chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort, Muscle spasms, Myalgia, Nausea
Clinical narrative: LEG CRAMPS; HEAVY LEGS; MUSCLE ACHES; DIARRHEA; CHILLS; INCREASED HEART RATE; NAUSEA; HEAVY ARM; INJECTION SITE PAIN; TIRED; HEADACHE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced heavy arm. On 01-APR-2021, the subject experienced injection site pain. On 01-APR-2021, the subject experienced tired. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced increased heart rate. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced diarrhea. On 04-APR-2021, the subject experienced muscle aches. On 05-APR-2021, the subject experienced heavy legs. On 06-APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, chills, injection site pain, tired, headache, and nausea on 02-APR-2021, diarrhea on 03-APR-2021, heavy arm on 01-APR-2021, and muscle aches on 05-APR-2021, and had not recovered from heavy legs, and leg cramps. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose, Blood glucose increased
Clinical narrative: ELEVATED BLOOD SUGAR OF 400; STOMACH CRAMPS; 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 concurrent conditions included seasonal allergies, non-alcohol user, and non-smoker. The patient has no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on right deltoid muscle on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  In MAR-2021, the patient had elevated blood sugar of 400. On 15-MAR-2021, the patient visited urgent care where her capillary blood glucose was 400 (units unspecified). In 2021, the patient experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach cramps, and had not recovered from elevated blood sugar of 400. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210410812-covid-19 vaccine ad26.cov2.s -elevated blood sugar of 400. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia, Migraine, Pain, Pyrexia
Clinical narrative: SYNCOPE; MIGRAINE; WHOLE BODY TREMORS; VOMITING; NUMBNESS IN HAND AND FEET; WHOLE BODY ACHES; 105.0 F TEMPERATURE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 120 pounds, and height was 60 inches. Obstetrics history included gravida 1 para 1 (gave birth to a daughter 8 weeks ago). Concurrent conditions included penicillin allergy, non-alcohol user and non-smoker. The patient was not pregnant at the time of vaccination and had no history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on left arm on 03-APR-2021 for prophylactic vaccination. The product was stored properly from receipt to administration. No concomitant medications were reported.  On 03-APR-2021, the patient experienced migraine, whole body tremors, vomiting, had a temperature of 105.0 F (required emergency room visit/urgent care), numbness in hand and feet, and whole body aches. On the same day, she recovered from whole body tremors. On 04-APR-2021, the patient experienced syncope. On the same day, she recovered from syncope, vomiting, and numbness in hand and feet. On 05-APR-2021, she recovered from whole body aches and 'temperature 105.0 F'. The patient was breastfeeding her child at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, vomiting, numbness in hand and feet, 105.0 F temperature, whole body aches and whole body tremors, and was recovering from migraine. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210412341.; Sender's Comments: V0:20210411086-covid-19 vaccine ad26.cov2.s-Syncope. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: SYNCOPE; MIGRAINE; WHOLE BODY TREMORS; VOMITING; NUMBNESS IN HAND AND FEET; WHOLE BODY ACHES; 105.0 F TEMPERATURE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 120 pounds, and height was 60 inches. Obstetrics history included gravida 1 para 1 (gave birth to a daughter 8 weeks ago). Concurrent conditions included penicillin allergy, non-alcohol user and non-smoker. The patient was not pregnant at the time of vaccination and had no history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on left arm on 03-APR-2021 for prophylactic vaccination. The product was stored properly from receipt to administration. No concomitant medications were reported.  On 03-APR-2021, the patient experienced migraine, whole body tremors, vomiting, had a temperature of 105.0 F (required emergency room visit/urgent care), numbness in hand and feet, and whole body aches. On the same day, she recovered from whole body tremors. On 04-APR-2021, the patient experienced syncope. On the same day, she recovered from syncope, vomiting, and numbness in hand and feet. On 05-APR-2021, she recovered from whole body aches and 'temperature 105.0 F'. The patient was breastfeeding her child at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, vomiting, numbness in hand and feet, 105.0 F temperature, whole body aches and whole body tremors, and was recovering from migraine. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210412341.; Sender's Comments: V0:20210411086-covid-19 vaccine ad26.cov2.s-Syncope. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Influenza B virus test, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; INFLUENZA B INFECTION; This spontaneous report received from a patient concerned a 61 year old 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 and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced covid-19 infection. On 31-MAR-2021, the subject experienced influenza b infection.  Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE, and Influenza B virus test (NR: not provided) POSITIVE. Treatment medications (dates unspecified) included: ascorbic acid, azithromycin, colecalciferol, and oseltamivir phosphate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 infection, and influenza b infection. This report was non-serious. The case was associated with a product quality complaint number: 90000175465; Sender's Comments: V0: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Anxiety, Body temperature, Body temperature abnormal, Decreased appetite, Fatigue
Clinical narrative: NOT FEELING HUNGRY; FELT SCARED WORSENED/ANXIOUS WORSENED; OFF LABEL USE; TEMPERATURE OF 101; FATIGUE; HEADACHE; 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 past medical history included felt muscle aches in legs, and concurrent conditions included multiple sclerosis, numbness, tingling, visual disturbances, swollen ankles, trouble sleeping, crohns disease, not able to do things which friends could do, nausea, vomiting, felt anxious/scared, sometimes pain in stomach or abdomen, and eight watery stools/loose stools.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, The batch number was not reported. The company was unable to perform follow up to request batch number. expiry: unknown) dose was not reported, administered on 22-MAR-2021, and dose was not reported, administered on 22-FEB-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 22-JAN-2021 to 22-JAN-2021, and dose was not reported, 1 time every 14 days from 05-FEB-2021 to 05-FEB-2021 for crohns disease; and adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 19-FEB-2021 to 19-FEB-2021 for crohn's disease. No concomitant medications were reported.  On 2021, the subject experienced fatigue. On 2021, the subject experienced headache. On 23-MAR-2021, the subject experienced temperature of 101. Laboratory data included: Body temperature (NR: not provided) 101.01 F. On an unspecified date, the subject experienced not feeling hungry, felt scared worsened/anxious worsened, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 2021, had not recovered from not feeling hungry, and the outcome of temperature of 101, felt scared worsened/anxious worsened and off label use was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Headache, Off label use
Clinical narrative: NOT FEELING HUNGRY; FELT SCARED WORSENED/ANXIOUS WORSENED; OFF LABEL USE; TEMPERATURE OF 101; FATIGUE; HEADACHE; 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 past medical history included felt muscle aches in legs, and concurrent conditions included multiple sclerosis, numbness, tingling, visual disturbances, swollen ankles, trouble sleeping, crohns disease, not able to do things which friends could do, nausea, vomiting, felt anxious/scared, sometimes pain in stomach or abdomen, and eight watery stools/loose stools.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, The batch number was not reported. The company was unable to perform follow up to request batch number. expiry: unknown) dose was not reported, administered on 22-MAR-2021, and dose was not reported, administered on 22-FEB-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 22-JAN-2021 to 22-JAN-2021, and dose was not reported, 1 time every 14 days from 05-FEB-2021 to 05-FEB-2021 for crohns disease; and adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 14 days from 19-FEB-2021 to 19-FEB-2021 for crohn's disease. No concomitant medications were reported.  On 2021, the subject experienced fatigue. On 2021, the subject experienced headache. On 23-MAR-2021, the subject experienced temperature of 101. Laboratory data included: Body temperature (NR: not provided) 101.01 F. On an unspecified date, the subject experienced not feeling hungry, felt scared worsened/anxious worsened, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 2021, had not recovered from not feeling hungry, and the outcome of temperature of 101, felt scared worsened/anxious worsened and off label use was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY ACHE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, no alcohol use, smoking, and depression, and other pre-existing medical conditions included the patient has no known allergies and no history of drug abuse or illicit drug use. The patient was not pregnant at the time of event reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: unknown) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included venlafaxine for anxiety, and depression, bupropion hydrochloride for depression, and ethinylestradiol/norgestimate. On 06-APR-2021 17:00, the subject experienced body ache. On 06-APR-2021 17:00, the subject experienced chills. On 06-APR-2021 17:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, headache, and chills. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient did a blood work 2 weeks after taking the vaccine for the purpose of donating blood yet, she had no antibodies to the covid19 virus (suspected immunological vaccine failure.) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411516-COVID-19 VACCINE AD26.COV2.S -Suspected Immunological Vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Pyrexia, Tachycardia
Clinical narrative: TACHYCARDIA (FAST HEART RATE 116); HIGH FEVER; This spontaneous report received from a consumer concerned a 19 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced tachycardia (fast heart rate 116). On 06-APR-2021, the subject experienced high fever. Laboratory data included: Heart rate (NR: not provided) 116. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, and tachycardia (fast heart rate 116). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Fall, Feeling hot, Gait disturbance
Clinical narrative: WENT LIMP; DIZZINESS; CAN'T SLEEP; FEELING OF WARMTH; FELL DOWN; STOMACH UPSET; FELT LIKE FLU(HEADACHE, BODY TIREDNESS, SORE THROAT); WEAK IN KNEES; NAUSEA; This spontaneous report received from a patient concerned a 76 year old 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced went limp. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced can't sleep. On 06-APR-2021, the subject experienced feeling of warmth. On 06-APR-2021, the subject experienced fell down. On 06-APR-2021, the subject experienced stomach upset. On 06-APR-2021, the subject experienced felt like flu (headache, body tiredness, sore throat). On 06-APR-2021, the subject experienced weak in knees. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling of warmth, had not recovered from nausea, dizziness, can't sleep, weak in knees, stomach upset, and felt like flu(headache, body tiredness, sore throat), and the outcome of fell down and went limp was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Muscular weakness, Nausea
Clinical narrative: WENT LIMP; DIZZINESS; CAN'T SLEEP; FEELING OF WARMTH; FELL DOWN; STOMACH UPSET; FELT LIKE FLU(HEADACHE, BODY TIREDNESS, SORE THROAT); WEAK IN KNEES; NAUSEA; This spontaneous report received from a patient concerned a 76 year old 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced went limp. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced can't sleep. On 06-APR-2021, the subject experienced feeling of warmth. On 06-APR-2021, the subject experienced fell down. On 06-APR-2021, the subject experienced stomach upset. On 06-APR-2021, the subject experienced felt like flu (headache, body tiredness, sore throat). On 06-APR-2021, the subject experienced weak in knees. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling of warmth, had not recovered from nausea, dizziness, can't sleep, weak in knees, stomach upset, and felt like flu(headache, body tiredness, sore throat), and the outcome of fell down and went limp was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Heart rate, Heart rate increased, Loss of consciousness
Clinical narrative: BLACKED OUT; RAPID/STRONG HEARTBEAT; TINGLING ARMS AND LEGS; COUGH; WHITE NOISE IN EARS; HEADACHE; This spontaneous report received from a patient concerned 50 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 administration not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, administered on 06-APR-2021 at about 8:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, after about 5 minutes of vaccination, the patient experienced 'white noise' in ears, vision changes, had a visual aura (a pattern around side of vision and moved to front of vision) and blacked out only for few minutes. He blacked out in the pharmacy but was not sure for how long. On 06-APR-2021, the patient felt a little dizzy, experienced headache, and tingling in arms and legs (reported as ''arms and legs felt like they were gone''). On the same day, he also had a rapid/strong heartbeat for a while that made him cough and it went away after about 45 minutes. The strong heart beat had come and gone throughout the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out and cough, and the outcome of white noise in ears, tingling arms and legs, rapid/strong heartbeat, and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411724 - Covid-19 vaccine ad26.cov2.s- BLACKED OUT. 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: BLACKED OUT; RAPID/STRONG HEARTBEAT; TINGLING ARMS AND LEGS; COUGH; WHITE NOISE IN EARS; HEADACHE; This spontaneous report received from a patient concerned 50 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 administration not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, administered on 06-APR-2021 at about 8:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, after about 5 minutes of vaccination, the patient experienced 'white noise' in ears, vision changes, had a visual aura (a pattern around side of vision and moved to front of vision) and blacked out only for few minutes. He blacked out in the pharmacy but was not sure for how long. On 06-APR-2021, the patient felt a little dizzy, experienced headache, and tingling in arms and legs (reported as ''arms and legs felt like they were gone''). On the same day, he also had a rapid/strong heartbeat for a while that made him cough and it went away after about 45 minutes. The strong heart beat had come and gone throughout the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out and cough, and the outcome of white noise in ears, tingling arms and legs, rapid/strong heartbeat, and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411724 - Covid-19 vaccine ad26.cov2.s- BLACKED OUT. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Fatigue, Myalgia
Clinical narrative: ALMOST PASSED OUT BUT SHE DID NOT; LOSS OF TASTE; LOSS OF SMELL; FATIGUE; MUSCLE ACHE; This spontaneous report received from a health care professional concerned an adult 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced loss of smell. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced almost passed out but she did not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, muscle ache, loss of taste, almost passed out but she did not and loss of smell was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure via breast milk, Mucous stools, Rash, Restlessness
Clinical narrative: VOMITING; LOOSE STOOLS; RESTLESSNESS/EXCESSIVE FUSSINESS; RASH OVER FACE, NECK AND FEET; MUCUS IN STOOLS; VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an 8 week old female. The patient's weight was 6.8 kilograms, and height was 25 inches. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug use. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced vaccine exposure via breast milk. On APR-2021, the subject experienced mucus in stools. On 03-APR-2021, the subject experienced rash over face, neck and feet. On 04-APR-2021, the subject experienced loose stools. On 04-APR-2021, the subject experienced restlessness/excessive fussiness. On 05-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 05-APR-2021, was recovering from restlessness/excessive fussiness, had not recovered from loose stools, and rash over face, neck and feet, and the outcome of vaccine exposure via breast milk and mucus in stools was not reported. This report was non-serious. This parent/child case is linked to 20210411086.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; LOOSE STOOLS; RESTLESSNESS/EXCESSIVE FUSSINESS; RASH OVER FACE, NECK AND FEET; MUCUS IN STOOLS; VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an 8 week old female. The patient's weight was 6.8 kilograms, and height was 25 inches. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug use. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced vaccine exposure via breast milk. On APR-2021, the subject experienced mucus in stools. On 03-APR-2021, the subject experienced rash over face, neck and feet. On 04-APR-2021, the subject experienced loose stools. On 04-APR-2021, the subject experienced restlessness/excessive fussiness. On 05-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 05-APR-2021, was recovering from restlessness/excessive fussiness, had not recovered from loose stools, and rash over face, neck and feet, and the outcome of vaccine exposure via breast milk and mucus in stools was not reported. This report was non-serious. This parent/child case is linked to 20210411086.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site, Reflexes abnormal
Clinical narrative: MUSCLE REFLEX WHICH CAUSED ARM TO MOVE; VACCINE PROVIDED A LITTLE HIGH ON ARM; PAIN IN ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfonamide allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle reflex which caused arm to move. On 06-APR-2021, the subject experienced vaccine provided a little high on arm. On 06-APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm on 06-APR-2021, and the outcome of muscle reflex which caused arm to move and vaccine provided a little high on arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Pain
Clinical narrative: BODY AND NECK GOING ALL THE WAY DOWN TO HER FEET; COULDN'T SLEEP AND WAS TOSSING AND TURNING ALL NIGHT; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body and neck pain going all the way down to her feet. On 06-APR-2021, the subject experienced couldn't sleep and was tossing and turning all night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body and neck pain going all the way down to her feet, and couldn't sleep and was tossing and turning all night. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Hypoaesthesia, Nausea
Clinical narrative: TIRED; NUMB FACE,PRIVATE AREA,TONGUE,LEGS AND SKIN(NO PAIN SENSATION IN TONGUE WHILE BITING); DIARRHEA; HEAD CLOUDINESS; BODY ACHE WHILE IN SLEEP; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no history of anaphylaxis reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism. On 06-APR-2021, the subject experienced numb face, private area, tongue, legs and skin (no pain sensation in tongue while biting). On 06-APR-2021, the subject experienced diarrhea. On 06-APR-2021, the subject experienced head cloudiness. On 06-APR-2021, the subject experienced body ache while in sleep. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, head cloudiness, and body ache while in sleep on 06-APR-2021, had not recovered from numb face, private area, tongue, legs and skin(no pain sensation in tongue while biting), and the outcome of nausea and tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: TIRED; NUMB FACE,PRIVATE AREA,TONGUE,LEGS AND SKIN(NO PAIN SENSATION IN TONGUE WHILE BITING); DIARRHEA; HEAD CLOUDINESS; BODY ACHE WHILE IN SLEEP; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no history of anaphylaxis reaction. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism. On 06-APR-2021, the subject experienced numb face, private area, tongue, legs and skin (no pain sensation in tongue while biting). On 06-APR-2021, the subject experienced diarrhea. On 06-APR-2021, the subject experienced head cloudiness. On 06-APR-2021, the subject experienced body ache while in sleep. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, head cloudiness, and body ache while in sleep on 06-APR-2021, had not recovered from numb face, private area, tongue, legs and skin(no pain sensation in tongue while biting), and the outcome of nausea and tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: FELT WORSE; FULL BODY ACHES; FEVER (100.7 F); This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 06-APR-2021, the subject experienced full body aches. On 06-APR-2021, the subject experienced fever (100.7 f). On 07-APR-2021, the subject experienced felt worse. Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (100.7 f), full body aches, and felt worse. This report was non-serious.; 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: Abdominal discomfort, COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; A LITTLE STOMACH UPSET; 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: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced a little stomach upset. On 07-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a little stomach upset and confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case is assessed non serious.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Chills, Diarrhoea, Dyspnoea
Clinical narrative: PASSED OUT; LOW BLOOD PRESSURE; DIFFICULTY BREATHING; DIARRHEA; BACK PAIN; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 38 year old 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: 042A21A) dose was not reported, frequency once total, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, Laboratory data included: Blood pressure (NR: not provided) low. The patient experienced side effects of chills, back pain, felt passed out, low blood pressure, headaches and diarrhea. The patient had difficulty breathing and went to emergency room stable at the time of reporting.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, low blood pressure, difficulty breathing, diarrhea, and chills on 06-APR-2021, and had not recovered from back pain, and headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210414531-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. 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: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypotension, Loss of consciousness
Clinical narrative: PASSED OUT; LOW BLOOD PRESSURE; DIFFICULTY BREATHING; DIARRHEA; BACK PAIN; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 38 year old 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: 042A21A) dose was not reported, frequency once total, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, Laboratory data included: Blood pressure (NR: not provided) low. The patient experienced side effects of chills, back pain, felt passed out, low blood pressure, headaches and diarrhea. The patient had difficulty breathing and went to emergency room stable at the time of reporting.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, low blood pressure, difficulty breathing, diarrhea, and chills on 06-APR-2021, and had not recovered from back pain, and headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210414531-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. 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: Asthenia, Chills, Confusional state, Dizziness, Dyspnoea
Clinical narrative: BAD BODY ACHES; DIZZY; RAISED HEART BEAT; FELT LIKE SHE WOULD FAINT; CONFUSED; FEELING REALLY HORRIBLE; RUNNY NOSE; SORE THROAT; HARD TO BREATH; BODY WEAKNESS; CHILLS; HEADACHE; FEVER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A2LA, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 08:30 at left arm for prophylactic vaccination.  No concomitant medications were reported. On APR-2021, the subject experienced bad body aches. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced raised heart beat. On APR-2021, the subject experienced felt like she would faint. On APR-2021, the subject experienced confused. On APR-2021, the subject experienced feeling really horrible. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced hard to breath. On APR-2021, the subject experienced body weakness. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, dizzy, body weakness, raised heart beat, felt like she would faint, headache, bad body aches, fever, confused, feeling really horrible, runny nose, sore throat and hard to breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Oropharyngeal pain, Pain
Clinical narrative: BAD BODY ACHES; DIZZY; RAISED HEART BEAT; FELT LIKE SHE WOULD FAINT; CONFUSED; FEELING REALLY HORRIBLE; RUNNY NOSE; SORE THROAT; HARD TO BREATH; BODY WEAKNESS; CHILLS; HEADACHE; FEVER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A2LA, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 08:30 at left arm for prophylactic vaccination.  No concomitant medications were reported. On APR-2021, the subject experienced bad body aches. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced raised heart beat. On APR-2021, the subject experienced felt like she would faint. On APR-2021, the subject experienced confused. On APR-2021, the subject experienced feeling really horrible. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced hard to breath. On APR-2021, the subject experienced body weakness. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, dizzy, body weakness, raised heart beat, felt like she would faint, headache, bad body aches, fever, confused, feeling really horrible, runny nose, sore throat and hard to breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia, Rhinorrhoea
Clinical narrative: BAD BODY ACHES; DIZZY; RAISED HEART BEAT; FELT LIKE SHE WOULD FAINT; CONFUSED; FEELING REALLY HORRIBLE; RUNNY NOSE; SORE THROAT; HARD TO BREATH; BODY WEAKNESS; CHILLS; HEADACHE; FEVER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A2LA, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 08:30 at left arm for prophylactic vaccination.  No concomitant medications were reported. On APR-2021, the subject experienced bad body aches. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced raised heart beat. On APR-2021, the subject experienced felt like she would faint. On APR-2021, the subject experienced confused. On APR-2021, the subject experienced feeling really horrible. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced hard to breath. On APR-2021, the subject experienced body weakness. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, dizzy, body weakness, raised heart beat, felt like she would faint, headache, bad body aches, fever, confused, feeling really horrible, runny nose, sore throat and hard to breath was not reported. This report was non-serious.