chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: MILD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 118 pounds, and height was not reported. The patient's concurrent conditions included hashimoto's hypothyroidism autoimmune disease, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) 98.4 to 99.9 Fahrenheit, 97.6 Fahrenheit, 100.0 Ferhenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 94.5 Fahrenheit.  On 28-APR-2021, the subject experienced mild headache. On 28-APR-2021, the subject experienced fever. On 29-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit. On 12-MAY-2021, treatment medications included: amoxicillin trihydrate/clavulanate potassium.  On 17-MAY-2021, treatment medications included: doxycycline, and methylprednisolone. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from mild headache, and fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Headache, Pyrexia, Sinusitis
Clinical narrative: MILD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 118 pounds, and height was not reported. The patient's concurrent conditions included hashimoto's hypothyroidism autoimmune disease, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) 98.4 to 99.9 Fahrenheit, 97.6 Fahrenheit, 100.0 Ferhenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 94.5 Fahrenheit.  On 28-APR-2021, the subject experienced mild headache. On 28-APR-2021, the subject experienced fever. On 29-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Fahrenheit. On 12-MAY-2021, treatment medications included: amoxicillin trihydrate/clavulanate potassium.  On 17-MAY-2021, treatment medications included: doxycycline, and methylprednisolone. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from mild headache, and fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Fatigue, Investigation, Myalgia
Clinical narrative: LEG PAIN; TIREDNESS; SORE MUSCLES; SHAKINESS; SORE SHOULDER; This spontaneous report received from a consumer concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatic in leg, sulfa allergy, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no other health conditions or current medication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced shakiness. On 12-MAY-2021, the subject experienced sore shoulder. On 12-MAY-2021, the subject experienced tiredness. On 12-MAY-2021, the subject experienced sore muscles. On 13-MAY-2021, the subject experienced leg pain. Laboratory data included: Screening test (NR: not provided) Unknown. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal (Platelet count was normal). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shakiness, tiredness, sore shoulder, and sore muscles, and the outcome of leg pain was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: LEG PAIN; TIREDNESS; SORE MUSCLES; SHAKINESS; SORE SHOULDER; This spontaneous report received from a consumer concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatic in leg, sulfa allergy, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no other health conditions or current medication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced shakiness. On 12-MAY-2021, the subject experienced sore shoulder. On 12-MAY-2021, the subject experienced tiredness. On 12-MAY-2021, the subject experienced sore muscles. On 13-MAY-2021, the subject experienced leg pain. Laboratory data included: Screening test (NR: not provided) Unknown. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal (Platelet count was normal). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shakiness, tiredness, sore shoulder, and sore muscles, and the outcome of leg pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: JANSSEN COVID-19 VACCINE ADMINISTERED AFTER BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS; JANSSEN COVID-19 VACCINE BEING AT ROOM TEMPERATURE FOR OVER 2 HOURS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced janssen covid-19 vaccine administered after being at room temperature for over 2 hours. On 18-MAY-2021, the subject experienced janssen covid-19 vaccine being at room temperature for over 2 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the janssen covid-19 vaccine administered after being at room temperature for over 2 hours and janssen covid-19 vaccine being at room temperature for over 2 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545147.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seizure. 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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levetiracetam for seizures. On 21-MAY-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: THROBBING; ARM SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced arm sore at injection site. On 21-MAY-2021, the subject experienced throbbing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore at injection site, and the outcome of throbbing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, General physical health deterioration, Injection site pain, Muscle spasms, Pain in extremity
Clinical narrative: CRAMPS IN THIGHS; DOWNHILL FEELING OF BODY; ARTHRITIS FLARE UP; SORE ARM FOR LITTLE BIT; BURNED WHEN VACCINE WENT IN; 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 past medical history included cramp. 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-MAR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced cramps in thighs, downhill feeling of body, arthritis flare up, sore arm for little bit, and burned when vaccine went in. Laboratory data (dates unspecified) included: X-ray (NR: not provided) swollen and could be arthritis. Treatment medications (dates unspecified) included: vitamins nos, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramps in thighs, burned when vaccine went in, sore arm for little bit, downhill feeling of body, and arthritis flare up. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: CRAMPS IN THIGHS; DOWNHILL FEELING OF BODY; ARTHRITIS FLARE UP; SORE ARM FOR LITTLE BIT; BURNED WHEN VACCINE WENT IN; 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 past medical history included cramp. 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-MAR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced cramps in thighs, downhill feeling of body, arthritis flare up, sore arm for little bit, and burned when vaccine went in. Laboratory data (dates unspecified) included: X-ray (NR: not provided) swollen and could be arthritis. Treatment medications (dates unspecified) included: vitamins nos, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramps in thighs, burned when vaccine went in, sore arm for little bit, downhill feeling of body, and arthritis flare up. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, Chills, Injection site pain, Sinus headache
Clinical narrative: LOW WHITE BLOOD COUNT; LOW THYROID STIMULATING HORMONE; CHILLS; SORENESS AT INJECTION SITE; MILD SINUS HEADACHE; 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 rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included leflunomide for rheumatoid arthritis, and levothyroxine sodium. On 30-JUN-2020, Laboratory data included: White blood cell count (NR: not provided) 3.8 10*9/L. On 21-OCT-2020, Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.67, and White blood cell count (NR: not provided) 3.9 10*9/L. On 22-JAN-2021, Laboratory data included: White blood cell count (NR: not provided) 3.4 10*9/L. On 10-MAR-2021, the subject experienced mild sinus headache. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced soreness at injection site. On 14-APR-2021, Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.41. On 06-MAY-2021, the subject experienced low thyroid stimulating hormone. Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.20. On 14-MAY-2021, the subject experienced low white blood count. Laboratory data included: White blood cell count (NR: not provided) 2.4 10*9/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild sinus headache, chills, soreness at injection site, low white blood count and low thyroid stimulating hormone was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: LOW WHITE BLOOD COUNT; LOW THYROID STIMULATING HORMONE; CHILLS; SORENESS AT INJECTION SITE; MILD SINUS HEADACHE; 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 rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included leflunomide for rheumatoid arthritis, and levothyroxine sodium. On 30-JUN-2020, Laboratory data included: White blood cell count (NR: not provided) 3.8 10*9/L. On 21-OCT-2020, Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.67, and White blood cell count (NR: not provided) 3.9 10*9/L. On 22-JAN-2021, Laboratory data included: White blood cell count (NR: not provided) 3.4 10*9/L. On 10-MAR-2021, the subject experienced mild sinus headache. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced soreness at injection site. On 14-APR-2021, Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.41. On 06-MAY-2021, the subject experienced low thyroid stimulating hormone. Laboratory data included: Thyroid stimulating hormone (NR: not provided) 0.20. On 14-MAY-2021, the subject experienced low white blood count. Laboratory data included: White blood cell count (NR: not provided) 2.4 10*9/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild sinus headache, chills, soreness at injection site, low white blood count and low thyroid stimulating hormone was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pyrexia
Clinical narrative: MILD HEADACHE; MILD FEVER; MUSCLE SPASMS ALL OVER BODY FROM TONGUE TO LEGS CONTINUOUSLY INCREASING IN SEVERITY BUT NOT ASSOCIATED WITH PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAY-2021 16:00 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 20-MAY-2021, the subject experienced muscle spasms all over body from tongue to legs continuously increasing in severity but not associated with pain. On 21-MAY-2021, the subject experienced mild headache. On 21-MAY-2021, the subject experienced mild fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from muscle spasms all over body from tongue to legs continuously increasing in severity but not associated with pain, mild headache, and mild fever. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHE; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, chills, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, body ache and fatigue was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: TINGLING IN ARMS; NUMBNESS; This spontaneous report received from a pharmacist concerned a 31 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: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAY-2021, the subject experienced tingling in arms. On 22-MAY-2021, the subject experienced numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in arms on 22-MAY-2021, and had not recovered from numbness. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Gastric dilatation, Headache, Pain
Clinical narrative: DIARRHEA; REALLY BLOATED/STOMACH DISTENSION; BODY ACHES WORSENING FROM  PREVIOUS LEVEL; ABDOMINAL PAIN; RASH ON THE FRONT OF THE RIGHT SHIN / RASH THAT GOES AROUND THE LEFT  SHIN; POSSIBLE WORSENING OF PREVIOUS  HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included degenerative disc disorder, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included golimumab for rheumatoid arthritis. On 21-MAY-2021, the subject experienced diarrhea. On 21-MAY-2021, the subject experienced really bloated/stomach distension. On 21-MAY-2021, the subject experienced body aches worsening from previous level. On 21-MAY-2021, the subject experienced abdominal pain. On 21-MAY-2021, the subject experienced rash on the front of the right shin / rash that goes around the left shin. On 21-MAY-2021, the subject experienced possible worsening of previous headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, really bloated/stomach distension, body aches worsening from previous level, possible worsening of previous headaches, rash on the front of the right shin / rash that goes around the left shin, and abdominal pain. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: DIARRHEA; REALLY BLOATED/STOMACH DISTENSION; BODY ACHES WORSENING FROM  PREVIOUS LEVEL; ABDOMINAL PAIN; RASH ON THE FRONT OF THE RIGHT SHIN / RASH THAT GOES AROUND THE LEFT  SHIN; POSSIBLE WORSENING OF PREVIOUS  HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included degenerative disc disorder, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included golimumab for rheumatoid arthritis. On 21-MAY-2021, the subject experienced diarrhea. On 21-MAY-2021, the subject experienced really bloated/stomach distension. On 21-MAY-2021, the subject experienced body aches worsening from previous level. On 21-MAY-2021, the subject experienced abdominal pain. On 21-MAY-2021, the subject experienced rash on the front of the right shin / rash that goes around the left shin. On 21-MAY-2021, the subject experienced possible worsening of previous headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, really bloated/stomach distension, body aches worsening from previous level, possible worsening of previous headaches, rash on the front of the right shin / rash that goes around the left shin, and abdominal pain. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 70 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: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced muscle aches. On 23-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, and fatigue. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN THE FEET/TINGLING RADIATED UP THROUGH HER BODY; This spontaneous report received from a pharmacist concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, 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, intramuscular, batch number: 042A21A, expiry: 21-JUN-2021) .5 ml, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced tingling in the feet/tingling radiated up through her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in the feet/tingling radiated up through her body. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, COVID-19, Fatigue, Headache
Clinical narrative: BODY ACHES; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test negative, and antibody test, and concurrent conditions included cholesterol, and other pre-existing medical conditions included patient had no known allergies. patient was on low dose of statin and taking medication for blood pressure. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced body aches. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 101.2. On 22-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.8. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from body aches, headache, fever, and fatigue. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test negative, and antibody test, and concurrent conditions included cholesterol, and other pre-existing medical conditions included patient had no known allergies. patient was on low dose of statin and taking medication for blood pressure. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced body aches. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 101.2. On 22-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.8. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from body aches, headache, fever, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dry mouth, Fatigue
Clinical narrative: HARD TO WALK AROUND; BODY WAS ACHY; ACHINESS IN MUSCLE; FEELS VERY WEAK; HEADACHE; ACHINESS IN JOINTS; NAUSEOUS; EXTREMELY TIRED; SORE ARM AT THE SITE OF VACCINATION; BRUISED AT THE SITE OF VACCINATION; DRY MOUTH; NOT MUCH OF APPETITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced dry mouth. On MAY-2021, the subject experienced not much of appetite. On MAY-2021, the subject experienced bruised at the site of vaccination. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced sore arm at the site of vaccination. On 19-MAY-2021, the subject experienced hard to walk around. On 19-MAY-2021, the subject experienced body was achy. On 19-MAY-2021, the subject experienced achiness in joints. On 19-MAY-2021, the subject experienced nauseous. On 19-MAY-2021, the subject experienced achiness in muscle. On 19-MAY-2021, the subject experienced feels very weak. On 19-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm at the site of vaccination, headache, nauseous, extremely tired, achiness in joints, dry mouth, feels very weak, not much of appetite, hard to walk around, bruised at the site of vaccination, and achiness in muscle, and the outcome of body was achy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Injection site bruising, Injection site pain, Myalgia
Clinical narrative: HARD TO WALK AROUND; BODY WAS ACHY; ACHINESS IN MUSCLE; FEELS VERY WEAK; HEADACHE; ACHINESS IN JOINTS; NAUSEOUS; EXTREMELY TIRED; SORE ARM AT THE SITE OF VACCINATION; BRUISED AT THE SITE OF VACCINATION; DRY MOUTH; NOT MUCH OF APPETITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced dry mouth. On MAY-2021, the subject experienced not much of appetite. On MAY-2021, the subject experienced bruised at the site of vaccination. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced sore arm at the site of vaccination. On 19-MAY-2021, the subject experienced hard to walk around. On 19-MAY-2021, the subject experienced body was achy. On 19-MAY-2021, the subject experienced achiness in joints. On 19-MAY-2021, the subject experienced nauseous. On 19-MAY-2021, the subject experienced achiness in muscle. On 19-MAY-2021, the subject experienced feels very weak. On 19-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm at the site of vaccination, headache, nauseous, extremely tired, achiness in joints, dry mouth, feels very weak, not much of appetite, hard to walk around, bruised at the site of vaccination, and achiness in muscle, and the outcome of body was achy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: HARD TO WALK AROUND; BODY WAS ACHY; ACHINESS IN MUSCLE; FEELS VERY WEAK; HEADACHE; ACHINESS IN JOINTS; NAUSEOUS; EXTREMELY TIRED; SORE ARM AT THE SITE OF VACCINATION; BRUISED AT THE SITE OF VACCINATION; DRY MOUTH; NOT MUCH OF APPETITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced dry mouth. On MAY-2021, the subject experienced not much of appetite. On MAY-2021, the subject experienced bruised at the site of vaccination. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced sore arm at the site of vaccination. On 19-MAY-2021, the subject experienced hard to walk around. On 19-MAY-2021, the subject experienced body was achy. On 19-MAY-2021, the subject experienced achiness in joints. On 19-MAY-2021, the subject experienced nauseous. On 19-MAY-2021, the subject experienced achiness in muscle. On 19-MAY-2021, the subject experienced feels very weak. On 19-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm at the site of vaccination, headache, nauseous, extremely tired, achiness in joints, dry mouth, feels very weak, not much of appetite, hard to walk around, bruised at the site of vaccination, and achiness in muscle, and the outcome of body was achy was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: PUNCTURED JANSSEN VACCINE ON 20 MAY 2021 AT 11.45 AM ADMINISTERED TO A PATIENT ON 20 MAY 2021  IN THE MORNING; This spontaneous report received from a pharmacist concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808986 expiry: 04-JUL-2021) .5 ml, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced punctured janssen vaccine on 20 may 2021 at 11.45 am administered to a subject on 20 may 2021 in the morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of punctured janssen vaccine on 20 may 2021 at 11.45 am administered to a patient on 20 may 2021 in the morning was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PATIENT RECEIVED THE VACCINE OUTSIDE OF THE RECOMMENDED TEMPERATURE RANGE 46.8 F TO 52.7 F AFTER  PUNCTURE; THE VIAL TEMPERATURE WENT FROM 46.8 F TO 52.7 F AFTER FIRST PUNCTURE BETWEEN 11AM- 2:41PM; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced subject received the vaccine outside of the recommended temperature range 46.8 f to 52.7 f after puncture. On 19-MAY-2021, the subject experienced the vial temperature went from 46.8 f to 52.7 f after first puncture between 11am- 2:41pm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the vaccine outside of the recommended temperature range 46.8 f to 52.7 f after puncture and the vial temperature went from 46.8 f to 52.7 f after first puncture between 11am- 2:41pm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210540217.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: WHEALS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced wheals. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wheals was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Hyperhidrosis, Influenza, Injection site erythema
Clinical narrative: FLU SYMPTOMS; ACHING BONES; HEADACHE; INTERMITTENT SWEATING; PAIN AND SORENESS IN THE LEFT ARM AT INJECTION SITE; REDNESS IN LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 214 pounds, and height was 65 inches. The patient's past medical history included lumpectomy of right breast, radiation therapy, and colon resection, and concurrent conditions included breast cancer, non-insulin-dependent diabetes mellitus, asthmatic, second hand smoke, chronic obstructive pulmonary disease, neuropathy, iodine allergy, sulfa allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient cannot take certain antibiotics because it upsets stomach. The patient experienced bad reaction with colon when treated with prednisone for drug used for unknown indication, and ministroke when treated with midazolam hydrochloride, and blood pressure problems and headache when treated with celecoxib, stomach upset when treated with erythromycin, and blood pressure increased when treated with salbutamol. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 7808980 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced intermittent sweating. On MAY-2021, the subject experienced pain and soreness in the left arm at injection site. On MAY-2021, the subject experienced redness in left arm at injection site. On 13-MAY-2021, the subject experienced flu symptoms. On 13-MAY-2021, the subject experienced aching bones. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain and soreness in the left arm at injection site, and the outcome of flu symptoms, aching bones, headache, redness in left arm at injection site and intermittent sweating was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: FLU SYMPTOMS; ACHING BONES; HEADACHE; INTERMITTENT SWEATING; PAIN AND SORENESS IN THE LEFT ARM AT INJECTION SITE; REDNESS IN LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 214 pounds, and height was 65 inches. The patient's past medical history included lumpectomy of right breast, radiation therapy, and colon resection, and concurrent conditions included breast cancer, non-insulin-dependent diabetes mellitus, asthmatic, second hand smoke, chronic obstructive pulmonary disease, neuropathy, iodine allergy, sulfa allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient cannot take certain antibiotics because it upsets stomach. The patient experienced bad reaction with colon when treated with prednisone for drug used for unknown indication, and ministroke when treated with midazolam hydrochloride, and blood pressure problems and headache when treated with celecoxib, stomach upset when treated with erythromycin, and blood pressure increased when treated with salbutamol. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 7808980 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced intermittent sweating. On MAY-2021, the subject experienced pain and soreness in the left arm at injection site. On MAY-2021, the subject experienced redness in left arm at injection site. On 13-MAY-2021, the subject experienced flu symptoms. On 13-MAY-2021, the subject experienced aching bones. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain and soreness in the left arm at injection site, and the outcome of flu symptoms, aching bones, headache, redness in left arm at injection site and intermittent sweating was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Headache
Clinical narrative: TRANSPARENT URINE; MILD HEADACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 54 kilograms, and height was 60 inches. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced transparent urine. On 22-MAY-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from transparent urine, and the outcome of mild headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545645.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; TIRED; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included hives, and concurrent conditions included asthma, ibuprofen allergy, sulfa allergy, non smoker, and abstains from alcohol. The patient experienced drug allergy when treated with acetylsalicylic acid for asthma.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced tired. On 21-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from tired, and had not recovered from headache. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING ALL OVER; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, shell fish allergy, gold allergy, and silver allergy. The patient experienced drug allergy when treated with pethidine hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced itching all over. Treatment medications included: cetirizine hydrochloride, and loratadine. On 21-MAY-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Decreased appetite, Feeling cold
Clinical narrative: STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILLS; WEAKNESS; LEFT ARM PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcoholic. 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced stomach hurt. On 21-MAY-2021, the subject experienced vomiting /threw up brown liquid. On 21-MAY-2021, the subject experienced can't eat or drink anything. On 21-MAY-2021, the subject experienced feeling cold. On 21-MAY-2021, the subject experienced body chills. On 21-MAY-2021, the subject experienced weakness. On 21-MAY-2021, the subject experienced left arm pain. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting /threw up brown liquid, left arm pain, and nausea on 21-MAY-2021, had not recovered from headache, body chills, stomach hurt, weakness, and feeling cold, and the outcome of can't eat or drink anything was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILLS; WEAKNESS; LEFT ARM PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcoholic. 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced stomach hurt. On 21-MAY-2021, the subject experienced vomiting /threw up brown liquid. On 21-MAY-2021, the subject experienced can't eat or drink anything. On 21-MAY-2021, the subject experienced feeling cold. On 21-MAY-2021, the subject experienced body chills. On 21-MAY-2021, the subject experienced weakness. On 21-MAY-2021, the subject experienced left arm pain. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting /threw up brown liquid, left arm pain, and nausea on 21-MAY-2021, had not recovered from headache, body chills, stomach hurt, weakness, and feeling cold, and the outcome of can't eat or drink anything was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 36 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: 180095, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced body ache. On 20-MAY-2021, the subject experienced chills. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and fatigue on MAY-2021. This report was non-serious.