chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: DIZZINESS; LIGHT HEADEDNESS; SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.5-101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, sore arm, dizziness and light headedness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dizziness, Fatigue, Heart rate
Clinical narrative: HEART RATE INCREASED; MILD INJECTION SITE PAIN; INCREASED BODY TEMPERATURE; MUSCLE SORENESS; TIRED; DIZZINESS; FLU; STINGING PAIN IN LEFT KNEE; 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, and batch number were not reported) dose was not reported, 1 total, administered on 10-APR-2021 16:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced flu. On APR-2021, the subject experienced stinging pain in left knee. On APR-2021, the subject experienced mild injection site pain. On APR-2021, the subject experienced increased body temperature. On APR-2021, the subject experienced muscle soreness. On APR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 37.5. On 11-APR-2021, the subject experienced heart rate increased. Laboratory data included: Heart rate (NR: not provided) 90. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu, and the outcome of mild injection site pain, stinging pain in left knee, increased body temperature, muscle soreness, dizziness, tired and heart rate increased was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza, Injection site pain, Myalgia, Pain
Clinical narrative: HEART RATE INCREASED; MILD INJECTION SITE PAIN; INCREASED BODY TEMPERATURE; MUSCLE SORENESS; TIRED; DIZZINESS; FLU; STINGING PAIN IN LEFT KNEE; 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, and batch number were not reported) dose was not reported, 1 total, administered on 10-APR-2021 16:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced flu. On APR-2021, the subject experienced stinging pain in left knee. On APR-2021, the subject experienced mild injection site pain. On APR-2021, the subject experienced increased body temperature. On APR-2021, the subject experienced muscle soreness. On APR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 37.5. On 11-APR-2021, the subject experienced heart rate increased. Laboratory data included: Heart rate (NR: not provided) 90. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu, and the outcome of mild injection site pain, stinging pain in left knee, increased body temperature, muscle soreness, dizziness, tired and heart rate increased was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: HEADACHE; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 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 06-APR-2021, the subject experienced injection site soreness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 08-APR-2021, and had not recovered from injection site soreness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administration error
Clinical narrative: PRODUCT ADMINISTRATION ERROR; OFF LABEL USE; This spontaneous report received from a health care professional 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 product administration error, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administration error and off label use was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: DIZZINESS (MORE LIKE LIGHT HEADEDNESS); Leg pain; Nausea; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies or any medical condition. 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 and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced dizziness (more like light headedness). On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced nausea.  Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness (more like light headedness) and leg pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEEL HOT; FEEL OVERLY TIRED; 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 covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced feel hot. On 09-APR-2021, the subject experienced feel overly tired. On 09-APR-2021, the subject experienced chills. On 09-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, body aches, chills, feel hot, and feel overly tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: COULD NOT MOVE ON; FELT TERRIBLE; SWEATING; COUGH; FEELING SICK; FEVER; CHILLS; 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: JNJ041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced headache. On 07-APR-2021 21:30, the subject experienced chills. On 08-APR-2021, the subject experienced could not move on. On 08-APR-2021, the subject experienced felt terrible. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced feeling sick. On 08-APR-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on APR-2021, was recovering from feeling sick, and the outcome of headache, chills, fever, sweating, felt terrible and could not move on was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Malaise, Pyrexia
Clinical narrative: COULD NOT MOVE ON; FELT TERRIBLE; SWEATING; COUGH; FEELING SICK; FEVER; CHILLS; 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: JNJ041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced headache. On 07-APR-2021 21:30, the subject experienced chills. On 08-APR-2021, the subject experienced could not move on. On 08-APR-2021, the subject experienced felt terrible. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced feeling sick. On 08-APR-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on APR-2021, was recovering from feeling sick, and the outcome of headache, chills, fever, sweating, felt terrible and could not move on was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Lymphadenopathy, Musculoskeletal stiffness, Nausea
Clinical narrative: LYMPH NODES UNDER RIGHT ARM WORSENING AND GETTING SPREADING; STIFFNESS; Nausea; FELT JUNK; SHOULDER SORE; This spontaneous report received from a patient concerned an 18 year old male. The patient's weight was 170 pounds, and height was 71 inches. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient has no known allergies and non 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: Unknown) dose was not reported, administered on 07-APR-2021 for vaccination prophylactic. The batch number was not provided and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt junk. On 07-APR-2021, the subject experienced shoulder sore. On 07-APR-2021 15:30, the subject experienced stiffness. On 07-APR-2021 15:30, the subject experienced nausea. On 08-APR-2021, the subject experienced lymph nodes under right arm worsening and getting spreading. On 10-APR-2021, treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt junk, had not recovered from lymph nodes under right arm worsening and getting spreading, and the outcome of nausea, stiffness and shoulder sore was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Decreased appetite, Malaise
Clinical narrative: DOES NOT FEEL LIKE EATING; BONES HURTING; NOT FEELING WELL; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced does not feel like eating. On 09-APR-2021, the subject experienced bones hurting. On 09-APR-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling well, does not feel like eating, and bones hurting. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: BONE PAIN; CHILLS; HEADACHE; FATIGUE; INJECTION SITE PAIN; 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 09-APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced bone pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fatigue, and fever on 10-APR-2021, and had not recovered from headache, bone pain, and injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BONE PAIN; CHILLS; HEADACHE; FATIGUE; INJECTION SITE PAIN; 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 09-APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced bone pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fatigue, and fever on 10-APR-2021, and had not recovered from headache, bone pain, and injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Malaise
Clinical narrative: ACHES; FEELING VERY MISERABLE; CHILLS; NOT FEELING WELL AT ALL; FATIGUE; FEVER BUT NO ACTUAL FEVER; This spontaneous report received from a consumer concerned a 48 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced aches. On 09-APR-2021, the subject experienced feeling very miserable. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced not feeling well at all. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced fever but no actual fever. Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, fatigue, chills, feeling very miserable, and fever but no actual fever, and the outcome of not feeling well at all was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHES; FEELING VERY MISERABLE; CHILLS; NOT FEELING WELL AT ALL; FATIGUE; FEVER BUT NO ACTUAL FEVER; This spontaneous report received from a consumer concerned a 48 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced aches. On 09-APR-2021, the subject experienced feeling very miserable. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced not feeling well at all. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced fever but no actual fever. Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, fatigue, chills, feeling very miserable, and fever but no actual fever, and the outcome of not feeling well at all was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Malaise
Clinical narrative: SWEATS; CAN'T SLEEP; CHILLS; NOT FEELING OK; FEELS LIKE VOMITING; HEADACHE; This spontaneous report received from a consumer concerned a 21 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) NEGATIVE. On 08-APR-2021, the subject experienced sweats. On 08-APR-2021, the subject experienced can't sleep. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced not feeling ok. On 08-APR-2021, the subject experienced feels like vomiting. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, sweats, can't sleep, feels like vomiting and not feeling ok was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: SWEATS; CAN'T SLEEP; CHILLS; NOT FEELING OK; FEELS LIKE VOMITING; HEADACHE; This spontaneous report received from a consumer concerned a 21 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) NEGATIVE. On 08-APR-2021, the subject experienced sweats. On 08-APR-2021, the subject experienced can't sleep. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced not feeling ok. On 08-APR-2021, the subject experienced feels like vomiting. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, sweats, can't sleep, feels like vomiting and not feeling ok was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; LOW GRADE FEVER; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 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-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 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced low grade fever. On 10-APR-2021, the subject experienced massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, low grade fever and massive headache was not reported. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site pain, Pain, Skin warm
Clinical narrative: LITTLE WARM TO TOUCH; PAIN GOING DOWN AFTER RESTING; SORENESS ON INJECTION  SITE; SEVERE STOMACH ACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included consume alcohol sometimes, and non-smoker, and other pre-existing medical conditions included the patient have no known drug allergies and there was no history of drug abuse/illicit drug use. 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 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced severe stomach ache. On an unspecified date, the subject experienced little warm to touch, pain going down after resting, and soreness on 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 had not recovered from severe stomach ache, and the outcome of little warm to touch, soreness on injection site and pain going down after resting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Eating disorder, Influenza like illness, Pain, Pyrexia
Clinical narrative: BODY ACHES; TROUBLE EATING; EVERYTHING TASTES WEIRD; LIKE SHE HAD FLU; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced trouble eating. On 09-APR-2021, the subject experienced everything tastes weird. On 09-APR-2021, the subject experienced like she had flu. On 09-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, body aches, trouble eating, everything tastes weird, and like she had flu. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: FELT NAUSEOUS; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to gluten, and migraines, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included ondansetron for associated nausea, and sumatriptan for migraines. On 09-APR-2021, the subject experienced felt nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt nauseous. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Fatigue, Feeling hot
Clinical narrative: THROAT SCRATCHY; BODY ACHES ALL OVER; FEELING HOT; SWEATY AND CLAMMY; CHILLS; ARM HURT; FEVER; TIRED; This spontaneous report received from a patient concerned a 35 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced throat scratchy. On 10-APR-2021, the subject experienced body aches all over. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced sweaty and clammy. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced tired. 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 chills on APR-2021, and had not recovered from fever, body aches all over, tired, arm hurt, sweaty and clammy, throat scratchy, and feeling hot. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Throat irritation
Clinical narrative: THROAT SCRATCHY; BODY ACHES ALL OVER; FEELING HOT; SWEATY AND CLAMMY; CHILLS; ARM HURT; FEVER; TIRED; This spontaneous report received from a patient concerned a 35 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced throat scratchy. On 10-APR-2021, the subject experienced body aches all over. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced sweaty and clammy. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced tired. 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 chills on APR-2021, and had not recovered from fever, body aches all over, tired, arm hurt, sweaty and clammy, throat scratchy, and feeling hot. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Pain, Tremor
Clinical narrative: SORENESS; MIGRAINE HEADACHE; FATIGUE; CHILLS; TREMORS; 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 pre-existing medical conditions included none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tremors. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced soreness. On 09-APR-2021, the subject experienced migraine headache. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors, and chills on 08-APR-2021, and migraine headache on 09-APR-2021, and the outcome of soreness and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Headache, Pain in extremity
Clinical narrative: FELT HOT (NO FEVER); CHILLS ON AND OFF; PAIN IN ARM OF INJECTION; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the 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) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced felt hot (no fever). On 10-APR-2021, the subject experienced chills on and off. On 10-APR-2021, the subject experienced pain in arm of injection. On 10-APR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm of injection, and had not recovered from severe headache, chills on and off, and felt hot (no fever). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nonspecific reaction
Clinical narrative: MIGRAINE; TROUBLE GETTING OUT OF BED; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 15:40 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced migraine. On 08-APR-2021, the subject experienced trouble getting out of bed. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from migraine, severe headache, and trouble getting out of bed. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: BODY ACHES; CHILLS; FATIGUE; INJECTION SITE PAIN; NAUSEA; This spontaneous report received from a patient concerned a 27 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from injection site pain, chills, and body aches, and the outcome of nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MILD SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included single factor V Leiden Mutation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. . The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN A 2 DAYS OLD  VACCINE; This spontaneous report received from a health care professional concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, 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 given a 2 days old vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of given a 2 days old vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE SIDE EFFECTS; 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417646.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-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 fever, and the outcome of headache and chills was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Sinus headache
Clinical narrative: SINUS HEADACHE; DRY MOUTH; This spontaneous report received from a patient concerned a 49 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 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced sinus headache. On 10-APR-2021, the subject experienced dry mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus headache, and dry mouth. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia
Clinical narrative: ARM TINGLING; FATIGUE; This spontaneous report received from a patient concerned a 44 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced arm tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 09-APR-2021, and had not recovered from arm tingling. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included brain injury, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies or drug abuse/ illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 09-APR-2021, the subject experienced chills. On 09-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, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Nausea, Suspected COVID-19
Clinical narrative: COVID-LIKE SYMPTOMS; LIGHTHEADEDNESS UPON STANDING  UP; DIZZY; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: -JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced covid-like symptoms. On APR-2021, the subject experienced lightheadedness upon standing up. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, nausea, lightheadedness upon standing up and covid-like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Hypoaesthesia, Pyrexia
Clinical narrative: NUMBING THROUGH THE WHOLE BODY AND TOP RIGHT SHOULDER; CHILLS; FEVER; TIREDNESS; HARD TIME BREATHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced hard time breathing. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced numbing through the whole body and top right shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbing through the whole body and top right shoulder on 10-APR-2021, and had not recovered from chills, fever, hard time breathing, and tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Gastric disorder, Headache, Pain in extremity
Clinical narrative: DROWSY/SLEEPY; HEADACHE; VOMITING; UPSET STOMACH; UPPER STOMACH HARDNESS; SHOOTING PAIN ON LOWER BACK; SHOOTING PAIN ON LEFT LEG/RIGHT LEG; 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, 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 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced upper stomach hardness. On 08-APR-2021, the subject experienced shooting pain on lower back. On 08-APR-2021, the subject experienced shooting pain on left leg/right leg. On 09-APR-2021, the subject experienced drowsy/sleepy. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper stomach hardness on APR-2021, had not recovered from shooting pain on left leg/right leg, headache, shooting pain on lower back, vomiting, and drowsy/sleepy, and the outcome of upset stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: DROWSY/SLEEPY; HEADACHE; VOMITING; UPSET STOMACH; UPPER STOMACH HARDNESS; SHOOTING PAIN ON LOWER BACK; SHOOTING PAIN ON LEFT LEG/RIGHT LEG; 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, 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 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced upper stomach hardness. On 08-APR-2021, the subject experienced shooting pain on lower back. On 08-APR-2021, the subject experienced shooting pain on left leg/right leg. On 09-APR-2021, the subject experienced drowsy/sleepy. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper stomach hardness on APR-2021, had not recovered from shooting pain on left leg/right leg, headache, shooting pain on lower back, vomiting, and drowsy/sleepy, and the outcome of upset stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON HER BACK AND BELLY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced rash on her back and belly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on her back and belly was not reported. This report was non-serious.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: ADMINISTERED THE ENTIRE VIAL OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned an 84 year old male. The patient's weight was 210 pounds, and height was 68 inches. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included no known allergies, no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: 21/JUN/2021) .5 ml, administered on 02-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administered the entire vial of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered the entire vial of the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421803 and 20210408236.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; TIRED; MUSCLE PAIN; 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, tired, and muscle pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 96 F, 98 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, tired and muscle pain was not reported. This report was non-serious.