chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Injection site pain, Oxygen saturation, Pyrexia, Vomiting
Clinical narrative: DIZZY; CHILLS; LEFT ARM PAIN AT INJECTION SITE; FEVER; HEADACHE; VOMITING; LEFT-SIDE STOMACH PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, alcohol user (twice a month), and non-smoker, and other pre-existing medical conditions included the patient had no illicit drug usage and drug abuse. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced left-side stomach pain. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced left arm pain at injection site. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.5 F, Heart rate (NR: not provided) 120 BPM, and Pulse oximetry (NR: not provided) 91 %. On 16-APR-2021, the subject experienced dizzy. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, left-side stomach pain, and chills on 16-APR-2021, was recovering from dizzy, and had not recovered from headache, fever, and left arm pain at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: SORE BODY; SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore body, sore arm, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, sore body and tiredness was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Nasopharyngitis, Nausea, Pyrexia, Urticaria
Clinical narrative: HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold. On 09-APR-2021, the subject experienced body parts felt bad. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and nausea, had not recovered from hives, and the outcome of fever and body parts felt bad was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Blood test normal, Heavy menstrual bleeding, Impaired work ability, Laboratory test normal
Clinical narrative: HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold. On 09-APR-2021, the subject experienced body parts felt bad. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and nausea, had not recovered from hives, and the outcome of fever and body parts felt bad was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mobility decreased, Nausea, Polymenorrhoea, Pruritus
Clinical narrative: HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold. On 09-APR-2021, the subject experienced body parts felt bad. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and nausea, had not recovered from hives, and the outcome of fever and body parts felt bad was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Thrombosis
Clinical narrative: HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold. On 09-APR-2021, the subject experienced body parts felt bad. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and nausea, had not recovered from hives, and the outcome of fever and body parts felt bad was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SEVERE PAIN IN ARM; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 205 pounds, and height was not reported. The patient's concurrent conditions included pencilin allergy, non smoker, and alcohol user, and other pre-existing medical conditions included patient had no drug abuse or drug illicit usage patient had no available diagnostic lab data. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042192119 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced severe pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Fatigue, Illness, Pain in extremity
Clinical narrative: SICKNESS; PAIN UNDERNEATH ARM LIKE IN LYMPH NODES; LOW ENERGY; LEG PAIN; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 5 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: 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 APR-2021, the subject experienced sickness. On APR-2021, the subject experienced pain underneath arm like in lymph nodes. On APR-2021, the subject experienced low energy. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sickness, low energy, tiredness, leg pain, and pain underneath arm like in lymph nodes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site bruising, Myalgia
Clinical narrative: BLACK AND BLUE INJECTION SITE; BAD HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced black and blue injection site. On 2021, the subject experienced bad headache. On 2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad headache, muscle ache and black and blue injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210429847.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; SPIKING FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced spiking fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and spiking fever was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARM AT INJECTION SITE AND FELT LIKE SOMEONE PUNCHED IN ARM; This spontaneous report received from a patient concerned a 60 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced sore arm at injection site and felt like someone punched in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site and felt like someone punched in arm on 12-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Lethargy, Pain in extremity
Clinical narrative: PAIN IN THE LEFT LEG; CONFUSION; LETHARGY; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included dust mite allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced lethargy. On 22-MAR-2021, the subject experienced confusion. On 30-MAR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confusion on 29-MAR-2021, and pain in the left leg on 10-APR-2021, had not recovered from lethargy, and the outcome of fatigue was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: STOMACH CRAMPING; DIARRHEA; NAUSEA; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 54 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: 8351698, and batch number: 8351698 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced loss of appetite. On 16-APR-2021, the subject experienced stomach cramping. On 16-APR-2021, the subject experienced diarrhea. On 16-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: loperamide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite, nausea, stomach cramping, and diarrhea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Dysaesthesia, Nausea, Pyrexia
Clinical narrative: SENSATION OF PULSATING ON THIGH ABOVE THE KNEE ON THE QUADRICEPS WHEN LYING DOWN; ACHING BONES; FEVER; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sensation of pulsating on thigh above the knee on the quadriceps when lying down. On APR-2021, the subject experienced aching bones. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 38 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching bones, fever, and nausea on APR-2021, and had not recovered from sensation of pulsating on thigh above the knee on the quadriceps when lying down. This report was non-serious.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: RASH; ITCHY AREAS ON SHOULDER, EARS WAISTLINES, THIGHS AND ARMS; This spontaneous report received from a patient concerned a 90 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced itchy areas on shoulder, ears waistlines, thighs and arms. On 11-APR-2021, the subject experienced rash. Treatment medications (dates unspecified) included: calamine/camphor/diphenhydramine hydrochloride/glycerol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy areas on shoulder, ears waistlines, thighs and arms, and the outcome of rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling hot, Pyrexia, Respiratory disorder
Clinical narrative: BODY FELT HOT ALL TIME; HOT BREATH; TROUBLE BREATHING; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-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 fever. On 15-APR-2021, the subject experienced trouble breathing. On an unspecified date, the subject experienced body felt hot all time, and hot breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of body felt hot all time, hot breath and trouble breathing was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Audiogram, Blood test, Burning sensation
Clinical narrative: MELT DOWN; SHIRT WRINGING WET; ALLERGIC REACTION; BODY CHILLS ON/OFF; BURNING/CHERRY RED LEGS AND WHOLE BODY BURNING; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced burning/cherry red legs and whole body burning. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced body chills on/off. Laboratory data included: Audiogram (NR: not provided) Negative, and Blood test (NR: not provided) Everything came back negative. On 09-APR-2021 17:00, the subject experienced allergic reaction. On 15-APR-2021, the subject experienced melt down. On 15-APR-2021, the subject experienced shirt wringing wet. On 17-APR-2021, treatment medications included: pregabalin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from allergic reaction, burning/cherry red legs and whole body burning, body chills on/off, abdominal pain, melt down, and shirt wringing wet. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Hypersensitivity
Clinical narrative: MELT DOWN; SHIRT WRINGING WET; ALLERGIC REACTION; BODY CHILLS ON/OFF; BURNING/CHERRY RED LEGS AND WHOLE BODY BURNING; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced burning/cherry red legs and whole body burning. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced body chills on/off. Laboratory data included: Audiogram (NR: not provided) Negative, and Blood test (NR: not provided) Everything came back negative. On 09-APR-2021 17:00, the subject experienced allergic reaction. On 15-APR-2021, the subject experienced melt down. On 15-APR-2021, the subject experienced shirt wringing wet. On 17-APR-2021, treatment medications included: pregabalin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from allergic reaction, burning/cherry red legs and whole body burning, body chills on/off, abdominal pain, melt down, and shirt wringing wet. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: ACHY; MILD FEVER; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced achy, mild fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever, achy and tired was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Nausea, Pain
Clinical narrative: SWEATING; BODY HURT ALL OVER; NO APPETITE; CHILLS; BAD NAUSEA; This spontaneous report received from a patient concerned a 20 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced body hurt all over. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced bad nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 09-APR-2021, body hurt all over, and no appetite on 11-APR-2021, chills on 08-APR-2021, and bad nausea on 12-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Restlessness
Clinical narrative: MIGRAINE; RESTLESS NIGHT AND DAY IN BED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, and restless night and day in bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine and restless night and day in bed was not reported. This report was non-serious. This case, from the same reporter is linked to 20210428170.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vertigo
Clinical narrative: Vertigo; FATIGUE; 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 immune compromised, and other pre-existing medical conditions included had a boot on left ankle. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, fatigue and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Headache, Nausea
Clinical narrative: LIGHT HEADED; HEADACHE; NAUSEA; STOMACH PAIN; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 270 pounds, and height was 68 inches. The patient's concurrent conditions included alcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug 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, route of admin not reported, batch number: 043a21a, 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 stomach pain. On APR-2021, the subject experienced nausea. On 15-APR-2021, the subject experienced light headed. On 15-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, and had not recovered from headache, nausea, and stomach pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: LEG PAIN; JOINT PAIN; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced joint pain. On 17-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and joint pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Somnolence
Clinical narrative: SUPER BAD ACHES; LETHARGIC; SLEEP WHOLE DAY; HEADACHE; This spontaneous report received from a consumer 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced super bad aches. On 2021, the subject experienced lethargic. On 2021, the subject experienced sleep whole day. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, super bad aches, lethargic and sleep whole day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210427663.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED/WIPED OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. 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 APR-2021, the subject experienced tired/wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired / wiped out was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421077.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Illness
Clinical narrative: PAIN IN RIGHT HIP/JOINT RADIATING DOWN LEG/SHOULDER JOINT PAIN RADIATING DOWN ARM; SLIGHT ILLNESS; SLIGHT DIZZINESS; This spontaneous report received from a patient concerned a 46 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: OH1A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced slight dizziness. On 07-APR-2021, the subject experienced slight illness. On 10-APR-2021, the subject experienced pain in right hip/joint radiating down leg/shoulder joint pain radiating down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right hip/joint radiating down leg/shoulder joint pain radiating down arm on 17-APR-2021, and the outcome of slight dizziness and slight illness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Coagulation test, Contusion
Clinical narrative: ITCHINESS ALL OVER BODY; BRUISING; RASH ON ARM, SPREAD TO BACK LEFT, SHOULDER; CHILLS; LACK OF ENERGY; HEADACHE; FEVER; LACK OF APPETITE/COULD NOT EAT; COULD NOT GET OFF THE COUCH; EXTREME BACKACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold, flu, meningitis, and petechiae, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel. On 03-APR-2021, the subject experienced extreme backache. On 04-APR-2021, the subject experienced lack of appetite/could not eat. On 04-APR-2021, the subject experienced could not get off the couch. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced lack of energy. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced itchiness all over body. On 16-APR-2021, the subject experienced bruising. On 16-APR-2021, the subject experienced rash on arm, spread to back left, shoulder. On 17-APR-2021, Laboratory data included: Coagulation test (NR: not provided) NORMAL, Full blood count (NR: not provided) NORMAL, Platelet count (NR: not provided) Lower end of normal, Urine analysis (NR: not provided) NORMAL, and WBC count (NR: 4 - 11) Normal. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme backache, lack of appetite/could not eat, could not get off the couch, chills, lack of energy, headache, and fever on 05-APR-2021, had not recovered from rash on arm, spread to back left, shoulder, and itchiness all over body, and the outcome of bruising was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Full blood count, Headache, Ill-defined disorder, Platelet count
Clinical narrative: ITCHINESS ALL OVER BODY; BRUISING; RASH ON ARM, SPREAD TO BACK LEFT, SHOULDER; CHILLS; LACK OF ENERGY; HEADACHE; FEVER; LACK OF APPETITE/COULD NOT EAT; COULD NOT GET OFF THE COUCH; EXTREME BACKACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold, flu, meningitis, and petechiae, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel. On 03-APR-2021, the subject experienced extreme backache. On 04-APR-2021, the subject experienced lack of appetite/could not eat. On 04-APR-2021, the subject experienced could not get off the couch. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced lack of energy. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced itchiness all over body. On 16-APR-2021, the subject experienced bruising. On 16-APR-2021, the subject experienced rash on arm, spread to back left, shoulder. On 17-APR-2021, Laboratory data included: Coagulation test (NR: not provided) NORMAL, Full blood count (NR: not provided) NORMAL, Platelet count (NR: not provided) Lower end of normal, Urine analysis (NR: not provided) NORMAL, and WBC count (NR: 4 - 11) Normal. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme backache, lack of appetite/could not eat, could not get off the couch, chills, lack of energy, headache, and fever on 05-APR-2021, had not recovered from rash on arm, spread to back left, shoulder, and itchiness all over body, and the outcome of bruising was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Urine analysis, White blood cell count
Clinical narrative: ITCHINESS ALL OVER BODY; BRUISING; RASH ON ARM, SPREAD TO BACK LEFT, SHOULDER; CHILLS; LACK OF ENERGY; HEADACHE; FEVER; LACK OF APPETITE/COULD NOT EAT; COULD NOT GET OFF THE COUCH; EXTREME BACKACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold, flu, meningitis, and petechiae, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel. On 03-APR-2021, the subject experienced extreme backache. On 04-APR-2021, the subject experienced lack of appetite/could not eat. On 04-APR-2021, the subject experienced could not get off the couch. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced lack of energy. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced itchiness all over body. On 16-APR-2021, the subject experienced bruising. On 16-APR-2021, the subject experienced rash on arm, spread to back left, shoulder. On 17-APR-2021, Laboratory data included: Coagulation test (NR: not provided) NORMAL, Full blood count (NR: not provided) NORMAL, Platelet count (NR: not provided) Lower end of normal, Urine analysis (NR: not provided) NORMAL, and WBC count (NR: 4 - 11) Normal. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme backache, lack of appetite/could not eat, could not get off the couch, chills, lack of energy, headache, and fever on 05-APR-2021, had not recovered from rash on arm, spread to back left, shoulder, and itchiness all over body, and the outcome of bruising was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: LOWER BACK PAIN; LEG PAIN; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, and had not recovered from leg pain, lower back pain, and tiredness. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Lip swelling, Nausea
Clinical narrative: SWOLLEN LIPS; SICK; NAUSEA; FATIGUE; This spontaneous report received from a patient by a Business partner on 15-APR-2021 was received on 15-APR-2021 and concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included waldenstrom's macroglobulinemia, and sulfa antibiotics allergy, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included alprazolam, ascorbic acid, bifidobacterium lactis, chlordiazepoxide hydrochloride/clidinium bromide, denosumab, fluoxetine hydrochloride, ibuprofen, nebivolol hydrochloride, and vitamin d nos. On an unspecified date, the subject experienced swollen lips, sick, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fatigue, swollen lips and sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20201245161.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Ultrasound scan
Clinical narrative: MUSCLE CRAMPS IN LEGS; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, asthma, cat allergy, dog allergy, and allergic to medicines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085025, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced muscle cramps in legs. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on MAR-2021, and had not recovered from muscle cramps in legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; EXHAUSTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever, and was recovering from exhaustion. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: SKIN REACTION OR ALLERGIC REACTION; 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, 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 skin reaction or allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin reaction or allergic reaction was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus, Rash
Clinical narrative: ITCHY PATCH ON FEET/ ON SHINS/SIDE OF KNEES; PATCHY BURNING RASH ON LOWER BACK/TOP OF BUTTOCKS; SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was very healthy, does not have skin, breathing problems and also not taking any medications. The patient 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 12-APR-2021, the subject experienced sore arm. On 12-APR-2021, the subject experienced fatigue. On 16-APR-2021, the subject experienced itchy patch on feet/ on shins/side of knees. On 16-APR-2021, the subject experienced patchy burning rash on lower back/top of buttocks. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, sore arm, patchy burning rash on lower back/top of buttocks, and itchy patch on feet/ on shins/side of knees. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: VACCINE SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine side effects. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHES; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 an unspecified date, the subject experienced aches, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and low grade fever. This report was non-serious.