chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Diplopia, Inflammation, Magnetic resonance imaging normal
Clinical narrative: 6th. nerve Palsy; double vision  - left eye; lost 14 lbs; Lethargic; loss of appetite; it might be small cell arthritis; had a hyper inflammatory response; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:00 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunization. Medical history included High BP, Breast Cancer (Radiation, Partial Lumpectomy, and Medication), Known allergies: Penicillin. The patient experienced 6th. nerve palsy, double vision - left eye, lost 14 lbs, lethargic, loss of appetite, it might be small cell arthritis and had a hyper inflammatory response all on 01Jun2021 at 08:00. It was reported that on First week of June2021 sudden onset of double vision  - left eye, lost 14 lbs. in 5 weeks, Lethargic, loss of appetite, Ophthalmologist said it was 6th. nerve Palsy. Referred to Neurologist, ENT, and Rheumatologist. Physicians thought it might be small cell arthritis, due to off the charts blood work, have been on Prednisone since June2021. Double vision stopped a week after taking Prednisone, they are weaning me off now. Brain MRI clean, no other symptoms to support small cell diagnosis, told I had a hyper inflammatory response after vaccinations. Treatment received for the adverse event includes Prednisone and blood work. The patient received initial dose of BNT162B2 on 03Mar2021 (Batch/lot number : EN6200, Anatomical Location : Arm Left, Dose Number : 1). The patient underwent lab tests and procedures which included blood test: unknown results and Brain MRI (magnetic resonance imaging head): clean both on unspecified date. Therapeutic measures were taken as a result of 6th. nerve palsy, double vision  - left eye, lost 14 lbs, lethargic, loss of appetite, it might be small cell arthritis and had a hyper inflammatory response. Outcome of the event double vision  - left eye was recovered on an unspecified date. Outcome of all the other events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Blood test, Decreased appetite, Diplopia, Inflammation
Clinical narrative: 6th. nerve Palsy; double vision  - left eye; lost 14 lbs; Lethargic; loss of appetite; it might be small cell arthritis; had a hyper inflammatory response; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:00 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunization. Medical history included High BP, Breast Cancer (Radiation, Partial Lumpectomy, and Medication), Known allergies: Penicillin. The patient experienced 6th. nerve palsy, double vision - left eye, lost 14 lbs, lethargic, loss of appetite, it might be small cell arthritis and had a hyper inflammatory response all on 01Jun2021 at 08:00. It was reported that on First week of June2021 sudden onset of double vision  - left eye, lost 14 lbs. in 5 weeks, Lethargic, loss of appetite, Ophthalmologist said it was 6th. nerve Palsy. Referred to Neurologist, ENT, and Rheumatologist. Physicians thought it might be small cell arthritis, due to off the charts blood work, have been on Prednisone since June2021. Double vision stopped a week after taking Prednisone, they are weaning me off now. Brain MRI clean, no other symptoms to support small cell diagnosis, told I had a hyper inflammatory response after vaccinations. Treatment received for the adverse event includes Prednisone and blood work. The patient received initial dose of BNT162B2 on 03Mar2021 (Batch/lot number : EN6200, Anatomical Location : Arm Left, Dose Number : 1). The patient underwent lab tests and procedures which included blood test: unknown results and Brain MRI (magnetic resonance imaging head): clean both on unspecified date. Therapeutic measures were taken as a result of 6th. nerve palsy, double vision  - left eye, lost 14 lbs, lethargic, loss of appetite, it might be small cell arthritis and had a hyper inflammatory response. Outcome of the event double vision  - left eye was recovered on an unspecified date. Outcome of all the other events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Magnetic resonance imaging head, VIth nerve paralysis, Weight decreased
Clinical narrative: 6th. nerve Palsy; double vision  - left eye; lost 14 lbs; Lethargic; loss of appetite; it might be small cell arthritis; had a hyper inflammatory response; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:00 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunization. Medical history included High BP, Breast Cancer (Radiation, Partial Lumpectomy, and Medication), Known allergies: Penicillin. The patient experienced 6th. nerve palsy, double vision - left eye, lost 14 lbs, lethargic, loss of appetite, it might be small cell arthritis and had a hyper inflammatory response all on 01Jun2021 at 08:00. It was reported that on First week of June2021 sudden onset of double vision  - left eye, lost 14 lbs. in 5 weeks, Lethargic, loss of appetite, Ophthalmologist said it was 6th. nerve Palsy. Referred to Neurologist, ENT, and Rheumatologist. Physicians thought it might be small cell arthritis, due to off the charts blood work, have been on Prednisone since June2021. Double vision stopped a week after taking Prednisone, they are weaning me off now. Brain MRI clean, no other symptoms to support small cell diagnosis, told I had a hyper inflammatory response after vaccinations. Treatment received for the adverse event includes Prednisone and blood work. The patient received initial dose of BNT162B2 on 03Mar2021 (Batch/lot number : EN6200, Anatomical Location : Arm Left, Dose Number : 1). The patient underwent lab tests and procedures which included blood test: unknown results and Brain MRI (magnetic resonance imaging head): clean both on unspecified date. Therapeutic measures were taken as a result of 6th. nerve palsy, double vision  - left eye, lost 14 lbs, lethargic, loss of appetite, it might be small cell arthritis and had a hyper inflammatory response. Outcome of the event double vision  - left eye was recovered on an unspecified date. Outcome of all the other events was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: presented to ED after syncope episode in driveway while on his way to get a COVID test; positive for COVID; cough and SOB x 4 days prior to ED visit, nausea and vomiting x 2 days; wheezing; hs of DM2, HTN, prostate CA; condition worsened and patient died in the hospital; COVID viral pneumonia
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Death, Dyspnoea
Clinical narrative: presented to ED after syncope episode in driveway while on his way to get a COVID test; positive for COVID; cough and SOB x 4 days prior to ED visit, nausea and vomiting x 2 days; wheezing; hs of DM2, HTN, prostate CA; condition worsened and patient died in the hospital; COVID viral pneumonia
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test positive, Syncope, Vomiting, Wheezing
Clinical narrative: presented to ED after syncope episode in driveway while on his way to get a COVID test; positive for COVID; cough and SOB x 4 days prior to ED visit, nausea and vomiting x 2 days; wheezing; hs of DM2, HTN, prostate CA; condition worsened and patient died in the hospital; COVID viral pneumonia
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Burning sensation, Headache, Migraine, Pain in extremity
Clinical narrative: Severe persistent migraine; Migraine started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure; Severe persistent migraine; Migraine started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure; had bad temple and nose sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FD8448 and Expiration date was not reported) via an unknown route of administration in left arm on 24Aug2021 at 16:00 hours (at the age of 33-years-old) as dose 1, single for COVID-19 immunization administered at pharmacy or drug store. Patient's medical history included thyroid issues from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine within four weeks of vaccination. Concomitant medications in two weeks included levothyroxine, folic acid, iron (Prenatal), Coenzyme Q10 (ubidecarenone) and colecalciferol (Vitamin D) (all taken for an unspecified indication, start and stop date were not reported). Patient was not diagnosed with COVID-19, prior to vaccination. On 24Aug2021, at 21:00 hours, patient experienced severe persistent migraine, migraine started within 6 hours of getting the shot and had persisted 24/7 and was ongoing. Patient stated that her head feels like it was on fire and she had bad temple and nose sinus pressure. Patient received no treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for all the events. On 24Aug2021, patient had been tested for COVID-19, since the vaccination by nasal swab (Binaxnow) test and result was negative. On 26Aug2021, patient again had been tested for COVID-19, since the vaccination by nasal swab (Binaxnow) test and result was negative. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Severe persistent migraine; Migraine started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure; Severe persistent migraine; Migraine started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure; had bad temple and nose sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FD8448 and Expiration date was not reported) via an unknown route of administration in left arm on 24Aug2021 at 16:00 hours (at the age of 33-years-old) as dose 1, single for COVID-19 immunization administered at pharmacy or drug store. Patient's medical history included thyroid issues from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine within four weeks of vaccination. Concomitant medications in two weeks included levothyroxine, folic acid, iron (Prenatal), Coenzyme Q10 (ubidecarenone) and colecalciferol (Vitamin D) (all taken for an unspecified indication, start and stop date were not reported). Patient was not diagnosed with COVID-19, prior to vaccination. On 24Aug2021, at 21:00 hours, patient experienced severe persistent migraine, migraine started within 6 hours of getting the shot and had persisted 24/7 and was ongoing. Patient stated that her head feels like it was on fire and she had bad temple and nose sinus pressure. Patient received no treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for all the events. On 24Aug2021, patient had been tested for COVID-19, since the vaccination by nasal swab (Binaxnow) test and result was negative. On 26Aug2021, patient again had been tested for COVID-19, since the vaccination by nasal swab (Binaxnow) test and result was negative. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Migraine, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: Severe persistent migraine; Migraine started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure; Severe persistent migraine; Migraine started within 6 hours of getting the shot and has persisted 24/7 and is ongoing. My head feels like it's on fire and I have bad temple and nose sinus pressure; had bad temple and nose sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FD8448 and Expiration date was not reported) via an unknown route of administration in left arm on 24Aug2021 at 16:00 hours (at the age of 33-years-old) as dose 1, single for COVID-19 immunization administered at pharmacy or drug store. Patient's medical history included thyroid issues from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine within four weeks of vaccination. Concomitant medications in two weeks included levothyroxine, folic acid, iron (Prenatal), Coenzyme Q10 (ubidecarenone) and colecalciferol (Vitamin D) (all taken for an unspecified indication, start and stop date were not reported). Patient was not diagnosed with COVID-19, prior to vaccination. On 24Aug2021, at 21:00 hours, patient experienced severe persistent migraine, migraine started within 6 hours of getting the shot and had persisted 24/7 and was ongoing. Patient stated that her head feels like it was on fire and she had bad temple and nose sinus pressure. Patient received no treatment for the events. Patient had doctor or other healthcare professional office/clinic visit for all the events. On 24Aug2021, patient had been tested for COVID-19, since the vaccination by nasal swab (Binaxnow) test and result was negative. On 26Aug2021, patient again had been tested for COVID-19, since the vaccination by nasal swab (Binaxnow) test and result was negative. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Fatigue, Headache, Hypoaesthesia, Nausea
Clinical narrative: NUMBNESS AND TINGLING OF LEGS,GENERALIZED BRUISES ON LEGS ,PAIN TO BILATERAL LOWER EXTEMITIES ,HEADACHE,EXTREME FATIGUE STILL PERSISTENT AFTER A MONTH
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: NUMBNESS AND TINGLING OF LEGS,GENERALIZED BRUISES ON LEGS ,PAIN TO BILATERAL LOWER EXTEMITIES ,HEADACHE,EXTREME FATIGUE STILL PERSISTENT AFTER A MONTH
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Fatigue, Full blood count, Headache, Hypoaesthesia
Clinical narrative: NUMBNESS AND TINGLING OF LEGS,GENERALIZED BRUISES ON LEGS ,PAIN TO BILATERAL LOWER EXTEMITIES ,HEADACHE,EXTREME FATIGUE STILL PERSISTENT AFTER A MONTH
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Platelet count, Spinal X-ray
Clinical narrative: NUMBNESS AND TINGLING OF LEGS,GENERALIZED BRUISES ON LEGS ,PAIN TO BILATERAL LOWER EXTEMITIES ,HEADACHE,EXTREME FATIGUE STILL PERSISTENT AFTER A MONTH
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Fatigue, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: NUMBNESS AND TINGLING OF LEGS,GENERALIZED BRUISES ON LEGS ,PAIN TO BILATERAL LOWER EXTEMITIES ,HEADACHE,EXTREME FATIGUE STILL PERSISTENT AFTER A MONTH
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: NUMBNESS AND TINGLING OF LEGS,GENERALIZED BRUISES ON LEGS ,PAIN TO BILATERAL LOWER EXTEMITIES ,HEADACHE,EXTREME FATIGUE STILL PERSISTENT AFTER A MONTH
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: NUMBNESS IN TOES AND BOTH FEET; ZERO ENERGY; LOST SENSE OF TASTE; FACIAL NUMBNESS IN LIPS NOSE AND REST OF FACE; UPPER BACK PAIN/BACK PAIN/MUSCLE ACHES; PAIN IN BACK MOVED TO SPINE; SKIN IS ON FIRE MOSTLY FELT ON ARMS BUT ALSO ENTIRE BODY LIKE EVERY NERVE ENDING ON MY SKIN IS ON FIRE AND EXTREMELY SENSITIVE TO TOUCH HOT WATER AND COLD WATER; NOT BEEN ABLE TO SLEEP; DEEP MUSCLE PAIN IN THE ENTIRE BACK MUSCLES/DULL MUSCLE  ACHE IN THE LOWER BACK/ THROBBING BACK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water. On 30-AUG-2021, the patient experienced not been able to sleep. On 30-AUG-2021, the patient experienced deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain. On SEP-2021, the patient experienced upper back pain/back pain/muscle aches. On SEP-2021, the patient experienced pain in back moved to spine. On 10-SEP-2021, the patient experienced facial numbness in lips nose and rest of face. Laboratory data included: Blood test (NR: not provided) Normal, and COVID-19 virus test (NR: not provided) Negative. On 12-SEP-2021, the patient experienced lost sense of taste. On 13-SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, CAT scan (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced numbness in toes and both feet. On 18-SEP-2021, the patient experienced zero energy. Treatment medications (dates unspecified) included: naproxen, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain, not been able to sleep, facial numbness in lips nose and rest of face, zero energy, and pain in back moved to spine, and had not recovered from skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water, numbness in toes and both feet, lost sense of taste, and upper back pain/back pain/muscle aches. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Hypogeusia, Insomnia
Clinical narrative: NUMBNESS IN TOES AND BOTH FEET; ZERO ENERGY; LOST SENSE OF TASTE; FACIAL NUMBNESS IN LIPS NOSE AND REST OF FACE; UPPER BACK PAIN/BACK PAIN/MUSCLE ACHES; PAIN IN BACK MOVED TO SPINE; SKIN IS ON FIRE MOSTLY FELT ON ARMS BUT ALSO ENTIRE BODY LIKE EVERY NERVE ENDING ON MY SKIN IS ON FIRE AND EXTREMELY SENSITIVE TO TOUCH HOT WATER AND COLD WATER; NOT BEEN ABLE TO SLEEP; DEEP MUSCLE PAIN IN THE ENTIRE BACK MUSCLES/DULL MUSCLE  ACHE IN THE LOWER BACK/ THROBBING BACK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water. On 30-AUG-2021, the patient experienced not been able to sleep. On 30-AUG-2021, the patient experienced deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain. On SEP-2021, the patient experienced upper back pain/back pain/muscle aches. On SEP-2021, the patient experienced pain in back moved to spine. On 10-SEP-2021, the patient experienced facial numbness in lips nose and rest of face. Laboratory data included: Blood test (NR: not provided) Normal, and COVID-19 virus test (NR: not provided) Negative. On 12-SEP-2021, the patient experienced lost sense of taste. On 13-SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, CAT scan (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced numbness in toes and both feet. On 18-SEP-2021, the patient experienced zero energy. Treatment medications (dates unspecified) included: naproxen, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain, not been able to sleep, facial numbness in lips nose and rest of face, zero energy, and pain in back moved to spine, and had not recovered from skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water, numbness in toes and both feet, lost sense of taste, and upper back pain/back pain/muscle aches. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, SARS-CoV-2 test negative, Skin warm, Spinal pain, X-ray normal
Clinical narrative: NUMBNESS IN TOES AND BOTH FEET; ZERO ENERGY; LOST SENSE OF TASTE; FACIAL NUMBNESS IN LIPS NOSE AND REST OF FACE; UPPER BACK PAIN/BACK PAIN/MUSCLE ACHES; PAIN IN BACK MOVED TO SPINE; SKIN IS ON FIRE MOSTLY FELT ON ARMS BUT ALSO ENTIRE BODY LIKE EVERY NERVE ENDING ON MY SKIN IS ON FIRE AND EXTREMELY SENSITIVE TO TOUCH HOT WATER AND COLD WATER; NOT BEEN ABLE TO SLEEP; DEEP MUSCLE PAIN IN THE ENTIRE BACK MUSCLES/DULL MUSCLE  ACHE IN THE LOWER BACK/ THROBBING BACK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water. On 30-AUG-2021, the patient experienced not been able to sleep. On 30-AUG-2021, the patient experienced deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain. On SEP-2021, the patient experienced upper back pain/back pain/muscle aches. On SEP-2021, the patient experienced pain in back moved to spine. On 10-SEP-2021, the patient experienced facial numbness in lips nose and rest of face. Laboratory data included: Blood test (NR: not provided) Normal, and COVID-19 virus test (NR: not provided) Negative. On 12-SEP-2021, the patient experienced lost sense of taste. On 13-SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, CAT scan (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced numbness in toes and both feet. On 18-SEP-2021, the patient experienced zero energy. Treatment medications (dates unspecified) included: naproxen, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain, not been able to sleep, facial numbness in lips nose and rest of face, zero energy, and pain in back moved to spine, and had not recovered from skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water, numbness in toes and both feet, lost sense of taste, and upper back pain/back pain/muscle aches. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Asthenia, Back pain, Hypoaesthesia, Insomnia
Clinical narrative: NUMBNESS IN TOES AND BOTH FEET; ZERO ENERGY; LOST SENSE OF TASTE; FACIAL NUMBNESS IN LIPS NOSE AND REST OF FACE; UPPER BACK PAIN/BACK PAIN/MUSCLE ACHES; PAIN IN BACK MOVED TO SPINE; SKIN IS ON FIRE MOSTLY FELT ON ARMS BUT ALSO ENTIRE BODY LIKE EVERY NERVE ENDING ON MY SKIN IS ON FIRE AND EXTREMELY SENSITIVE TO TOUCH HOT WATER AND COLD WATER; NOT BEEN ABLE TO SLEEP; DEEP MUSCLE PAIN IN THE ENTIRE BACK MUSCLES/DULL MUSCLE  ACHE IN THE LOWER BACK/ THROBBING BACK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water. On 30-AUG-2021, the patient experienced not been able to sleep. On 30-AUG-2021, the patient experienced deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain. On SEP-2021, the patient experienced upper back pain/back pain/muscle aches. On SEP-2021, the patient experienced pain in back moved to spine. On 10-SEP-2021, the patient experienced facial numbness in lips nose and rest of face. Laboratory data included: Blood test (NR: not provided) Normal, and COVID-19 virus test (NR: not provided) Negative. On 12-SEP-2021, the patient experienced lost sense of taste. On 13-SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, CAT scan (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced numbness in toes and both feet. On 18-SEP-2021, the patient experienced zero energy. Treatment medications (dates unspecified) included: naproxen, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain, not been able to sleep, facial numbness in lips nose and rest of face, zero energy, and pain in back moved to spine, and had not recovered from skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water, numbness in toes and both feet, lost sense of taste, and upper back pain/back pain/muscle aches. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Skin burning sensation, Spinal pain
Clinical narrative: NUMBNESS IN TOES AND BOTH FEET; ZERO ENERGY; LOST SENSE OF TASTE; FACIAL NUMBNESS IN LIPS NOSE AND REST OF FACE; UPPER BACK PAIN/BACK PAIN/MUSCLE ACHES; PAIN IN BACK MOVED TO SPINE; SKIN IS ON FIRE MOSTLY FELT ON ARMS BUT ALSO ENTIRE BODY LIKE EVERY NERVE ENDING ON MY SKIN IS ON FIRE AND EXTREMELY SENSITIVE TO TOUCH HOT WATER AND COLD WATER; NOT BEEN ABLE TO SLEEP; DEEP MUSCLE PAIN IN THE ENTIRE BACK MUSCLES/DULL MUSCLE  ACHE IN THE LOWER BACK/ THROBBING BACK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water. On 30-AUG-2021, the patient experienced not been able to sleep. On 30-AUG-2021, the patient experienced deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain. On SEP-2021, the patient experienced upper back pain/back pain/muscle aches. On SEP-2021, the patient experienced pain in back moved to spine. On 10-SEP-2021, the patient experienced facial numbness in lips nose and rest of face. Laboratory data included: Blood test (NR: not provided) Normal, and COVID-19 virus test (NR: not provided) Negative. On 12-SEP-2021, the patient experienced lost sense of taste. On 13-SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, CAT scan (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced numbness in toes and both feet. On 18-SEP-2021, the patient experienced zero energy. Treatment medications (dates unspecified) included: naproxen, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain, not been able to sleep, facial numbness in lips nose and rest of face, zero energy, and pain in back moved to spine, and had not recovered from skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water, numbness in toes and both feet, lost sense of taste, and upper back pain/back pain/muscle aches. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Tinnitus
Clinical narrative: Within four hours of receiving the vaccine I started having acute tinnitus and it has not stopped since; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Jul2021 (at the age of 59 years old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, "within four hours of receiving the vaccine i started having acute tinnitus and it has not stopped since" on 20Jul2021. Reported as, Within four hours of receiving the vaccine patient started having acute tinnitus and it has not stopped since. Before the vaccine patient had never had tinnitus before. patient have read of others with a similar experience. It was severally affecting patient quality of life. Patient tried steroids, acupuncture, a psychotherapist, ENT for sound masking but still has this side effect and was affecting her life. Therapeutic measures were taken as a result of within four hours of receiving the vaccine i started having acute tinnitus and it has not stopped since. Outcome of the event was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Within four hours of receiving the vaccine I started having acute tinnitus and it has not stopped since; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Jul2021 (at the age of 59 years old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, "within four hours of receiving the vaccine i started having acute tinnitus and it has not stopped since" on 20Jul2021. Reported as, Within four hours of receiving the vaccine patient started having acute tinnitus and it has not stopped since. Before the vaccine patient had never had tinnitus before. patient have read of others with a similar experience. It was severally affecting patient quality of life. Patient tried steroids, acupuncture, a psychotherapist, ENT for sound masking but still has this side effect and was affecting her life. Therapeutic measures were taken as a result of within four hours of receiving the vaccine i started having acute tinnitus and it has not stopped since. Outcome of the event was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Poor quality sleep, Somnolence
Clinical narrative: insomnia; waking up frequently in the middle of the night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Sep2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported side effects after receiving her first dose of the Pfizer vaccine on 10Sep2021. On an unspecified date, the patient experienced insomnia and woke up frequently in the middle of the night. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Sleep disorder
Clinical narrative: insomnia; waking up frequently in the middle of the night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Sep2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported side effects after receiving her first dose of the Pfizer vaccine on 10Sep2021. On an unspecified date, the patient experienced insomnia and woke up frequently in the middle of the night. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Parent falsified child's date of birth to get child vaccinated with Covid-19 vaccine. No side effects reported.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Parent falsified child's date of birth to get child vaccinated with Covid-19 vaccine. No side effects reported.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Day of shot exactly 12 hours after the shot at 20:30 the bodyaches started; chills; Fever started at 99.4 and went up to 101.3; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 17Sep2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included stage 3 rectal cancer since an unknown date in 2016 (now in remission for 5 years), benign desmoid tumor since an unknown date in Mar2021, radiation finished in Jul2021, anxiety and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 27Aug2021 at 10:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient previously received lorazepam (ATIVA) and citalopram hydrobromide (CELEXA); both for anxiety and depression from an unknown date and unknown if ongoing. On 17Sep2021 at 20:30, after the second dose of vaccine on the day of the shot, exactly 12 hours after the shot, the patient experienced body aches, followed by chills and fever. The fever started at 99.4 (unspecified units) and went up to 101.3 (units not specified), was reduced soon by taking naproxen sodium to reduce the fever. Ice packs and cold washcloths helped with the fever too. She was then fever free by 18Sep2021 morning with 98.5 temperature (units not specified). On 18Sep2021, she still had body aches and fatigue, so she rested. On 19Sep2021, she felt better and like herself again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events the body aches started, chills and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever started at 99.4 and went up to 101.3 was recovered on 18Sep2021. The clinical outcome of the events day of shot exactly 12 hours after the shot at 20:30 the body aches started, chills, and fatigue were recovered on 19Sep2021.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Day of shot exactly 12 hours after the shot at 20:30 the bodyaches started; chills; Fever started at 99.4 and went up to 101.3; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 17Sep2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included stage 3 rectal cancer since an unknown date in 2016 (now in remission for 5 years), benign desmoid tumor since an unknown date in Mar2021, radiation finished in Jul2021, anxiety and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 27Aug2021 at 10:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient previously received lorazepam (ATIVA) and citalopram hydrobromide (CELEXA); both for anxiety and depression from an unknown date and unknown if ongoing. On 17Sep2021 at 20:30, after the second dose of vaccine on the day of the shot, exactly 12 hours after the shot, the patient experienced body aches, followed by chills and fever. The fever started at 99.4 (unspecified units) and went up to 101.3 (units not specified), was reduced soon by taking naproxen sodium to reduce the fever. Ice packs and cold washcloths helped with the fever too. She was then fever free by 18Sep2021 morning with 98.5 temperature (units not specified). On 18Sep2021, she still had body aches and fatigue, so she rested. On 19Sep2021, she felt better and like herself again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events the body aches started, chills and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever started at 99.4 and went up to 101.3 was recovered on 18Sep2021. The clinical outcome of the events day of shot exactly 12 hours after the shot at 20:30 the body aches started, chills, and fatigue were recovered on 19Sep2021.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chills, Computerised tomogram head, Diarrhoea
Clinical narrative: Facial numbness; Severe headaches; Shooting pain through head/skull; Blurred vision at times; Body aches; Fever; Chills; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 14Sep2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included pacemaker for sick sinus syndrome, hypothyroidism and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included thyroid (ARMOUR THYROID), pantoprazole (MANUFACTURER UNKNOWN) and medroxyprogesterone (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received technetium tc 99m imidodiphosphate (TECHNETIUM 99M IDP) and propylthiouracil (PROPYLTHIURACIL); both for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 24Aug2021 at 12:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 13Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 14Sep2021 at 13:00 the patient experienced facial numbness, severe headaches, shooting pain through head/skull, blurred vision at times, body aches, fever, chills, sore arm, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 15Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 17Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events facial numbness, severe headaches, shooting pain through head/skull, blurred vision at times, body aches, fever, chills, sore arm, fatigue was not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Headache, Hypoaesthesia, Pain, Paraesthesia oral
Clinical narrative: Facial numbness; Severe headaches; Shooting pain through head/skull; Blurred vision at times; Body aches; Fever; Chills; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 14Sep2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included pacemaker for sick sinus syndrome, hypothyroidism and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included thyroid (ARMOUR THYROID), pantoprazole (MANUFACTURER UNKNOWN) and medroxyprogesterone (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received technetium tc 99m imidodiphosphate (TECHNETIUM 99M IDP) and propylthiouracil (PROPYLTHIURACIL); both for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 24Aug2021 at 12:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 13Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 14Sep2021 at 13:00 the patient experienced facial numbness, severe headaches, shooting pain through head/skull, blurred vision at times, body aches, fever, chills, sore arm, and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 15Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 17Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events facial numbness, severe headaches, shooting pain through head/skull, blurred vision at times, body aches, fever, chills, sore arm, fatigue was not resolved at the time of this report.