chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Glassy eyes, Injection site swelling, Mass, Pain
Clinical narrative: GLASSY EYES; CHILLS; STOMACH DISCOMFORT; FATIGUE; SWELLING AT INJECTION SITE; LUMP; PAINFUL; REDNESS; WARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced lump. On 12-APR-2021, the subject experienced painful. On 12-APR-2021, the subject experienced redness. On 12-APR-2021, the subject experienced warm. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced swelling at injection site. On 21-APR-2021, the subject experienced stomach discomfort. On 22-APR-2021, the subject experienced glassy eyes. On 22-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm, and swelling at injection site on 21-APR-2021, and chills on 23-APR-2021, was recovering from stomach discomfort, fatigue, and glassy eyes, and had not recovered from lump, painful, and redness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chest X-ray, Computerised tomogram, Electrocardiogram
Clinical narrative: ADVERSE SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 adverse side effects. Laboratory data included: CT scan (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, and EKG (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse side effects was not reported. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache
Clinical narrative: DIFFICULTY BREATHING; DIZZINESS; SEVERE HEADACHES; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included enlarged heart, and poor lung function. 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 and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headaches, dizziness and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: PAIN IN ARM; FLU LIKE SYMPTOMS; 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) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company was unable to perform follow-up to request batch number. On an unspecified date, the subject experienced pain in arm, and flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and flu like symptoms was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Dehydration, Feeling of body temperature change, Hypoaesthesia
Clinical narrative: FEELING COLD/HOT SENSATIONS IN LEFT ARM; RASH ON ARM; NAUSEA; REALLY BAD STOMACH ACHE; DEHYDRATION; NERVE PAIN; FELT COLD RUSH DOWN HER LEFT ARM/ FEEL NUMB FOR A MINUTE/ NUMBNESS FIZZLED OUT; EXTREME ARM PAIN/ BURNING ARM PAIN/ FELT LIKE A REALLY BAD SUNBURN/ ARM SORENESS / ARM BEGAN TO SHAKE/ INNER ARM AND ARMPITS SORE/ FEELING WARM, FUZZY PAIN IN LEFT ARM; INJECTION SITE SORENESS; CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included born with cleft palate, non alcohol user, non smoker, pollen allergy, and mild cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out. On 31-MAR-2021, the subject experienced extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced high fever. On 31-MAR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced nerve pain. On 07-APR-2021, the subject experienced dehydration. On 10-APR-2021, the subject experienced really bad stomach ache. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced feeling cold/hot sensations in left arm, and rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out on 31-MAR-2021, rash on arm, chills on 01-APR-2021, and high fever on 02-APR-2021, was recovering from injection site soreness, had not recovered from nerve pain, and extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm, and the outcome of dehydration, really bad stomach ache, nausea and feeling cold/hot sensations in left arm was not reported. 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: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Nausea, Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: FEELING COLD/HOT SENSATIONS IN LEFT ARM; RASH ON ARM; NAUSEA; REALLY BAD STOMACH ACHE; DEHYDRATION; NERVE PAIN; FELT COLD RUSH DOWN HER LEFT ARM/ FEEL NUMB FOR A MINUTE/ NUMBNESS FIZZLED OUT; EXTREME ARM PAIN/ BURNING ARM PAIN/ FELT LIKE A REALLY BAD SUNBURN/ ARM SORENESS / ARM BEGAN TO SHAKE/ INNER ARM AND ARMPITS SORE/ FEELING WARM, FUZZY PAIN IN LEFT ARM; INJECTION SITE SORENESS; CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included born with cleft palate, non alcohol user, non smoker, pollen allergy, and mild cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out. On 31-MAR-2021, the subject experienced extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced high fever. On 31-MAR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced nerve pain. On 07-APR-2021, the subject experienced dehydration. On 10-APR-2021, the subject experienced really bad stomach ache. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced feeling cold/hot sensations in left arm, and rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out on 31-MAR-2021, rash on arm, chills on 01-APR-2021, and high fever on 02-APR-2021, was recovering from injection site soreness, had not recovered from nerve pain, and extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm, and the outcome of dehydration, really bad stomach ache, nausea and feeling cold/hot sensations in left arm was not reported. 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: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: FEELING COLD/HOT SENSATIONS IN LEFT ARM; RASH ON ARM; NAUSEA; REALLY BAD STOMACH ACHE; DEHYDRATION; NERVE PAIN; FELT COLD RUSH DOWN HER LEFT ARM/ FEEL NUMB FOR A MINUTE/ NUMBNESS FIZZLED OUT; EXTREME ARM PAIN/ BURNING ARM PAIN/ FELT LIKE A REALLY BAD SUNBURN/ ARM SORENESS / ARM BEGAN TO SHAKE/ INNER ARM AND ARMPITS SORE/ FEELING WARM, FUZZY PAIN IN LEFT ARM; INJECTION SITE SORENESS; CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included born with cleft palate, non alcohol user, non smoker, pollen allergy, and mild cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out. On 31-MAR-2021, the subject experienced extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced high fever. On 31-MAR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced nerve pain. On 07-APR-2021, the subject experienced dehydration. On 10-APR-2021, the subject experienced really bad stomach ache. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced feeling cold/hot sensations in left arm, and rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out on 31-MAR-2021, rash on arm, chills on 01-APR-2021, and high fever on 02-APR-2021, was recovering from injection site soreness, had not recovered from nerve pain, and extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm, and the outcome of dehydration, really bad stomach ache, nausea and feeling cold/hot sensations in left arm was not reported. 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: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Nerve injury
Clinical narrative: FEELING COLD/HOT SENSATIONS IN LEFT ARM; RASH ON ARM; NAUSEA; REALLY BAD STOMACH ACHE; DEHYDRATION; NERVE PAIN; FELT COLD RUSH DOWN HER LEFT ARM/ FEEL NUMB FOR A MINUTE/ NUMBNESS FIZZLED OUT; EXTREME ARM PAIN/ BURNING ARM PAIN/ FELT LIKE A REALLY BAD SUNBURN/ ARM SORENESS / ARM BEGAN TO SHAKE/ INNER ARM AND ARMPITS SORE/ FEELING WARM, FUZZY PAIN IN LEFT ARM; INJECTION SITE SORENESS; CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included born with cleft palate, non alcohol user, non smoker, pollen allergy, and mild cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out. On 31-MAR-2021, the subject experienced extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced high fever. On 31-MAR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced nerve pain. On 07-APR-2021, the subject experienced dehydration. On 10-APR-2021, the subject experienced really bad stomach ache. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced feeling cold/hot sensations in left arm, and rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out on 31-MAR-2021, rash on arm, chills on 01-APR-2021, and high fever on 02-APR-2021, was recovering from injection site soreness, had not recovered from nerve pain, and extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm, and the outcome of dehydration, really bad stomach ache, nausea and feeling cold/hot sensations in left arm was not reported. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence, Influenza like illness, Mucous stools
Clinical narrative: DIARRHEA; MUCOUS STOOLS; STOMACH TURNING; STOMACH GAS; STOMACH ACHE; FLU LIKE SYMPTOMS EXCEPT FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 169 pounds, and height was 172 centimeters. The patient's concurrent conditions included lactose intolerant, sulfonamide allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included no pertinent medical history. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced flu like symptoms except fever. On 17-APR-2021, the subject experienced stomach gas. On 17-APR-2021, the subject experienced stomach ache. On 17-APR-2021, the subject experienced stomach turning. On 17-APR-2021 12:00, the subject experienced diarrhea. On 17-APR-2021 12:00, the subject experienced mucous stools. On 24-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and Urine analysis (NR: not provided) Negative. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, flu like symptoms except fever, stomach ache, stomach gas, and mucous stools, and the outcome of stomach turning was not reported. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Urine analysis
Clinical narrative: DIARRHEA; MUCOUS STOOLS; STOMACH TURNING; STOMACH GAS; STOMACH ACHE; FLU LIKE SYMPTOMS EXCEPT FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 169 pounds, and height was 172 centimeters. The patient's concurrent conditions included lactose intolerant, sulfonamide allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included no pertinent medical history. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced flu like symptoms except fever. On 17-APR-2021, the subject experienced stomach gas. On 17-APR-2021, the subject experienced stomach ache. On 17-APR-2021, the subject experienced stomach turning. On 17-APR-2021 12:00, the subject experienced diarrhea. On 17-APR-2021 12:00, the subject experienced mucous stools. On 24-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and Urine analysis (NR: not provided) Negative. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, flu like symptoms except fever, stomach ache, stomach gas, and mucous stools, and the outcome of stomach turning was not reported. 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: VAGINAL BLEEDING; 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: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, the subject experienced vaginal bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaginal bleeding. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; 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: 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 fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Magnetic resonance imaging, Rotator cuff syndrome, Tendonitis
Clinical narrative: BURSITIS (BRUISES / PAIN IN SHOULDER); TENDONITIS; TEAR IN ROTATOR CUFF; 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: 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 2021, the subject experienced bursitis (bruises / pain in shoulder),  tendonitis and  tear in rotator cuff.  Laboratory data included: MRI (NR: not provided) Bursitis, Tendinitis, and a tear in rotator cuff. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tear in rotator cuff, and the outcome of bursitis (bruises / pain in shoulder) and tendonitis was unknown. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: TACHYCARDIA; LOSS OF APPETITE; DIFFICULTY IN BREATHING; SWEATING; BURNING BY THE WAIST AND BACK; SHOULDER FELT NUMB AND IN BACK; CHILLS; HEADACHE; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patients 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 05-APR-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 an unspecified date, the patient experienced tachycardia, loss of appetite, difficulty in breathing, sweating, burning by the waist and back, shoulder felt numb and in back, chills, headache, fever, fatigue, and nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tachycardia, fatigue, loss of appetite, chills, and fever, and the outcome of difficulty in breathing, sweating, burning by the waist and back and shoulder felt numb and in back was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Nausea, Pyrexia
Clinical narrative: TACHYCARDIA; LOSS OF APPETITE; DIFFICULTY IN BREATHING; SWEATING; BURNING BY THE WAIST AND BACK; SHOULDER FELT NUMB AND IN BACK; CHILLS; HEADACHE; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patients 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 05-APR-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 an unspecified date, the patient experienced tachycardia, loss of appetite, difficulty in breathing, sweating, burning by the waist and back, shoulder felt numb and in back, chills, headache, fever, fatigue, and nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tachycardia, fatigue, loss of appetite, chills, and fever, and the outcome of difficulty in breathing, sweating, burning by the waist and back and shoulder felt numb and in back was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: TACHYCARDIA; LOSS OF APPETITE; DIFFICULTY IN BREATHING; SWEATING; BURNING BY THE WAIST AND BACK; SHOULDER FELT NUMB AND IN BACK; CHILLS; HEADACHE; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patients 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 05-APR-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 an unspecified date, the patient experienced tachycardia, loss of appetite, difficulty in breathing, sweating, burning by the waist and back, shoulder felt numb and in back, chills, headache, fever, fatigue, and nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tachycardia, fatigue, loss of appetite, chills, and fever, and the outcome of difficulty in breathing, sweating, burning by the waist and back and shoulder felt numb and in back was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash pruritic
Clinical narrative: ITCHY RASH ON CHEST, NIPPLES AND GRADUALLY SPREAD TO LEFT LEG; LEFT SIDED HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced left sided headache. On 11-APR-2021, the subject experienced itchy rash on chest, nipples and gradually spread to left leg. On 13-APR-2021, treatment medications included: diphenhydramine hydrochloride, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left sided headache, and had not recovered from itchy rash on chest, nipples and gradually spread to left leg. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHE; SEVERE CHILLS; This spontaneous report received from a patient 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 body ache, and severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache and severe chills was not reported. This report was non-serious. This case, from the same reporter is linked to.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Ehlers-Danlos syndrome, Injection site swelling, Muscle spasms
Clinical narrative: HYPERMOBILE TYPE EHLERS-DANLOS SYNDROME (HEDS); WORSE CRAMPS; VERY DIZZY; SORE; INJECTION SITE SWELLING; 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: Unknown) dose was not reported, administered on APR-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. No concomitant medications were reported.  On APR-2021, the subject experienced hypermobile type ehlers-danlos syndrome (heds). On APR-2021, the subject experienced worse cramps. On APR-2021, the subject experienced very dizzy. On APR-2021, the subject experienced sore. On APR-2021, the subject experienced injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very dizzy, and sore, had not recovered from injection site swelling, and the outcome of worse cramps and hypermobile type ehlers-danlos syndrome (heds) was not reported. This report was non-serious.; Sender's Comments: V0 20210449461, covid-19 vaccine ad26.cov2.s -Medical assessment comment not required as per standard procedure since case was assessed as Non serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 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 05-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 fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate increased, Hypoaesthesia, Insomnia
Clinical narrative: BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 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 05-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 fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 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 05-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 fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Ultrasound scan, Vision blurred
Clinical narrative: BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 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 05-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 fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: FEVER; FELT LIKE GOING TO THROW UP; 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 fever, and felt like going to throw up. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and felt like going to throw up. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Gingival pain, Gingival swelling
Clinical narrative: Patient states that she developed 102 fever and gum swelling with pain. Also complains of submandibular lymphadenopathy.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: Patient states that three weeks ago he received dose number 2 of Pfizer covid 19 vaccination. Within the next few days he developed joint pain and swelling both hands and right knee
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular
Clinical narrative: Arm had started to get few blotchy red spots day after, but today almost entire humerus solid red not blotchy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the subject experienced suspected covid-19 infection. Treatment medications included: fexofenadine hydrochloride. On 20-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious. This report was associated with product quality complaint: 90000177470 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Rash papular, Rash pruritic
Clinical narrative: Cold sores on lips Itchy rashes or varying sizes with papules in random locations on body. In order or appearance: face-especially left side including around eyes, left forearm, right forearm, neck, behind ears, inner right thigh, right knee, outer right calf
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Patient states that two days after vaccination he developed painful swelling right elbow region. The vaccination had been administered to left arm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder ache.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Fatigue, Injection site pain, Muscular weakness
Clinical narrative: About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke myself up several times talking in my sleep. I woke up to chills, fever, vertigo, muscle weakness and pain, shin sensitivity on back only. A lot of pan on vaccination site. Pressure behind my eyes, fatigue.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ocular discomfort, Pyrexia, Sensitive skin, Sleep disorder
Clinical narrative: About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke myself up several times talking in my sleep. I woke up to chills, fever, vertigo, muscle weakness and pain, shin sensitivity on back only. A lot of pan on vaccination site. Pressure behind my eyes, fatigue.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke myself up several times talking in my sleep. I woke up to chills, fever, vertigo, muscle weakness and pain, shin sensitivity on back only. A lot of pan on vaccination site. Pressure behind my eyes, fatigue.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Intermittent sharp chest pain beginning approximately 10 minutes after vaccine administration. Symptoms subsided after several hours without treatment.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Blood test normal, Breast tenderness, Computerised tomogram
Clinical narrative: 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints  2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Lymphadenopathy, Mammogram normal
Clinical narrative: 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints  2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pain in jaw, Scan with contrast, Swelling
Clinical narrative: 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints  2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints  2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.