and really thirsty was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210523526-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: MASSIVE SHINGLES OUTBREAK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 massive shingles outbreak. The action taken with covid-19 vaccine  was not applicable. The outcome of massive shingles outbreak was not reported. This report was non-serious. This case, from the same reporter is linked to 20210526416 and 20210526445.; Sender's Comments: V0-Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Abscess
Clinical narrative: ABSCESS/ARM DRAINED; This spontaneous report received from a patient concerned a 39 year old white, Not Hispanic or Latino of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once total administered on 04-MAY-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient reported that ,saw a primary care and an orthopedic, sent back to the hospital to had the arm drained and was given antibiotics in the ER. 100 cc was removed and was still draining puss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abscess/arm drained. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210525721-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Abscess/arm drained. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Dizziness, Malaise, SARS-CoV-2 test negative
Clinical narrative: SORE BREAST; CHILLS; FEELING SICK; DIZZINESS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, injury, and shampoo allergy, and other pre-existing medical conditions included allergy to spicy food start sweating really bad and my face burns and that has been for years. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included morphine for injury, and hydrocodone. On 09-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced sore breast. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced feeling sick. Laboratory data (dates unspecified) included: COVID-19 rapid POC test negative (NR: not provided) Negative. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness, and sore breast on 17-APR-2021, and had not recovered from chills, and feeling sick. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Language disorder
Clinical narrative: DIFFICULTY TALKING; TROUBLE BREATHING; SPLITTING 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 cancer.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 difficulty talking, trouble breathing, and splitting headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the splitting headache, difficulty talking and trouble breathing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple 6 female patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported), frequency once total, 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 consumer stated that 6 patients experienced blood clots from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210526046-Covid 19 vaccine- blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Manufacturing issue
Clinical narrative: VACCINE PRODUCTION FACILITY FILTHY AND DIRTY; FEEL AWFUL; HEADACHE; FEELING SICK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced feeling sick. On an unspecified date, the subject experienced vaccine production facility filthy and dirty, feel awful, and headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache, and feel awful, and the outcome of feeling sick and vaccine production facility filthy and dirty was not reported. This report was non-serious. This case, from the same reporter is linked to 20210526416 and 20210525676.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 22 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 13-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.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 22 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 13-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.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SON WAS VERY SICK FOR 2 DAYS; This spontaneous report received from a parent via a company representative concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-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 02-MAY-2021, the subject experienced son was very sick for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from son was very sick for 2 days on 05-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210526182.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SUDDEN ONSET DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included pleurisy, and complete hysterectomy, and concurrent conditions included penicillin allergy, sulfa allergy, rheumatoid, polyps in throat, non-smoker, non alcohol user, melanoma, and cancer survivor, and other pre-existing medical conditions included the patient did not have any abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included clozapine, diphenhydramine hydrochloride, prednisone, and salbutamol. On 15-MAY-2021, the subject experienced sudden onset difficulty breathing. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from sudden onset difficulty breathing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: COMPLETELY REGAINED SENSE OF SMELL AND ANY SENSE OF TASTE THAT HAD LOST AS A RESULT OF LACK OF SMELL; 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. The patient's concurrent conditions included sinus infections, upper respiratory problems, parkinson's, phantosmia/parosmia, complete loss of smell, and loss of taste. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-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 APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced completely regained sense of smell and any sense of taste that had lost as a result of lack of smell. The action taken with covid-19 vaccine  was not applicable. The outcome of the fatigue and completely regained sense of smell and any sense of taste that had lost as a result of lack of smell was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: SWEAT; FEVER; NAUSEA; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa medications allergy, tramadol allergy, alcohol user, and cigarette smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23/JUN/2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced sweat. On 14-MAY-2021, the subject experienced fever. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced injection site pain. On 14-MAY-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nausea, and tired on 14-MAY-2021, was recovering from fever, and sweat, and had not recovered from headache, and injection site pain. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: SWEAT; FEVER; NAUSEA; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa medications allergy, tramadol allergy, alcohol user, and cigarette smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23/JUN/2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced sweat. On 14-MAY-2021, the subject experienced fever. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced injection site pain. On 14-MAY-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nausea, and tired on 14-MAY-2021, was recovering from fever, and sweat, and had not recovered from headache, and injection site pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: UNDERDOSE; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have drug abuse or illicit drug. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced underdose. The action taken with covid-19 vaccine  was not applicable. The outcome of underdose was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Cough, Diarrhoea, Fatigue, Nausea
Clinical narrative: COLD SWEATS; COUGHING; DIARRHEA; TIRED AND SLEEP; NAUSEA; This spontaneous report received from a consumer concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced cold sweats. On 14-MAY-2021, the subject experienced coughing. On 14-MAY-2021, the subject experienced diarrhea. On 14-MAY-2021, the subject experienced tired and sleep. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the cold sweats, tired and sleep, diarrhea, coughing and nausea was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Hyperhidrosis, Hyperventilation
Clinical narrative: DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 235 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and abstains from alcohol, and other pre-existing medical conditions included patient took water pills twice a day. patient had history of illicit drug use. The patient was previously treated with oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and metformin for drug used for unknown indication. On 10-MAY-2021, the subject experienced dizzy. On 10-MAY-2021, the subject experienced head spinning. On 10-MAY-2021, the subject experienced not feeling himself. On 10-MAY-2021, the subject experienced hyperventilating. On 10-MAY-2021, the subject experienced sweating. On 10-MAY-2021, the subject experienced weak. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from weak, dizzy, nausea, head spinning, not feeling himself, hyperventilating, and sweating. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 235 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and abstains from alcohol, and other pre-existing medical conditions included patient took water pills twice a day. patient had history of illicit drug use. The patient was previously treated with oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and metformin for drug used for unknown indication. On 10-MAY-2021, the subject experienced dizzy. On 10-MAY-2021, the subject experienced head spinning. On 10-MAY-2021, the subject experienced not feeling himself. On 10-MAY-2021, the subject experienced hyperventilating. On 10-MAY-2021, the subject experienced sweating. On 10-MAY-2021, the subject experienced weak. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from weak, dizzy, nausea, head spinning, not feeling himself, hyperventilating, and sweating. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included rash. The patient was previously treated with diphenhydramine hydrochloride for rash. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced rash. The action taken with covid-19 vaccine was not applicable. The outcome of rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: EXPERIENCED SIDE EFFECTS AFTER GETTING THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced experienced side effects after getting the vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of experienced side effects after getting the vaccine was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Headache, Pain in extremity
Clinical narrative: FATIGUE; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disorder, and other pre-existing medical conditions included the patient had serious reaction in the past when treated with unspecified vaccine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 15-MAR-2021, the subject experienced sore arm. On 15-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore arm, and headache on 17-MAR-2021, and fatigue on 18-MAR-2021. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: WHOLE RIGHT ARM STARTED TINGLING FROM SHOULDER TO FINGERS; FINGERS NUMB; BICEP HURTS ALL ON THE INNER SIDE OF ARM; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health and did not have any symptoms before the vaccination. 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 03-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced whole right arm started tingling from shoulder to fingers. On APR-2021, the subject experienced fingers numb. On APR-2021, the subject experienced bicep hurts all on the inner side of arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from whole right arm started tingling from shoulder to fingers, fingers numb, and bicep hurts all on the inner side of arm. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FEELING SLIGHTLY TIRED; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 16:00:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced feeling slightly tired. The action taken with covid-19 vaccine  was not applicable. The outcome of feeling slightly tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Computerised tomogram head, Electromyogram, Fatigue
Clinical narrative: TINGLING SENSATION; BURNING SENSATION; FLU LIKE REACTION; VAGUE BODY ACHES; EXTREME TIREDNESS; NAUSEA; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A021A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced flu like reaction, tingling sensation, burning sensation, vague body aches, extreme tiredness, nausea, and headaches. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL, Electromyogram (NR: not provided) Results awaited, Head CT (NR: not provided) NORMAL, MRI (NR: not provided) NORMAL, and Nerve conduction studies abnormal (NR: not provided) Results awaited. The action taken with covid-19 vaccine  was not applicable. The patient recovered from flu like reaction, was recovering from extreme tiredness, and nausea, and the outcome of headaches, vague body aches, tingling sensation and burning sensation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Magnetic resonance imaging, Nausea, Nerve conduction studies abnormal
Clinical narrative: TINGLING SENSATION; BURNING SENSATION; FLU LIKE REACTION; VAGUE BODY ACHES; EXTREME TIREDNESS; NAUSEA; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A021A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced flu like reaction, tingling sensation, burning sensation, vague body aches, extreme tiredness, nausea, and headaches. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL, Electromyogram (NR: not provided) Results awaited, Head CT (NR: not provided) NORMAL, MRI (NR: not provided) NORMAL, and Nerve conduction studies abnormal (NR: not provided) Results awaited. The action taken with covid-19 vaccine  was not applicable. The patient recovered from flu like reaction, was recovering from extreme tiredness, and nausea, and the outcome of headaches, vague body aches, tingling sensation and burning sensation was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: TINGLING SENSATION; BURNING SENSATION; FLU LIKE REACTION; VAGUE BODY ACHES; EXTREME TIREDNESS; NAUSEA; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A021A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced flu like reaction, tingling sensation, burning sensation, vague body aches, extreme tiredness, nausea, and headaches. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL, Electromyogram (NR: not provided) Results awaited, Head CT (NR: not provided) NORMAL, MRI (NR: not provided) NORMAL, and Nerve conduction studies abnormal (NR: not provided) Results awaited. The action taken with covid-19 vaccine  was not applicable. The patient recovered from flu like reaction, was recovering from extreme tiredness, and nausea, and the outcome of headaches, vague body aches, tingling sensation and burning sensation was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache
Clinical narrative: STOMACH ACHE; CHILLS; HEADACHE - PAIN BEHIND EYES; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe spinal stenosis, smoker, penicillin allergy, and non-alcoholic, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, intramuscular, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced stomach ache. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache - pain behind eyes. On 16-MAY-2021, the subject experienced fatigue. On 16-MAY-2021 16:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache - pain behind eyes, stomach ache, chills, and fatigue. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Palpitations, Pyrexia
Clinical narrative: PALPITATIONS; HEADACHE; FEVER 102 F; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced palpitations. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced fever 102 f. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever 102 f, and palpitations. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: LIQUID SEEN DRIPPING OFF THE ARM AFTER ADMINISTRATION OF VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced liquid seen dripping off the arm after administration of vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of liquid seen dripping off the arm after administration of vaccine was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: RED SPOTS ON BOTH THIGHS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy, betadine allergy, abstains from alcohol, non-smoker, and latex allergy, and other pre-existing medical conditions included the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced red spots on both thighs. The action taken with covid-19 vaccine  was not applicable. The patient recovered from red spots on both thighs on 14-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced severe reaction. The action taken with covid-19 vaccine was not applicable. The outcome of severe reaction was not reported. This report was non-serious.