chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Death, Hemiplegia
Clinical narrative: PARALYZED LEFT SIDE OF THE BODY; DEATH; This spontaneous report received from a health care professional concerned a 29 year old female. Initial information received on 16-APR-2021, processed along with information received via telephone communication on 20-APR-2021. The patient's weight was estimated about 200 pounds (reported as overweight but healthy). The patient's height and medical history were not reported. The patient had a baby in JAN-2021 and had a epidural at the time of birth.  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. The vaccination site was not reported. No concomitant medications were reported.  The reporter, which is a health care professional, reported that the patient's (the reporter's cousin) death cause could be JANSSEN COVID-19 vaccine. The reporter said that the patient was fine without symptoms for one week after her scheduled vaccine.  As per the reporter, the patient received the JANSSEN COVID-19 vaccine approximately 2 weeks ago (the patient was scheduled and her family assumed she went and received the vaccine). The reporter said that one week after the vaccine date the patient went to get her hair done, and when the patient sat on the chair, she suddenly could not move her left side. Ambulance/emergency room was called and the patient was taken to the hospital. The patient was in the hospital about a week and then passed away. An autopsy was performed but results were pending. The reporter had no details regarding imaging studies or laboratory values (platelet counts, D-dimer or fibrinogen), and does not know anything about the hospital course. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 16-APR-2021, and the outcome of paralyzed left side of the body was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This is a spontaneous report of a 29-year-old female who developed sudden hemiplegia approximately one week after receiving the Janssen COVID-19 vaccine, was hospitalized and died one week later.  The patient had a history of being overweight, and was approximately 3 months post-partum.  No medical history or concomitant medications were reported.  The hospital details and cause of death were not provided.  There are insufficient details to make a meaningful medical assessment at this time. Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Application site discolouration, Burning sensation, Dry throat, Ear pain, Injection site haemorrhage
Clinical narrative: PINKISH RED SKIN; DRY TONGUE; DRY THROAT; BURNING ITCHY SENSATION AROUND JAW , NECK AND EYE; EARS PAIN; HOT ITCHY EARS/NECK/BACK/ARM; INJECTION SITE PAIN; INJECTION SITE SORE  AND BLED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included ldl high, and other pre-existing medical conditions included the patient does not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and diphenhydramine hydrochloride.  On 31-MAR-2021, the subject experienced injection site sore and bled. On 31-MAR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced ears pain. On 13-APR-2021, the subject experienced hot itchy ears/neck/back/arm. On 13-APR-2021, the subject experienced burning itchy sensation around jaw, neck and eye. On 14-APR-2021, the subject experienced pinkish red skin. On 14-APR-2021, the subject experienced dry tongue. On 14-APR-2021, the subject experienced dry throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, injection site sore and bled, ears pain, pinkish red skin, burning itchy sensation around jaw , neck and eye, dry tongue, and dry throat, and had not recovered from hot itchy ears/neck/back/arm. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pruritus, Tongue dry
Clinical narrative: PINKISH RED SKIN; DRY TONGUE; DRY THROAT; BURNING ITCHY SENSATION AROUND JAW , NECK AND EYE; EARS PAIN; HOT ITCHY EARS/NECK/BACK/ARM; INJECTION SITE PAIN; INJECTION SITE SORE  AND BLED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included ldl high, and other pre-existing medical conditions included the patient does not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and diphenhydramine hydrochloride.  On 31-MAR-2021, the subject experienced injection site sore and bled. On 31-MAR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced ears pain. On 13-APR-2021, the subject experienced hot itchy ears/neck/back/arm. On 13-APR-2021, the subject experienced burning itchy sensation around jaw, neck and eye. On 14-APR-2021, the subject experienced pinkish red skin. On 14-APR-2021, the subject experienced dry tongue. On 14-APR-2021, the subject experienced dry throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, injection site sore and bled, ears pain, pinkish red skin, burning itchy sensation around jaw , neck and eye, dry tongue, and dry throat, and had not recovered from hot itchy ears/neck/back/arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: ACHES; FELT OUT OF IT; CHILLS; PROBABLY A SLIGHT FEVER; TIRED; FELT LIKE A MINOR FLU; 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced aches. On APR-2021, the subject experienced felt out of it. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced probably a slight fever. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced felt like a minor flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and probably a slight fever on APR-2021, had not recovered from tired, and felt out of it, and the outcome of felt like a minor flu was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHES; FELT OUT OF IT; CHILLS; PROBABLY A SLIGHT FEVER; TIRED; FELT LIKE A MINOR FLU; 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced aches. On APR-2021, the subject experienced felt out of it. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced probably a slight fever. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced felt like a minor flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and probably a slight fever on APR-2021, had not recovered from tired, and felt out of it, and the outcome of felt like a minor flu was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. 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 chills. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain
Clinical narrative: BODY ACHES; VERY LITTLE ENERGY; HEADACHE; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, very little energy, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very little energy, body aches and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Injection site pruritus, Joint stiffness
Clinical narrative: DIARRHEA; ACHYNESS; FATIGUE; JOINT STIFFNESS; INTENSIFYING LIGHTHEADEDNESS; ITCHINESS AT INJECTION SITE; MUSCLE STIFFENING; MUSCLE ACHES; 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced itchiness at injection site. On 11-APR-2021, the subject experienced muscle stiffening. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021 21:00, the subject experienced joint stiffness. On 11-APR-2021 21:00, the subject experienced intensifying lightheadedness. On 17-APR-2021, the subject experienced diarrhea. On 17-APR-2021, the subject experienced achyness. On 17-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diarrhea, and achyness, and had not recovered from joint stiffness, muscle aches, fatigue, itchiness at injection site, muscle stiffening, and intensifying lightheadedness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: DIARRHEA; ACHYNESS; FATIGUE; JOINT STIFFNESS; INTENSIFYING LIGHTHEADEDNESS; ITCHINESS AT INJECTION SITE; MUSCLE STIFFENING; MUSCLE ACHES; 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced itchiness at injection site. On 11-APR-2021, the subject experienced muscle stiffening. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021 21:00, the subject experienced joint stiffness. On 11-APR-2021 21:00, the subject experienced intensifying lightheadedness. On 17-APR-2021, the subject experienced diarrhea. On 17-APR-2021, the subject experienced achyness. On 17-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diarrhea, and achyness, and had not recovered from joint stiffness, muscle aches, fatigue, itchiness at injection site, muscle stiffening, and intensifying lightheadedness. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Fatigue, Nightmare, Skin atrophy
Clinical narrative: ELASTICITY ON BACK OF HANDS UNRESPONSIVE; TIREDNESS; BACKACHE; NIGHTMARES; DIARRHEA; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported.  The patient's past medical history included herniated disc, and concurrent conditions included penicillin allergy, high blood pressure, smoker, back pain, plantars wart, diabetes, and alcohol user.  The patient experienced drug allergy when treated with Cleocin (clindamycin hydrochloride).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  Concomitant medications included metformin for diabetes, losartan for high blood pressure, salicylic acid for plantars wart, and Wellbutrin (bupropion hydrochloride).  On 08-APR-2021, the subject experienced nightmares. On 08-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced backache. On 10-APR-2021, the subject experienced tiredness. On 16-APR-2021, the subject experienced elasticity on back of hands unresponsive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elasticity on back of hands unresponsive, and the outcome of backache, tiredness, nightmares and diarrhea was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Influenza like illness, Injection site pain, Sluggishness
Clinical narrative: FEELING HOT AND COLD; SLUGGISHNESS; FLU LIKE SYMPTOMS; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling hot and cold. On APR-2021, the subject experienced sluggishness. On APR-2021, the subject experienced flu like symptoms. On APR-2021, the subject experienced soreness at injection site. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, had not recovered from soreness at injection site, and the outcome of feeling hot and cold and sluggishness was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Feeling hot, Headache
Clinical narrative: BURNING NEEDLE IN INJECTION SITE; STOMACH ACHE; FEELING HOT INSIDE; THROWING UP; HAVING THE RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced feeling hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced having the runs.  On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced burning needle in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, feeling hot inside, chills on and off, throwing up, and having the runs, and the outcome of burning needle in injection site was not reported. This report was non-serious. This case, involving the same patient is linked to 20210435721.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vomiting
Clinical narrative: BURNING NEEDLE IN INJECTION SITE; STOMACH ACHE; FEELING HOT INSIDE; THROWING UP; HAVING THE RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced feeling hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced having the runs.  On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced burning needle in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, feeling hot inside, chills on and off, throwing up, and having the runs, and the outcome of burning needle in injection site was not reported. This report was non-serious. This case, involving the same patient is linked to 20210435721.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Pyrexia
Clinical narrative: ABDOMINAL PAIN; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 115 pounds, and height was 64 inches. The patient's concurrent conditions included non-smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever on APR-2021, and had not recovered from abdominal pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: WHOLE BODY SORENESS; FATIGUE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 19 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 batch number: 201A21A 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 whole body soreness. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body soreness, and fatigue on APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: MUSCLE ACHES; INJECTION SITE SORENESS; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, no alcohol use, and non-smoker, and other pre-existing medical conditions included 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: 206A21 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced injection site soreness. On 11-APR-2021, the subject experienced injection site redness. On an unspecified date, the subject experienced muscle aches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, and was recovering from injection site soreness, and injection site redness. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISE ON UPPER RIGHT SIDE OF  CHEST; This spontaneous report received from a consumer 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: 041A21A, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced bruise on upper right side of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on upper right side of chest. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Hypoaesthesia, Pain
Clinical narrative: NUMBNESS IN LEG; PAIN IN HIS RIGHT LEG BELOW THE CALF AND PAIN MOVE UP AND INCREASING IN SEVERITY; BODY PAIN; DIZZINESS WHEN HE STOOD UP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021 02:00, the subject experienced chills. On 11-APR-2021 02:00, the subject experienced fever. On 11-APR-2021 06:00, Laboratory data included: Body temperature (NR: not provided) 100.7 (unit not reported). On 12-APR-2021 06:00, the subject experienced body pain. On 12-APR-2021 06:00, the subject experienced dizziness when he stood up. On 13-APR-2021, the subject experienced numbness in leg. On 13-APR-2021, the subject experienced pain in his right leg below the calf and pain move up and increasing in severity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in his right leg below the calf and pain move up and increasing in severity, and numbness in leg, and the outcome of fever, chills, body pain and dizziness when he stood up was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: NUMBNESS IN LEG; PAIN IN HIS RIGHT LEG BELOW THE CALF AND PAIN MOVE UP AND INCREASING IN SEVERITY; BODY PAIN; DIZZINESS WHEN HE STOOD UP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021 02:00, the subject experienced chills. On 11-APR-2021 02:00, the subject experienced fever. On 11-APR-2021 06:00, Laboratory data included: Body temperature (NR: not provided) 100.7 (unit not reported). On 12-APR-2021 06:00, the subject experienced body pain. On 12-APR-2021 06:00, the subject experienced dizziness when he stood up. On 13-APR-2021, the subject experienced numbness in leg. On 13-APR-2021, the subject experienced pain in his right leg below the calf and pain move up and increasing in severity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in his right leg below the calf and pain move up and increasing in severity, and numbness in leg, and the outcome of fever, chills, body pain and dizziness when he stood up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Pain in extremity, Palpitations, Platelet count decreased, Pyrexia
Clinical narrative: RACING HEART; HIVES; RASH ON CHEST/ RED DOTS ON BELLY; LOW GRADE FEVER; SORE ARM; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient never had a severe allergic reaction. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: diphenhydramine hydrochloride ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced racing heart. On 11-APR-2021, the subject experienced hives. On 11-APR-2021, the subject experienced rash on chest/ red dots on belly. On 11-APR-2021, the subject experienced low grade fever. On 12-APR-2021, Laboratory data included: Low platelets (NR: not provided) 118. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on chest/ red dots on belly, and the outcome of low grade fever, hives, racing heart and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Urticaria
Clinical narrative: RACING HEART; HIVES; RASH ON CHEST/ RED DOTS ON BELLY; LOW GRADE FEVER; SORE ARM; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient never had a severe allergic reaction. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: diphenhydramine hydrochloride ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced racing heart. On 11-APR-2021, the subject experienced hives. On 11-APR-2021, the subject experienced rash on chest/ red dots on belly. On 11-APR-2021, the subject experienced low grade fever. On 12-APR-2021, Laboratory data included: Low platelets (NR: not provided) 118. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on chest/ red dots on belly, and the outcome of low grade fever, hives, racing heart and sore arm was not reported. This report was non-serious.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Urticaria
Clinical narrative: HIVES ON BACK AND ARM; BODY ACHED UNDERARM; CHILLS; TIRED; This spontaneous report received from a patient concerned a 60 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: 041A21A, and batch number: 041A21A 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 tired. On 02-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced body ached underarm. On 07-APR-2021, the subject experienced hives on back and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ached underarm on 05-APR-2021, chills on 03-APR-2021, and tired on 04-APR-2021, and was recovering from hives on back and arm. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Testicular pain
Clinical narrative: PAIN IN LEFT TESTICLE; HEADACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 240 pounds, and height was 78 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included 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: 203A21A expiry: 23-JUN-2021) .5 ml, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced pain in left testicle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-APR-2021, and had not recovered from pain in left testicle. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Pain, Pain in extremity
Clinical narrative: ARM PAIN; CHILLS; LOW GRADE FEVER; EXHAUSTED; BODY ACHE; HOT FLASHES; This spontaneous report received from a patient concerned a 45 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced hot flashes. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced exhausted. On 15-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-MAR-2021, and low grade fever on 11-MAR-2021, and had not recovered from body ache, exhausted, hot flashes, and arm pain. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ARM PAIN; CHILLS; LOW GRADE FEVER; EXHAUSTED; BODY ACHE; HOT FLASHES; This spontaneous report received from a patient concerned a 45 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced hot flashes. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced exhausted. On 15-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-MAR-2021, and low grade fever on 11-MAR-2021, and had not recovered from body ache, exhausted, hot flashes, and arm pain. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling cold, Feeling hot, Gait inability
Clinical narrative: FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN  ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Oedema peripheral, Pain
Clinical narrative: FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN  ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN  ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Chills, Pyrexia, Vaccination complication
Clinical narrative: REACTION TO COVID-19 VACCINE; CHILLS; FEVER; 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 guselkumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. 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 reaction to covid-19 vaccine, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The outcome of the fever, chills and reaction to covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Nausea, Pain, Pain in extremity
Clinical narrative: GENERALISED ACHING; APPETITE LOST; SORE ARM; FEVER; NAUSEA; 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: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced generalised aching. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching, appetite lost, sore arm, fever, and nausea on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: GENERALISED ACHING; APPETITE LOST; SORE ARM; FEVER; NAUSEA; 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: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced generalised aching. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching, appetite lost, sore arm, fever, and nausea on APR-2021. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: SORE ARM; ITCHING; GENERALIZED RASH; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 153 pounds, and height was 64 inches. The patient's concurrent conditions included hay fever, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021, the subject experienced itching. On 17-APR-2021, the subject experienced generalized rash. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized rash, and the outcome of itching and sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FEVER; EXTREME EXHAUSTION; 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: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced extreme exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and extreme exhaustion was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Dizziness, Headache
Clinical narrative: DIZZY; CHILLS; LEFT ARM PAIN AT INJECTION SITE; FEVER; HEADACHE; VOMITING; LEFT-SIDE STOMACH PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, alcohol user (twice a month), and non-smoker, and other pre-existing medical conditions included the patient had no illicit drug usage and drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced left-side stomach pain. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced left arm pain at injection site. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.5 F, Heart rate (NR: not provided) 120 BPM, and Pulse oximetry (NR: not provided) 91 %. On 16-APR-2021, the subject experienced dizzy. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, left-side stomach pain, and chills on 16-APR-2021, was recovering from dizzy, and had not recovered from headache, fever, and left arm pain at injection site. This report was non-serious.