chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral swelling, SARS-CoV-2 test positive, Skin discolouration
Clinical narrative: RIGHT MIDDLE FINGER TURNED PURPLE; FINGERS SWELLING; INSOMNIA; RINGING IN THE EARS; CHEST PAIN; SHORTNESS OF BREATH; FATIGUE; BODY ACHE; METALLIC TASTE IN MOUTH; FINGERS TURNED COLD AND TINGLY; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, "over Christmas" and had since recovered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 23-MAR-2021, the subject experienced metallic taste in mouth. On 23-MAR-2021, the subject experienced fingers turned cold and tingly. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced insomnia. On 25-MAR-2021, the subject experienced ringing in the ears. On 25-MAR-2021, the subject experienced chest pain. On 25-MAR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced right middle finger turned purple. On 08-APR-2021, the subject experienced fingers swelling. Treatment medications (dates unspecified) included: doxycycline, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right middle finger turned purple, chest pain, metallic taste in mouth, and fingers swelling, had not recovered from insomnia, ringing in the ears, and shortness of breath, and the outcome of fingers turned cold and tingly, body ache and fatigue was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RIGHT MIDDLE FINGER TURNED PURPLE; FINGERS SWELLING; INSOMNIA; RINGING IN THE EARS; CHEST PAIN; SHORTNESS OF BREATH; FATIGUE; BODY ACHE; METALLIC TASTE IN MOUTH; FINGERS TURNED COLD AND TINGLY; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, "over Christmas" and had since recovered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 23-MAR-2021, the subject experienced metallic taste in mouth. On 23-MAR-2021, the subject experienced fingers turned cold and tingly. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced insomnia. On 25-MAR-2021, the subject experienced ringing in the ears. On 25-MAR-2021, the subject experienced chest pain. On 25-MAR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced right middle finger turned purple. On 08-APR-2021, the subject experienced fingers swelling. Treatment medications (dates unspecified) included: doxycycline, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right middle finger turned purple, chest pain, metallic taste in mouth, and fingers swelling, had not recovered from insomnia, ringing in the ears, and shortness of breath, and the outcome of fingers turned cold and tingly, body ache and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anal haemorrhage, Blood urine present
Clinical narrative: BLEEDING WHILE URINATING; BLEEDING DURING DEFECATION; This spontaneous report received from a patient via a company representative 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced bleeding while urinating. On 2021, the subject experienced bleeding during defecation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding while urinating and bleeding during defecation was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Pyrexia
Clinical narrative: FLU; FELT LIKE CRAP FOR 24 HRS; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu, felt like crap for 24 hrs, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu, felt like crap for 24 hrs and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Malaise, Pain
Clinical narrative: BODY ACHE; SENSATION OF DIZZINESS; LACK OF ENERGY; FEELING SICK; HEADACHE ON ONE SIDE OF HEAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure.  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 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid for high blood pressure.  On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced sensation of dizziness. On APR-2021, the subject experienced lack of energy. On APR-2021, the subject experienced feeling sick. On APR-2021, the subject experienced headache on one side of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache on one side of head, and sensation of dizziness and the outcome of feeling sick, lack of energy and body ache was not reported. This report was non-serious. This same reporter case is linked to 20210440215.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye pain, Eye pruritus, Fatigue, Injection site pain
Clinical narrative: PAIN IN RIGHT EYE COMING FROM BACK OF HEAD  STOPS FOR A WHILE AND THEN REPEATS; EYE ITCHING; TIREDNESS; PAIN AT INJECTION SITE; STOMACH PAIN; This spontaneous report received from a patient concerned a 64 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 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On 05-APR-2021, the subject experienced stomach pain. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced pain in right eye coming from back of head stops for a while and then repeats. On 15-APR-2021, the subject experienced eye itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and pain at injection site, and tiredness on 07-APR-2021, had not recovered from pain in right eye coming from back of head stops for a while and then repeats, and the outcome of eye itching was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Peripheral coldness
Clinical narrative: FEET ICE COLD; CHILLS; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 05-SEP-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced feet ice cold. On 24-MAR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and feet ice cold. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Aptyalism, Asthenia, Burning sensation, Cough, Dry mouth
Clinical narrative: DRY MOUTH; NO ENERGY; SEVERE PAIN IN RIGHT LEG; HEADACHE; FEELING LIKE BODY TORN APART; WHOLE BODY NUMB/NUMBNESS TO RIGHT LEG, FACE, RIGHT ARM/HAND/EAR; WHOLE BODY PAIN; COUGH; HOLDING  FLUID; BUTTOCKS BURNING HEAVY; LOSS OF SENSATION; LACK OF SALIVA; LIPS DRY; 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 past medical history included mucous in chest, and cough, and concurrent conditions included hyperlipidemia, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling like body torn apart. On APR-2021, the subject experienced whole body numb/numbness to right leg, face, right arm/hand/ear. On APR-2021, the subject experienced whole body pain. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced holding fluid. On APR-2021, the subject experienced buttocks burning heavy. On APR-2021, the subject experienced loss of sensation. On APR-2021, the subject experienced lack of saliva. On APR-2021, the subject experienced lips dry. On APR-2021, the subject experienced severe pain in right leg. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced dry mouth. On 11-APR-2021, the subject experienced no energy. On 13-APR-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: furosemide/potassium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy, dry mouth, and whole body numb/numbness to right leg, face, right arm/hand/ear, and the outcome of feeling like body torn apart, whole body pain, cough, holding fluid, severe pain in right leg, buttocks burning heavy, loss of sensation, headache, lack of saliva and lips dry was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Fluid retention, Headache, Hypoaesthesia, Lip dry
Clinical narrative: DRY MOUTH; NO ENERGY; SEVERE PAIN IN RIGHT LEG; HEADACHE; FEELING LIKE BODY TORN APART; WHOLE BODY NUMB/NUMBNESS TO RIGHT LEG, FACE, RIGHT ARM/HAND/EAR; WHOLE BODY PAIN; COUGH; HOLDING  FLUID; BUTTOCKS BURNING HEAVY; LOSS OF SENSATION; LACK OF SALIVA; LIPS DRY; 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 past medical history included mucous in chest, and cough, and concurrent conditions included hyperlipidemia, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling like body torn apart. On APR-2021, the subject experienced whole body numb/numbness to right leg, face, right arm/hand/ear. On APR-2021, the subject experienced whole body pain. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced holding fluid. On APR-2021, the subject experienced buttocks burning heavy. On APR-2021, the subject experienced loss of sensation. On APR-2021, the subject experienced lack of saliva. On APR-2021, the subject experienced lips dry. On APR-2021, the subject experienced severe pain in right leg. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced dry mouth. On 11-APR-2021, the subject experienced no energy. On 13-APR-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: furosemide/potassium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy, dry mouth, and whole body numb/numbness to right leg, face, right arm/hand/ear, and the outcome of feeling like body torn apart, whole body pain, cough, holding fluid, severe pain in right leg, buttocks burning heavy, loss of sensation, headache, lack of saliva and lips dry was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Polymerase chain reaction, Sensory loss
Clinical narrative: DRY MOUTH; NO ENERGY; SEVERE PAIN IN RIGHT LEG; HEADACHE; FEELING LIKE BODY TORN APART; WHOLE BODY NUMB/NUMBNESS TO RIGHT LEG, FACE, RIGHT ARM/HAND/EAR; WHOLE BODY PAIN; COUGH; HOLDING  FLUID; BUTTOCKS BURNING HEAVY; LOSS OF SENSATION; LACK OF SALIVA; LIPS DRY; 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 past medical history included mucous in chest, and cough, and concurrent conditions included hyperlipidemia, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling like body torn apart. On APR-2021, the subject experienced whole body numb/numbness to right leg, face, right arm/hand/ear. On APR-2021, the subject experienced whole body pain. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced holding fluid. On APR-2021, the subject experienced buttocks burning heavy. On APR-2021, the subject experienced loss of sensation. On APR-2021, the subject experienced lack of saliva. On APR-2021, the subject experienced lips dry. On APR-2021, the subject experienced severe pain in right leg. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced dry mouth. On 11-APR-2021, the subject experienced no energy. On 13-APR-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: furosemide/potassium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy, dry mouth, and whole body numb/numbness to right leg, face, right arm/hand/ear, and the outcome of feeling like body torn apart, whole body pain, cough, holding fluid, severe pain in right leg, buttocks burning heavy, loss of sensation, headache, lack of saliva and lips dry was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain, Vomiting
Clinical narrative: HEADACHE; SICK TO STOMACH; BODY HURT/COULD NOT MOVE/FELT LIKE A SEMI HIT 5 TIMES; START TO THROW UP; SICK FOR 2 DAYS; This spontaneous report received from a patient concerned a 62 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, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sick for 2 days. On 09-APR-2021, the subject experienced body hurt/could not move/felt like a semi hit 5 times. On 09-APR-2021, the subject experienced start to throw up. On 09-APR-2021, the subject experienced sick to stomach. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body hurt/could not move/felt like a semi hit 5 times, had not recovered from sick to stomach, and the outcome of headache, sick for 2 days and start to throw up was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Pyrexia
Clinical narrative: INJECTION SITE PAIN; SLIGHT FEVER; This spontaneous report received from a consumer concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease. 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced injection site pain. On 2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The outcome of the injection site pain and slight fever was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 55 year old female. 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, intramuscular, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included adalimumab for rheumatoid arthritis. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-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, fever, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exposure via breast milk
Clinical narrative: EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a 2 year old male. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 an unspecified date, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain in extremity
Clinical narrative: BACK PAIN IN SHOULDER BLADES/SEVERE KNEE PAIN; SEVERE FOOT PAIN; CHEST PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 17-APR-2021, the subject experienced chest pain. On an unspecified date, the subject experienced back pain in shoulder blades/severe knee pain, and severe foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pain in shoulder blades/severe knee pain, severe foot pain and chest pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Neck pain, Pain in extremity
Clinical narrative: UNABLE TO SLEEP ON EITHER SIDE; SHOULDER PAIN; PAIN IN ARM; NECK PAIN; This spontaneous report received from a consumer 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, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced neck pain. On 02-APR-2021, the subject experienced shoulder pain. On 02-APR-2021, the subject experienced pain in arm. On an unspecified date, the subject experienced unable to sleep on either side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, shoulder pain, pain in arm and unable to sleep on either side was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: ONE RED SPOT ON ARM; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included torn rotator cuff. The patient experienced drug allergy when treated with codeine, and tramadol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021  for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced one red spot on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from one red spot on arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Erythema, Fatigue, Gait disturbance
Clinical narrative: BURNING HAND AND FEET; REDNESS HAND AND FEET; WALKING DIFFICULTY; CAN'T TOUCH ANYTHING; TEMPERATURE; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning hand and feet, redness hand and feet, walking difficulty, can't touch anything, temperature, tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning hand and feet, headache, tiredness, walking difficulty, can't touch anything, redness hand and feet and temperature was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sensory loss
Clinical narrative: BURNING HAND AND FEET; REDNESS HAND AND FEET; WALKING DIFFICULTY; CAN'T TOUCH ANYTHING; TEMPERATURE; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning hand and feet, redness hand and feet, walking difficulty, can't touch anything, temperature, tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning hand and feet, headache, tiredness, walking difficulty, can't touch anything, redness hand and feet and temperature was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Immune system disorder, Pain, Pain in extremity
Clinical narrative: STOMACH BRUISING; MILD IMMUNE RESPONSE; LITTLE ACHY; ARM PAIN; TIREDNESS/WORN DOWN; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced mild immune response. On 07-APR-2021, the subject experienced little achy. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced tiredness/worn down. On 17-APR-2021, the subject experienced stomach bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild immune response, little achy, arm pain, and tiredness/worn down on APR-2021, and had not recovered from stomach bruising. This report was non-serious.; Sender's Comments: :V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Pyrexia, Speech disorder, Swelling face
Clinical narrative: DIFFICULTY SPEAKING; SEVERE MIGRAINE IN HER FRONTAL LOBE (FRONT OF HER HEAD); SWELLING AT ONE SIDE OF THE FACE; SORE ARM; MINOR FEVER; URTICARIA FLARE-UP; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included idiopathic chronic urticaria, alcohol user, and non-smoker. The patient experienced vaccine allergy when treated with influenza vaccine inact split 4v. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced swelling at one side of the face. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced minor fever. On 06-APR-2021, the subject experienced urticaria flare-up. On 20-APR-2021, the subject experienced severe migraine in her frontal lobe (front of her head). On 20-APR-2021, the subject experienced difficulty speaking. Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling at one side of the face, sore arm, and minor fever on APR-2021, had not recovered from severe migraine in her frontal lobe (front of her head), and the outcome of urticaria flare-up and difficulty speaking was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: DIFFICULTY SPEAKING; SEVERE MIGRAINE IN HER FRONTAL LOBE (FRONT OF HER HEAD); SWELLING AT ONE SIDE OF THE FACE; SORE ARM; MINOR FEVER; URTICARIA FLARE-UP; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included idiopathic chronic urticaria, alcohol user, and non-smoker. The patient experienced vaccine allergy when treated with influenza vaccine inact split 4v. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced swelling at one side of the face. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced minor fever. On 06-APR-2021, the subject experienced urticaria flare-up. On 20-APR-2021, the subject experienced severe migraine in her frontal lobe (front of her head). On 20-APR-2021, the subject experienced difficulty speaking. Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling at one side of the face, sore arm, and minor fever on APR-2021, had not recovered from severe migraine in her frontal lobe (front of her head), and the outcome of urticaria flare-up and difficulty speaking was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: EAR FEELS CLOGGED; RINGING IN EARS; This spontaneous report received from a consumer concerned a 42 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced ear feels clogged. On 12-APR-2021, the subject experienced ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear feels clogged, and ringing in ears. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: SHAKING; BODY ACHE; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 4 decade 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: 1802068 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced shaking. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body ache, chills, headache, and fever on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210442616.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: RANDOMLY FELT LIKE PINS AND NEEDLES IN TOES,  FINGERS AND FACE; FEVER; This spontaneous report received from a patient concerned a 46 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, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced randomly felt like pins and needles in toes, fingers and face. On 11-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-APR-2021, and had not recovered from randomly felt like pins and needles in toes, fingers and face. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Sinus congestion, Tinnitus
Clinical narrative: RINGING IN THE EAR; DIZZINESS; CONGESTION; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 245 pounds, and height was 183 centimeters. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced ringing in the ear. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ear, and dizziness, and the outcome of congestion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Insomnia, Pain, Pain in extremity
Clinical narrative: CANNOT SLEEP; BODY PAINS; RIGHT ARM NUMBNESS; ITCHING; RIGHT ARM PAIN; RASH ON RIGHT ARM WHERE RECEIVED THE INJECTION; HIVES ON RIGHT ARM WHERE RECEIVED THE INJECTION; HEADACHE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced cannot sleep. On 2021, the subject experienced body pains. On 2021, the subject experienced right arm numbness. On 2021, the subject experienced itching. On 2021, the subject experienced right arm pain. On 2021, the subject experienced rash on right arm where received the injection. On 2021, the subject experienced hives on right arm where received the injection. On 2021, the subject experienced headache. Treatment medications included: diphenhydramine hydrochloride, and loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on right arm where received the injection, hives on right arm where received the injection, right arm pain, right arm numbness, headache, body pains, itching and cannot sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: CANNOT SLEEP; BODY PAINS; RIGHT ARM NUMBNESS; ITCHING; RIGHT ARM PAIN; RASH ON RIGHT ARM WHERE RECEIVED THE INJECTION; HIVES ON RIGHT ARM WHERE RECEIVED THE INJECTION; HEADACHE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced cannot sleep. On 2021, the subject experienced body pains. On 2021, the subject experienced right arm numbness. On 2021, the subject experienced itching. On 2021, the subject experienced right arm pain. On 2021, the subject experienced rash on right arm where received the injection. On 2021, the subject experienced hives on right arm where received the injection. On 2021, the subject experienced headache. Treatment medications included: diphenhydramine hydrochloride, and loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on right arm where received the injection, hives on right arm where received the injection, right arm pain, right arm numbness, headache, body pains, itching and cannot sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Restlessness
Clinical narrative: LITTLE MORE ENERGETIC; RESTLESS; This spontaneous report received from a consumer concerned an 84 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced little more energetic, and restless. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little more energetic and restless was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS; This spontaneous report received from a consumer concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscular weakness
Clinical narrative: EXCRUCIATING BACK PAIN; MUSCLES WEAKNESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included back pain. The patient experienced drug allergy when treated with cefepime, and vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029,expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscles weakness. Treatment medications included: lidocaine, and paracetamol. On 17-APR-2021, the subject experienced excruciating back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating back pain, and the outcome of muscles weakness was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Pain, Polymerase chain reaction
Clinical narrative: BODYACHE; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal for red blood cells (RBCs) and white blood cells (WBCs), and Polymerase chain reaction (NR: not provided) Negative. On 07-APR-2021, the subject experienced bodyache. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bodyache, tiredness and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia
Clinical narrative: SHORTNESS OF BREATH; PAIN IN THE LEG MUSCLE (SPECIFICALLY PAIN IN THE CALF AND BEHIND THE KNEE); 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced pain in the leg muscle (specifically pain in the calf and behind the knee). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on MAR-2021, and had not recovered from pain in the leg muscle (specifically pain in the calf and behind the knee). This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia
Clinical narrative: UPPER LEFT ARM PAIN/SORE/ACHES; CAN NOT SLEEP; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic kidney disease. 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 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced can not sleep. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced upper left arm pain/sore/aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upper left arm pain/sore/aches, and the outcome of can not sleep was not reported. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Headache, Heart rate normal
Clinical narrative: SLIGHT HEADACHE; CHEST PAIN DUE TO DIFFICULTY IN BREATHING; DIFFICULTY BREATHING; SLOW TO MOVE/LACK ENERGY; SORE ON LEFT SHOULDER FELT LIKE HE WAS PUNCHED IN THE SHOULDER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced chest pain due to difficulty in breathing. On 19-APR-2021, the subject experienced difficulty breathing. On 19-APR-2021, the subject experienced slow to move/lack energy. On 19-APR-2021, the subject experienced sore on left shoulder felt like he was punched in the shoulder. Laboratory data included: Normal pulse rate (NR: not provided) normal at around 60. On an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain due to difficulty in breathing, difficulty breathing, sore on left shoulder felt like he was punched in the shoulder, and slow to move/lack energy, and had not recovered from slight headache. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: SLIGHT HEADACHE; CHEST PAIN DUE TO DIFFICULTY IN BREATHING; DIFFICULTY BREATHING; SLOW TO MOVE/LACK ENERGY; SORE ON LEFT SHOULDER FELT LIKE HE WAS PUNCHED IN THE SHOULDER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced chest pain due to difficulty in breathing. On 19-APR-2021, the subject experienced difficulty breathing. On 19-APR-2021, the subject experienced slow to move/lack energy. On 19-APR-2021, the subject experienced sore on left shoulder felt like he was punched in the shoulder. Laboratory data included: Normal pulse rate (NR: not provided) normal at around 60. On an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain due to difficulty in breathing, difficulty breathing, sore on left shoulder felt like he was punched in the shoulder, and slow to move/lack energy, and had not recovered from slight headache. This report was non-serious.