chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: PAINS IN NECK; LOW BODY TEMPERATURE; COUGHING; SCAR LIKE NEXT TO VACCINE SITE; SORE ARM; FEVER; EXTREME SHORTNESS OF BREATH; NAUSEA; This spontaneous report received from a patient concerned a 54 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced extreme shortness of breath. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced pains in neck. On 11-APR-2021, the subject experienced low body temperature. On 11-APR-2021, the subject experienced coughing. On 11-APR-2021, the subject experienced scar like next to vaccine site. Laboratory data included: Body temperature decreased (NR: not provided) 94-95 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, was recovering from low body temperature, had not recovered from extreme shortness of breath, nausea, pains in neck, sore arm, and coughing, and the outcome of scar like next to vaccine site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425534 and 20210423876.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: UNDERDOSE; This spontaneous report received from a pharmacist concerned a 52 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: 042121A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 14:20 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced under dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of under dose was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous report received from a parent concerned a 32 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: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: STILL FEELING REALLY SICK; This spontaneous report received from a consumer concerned a 42 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: Unknown) dose was not reported, administered on 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 12-APR-2021, the subject experienced still feeling really sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still feeling really sick. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 INFECTION; This spontaneous report received from a consumer 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 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 covid 19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 infection was not reported. This report was non-serious. Product complaint number: 90000176141; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: FELT NUMBNESS RIGHT ON TOP OF BUTTOCKS AND ALL THROUGH THE BACK OF HER LEGS; HEAD PRESSURE; DIZZINESS; CHILLS; PAIN IN LEGS; LEGS WERE NOT STRONG ENOUGH FOR HER TO GET UP; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, and fibromyalgia, and other pre-existing medical conditions included not obese or overweight, not taking medication for high cholesterol or fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced felt numbness right on top of buttocks and all through the back of her legs. On 12-APR-2021, the subject experienced head pressure. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced pain in legs. On 12-APR-2021, the subject experienced legs were not strong enough for her to get up. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-APR-2021, and had not recovered from headache, head pressure, dizziness, nausea, felt numbness right on top of buttocks and all through the back of her legs, legs were not strong enough for her to get up, and pain in legs. 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Pain in extremity
Clinical narrative: FELT NUMBNESS RIGHT ON TOP OF BUTTOCKS AND ALL THROUGH THE BACK OF HER LEGS; HEAD PRESSURE; DIZZINESS; CHILLS; PAIN IN LEGS; LEGS WERE NOT STRONG ENOUGH FOR HER TO GET UP; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, and fibromyalgia, and other pre-existing medical conditions included not obese or overweight, not taking medication for high cholesterol or fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced felt numbness right on top of buttocks and all through the back of her legs. On 12-APR-2021, the subject experienced head pressure. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced pain in legs. On 12-APR-2021, the subject experienced legs were not strong enough for her to get up. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-APR-2021, and had not recovered from headache, head pressure, dizziness, nausea, felt numbness right on top of buttocks and all through the back of her legs, legs were not strong enough for her to get up, and pain in legs. 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.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath. This report was non-serious. This case, from the Others is linked to 20200953687.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenitis
Clinical narrative: INFLAMED LYMPH NODES; CHILLS; BAD HEADACHE; This spontaneous report received from a patient concerned a 62 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: 1805031 and expiry: 26-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced bad headache. On an unspecified date, the subject experienced inflamed lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed lymph nodes, and chills, and bad headache on 12-MAR-2021. 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: M
Vaccine: COVID19
Symptoms: Contusion, Joint swelling, Ultrasound scan
Clinical narrative: ANKLE SWELLING; BRUISING TO THE RIGHT LOWER LEG; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included deep vein thrombosis in lower extremity, animal allergy, seasonal allergy/tree allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced bruising to the right lower leg. On 06-APR-2021, the subject experienced ankle swelling. On 12-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising to the right lower leg, and ankle swelling. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Heart rate, Palpitations, Pharyngeal disorder
Clinical narrative: CONGESTED FEELING IN CHEST; HEART RACING; CONGESTED FEELING IN THROAT; TEMPORAL/FRONTAL LOBE HEADACHE; FEVERISH/LOW GRADE FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus pressure. 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 12-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 12-APR-2021, the subject experienced congested feeling in chest. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced congested feeling in throat. On 12-APR-2021, the subject experienced temporal/frontal lobe headache. On 12-APR-2021, the subject experienced feverish/low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F, and Heart rate (NR: not provided) 120 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temporal/frontal lobe headache, feverish/low grade fever, heart racing, congested feeling in chest, and congested feeling in throat. 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
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: CONGESTED FEELING IN CHEST; HEART RACING; CONGESTED FEELING IN THROAT; TEMPORAL/FRONTAL LOBE HEADACHE; FEVERISH/LOW GRADE FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus pressure. 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 12-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 12-APR-2021, the subject experienced congested feeling in chest. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced congested feeling in throat. On 12-APR-2021, the subject experienced temporal/frontal lobe headache. On 12-APR-2021, the subject experienced feverish/low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F, and Heart rate (NR: not provided) 120 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temporal/frontal lobe headache, feverish/low grade fever, heart racing, congested feeling in chest, and congested feeling in throat. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dry eye, Dry skin, Fatigue
Clinical narrative: DRY EYES; PAIN IN NECK; LETHARGIC; FELT ROUGH; PAIN IN RIGHT ARM/TENDER LEFT ARM; PAIN IN SHOULDER; WEAKNESS; DRAINED/TIREDNESS; PAIN IN HEAD/HEADACHE; BURNING SENSATION AT THE SITE OF VACCINATION; FLUTTER IN RIGHT WRIST; INJURY IN RIGHT WRIST; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injury in right wrist. On 10-APR-2021, the subject experienced flutter in right wrist. On 10-APR-2021, the subject experienced burning sensation at the site of vaccination. On 11-APR-2021, the subject experienced dry eyes. On 11-APR-2021, the subject experienced pain in neck. On 11-APR-2021, the subject experienced lethargic. On 11-APR-2021, the subject experienced felt rough. On 11-APR-2021, the subject experienced pain in right arm/tender left arm. On 11-APR-2021, the subject experienced pain in shoulder. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced drained/tiredness. On 11-APR-2021, the subject experienced pain in head/headache. On 11-APR-2021 10:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eyes, pain in neck, pain in shoulder, and pain in head/headache on 12-APR-2021, lethargic, and weakness on 13-APR-2021, and flutter in right wrist on 10-APR-2021, had not recovered from pain in right arm/tender left arm, and the outcome of burning sensation at the site of vaccination, felt rough, drained/tiredness and injury in right wrist was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Joint injury, Lethargy, Neck pain
Clinical narrative: DRY EYES; PAIN IN NECK; LETHARGIC; FELT ROUGH; PAIN IN RIGHT ARM/TENDER LEFT ARM; PAIN IN SHOULDER; WEAKNESS; DRAINED/TIREDNESS; PAIN IN HEAD/HEADACHE; BURNING SENSATION AT THE SITE OF VACCINATION; FLUTTER IN RIGHT WRIST; INJURY IN RIGHT WRIST; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injury in right wrist. On 10-APR-2021, the subject experienced flutter in right wrist. On 10-APR-2021, the subject experienced burning sensation at the site of vaccination. On 11-APR-2021, the subject experienced dry eyes. On 11-APR-2021, the subject experienced pain in neck. On 11-APR-2021, the subject experienced lethargic. On 11-APR-2021, the subject experienced felt rough. On 11-APR-2021, the subject experienced pain in right arm/tender left arm. On 11-APR-2021, the subject experienced pain in shoulder. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced drained/tiredness. On 11-APR-2021, the subject experienced pain in head/headache. On 11-APR-2021 10:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eyes, pain in neck, pain in shoulder, and pain in head/headache on 12-APR-2021, lethargic, and weakness on 13-APR-2021, and flutter in right wrist on 10-APR-2021, had not recovered from pain in right arm/tender left arm, and the outcome of burning sensation at the site of vaccination, felt rough, drained/tiredness and injury in right wrist was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sensory disturbance
Clinical narrative: DRY EYES; PAIN IN NECK; LETHARGIC; FELT ROUGH; PAIN IN RIGHT ARM/TENDER LEFT ARM; PAIN IN SHOULDER; WEAKNESS; DRAINED/TIREDNESS; PAIN IN HEAD/HEADACHE; BURNING SENSATION AT THE SITE OF VACCINATION; FLUTTER IN RIGHT WRIST; INJURY IN RIGHT WRIST; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injury in right wrist. On 10-APR-2021, the subject experienced flutter in right wrist. On 10-APR-2021, the subject experienced burning sensation at the site of vaccination. On 11-APR-2021, the subject experienced dry eyes. On 11-APR-2021, the subject experienced pain in neck. On 11-APR-2021, the subject experienced lethargic. On 11-APR-2021, the subject experienced felt rough. On 11-APR-2021, the subject experienced pain in right arm/tender left arm. On 11-APR-2021, the subject experienced pain in shoulder. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced drained/tiredness. On 11-APR-2021, the subject experienced pain in head/headache. On 11-APR-2021 10:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eyes, pain in neck, pain in shoulder, and pain in head/headache on 12-APR-2021, lethargic, and weakness on 13-APR-2021, and flutter in right wrist on 10-APR-2021, had not recovered from pain in right arm/tender left arm, and the outcome of burning sensation at the site of vaccination, felt rough, drained/tiredness and injury in right wrist was not reported. This report was non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS; This spontaneous report received from a consumer concerned an 87 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISING ON THIGHS AND BELOW GROIN AREA; This spontaneous report received from a patient concerned a 56 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bruising on thighs and below groin area. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising on thighs and below groin area. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: BODY ACHE-MOSTLY ALONG THE NECK  AND BACK; STIFFNESS ALONG SPINE; HEADACHE; FEVER (103F); 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 past medical history included thyroid removal, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body ache-mostly along the neck and back. On 08-APR-2021, the subject experienced stiffness along spine. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache-mostly along the neck and back, stiffness along spine, and headache on 11-APR-2021, and fever on 09-APR-2021. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oedema peripheral, Pain in extremity
Clinical narrative: SWELLING ON LEFT TOE; ARM HURT A LOT; VERY TIRED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure abnormal, and blood thinner. On 06-APR-2021, the subject experienced arm hurt a lot. On 06-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced swelling on left toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on left toe on 11-APR-2021, and arm hurt a lot, and very tired on 07-APR-2021. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as per standard operating procedures.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: EXTREME FATIGUE; DIARRHEA; NAUSEOUS; FACE AND LIPS NUMBING; TINGLING ON THE LEFT SIDE OF FACE INCLUDING THE EAR; 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 past medical history included meningitis, and concurrent conditions included chronic pain. The patient experienced drug allergy when treated with streptomycin, and vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced face and lips numbing. On 07-APR-2021, the subject experienced tingling on the left side of face including the ear. On 07-APR-2021, the subject experienced nauseous. On 08-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face and lips numbing, tingling on the left side of face including the ear, and nauseous on 10-APR-2021, and diarrhea on APR-2021, and had not recovered from extreme fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Vomiting
Clinical narrative: VOMITING; SICK; FATIGUE; This spontaneous report received from a consumer 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, fatigue and sick was not reported. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: BLACK AND BLUE ARM IN VACCINE INJECTION SITE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included strawberry allergy/peach allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0424214, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced black and blue arm in vaccine injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black and blue arm in vaccine injection site on APR-2021. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Coccydynia, Discomfort, Dysstasia, Furuncle
Clinical narrative: FELT LIKE THERE WAS NO CIRCULATION IN THE ARMS; ARMS WERE WEAK; ARM NUMBNESS; CONSTANT TINGLING IN THE ARMS; PAIN TO TAIL BONE; FEELS LIKE PRESSURE TO THE AREA; NUMBNESS IN THIGHS; DIFFICULTY IN STANDING FOR LONG PERIODS OF TIME; TINGLING IN THIGHS; BOILS THAT WITH PUS ON STOMACH AND UNDER THE STOMACH; ITCHY RASH ON THE STOMACH, LEGS, AND BUTTOCK; MUSCLE ACHES; FEVER; MILD HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced muscle aches. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced mild headache. On 18-MAR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 103 F. On 21-MAR-2021, the subject experienced boils that with pus on stomach and under the stomach. On 21-MAR-2021, the subject experienced itchy rash on the stomach, legs, and buttock. On 01-APR-2021, the subject experienced numbness in thighs. On 01-APR-2021, the subject experienced difficulty in standing for long periods of time. On 01-APR-2021, the subject experienced tingling in thighs. On 06-APR-2021, the subject experienced pain to tail bone. On 06-APR-2021, the subject experienced feels like pressure to the area. On 10-APR-2021, the subject experienced arm numbness. On 10-APR-2021, the subject experienced constant tingling in the arms. On 12-APR-2021, the subject experienced felt like there was no circulation in the arms. On 12-APR-2021, the subject experienced arms were weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from boils that with pus on stomach and under the stomach, and itchy rash on the stomach, legs, and buttock on 21-MAR-2021, muscle aches, and mild headache on MAR-2021, fever on 20-MAR-2021, and injection site pain on 23-MAR-2021, had not recovered from numbness in thighs, difficulty in standing for long periods of time, tingling in thighs, pain to tail bone, arm numbness, and constant tingling in the arms, and the outcome of felt like there was no circulation in the arms, arms were weak and feels like pressure to the area was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: FELT LIKE THERE WAS NO CIRCULATION IN THE ARMS; ARMS WERE WEAK; ARM NUMBNESS; CONSTANT TINGLING IN THE ARMS; PAIN TO TAIL BONE; FEELS LIKE PRESSURE TO THE AREA; NUMBNESS IN THIGHS; DIFFICULTY IN STANDING FOR LONG PERIODS OF TIME; TINGLING IN THIGHS; BOILS THAT WITH PUS ON STOMACH AND UNDER THE STOMACH; ITCHY RASH ON THE STOMACH, LEGS, AND BUTTOCK; MUSCLE ACHES; FEVER; MILD HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced muscle aches. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced mild headache. On 18-MAR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 103 F. On 21-MAR-2021, the subject experienced boils that with pus on stomach and under the stomach. On 21-MAR-2021, the subject experienced itchy rash on the stomach, legs, and buttock. On 01-APR-2021, the subject experienced numbness in thighs. On 01-APR-2021, the subject experienced difficulty in standing for long periods of time. On 01-APR-2021, the subject experienced tingling in thighs. On 06-APR-2021, the subject experienced pain to tail bone. On 06-APR-2021, the subject experienced feels like pressure to the area. On 10-APR-2021, the subject experienced arm numbness. On 10-APR-2021, the subject experienced constant tingling in the arms. On 12-APR-2021, the subject experienced felt like there was no circulation in the arms. On 12-APR-2021, the subject experienced arms were weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from boils that with pus on stomach and under the stomach, and itchy rash on the stomach, legs, and buttock on 21-MAR-2021, muscle aches, and mild headache on MAR-2021, fever on 20-MAR-2021, and injection site pain on 23-MAR-2021, had not recovered from numbness in thighs, difficulty in standing for long periods of time, tingling in thighs, pain to tail bone, arm numbness, and constant tingling in the arms, and the outcome of felt like there was no circulation in the arms, arms were weak and feels like pressure to the area was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Rash pruritic, Sensory disturbance
Clinical narrative: FELT LIKE THERE WAS NO CIRCULATION IN THE ARMS; ARMS WERE WEAK; ARM NUMBNESS; CONSTANT TINGLING IN THE ARMS; PAIN TO TAIL BONE; FEELS LIKE PRESSURE TO THE AREA; NUMBNESS IN THIGHS; DIFFICULTY IN STANDING FOR LONG PERIODS OF TIME; TINGLING IN THIGHS; BOILS THAT WITH PUS ON STOMACH AND UNDER THE STOMACH; ITCHY RASH ON THE STOMACH, LEGS, AND BUTTOCK; MUSCLE ACHES; FEVER; MILD HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced muscle aches. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced mild headache. On 18-MAR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 103 F. On 21-MAR-2021, the subject experienced boils that with pus on stomach and under the stomach. On 21-MAR-2021, the subject experienced itchy rash on the stomach, legs, and buttock. On 01-APR-2021, the subject experienced numbness in thighs. On 01-APR-2021, the subject experienced difficulty in standing for long periods of time. On 01-APR-2021, the subject experienced tingling in thighs. On 06-APR-2021, the subject experienced pain to tail bone. On 06-APR-2021, the subject experienced feels like pressure to the area. On 10-APR-2021, the subject experienced arm numbness. On 10-APR-2021, the subject experienced constant tingling in the arms. On 12-APR-2021, the subject experienced felt like there was no circulation in the arms. On 12-APR-2021, the subject experienced arms were weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from boils that with pus on stomach and under the stomach, and itchy rash on the stomach, legs, and buttock on 21-MAR-2021, muscle aches, and mild headache on MAR-2021, fever on 20-MAR-2021, and injection site pain on 23-MAR-2021, had not recovered from numbness in thighs, difficulty in standing for long periods of time, tingling in thighs, pain to tail bone, arm numbness, and constant tingling in the arms, and the outcome of felt like there was no circulation in the arms, arms were weak and feels like pressure to the area was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Influenza like illness, Rash
Clinical narrative: UNUSUAL SENSATION OF ELECTRICITY IN HEAD; FLU LIKE SYMPTOMS WHICH WERE HARSH; RASH ON STOMACH; This spontaneous report received from a patient via a company representative 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 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 unusual sensation of electricity in head, flu like symptoms which were harsh, and rash on stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms which were harsh, unusual sensation of electricity in head and rash on stomach was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling cold, Gait disturbance
Clinical narrative: DIZZY; SEVERE BODY ACHES; VOMITING; HEART WAS POUNDING OUT OF CHEST; WALKING DIAGONAL COULD NOT WALK STRAIGHT; FREEZING; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 antigen test (NR: not provided) Negative. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced severe body aches. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced heart was pounding out of chest. On 02-APR-2021, the subject experienced walking diagonal could not walk straight. On 02-APR-2021, the subject experienced freezing. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 03-APR-2021, and severe body aches, vomiting, heart was pounding out of chest, chills, fever, and nausea on 02-APR-2021, and the outcome of freezing and walking diagonal could not walk straight was not reported. This report was non-serious. This report was associated with a product quality compliant : 90000176248.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations, Pyrexia, SARS-CoV-2 test
Clinical narrative: DIZZY; SEVERE BODY ACHES; VOMITING; HEART WAS POUNDING OUT OF CHEST; WALKING DIAGONAL COULD NOT WALK STRAIGHT; FREEZING; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 antigen test (NR: not provided) Negative. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced severe body aches. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced heart was pounding out of chest. On 02-APR-2021, the subject experienced walking diagonal could not walk straight. On 02-APR-2021, the subject experienced freezing. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 03-APR-2021, and severe body aches, vomiting, heart was pounding out of chest, chills, fever, and nausea on 02-APR-2021, and the outcome of freezing and walking diagonal could not walk straight was not reported. This report was non-serious. This report was associated with a product quality compliant : 90000176248.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIZZY; SEVERE BODY ACHES; VOMITING; HEART WAS POUNDING OUT OF CHEST; WALKING DIAGONAL COULD NOT WALK STRAIGHT; FREEZING; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 antigen test (NR: not provided) Negative. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced severe body aches. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced heart was pounding out of chest. On 02-APR-2021, the subject experienced walking diagonal could not walk straight. On 02-APR-2021, the subject experienced freezing. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 03-APR-2021, and severe body aches, vomiting, heart was pounding out of chest, chills, fever, and nausea on 02-APR-2021, and the outcome of freezing and walking diagonal could not walk straight was not reported. This report was non-serious. This report was associated with a product quality compliant : 90000176248.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: DIZZY; INJECTION SITE PAIN RADIATING TO NECK; ALMOST FAINTED; EXCESSIVE SWEATING AROUND ABDOMEN; FINGERS TINGLING AND JUMPING; CHILLS; SORE ARM AT INJECTION SITE; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site pain radiating to neck. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced almost fainted. On 07-APR-2021, the subject experienced excessive sweating around abdomen. On 07-APR-2021, the subject experienced fingers tingling and jumping. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced sore arm at injection site. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, almost fainted, fingers tingling and jumping, chills, nausea, and fever on 08-APR-2021, and had not recovered from headache, sore arm at injection site, excessive sweating around abdomen, and injection site pain radiating to neck. This report was non-serious.; Sender's Comments: V0:MAC comment is not required for nonserious case as per standard protocol.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Paraesthesia, Presyncope, Pyrexia
Clinical narrative: DIZZY; INJECTION SITE PAIN RADIATING TO NECK; ALMOST FAINTED; EXCESSIVE SWEATING AROUND ABDOMEN; FINGERS TINGLING AND JUMPING; CHILLS; SORE ARM AT INJECTION SITE; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site pain radiating to neck. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced almost fainted. On 07-APR-2021, the subject experienced excessive sweating around abdomen. On 07-APR-2021, the subject experienced fingers tingling and jumping. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced sore arm at injection site. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, almost fainted, fingers tingling and jumping, chills, nausea, and fever on 08-APR-2021, and had not recovered from headache, sore arm at injection site, excessive sweating around abdomen, and injection site pain radiating to neck. This report was non-serious.; Sender's Comments: V0:MAC comment is not required for nonserious case as per standard protocol.