chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE PROVIDED TO A 17 YEAR OLD/VACCINE ADMINISTERED IN INAPPROPRIATE AGE GROUP; OFF LABEL USE; This spontaneous report received from a patient concerned a 17 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced vaccine provided to a 17 year old/vaccine administered in inappropriate age group. On 07-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine provided to a 17 year old/vaccine administered in inappropriate age group was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Renal pain
Clinical narrative: FEVER; HEADACHE; MUSCLE ACHE; NAUSEA; KIDNEY PAIN; This spontaneous report received from a parent concerned a 24 year old male. The patient's weight was 130 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-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 fever, headache, muscle ache, nausea, and kidney pain. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, muscle ache, nausea and kidney pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; DIZZINESS; FEVER; VERY TIRED FEELING; HEADACHE; This spontaneous report received from a patient concerned a 30 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, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body aches. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced very tired feeling. On 03-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, and had not recovered from body aches, very tired feeling, headache, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Pyrexia
Clinical narrative: DIZZINESS; FEVER; EXTREMELY TIRED; This spontaneous report received from a parent concerned a 30 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 06-APR-2021 17:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the subject experienced extremely tired. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100-101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 07-APR-2021, and was recovering from extremely tired, and fever. This report was non-serious. This case, from the same reporter is linked to 20210416407.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: DIZZINESS; FEVER; EXTREMELY TIRED; This spontaneous report received from a parent concerned a 30 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 06-APR-2021 17:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the subject experienced extremely tired. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100-101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 07-APR-2021, and was recovering from extremely tired, and fever. This report was non-serious. This case, from the same reporter is linked to 20210416407.
Sex: U
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: A BIT STIFF AT INJECTION SPOT ON RIGHT ARM; 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 administered on right arm, 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 a bit stiff at injection spot on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit stiff at injection spot on right arm was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hypoaesthesia, Myalgia, Nausea
Clinical narrative: SORENESS; NUMBNESS; FEELING HOT; CHILLS; NAUSEA; MUSCLE ACHES; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included contrast dye allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 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 soreness. On 08-APR-2021, the subject experienced numbness. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and nausea, and had not recovered from soreness, feeling hot, muscle aches, and numbness. This report was non-serious.       T
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SORENESS; NUMBNESS; FEELING HOT; CHILLS; NAUSEA; MUSCLE ACHES; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included contrast dye allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 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 soreness. On 08-APR-2021, the subject experienced numbness. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and nausea, and had not recovered from soreness, feeling hot, muscle aches, and numbness. This report was non-serious.       T
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Facial pain, Fatigue, Gingival pain
Clinical narrative: PAIN IN TEETH TOWARDS THE HEAD; PAIN IN GUMS TOWARDS THE HEAD; PAIN IN CHEEKBONE TOWARDS THE HEAD; EYES ACHE; UNCONTROLLABLE SHAKING; MUSCLE PAIN AT INJECTION SITE; CHILLS; DULL HEADACHE; FEELING WASHED OUT / TIREDNESS; This spontaneous report received from a patient concerned an 81 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain in teeth towards the head. On 06-APR-2021, the subject experienced pain in gums towards the head. On 06-APR-2021, the subject experienced pain in cheekbone towards the head. On 06-APR-2021, the subject experienced eyes ached. On 06-APR-2021, the subject experienced uncontrollable shaking. On 06-APR-2021, the subject experienced muscle pain at injection site. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced dull headache. On 06-APR-2021, the subject experienced feeling washed out. On 06-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in teeth towards the head, pain in gums towards the head, pain in cheekbone towards the head, eyes ached, dull headache, feeling washed out, and tired on 07-APR-2021, uncontrollable shaking, and chills on 06-APR-2021 22:35:00, and muscle pain at injection site on 06-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Toothache, Tremor
Clinical narrative: PAIN IN TEETH TOWARDS THE HEAD; PAIN IN GUMS TOWARDS THE HEAD; PAIN IN CHEEKBONE TOWARDS THE HEAD; EYES ACHE; UNCONTROLLABLE SHAKING; MUSCLE PAIN AT INJECTION SITE; CHILLS; DULL HEADACHE; FEELING WASHED OUT / TIREDNESS; This spontaneous report received from a patient concerned an 81 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain in teeth towards the head. On 06-APR-2021, the subject experienced pain in gums towards the head. On 06-APR-2021, the subject experienced pain in cheekbone towards the head. On 06-APR-2021, the subject experienced eyes ached. On 06-APR-2021, the subject experienced uncontrollable shaking. On 06-APR-2021, the subject experienced muscle pain at injection site. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced dull headache. On 06-APR-2021, the subject experienced feeling washed out. On 06-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in teeth towards the head, pain in gums towards the head, pain in cheekbone towards the head, eyes ached, dull headache, feeling washed out, and tired on 07-APR-2021, uncontrollable shaking, and chills on 06-APR-2021 22:35:00, and muscle pain at injection site on 06-APR-2021. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye swelling, Pyrexia
Clinical narrative: SLIGHT SWELLING AROUND BOTH EYES; TEMPERATURE OF 100 DEGREES; This spontaneous report received from a consumer 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: UKNOWN) dose was not reported, administered on 08-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 08-APR-2021, the patient experienced slight swelling around both eyes. On 08-APR-2021, the patient experienced temperature of 100 degrees. 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 had not recovered from temperature of 100 degrees, and slight swelling around both eyes. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: MUSCLE SPASM; MILD FEVER; This spontaneous report received from a consumer concerned a 54 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced mild fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle spasm, and the outcome of mild fever was not reported. This report was non-serious.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: COLD; KNEE PAIN; NAUSEA; MILD FEVER; This spontaneous report received from a patient concerned a 29 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. 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 cold. On APR-2021, the subject experienced knee pain. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, mild fever, cold and knee pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES/ GROWING CLUSTER THAT STARTED ON THE FOREHEAD AND WENT DOWN THE CHEEKS; 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, 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 hives/ growing cluster that started on the forehead and went down the cheeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives/ growing cluster that started on the forehead and went down the cheeks was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: NOT EATING; LETHARGIC; HIGH FEVER; This spontaneous report received from a parent concerned an 18 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced high fever. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced not eating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic, high fever and not eating was not reported. This report was non-serious.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: PAIN IN MY HIPS, LEGS, ARMS, NECK,  SHOULDERS, SO IT BECAME ALL OVER MY BODY; FATIGUE; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included nerve pain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included melatonin for sleeping problem. On 07-APR-2021, the subject experienced pain in my hips, legs, arms, neck, shoulders, so it became all over my body. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and pain in my hips, legs, arms, neck, shoulders, so it became all over my body. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 23 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 vaccinated at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, chills, and headache. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Burning sensation, Chills, Headache
Clinical narrative: BODY BURNING; CHILLS; FEVER; HEADACHE; FEELING EXTREMELY WEAK; 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 COPD and former smoker, and other pre-existing medical conditions included no known drug allergies, 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: 042A21A, 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 body burning. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced feeling extremely weak. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, body burning, headache and feeling extremely weak. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: BODY BURNING; CHILLS; FEVER; HEADACHE; FEELING EXTREMELY WEAK; 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 COPD and former smoker, and other pre-existing medical conditions included no known drug allergies, 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: 042A21A, 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 body burning. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced feeling extremely weak. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, body burning, headache and feeling extremely weak. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: BODY BURNING; CHILLS; FEVER; HEADACHE; FEELING EXTREMELY WEAK; 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 COPD and former smoker, and other pre-existing medical conditions included no known drug allergies, 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: 042A21A, 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 body burning. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced feeling extremely weak. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, body burning, headache and feeling extremely weak. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Headache, Injection site paraesthesia
Clinical narrative: NAUSEA; HEADACHE; TINGLING IN THE LEFT ARM; FEELING HOT; CHILLS; FEVER; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 170 pounds, and height was not reported. No past medical history or concurrent conditions were 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 08-APR-2021 17.00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tingling arm. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 104.2 F. On 09-APR-2021 02:30, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling arm on 08-APR-2021, had not recovered from fever, chills, nausea, and feeling hot, and the outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: NAUSEA; HEADACHE; TINGLING IN THE LEFT ARM; FEELING HOT; CHILLS; FEVER; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 170 pounds, and height was not reported. No past medical history or concurrent conditions were 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 08-APR-2021 17.00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tingling arm. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 104.2 F. On 09-APR-2021 02:30, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling arm on 08-APR-2021, had not recovered from fever, chills, nausea, and feeling hot, and the outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; 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, 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 sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain
Clinical narrative: PAIN; CHILLS; HEADACHE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 47 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 and batch number: 1808978 expiry: /2023) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, muscle aches, fever, and pain. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN; CHILLS; HEADACHE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 47 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 and batch number: 1808978 expiry: /2023) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, muscle aches, fever, and pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-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 07-APR-2021, the subject experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Mass, Myalgia, Pain
Clinical narrative: TENDER LUMP ON COLLAR BONE; TENDERNESS UNDER EAR TO UNDERNEATH SIDE OF BREAST; SWELLING; SORENESS AND JOINT PAIN; 5 TINY PIN SIZED BLISTERS ON CHEST AND TRUNK; SUN BURNED FEELING AT INJECTION SITE; SORE ARM; ARM MUSCLE SORENESS FROM INJECTION SITE TO SHOULDER JOINT TO MID ARM (ELBOW TO SHOULDER); WARM PAIN; This spontaneous report received from a patient concerned a 57 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: 180502, and batch number: 180502 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced warm pain. On 10-MAR-2021, the subject experienced sun burned feeling at injection site. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced arm muscle soreness from injection site to shoulder joint to mid arm (elbow to shoulder). On 11-MAR-2021, the subject experienced 5 tiny pin sized blisters on chest and trunk. On 12-MAR-2021, the subject experienced tender lump on collar bone. On 12-MAR-2021, the subject experienced tenderness under ear to underneath side of breast. On 12-MAR-2021, the subject experienced swelling. On 12-MAR-2021, the subject experienced soreness and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 5 tiny pin sized blisters on chest and trunk, was recovering from sore arm, tender lump on collar bone, soreness and joint pain, and swelling, and had not recovered from warm pain, tenderness under ear to underneath side of breast, sun burned feeling at injection site, and arm muscle soreness from injection site to shoulder joint to mid arm (elbow to shoulder). This report was non-serious.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Sunburn, Swelling, Tenderness
Clinical narrative: TENDER LUMP ON COLLAR BONE; TENDERNESS UNDER EAR TO UNDERNEATH SIDE OF BREAST; SWELLING; SORENESS AND JOINT PAIN; 5 TINY PIN SIZED BLISTERS ON CHEST AND TRUNK; SUN BURNED FEELING AT INJECTION SITE; SORE ARM; ARM MUSCLE SORENESS FROM INJECTION SITE TO SHOULDER JOINT TO MID ARM (ELBOW TO SHOULDER); WARM PAIN; This spontaneous report received from a patient concerned a 57 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: 180502, and batch number: 180502 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced warm pain. On 10-MAR-2021, the subject experienced sun burned feeling at injection site. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced arm muscle soreness from injection site to shoulder joint to mid arm (elbow to shoulder). On 11-MAR-2021, the subject experienced 5 tiny pin sized blisters on chest and trunk. On 12-MAR-2021, the subject experienced tender lump on collar bone. On 12-MAR-2021, the subject experienced tenderness under ear to underneath side of breast. On 12-MAR-2021, the subject experienced swelling. On 12-MAR-2021, the subject experienced soreness and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 5 tiny pin sized blisters on chest and trunk, was recovering from sore arm, tender lump on collar bone, soreness and joint pain, and swelling, and had not recovered from warm pain, tenderness under ear to underneath side of breast, sun burned feeling at injection site, and arm muscle soreness from injection site to shoulder joint to mid arm (elbow to shoulder). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES; This spontaneous report received from a consumer concerned a 68 year old. 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 an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches. This report was non-serious.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 24 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A 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 fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Feeling cold, Heart rate, Heart rate increased
Clinical narrative: ACHY BONES FEELING THROUGH THE SKIN; HEART RATE ELEVATED; FREEZING; CHILLS; FEVER AT 101.1; 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: 180980 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 achy bones feeling through the skin. On 08-APR-2021, the subject experienced heart rate elevated. On 08-APR-2021, the subject experienced freezing. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever at 101.1. Laboratory data (dates unspecified) included: Fever (NR: not provided) 101.1, 100.7, Heart rate (NR: not provided) 95, and Heart rate high (NR: not provided) 114. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, achy bones feeling through the skin, heart rate elevated, and fever at 101.1, and the outcome of freezing was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417646.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHY BONES FEELING THROUGH THE SKIN; HEART RATE ELEVATED; FREEZING; CHILLS; FEVER AT 101.1; 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: 180980 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 achy bones feeling through the skin. On 08-APR-2021, the subject experienced heart rate elevated. On 08-APR-2021, the subject experienced freezing. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever at 101.1. Laboratory data (dates unspecified) included: Fever (NR: not provided) 101.1, 100.7, Heart rate (NR: not provided) 95, and Heart rate high (NR: not provided) 114. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, achy bones feeling through the skin, heart rate elevated, and fever at 101.1, and the outcome of freezing was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417646.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza like illness, Sensitive skin
Clinical narrative: FLU LIKE SYMPTOMS; SENSITIVE SKIN; This spontaneous report received from a patient concerned a 35 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 07-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sensitive skin. Laboratory data included: Heart rate high (NR: not provided) 90-120 {beats}/min. Treatment medications included: ibuprofen. On 07-APR-2021 23:00, the subject experienced flu like symptoms. On 08-APR-2021, Laboratory data included: Heart rate high (NR: not provided) 85 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 08-APR-2021 01:00, and was recovering from sensitive skin. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: GENERAL BODY ACHES; FOGGY FEELING IN HEAD; HEADACHE; LOW FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 2021, the subject experienced general body aches. On 2021, the subject experienced foggy feeling in head. On 2021, the subject experienced headache. On 2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general body aches, foggy feeling in head, headache and low fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-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 tingling in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in arm was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 28 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:48:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101-102, 101.5 F. On 08-APR-2021 22:00, the subject experienced fever. On 08-APR-2021 23:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cognitive disorder, Malaise, Pain
Clinical narrative: BODY ACHES; INABILITY TO TELL WHAT WAS REAL OR NOT; FEELING LIKE FREIGHT TRAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a 25 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: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 08-APR-2021 21:00, the subject experienced body aches. On 08-APR-2021 21:00, the subject experienced inability to tell what was real or not. On 08-APR-2021 21:00, the subject experienced feeling like freight train. On 08-APR-2021 21:00, the subject experienced chills. On 08-APR-2021 21:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, was recovering from inability to tell what was real or not, and had not recovered from body aches, and feeling like freight train. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; INABILITY TO TELL WHAT WAS REAL OR NOT; FEELING LIKE FREIGHT TRAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a 25 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: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 08-APR-2021 21:00, the subject experienced body aches. On 08-APR-2021 21:00, the subject experienced inability to tell what was real or not. On 08-APR-2021 21:00, the subject experienced feeling like freight train. On 08-APR-2021 21:00, the subject experienced chills. On 08-APR-2021 21:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, was recovering from inability to tell what was real or not, and had not recovered from body aches, and feeling like freight train. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Therapeutic response unexpected
Clinical narrative: GOT RID OF ALLERGIES; SLEEPY; TIRED; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included sinusitis, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On 03-MAR-2021, the subject experienced sleepy. On 03-MAR-2021, the subject experienced tired. On APR-2021, the subject experienced got rid of allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, sleepy and got rid of allergies was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOW GRADE FEVER; This spontaneous report received from a parent 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Dyspnoea, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: HARD TO BREATHE; INCREASE HEART RATE; WHEEZING; 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 allergic to sulfa antibiotics, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced hard to breathe. On 01-APR-2021, the subject experienced increase heart rate. On 01-APR-2021, the subject experienced wheezing. Laboratory data included: Heart rate (NR: not provided) 104-114, Potassium (NR: not provided) Low, and SARS-CoV-2 test (NR: not provided) unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hard to breathe, increase heart rate, and wheezing. This report was non-serious.