chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: POSSIBLE INCORRECT ROUTE OF ADMINISTRATION; 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 possible incorrect route of administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible incorrect route of administration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Myalgia, Nausea
Clinical narrative: BURNING SENSATION IN VEIN; FEELING COLD INSIDE; SEVERE PAIN ALL OVER BODY; CHILLS; NAUSEA; HEADACHE; MUSCLE PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 burning sensation in vein, feeling cold inside, severe pain all over body, chills, nausea, headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe pain all over body, had not recovered from nausea, chills, and headache, and the outcome of feeling cold inside, muscle pain and burning sensation in vein was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vascular pain
Clinical narrative: BURNING SENSATION IN VEIN; FEELING COLD INSIDE; SEVERE PAIN ALL OVER BODY; CHILLS; NAUSEA; HEADACHE; MUSCLE PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 burning sensation in vein, feeling cold inside, severe pain all over body, chills, nausea, headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe pain all over body, had not recovered from nausea, chills, and headache, and the outcome of feeling cold inside, muscle pain and burning sensation in vein was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A SIGNIFICANT RINGING IN EARS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced a significant ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a significant ringing in ears was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Insomnia, Nausea, Pain in extremity
Clinical narrative: PALM OF HANDS ARE RED; CONGESTED; BOTH LEG MUSCLES HURTING; CHILLS; NAUSEOUS; BOTH EARS STARTED RINGING; VOMITING; COULDN'T SLEEP; HEAD FEELS LIKE IT IS IN A FOG; This spontaneous report received from a patient concerned a 56 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: 204A21A, 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 both ears started ringing. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced couldn't sleep. On 08-APR-2021, the subject experienced head feels like it is in a fog. On 08-APR-2021, the subject experienced both leg muscles hurting. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nauseous. On 09-APR-2021, the subject experienced palm of hands are red. On 09-APR-2021, the subject experienced congested. Laboratory data (dates unspecified) included: Rhesus antigen (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both ears started ringing, vomiting, couldn't sleep, both leg muscles hurting, chills, and nauseous, and had not recovered from head feels like it is in a fog, palm of hands are red, and congested. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palmar erythema, Rhesus antigen, Sinus congestion, Tinnitus, Vomiting
Clinical narrative: PALM OF HANDS ARE RED; CONGESTED; BOTH LEG MUSCLES HURTING; CHILLS; NAUSEOUS; BOTH EARS STARTED RINGING; VOMITING; COULDN'T SLEEP; HEAD FEELS LIKE IT IS IN A FOG; This spontaneous report received from a patient concerned a 56 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: 204A21A, 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 both ears started ringing. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced couldn't sleep. On 08-APR-2021, the subject experienced head feels like it is in a fog. On 08-APR-2021, the subject experienced both leg muscles hurting. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nauseous. On 09-APR-2021, the subject experienced palm of hands are red. On 09-APR-2021, the subject experienced congested. Laboratory data (dates unspecified) included: Rhesus antigen (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both ears started ringing, vomiting, couldn't sleep, both leg muscles hurting, chills, and nauseous, and had not recovered from head feels like it is in a fog, palm of hands are red, and congested. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous report received from a patient concerned a 26 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 and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced fever. On 11-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 headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Lethargy, Vomiting
Clinical narrative: A LITTLE LETHARGIC; ONE DIZZY SPELL; CHILLS; HEADACHE; VOMITING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 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 vomiting. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced a little lethargic. On 10-APR-2021, the subject experienced one dizzy spell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, and headache on APR-2021, and the outcome of a little lethargic and one dizzy spell was not reported. 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 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 subject experienced chills. On 08-APR-2021, 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. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: CHILLS; PAIN/MUSCLE ACHES; 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) dose was not reported, administered on 10-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain/muscle aches. On 11-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 chills, pain/muscle aches, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: RED HIVES ON TORSO THAT RAISED AND COVER THE LEFT SIDE BOTH FRONT AND BACK; LOW TO MODERATE FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is not prone to allergies or skin reactions. 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 10-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced red hives on torso that raised and cover the left side both front and back, and low to moderate fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low to moderate fever and red hives on torso that raised and cover the left side both front and back was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Nausea, Pain
Clinical narrative: JOINTS HURT (ARM, BODY, AND FEET); CHILLS  (LIKE SYMPTOMS OF FLU); NAUSEA; FEVER; FEELING ACHY; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A,  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 10-APR-2021 17:00, the subject experienced feeling achy. On 10-APR-2021 17:00, the subject experienced chills (like symptoms of flu). On 10-APR-2021 17:00, the subject experienced nausea. On 10-APR-2021 17:00, the subject experienced fever. On 11-APR-2021, the subject experienced joints hurt (arm, body, and feet). Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 11-APR-2021, was recovering from fever, and had not recovered from feeling achy, joints hurt (arm, body, and feet), and chills (like symptoms of flu). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: JOINTS HURT (ARM, BODY, AND FEET); CHILLS  (LIKE SYMPTOMS OF FLU); NAUSEA; FEVER; FEELING ACHY; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A,  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 10-APR-2021 17:00, the subject experienced feeling achy. On 10-APR-2021 17:00, the subject experienced chills (like symptoms of flu). On 10-APR-2021 17:00, the subject experienced nausea. On 10-APR-2021 17:00, the subject experienced fever. On 11-APR-2021, the subject experienced joints hurt (arm, body, and feet). Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 11-APR-2021, was recovering from fever, and had not recovered from feeling achy, joints hurt (arm, body, and feet), and chills (like symptoms of flu). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; COUGHING OCCASIONALLY; FEVER; PAIN ON INJECTION SITE; 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced coughing occasionally. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced pain on injection site. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, coughing occasionally and pain on injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flatulence, Myalgia
Clinical narrative: GASSY FEELING; CHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested.  No concomitant medications were reported. On 11-APR-2021, the subject experienced gassy feeling. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, chills and gassy feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Influenza, Palpitations
Clinical narrative: CHILLS; FEVER; HEART WAS RACING; FLU; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced heart was racing. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) 132. On 08-MAR-2021 19:30, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart was racing, and fever, and the outcome of chills and flu was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS; FEVER; HEART WAS RACING; FLU; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced heart was racing. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) 132. On 08-MAR-2021 19:30, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart was racing, and fever, and the outcome of chills and flu was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: RED ARM; SWOLLEN ARM; SORE ARM; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid positive. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced red arm. On 06-APR-2021, the subject experienced swollen arm. On 06-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, red arm, and swollen arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; FATIGUE; 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, 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 2021, the subject experienced body ache. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced fatigue. 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 was recovering from fever, chills, fatigue, and body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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: 20321A expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 10-APR-2021 11:45 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate increased, Nausea, Pain
Clinical narrative: BODY ACHE; HEART RATE HIGH; Feeling hot; LOW GRADE FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A 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 body ache. On 09-APR-2021, the subject experienced heart rate high. On 09-APR-2021, the subject experienced feeling hot. On 09-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced nausea. 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 heart rate high, and feeling hot on 10-APR-2021, was recovering from low grade fever, nausea, and body ache, and had not recovered from headache. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHE; HEART RATE HIGH; Feeling hot; LOW GRADE FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A 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 body ache. On 09-APR-2021, the subject experienced heart rate high. On 09-APR-2021, the subject experienced feeling hot. On 09-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced nausea. 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 heart rate high, and feeling hot on 10-APR-2021, was recovering from low grade fever, nausea, and body ache, and had not recovered from headache. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: BODY ACHES; FLU LIKE SYMPTOMS; SLIGHT DIARRHEA BUT NOT BAD; FEELS LIKE SINUS INFECTION; FEELING BLAH; SORE ARM/MUSCLES; CHILLS THAT COME AND GO; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sarcoidosis autoimmune disease, arthritis, and arthritis pain. The patient experienced swelling around ankles when treated with felodipine. 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. Concomitant medications included paracetamol for arthritis pain. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced slight diarrhea but not bad. On 09-APR-2021, the subject experienced feels like sinus infection. On 09-APR-2021, the subject experienced feeling blah. On 09-APR-2021, the subject experienced sore arm/muscles. On 09-APR-2021, the subject experienced chills that come and go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, flu like symptoms, chills that come and go, slight diarrhea but not bad, and sore arm/muscles, and the outcome of feels like sinus infection and feeling blah was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sinusitis
Clinical narrative: BODY ACHES; FLU LIKE SYMPTOMS; SLIGHT DIARRHEA BUT NOT BAD; FEELS LIKE SINUS INFECTION; FEELING BLAH; SORE ARM/MUSCLES; CHILLS THAT COME AND GO; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sarcoidosis autoimmune disease, arthritis, and arthritis pain. The patient experienced swelling around ankles when treated with felodipine. 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. Concomitant medications included paracetamol for arthritis pain. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced slight diarrhea but not bad. On 09-APR-2021, the subject experienced feels like sinus infection. On 09-APR-2021, the subject experienced feeling blah. On 09-APR-2021, the subject experienced sore arm/muscles. On 09-APR-2021, the subject experienced chills that come and go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, flu like symptoms, chills that come and go, slight diarrhea but not bad, and sore arm/muscles, and the outcome of feels like sinus infection and feeling blah was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Injection site pain
Clinical narrative: CHILLS; HEADACHE; FATIGUE; SORENESS/PAIN AT INJECTION SITE; FEELING HOT; SLEEPY; This spontaneous report received from a patient concerned a 49 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced feeling hot. On 05-APR-2021, the subject experienced sleepy. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced soreness/pain at injection site. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness/pain at injection site on 07-APR-2021, and had not recovered from fatigue, sleepy, headache, chills, and feeling hot. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: CHILLS; HEADACHE; FATIGUE; SORENESS/PAIN AT INJECTION SITE; FEELING HOT; SLEEPY; This spontaneous report received from a patient concerned a 49 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced feeling hot. On 05-APR-2021, the subject experienced sleepy. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced soreness/pain at injection site. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness/pain at injection site on 07-APR-2021, and had not recovered from fatigue, sleepy, headache, chills, and feeling hot. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: FEELING COLD; CHILLS; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies. 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:57 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and feeling cold. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 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 chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, headache and weakness was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEAD ACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hay fever, and other 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, 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 head ache. On 10-APR-2021, the subject experienced fever. 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 fever, and had not recovered from nausea, body aches, head ache, and chills. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a 21 year old. 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: 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 aches. On 08-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and aches. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: RED SPOT PAINFUL/RED/SWOLLEN AND HOT TOUCH; ARM SORENESS; ACTIVITIES OF DAILY LIVING AFFECTED; This spontaneous report received from a patient concerned a 25 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: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced activities of daily living affected. On 06-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced red spot painful/red/swollen and hot touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red spot painful/red/swollen and hot touch, and the outcome of arm soreness and activities of daily living affected was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain of skin
Clinical narrative: ACHY JOINTS; FATIGUE; CHILLS; PERIODIC HEADACHE PAIN/PAIN NEAR LEFT EYE AND EAR; SWELLING ON THE LEFT TOP AREA OF SKULL/ FLUID BETWEEN SCALP SKIN AND SKULL BONE; BIT OF TENDERNESS ON THE LEFT TOP AREA OF SKULL; This spontaneous report received from a patient concerned a 61 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swelling on the left top area of skull/ fluid between scalp skin and skull bone. On APR-2021, the subject experienced bit of tenderness on the left top area of skull. On APR-2021, the subject experienced periodic headache pain/pain near left eye and ear. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced achy joints. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy joints, fatigue, periodic headache pain/pain near left eye and ear, swelling on the left top area of skull/ fluid between scalp skin and skull bone and bit of tenderness on the left top area of skull was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: ACHY JOINTS; FATIGUE; CHILLS; PERIODIC HEADACHE PAIN/PAIN NEAR LEFT EYE AND EAR; SWELLING ON THE LEFT TOP AREA OF SKULL/ FLUID BETWEEN SCALP SKIN AND SKULL BONE; BIT OF TENDERNESS ON THE LEFT TOP AREA OF SKULL; This spontaneous report received from a patient concerned a 61 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swelling on the left top area of skull/ fluid between scalp skin and skull bone. On APR-2021, the subject experienced bit of tenderness on the left top area of skull. On APR-2021, the subject experienced periodic headache pain/pain near left eye and ear. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced achy joints. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy joints, fatigue, periodic headache pain/pain near left eye and ear, swelling on the left top area of skull/ fluid between scalp skin and skull bone and bit of tenderness on the left top area of skull was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bladder pain, Chills, Headache, Heavy menstrual bleeding, Pyrexia
Clinical narrative: HEAVY MENSTRUAL BLEEDING; CHILLS; HEADACHE; FEVER; URINARY TRACT INFECTION SYMPTOM/BLADDER PAIN; 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced urinary tract infection symptom/bladder pain. On 09-APR-2021, the subject experienced heavy menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, fever, and urinary tract infection symptom/bladder pain on APR-2021, and had not recovered from heavy menstrual bleeding. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: CHILLS; SEVERE JOINT PAIN ESPECIALLY IN THE KNEES; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary embolus, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. patient had extensive allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included warfarin for pulmonary embolus. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe joint pain especially in the knees. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, nausea, and fatigue on 10-APR-2021, and was recovering from severe joint pain especially in the knees. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Pain, Pyrexia
Clinical narrative: EXTREME BONE ACHES; EXTREME BODY ACHES; JOINT ACHES; CHILLS; 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced extreme bone aches. On 09-APR-2021, the subject experienced extreme body aches. On 09-APR-2021, the subject experienced joint aches. 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 was recovering from fever, chills, extreme bone aches, extreme body aches, and joint aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: BODY ACHES; HEADACHE; This spontaneous report received from a consumer concerned a 37 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 10-APR-2021 15:00 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 body aches. 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 body aches, and headache. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Malaise
Clinical narrative: SHAKING; CHILLS; HEADACHE; FEVER; LOWER BACK HURT; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 183 pounds, and height was 69 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no history of 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 08-APR-2021 13:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced not feeling well. On 09-APR-2021, the subject experienced lower back hurt. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 100. On 09-APR-2021 02:00, the subject experienced shaking. On 09-APR-2021 02:00, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and not feeling well, and chills on 09-APR-2021, and was recovering from fever, lower back hurt, and headache. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: SHAKING; CHILLS; HEADACHE; FEVER; LOWER BACK HURT; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 183 pounds, and height was 69 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no history of 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 08-APR-2021 13:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced not feeling well. On 09-APR-2021, the subject experienced lower back hurt. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 100. On 09-APR-2021 02:00, the subject experienced shaking. On 09-APR-2021 02:00, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and not feeling well, and chills on 09-APR-2021, and was recovering from fever, lower back hurt, and headache. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: ACHES; SWEATING; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced sweating. 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, chills, aches, headache, and sweating. This report was non-serious. This case, from the same reporter is linked to 20210421760.