chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Resting heart rate 130-138; Chest discomfort during deep breathing; Low blood pressure between 89/70 and 99/52; Fever of 102.5; achy; nausea; chills; exhaustion; dehydration; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 21-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 21Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunisation in other facility. No other vaccines were received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination. The patient medical history was not reported. There were no concomitant medications. On 22Apr2021 at 16:00, the patient experienced resting heart rate 130-138, chest discomfort during deep breathing, low blood pressure between 89/70 and 99/52, fever of 102.5, achy, nausea, chills, exhaustion and dehydration. The events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement: between 89/70 and 99/52 on 22Apr2021, body temperature: 102.5 on 22Apr2021, resting heart rate: 130-138 on 22Apr2021, sars-cov-2 test: negative on 22Apr2021. Therapeutic measures were taken as a result of the events with saline and Tylenol. The outcome of the events was resolved on an unspecified date in 2021.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Chills, Dehydration
Clinical narrative: Resting heart rate 130-138; Chest discomfort during deep breathing; Low blood pressure between 89/70 and 99/52; Fever of 102.5; achy; nausea; chills; exhaustion; dehydration; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 21-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 21Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunisation in other facility. No other vaccines were received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination. The patient medical history was not reported. There were no concomitant medications. On 22Apr2021 at 16:00, the patient experienced resting heart rate 130-138, chest discomfort during deep breathing, low blood pressure between 89/70 and 99/52, fever of 102.5, achy, nausea, chills, exhaustion and dehydration. The events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement: between 89/70 and 99/52 on 22Apr2021, body temperature: 102.5 on 22Apr2021, resting heart rate: 130-138 on 22Apr2021, sars-cov-2 test: negative on 22Apr2021. Therapeutic measures were taken as a result of the events with saline and Tylenol. The outcome of the events was resolved on an unspecified date in 2021.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Hypotension, Nausea
Clinical narrative: Resting heart rate 130-138; Chest discomfort during deep breathing; Low blood pressure between 89/70 and 99/52; Fever of 102.5; achy; nausea; chills; exhaustion; dehydration; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 21-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 21Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunisation in other facility. No other vaccines were received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination. The patient medical history was not reported. There were no concomitant medications. On 22Apr2021 at 16:00, the patient experienced resting heart rate 130-138, chest discomfort during deep breathing, low blood pressure between 89/70 and 99/52, fever of 102.5, achy, nausea, chills, exhaustion and dehydration. The events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement: between 89/70 and 99/52 on 22Apr2021, body temperature: 102.5 on 22Apr2021, resting heart rate: 130-138 on 22Apr2021, sars-cov-2 test: negative on 22Apr2021. Therapeutic measures were taken as a result of the events with saline and Tylenol. The outcome of the events was resolved on an unspecified date in 2021.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Resting heart rate 130-138; Chest discomfort during deep breathing; Low blood pressure between 89/70 and 99/52; Fever of 102.5; achy; nausea; chills; exhaustion; dehydration; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 21-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 21Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunisation in other facility. No other vaccines were received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination. The patient medical history was not reported. There were no concomitant medications. On 22Apr2021 at 16:00, the patient experienced resting heart rate 130-138, chest discomfort during deep breathing, low blood pressure between 89/70 and 99/52, fever of 102.5, achy, nausea, chills, exhaustion and dehydration. The events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement: between 89/70 and 99/52 on 22Apr2021, body temperature: 102.5 on 22Apr2021, resting heart rate: 130-138 on 22Apr2021, sars-cov-2 test: negative on 22Apr2021. Therapeutic measures were taken as a result of the events with saline and Tylenol. The outcome of the events was resolved on an unspecified date in 2021.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood creatine phosphokinase normal, Blood culture negative, Borrelia test negative, Epstein-Barr virus antibody negative
Clinical narrative: initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; persistent low grade fever; loss of mobility; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 15:00 (at the age of 53 years) (Batch/Lot Number: EW0191) as a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included ibuprofen (other medication in two weeks). On 06Jun2021 07:00, the patient experienced initial flu like aches which gave way to extreme muscle weakness in lower extremities moving to upper body weakness, persistent low grade fever, and loss of mobility. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 2 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19 since the vaccination (nasal swab) with result negative both on 18Jun2021 and 19Jun2021. Patient has no known allergies. Therapeutic measures were taken as a result of the events. The patient has not recovered from the events.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, HIV test negative, Myalgia, Pyrexia, Respiratory viral panel
Clinical narrative: initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; persistent low grade fever; loss of mobility; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 15:00 (at the age of 53 years) (Batch/Lot Number: EW0191) as a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included ibuprofen (other medication in two weeks). On 06Jun2021 07:00, the patient experienced initial flu like aches which gave way to extreme muscle weakness in lower extremities moving to upper body weakness, persistent low grade fever, and loss of mobility. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 2 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19 since the vaccination (nasal swab) with result negative both on 18Jun2021 and 19Jun2021. Patient has no known allergies. Therapeutic measures were taken as a result of the events. The patient has not recovered from the events.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Troponin normal
Clinical narrative: initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; persistent low grade fever; loss of mobility; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 15:00 (at the age of 53 years) (Batch/Lot Number: EW0191) as a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included ibuprofen (other medication in two weeks). On 06Jun2021 07:00, the patient experienced initial flu like aches which gave way to extreme muscle weakness in lower extremities moving to upper body weakness, persistent low grade fever, and loss of mobility. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 2 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19 since the vaccination (nasal swab) with result negative both on 18Jun2021 and 19Jun2021. Patient has no known allergies. Therapeutic measures were taken as a result of the events. The patient has not recovered from the events.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Influenza like illness, Mobility decreased, Muscular weakness, Pyrexia
Clinical narrative: initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; persistent low grade fever; loss of mobility; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 15:00 (at the age of 53 years) (Batch/Lot Number: EW0191) as a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included ibuprofen (other medication in two weeks). On 06Jun2021 07:00, the patient experienced initial flu like aches which gave way to extreme muscle weakness in lower extremities moving to upper body weakness, persistent low grade fever, and loss of mobility. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 2 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19 since the vaccination (nasal swab) with result negative both on 18Jun2021 and 19Jun2021. Patient has no known allergies. Therapeutic measures were taken as a result of the events. The patient has not recovered from the events.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; persistent low grade fever; loss of mobility; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 15:00 (at the age of 53 years) (Batch/Lot Number: EW0191) as a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included ibuprofen (other medication in two weeks). On 06Jun2021 07:00, the patient experienced initial flu like aches which gave way to extreme muscle weakness in lower extremities moving to upper body weakness, persistent low grade fever, and loss of mobility. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 2 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19 since the vaccination (nasal swab) with result negative both on 18Jun2021 and 19Jun2021. Patient has no known allergies. Therapeutic measures were taken as a result of the events. The patient has not recovered from the events.
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hip arthroplasty
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Discomfort, Dizziness, Dyspnoea
Clinical narrative: numbness in my hands has progressed to my feet and arms, and my fingers are beginning to hurt; difficulty breathing; stabbing pain in chest/burning and sore sensation in the middle of chest; issues of breathing whenever she exercised; I couldn't breathe because my chest was too tight; woke up with tingling and pain in my arm; woke up with tingling and pain in my arm/my fingers are beginning to hurt; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 11Jun2021 13:00 (at the age of 29 years) (Batch/Lot Number: Ew0172) as a single dose for COVID-19 immunization. Medical history included epilepsy and allergies: steroids. Concomitant medications included zonisamide (ZONEGRAN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE); both reported as other medications in two weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Patient previously took prednisone and experienced allergies. Patient is not pregnant at the time of vaccination. No other vaccine in four weeks. During the second shot, patient had difficulty breathing and stabbing pain in her chest as soon as she left the Pharmacy and began walking around. Patient called the CDC hotline, and they said that was a normal reaction. Patient took a Benadryl and slept off the pain and generalized side effects. From the next two weeks, patient began to have issues of breathing whenever she exercised. She would get stabbing pains in her chest if she moved too quickly or bent over. It felt like there was a burning and sore sensation in the middle of her chest. She could not breathe because her chest was too tight, so she would have to lay down and rest for a while until she caught her breath. When she woke up with tingling and pain in her arm, she checked into the ER. She was referred to a cardiologist for further testing. The numbness in her hands has progressed to her feet and arms, and her fingers are beginning to hurt. Adverse event start date was reported as 11Jun2021 13:15. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: Covid Test-ER) on 30Jun2021 with result unknown. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient has not recovered from the events. AE treatment: Zyrtec and observe if gets worse.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: numbness in my hands has progressed to my feet and arms, and my fingers are beginning to hurt; difficulty breathing; stabbing pain in chest/burning and sore sensation in the middle of chest; issues of breathing whenever she exercised; I couldn't breathe because my chest was too tight; woke up with tingling and pain in my arm; woke up with tingling and pain in my arm/my fingers are beginning to hurt; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 11Jun2021 13:00 (at the age of 29 years) (Batch/Lot Number: Ew0172) as a single dose for COVID-19 immunization. Medical history included epilepsy and allergies: steroids. Concomitant medications included zonisamide (ZONEGRAN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE); both reported as other medications in two weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Patient previously took prednisone and experienced allergies. Patient is not pregnant at the time of vaccination. No other vaccine in four weeks. During the second shot, patient had difficulty breathing and stabbing pain in her chest as soon as she left the Pharmacy and began walking around. Patient called the CDC hotline, and they said that was a normal reaction. Patient took a Benadryl and slept off the pain and generalized side effects. From the next two weeks, patient began to have issues of breathing whenever she exercised. She would get stabbing pains in her chest if she moved too quickly or bent over. It felt like there was a burning and sore sensation in the middle of her chest. She could not breathe because her chest was too tight, so she would have to lay down and rest for a while until she caught her breath. When she woke up with tingling and pain in her arm, she checked into the ER. She was referred to a cardiologist for further testing. The numbness in her hands has progressed to her feet and arms, and her fingers are beginning to hurt. Adverse event start date was reported as 11Jun2021 13:15. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: Covid Test-ER) on 30Jun2021 with result unknown. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient has not recovered from the events. AE treatment: Zyrtec and observe if gets worse.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Dyspnoea exertional, Hypoaesthesia
Clinical narrative: numbness in my hands has progressed to my feet and arms, and my fingers are beginning to hurt; difficulty breathing; stabbing pain in chest/burning and sore sensation in the middle of chest; issues of breathing whenever she exercised; I couldn't breathe because my chest was too tight; woke up with tingling and pain in my arm; woke up with tingling and pain in my arm/my fingers are beginning to hurt; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 11Jun2021 13:00 (at the age of 29 years) (Batch/Lot Number: Ew0172) as a single dose for COVID-19 immunization. Medical history included epilepsy and allergies: steroids. Concomitant medications included zonisamide (ZONEGRAN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE); both reported as other medications in two weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Patient previously took prednisone and experienced allergies. Patient is not pregnant at the time of vaccination. No other vaccine in four weeks. During the second shot, patient had difficulty breathing and stabbing pain in her chest as soon as she left the Pharmacy and began walking around. Patient called the CDC hotline, and they said that was a normal reaction. Patient took a Benadryl and slept off the pain and generalized side effects. From the next two weeks, patient began to have issues of breathing whenever she exercised. She would get stabbing pains in her chest if she moved too quickly or bent over. It felt like there was a burning and sore sensation in the middle of her chest. She could not breathe because her chest was too tight, so she would have to lay down and rest for a while until she caught her breath. When she woke up with tingling and pain in her arm, she checked into the ER. She was referred to a cardiologist for further testing. The numbness in her hands has progressed to her feet and arms, and her fingers are beginning to hurt. Adverse event start date was reported as 11Jun2021 13:15. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: Covid Test-ER) on 30Jun2021 with result unknown. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient has not recovered from the events. AE treatment: Zyrtec and observe if gets worse.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: numbness in my hands has progressed to my feet and arms, and my fingers are beginning to hurt; difficulty breathing; stabbing pain in chest/burning and sore sensation in the middle of chest; issues of breathing whenever she exercised; I couldn't breathe because my chest was too tight; woke up with tingling and pain in my arm; woke up with tingling and pain in my arm/my fingers are beginning to hurt; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 11Jun2021 13:00 (at the age of 29 years) (Batch/Lot Number: Ew0172) as a single dose for COVID-19 immunization. Medical history included epilepsy and allergies: steroids. Concomitant medications included zonisamide (ZONEGRAN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE); both reported as other medications in two weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Patient previously took prednisone and experienced allergies. Patient is not pregnant at the time of vaccination. No other vaccine in four weeks. During the second shot, patient had difficulty breathing and stabbing pain in her chest as soon as she left the Pharmacy and began walking around. Patient called the CDC hotline, and they said that was a normal reaction. Patient took a Benadryl and slept off the pain and generalized side effects. From the next two weeks, patient began to have issues of breathing whenever she exercised. She would get stabbing pains in her chest if she moved too quickly or bent over. It felt like there was a burning and sore sensation in the middle of her chest. She could not breathe because her chest was too tight, so she would have to lay down and rest for a while until she caught her breath. When she woke up with tingling and pain in her arm, she checked into the ER. She was referred to a cardiologist for further testing. The numbness in her hands has progressed to her feet and arms, and her fingers are beginning to hurt. Adverse event start date was reported as 11Jun2021 13:15. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: Covid Test-ER) on 30Jun2021 with result unknown. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient has not recovered from the events. AE treatment: Zyrtec and observe if gets worse.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Felt a little woozy; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced felt a little woozy on an unspecified date (the patient felt a little woozy on the first or second day after the vaccine. States he read it takes 2-4 weeks for the vaccine to be effective, so maybe it's still doing what it has to do to work). Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Nausea, Pain in extremity, Rash
Clinical narrative: Itching; Fever; Malaise; This is a spontaneous report from a contactable nurse.  A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0191 and expiration date: not reported), via intramuscular, in Left Deltoid, on 06Jul2021 at 16:30 at the age of 78-year-old, as DOSE 2, SINGLE for covid-19 immunization at Urgent Care Center. Medical history included ongoing asthma, irritable bowel syndrome, gastroesophageal reflux disease and anxiety pre 2001. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0183 and expiration date: not reported), via intramuscular, in Left Deltoid, on14Jun2021 at 15:00, at the age of 78-year-old, as DOSE  1, SINGLE for covid-19 immunization at Physician Office and Felt very sick, experienced rash, Sore arm, nausea, fever and malaise. The patient's concomitant medications were unknown. The patient experienced itching, fever and malaise on 05Jul2021 (as reported). No treatment was received for the events. The outcome of the events was recovered in Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pruritus, Pyrexia
Clinical narrative: Itching; Fever; Malaise; This is a spontaneous report from a contactable nurse.  A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0191 and expiration date: not reported), via intramuscular, in Left Deltoid, on 06Jul2021 at 16:30 at the age of 78-year-old, as DOSE 2, SINGLE for covid-19 immunization at Urgent Care Center. Medical history included ongoing asthma, irritable bowel syndrome, gastroesophageal reflux disease and anxiety pre 2001. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0183 and expiration date: not reported), via intramuscular, in Left Deltoid, on14Jun2021 at 15:00, at the age of 78-year-old, as DOSE  1, SINGLE for covid-19 immunization at Physician Office and Felt very sick, experienced rash, Sore arm, nausea, fever and malaise. The patient's concomitant medications were unknown. The patient experienced itching, fever and malaise on 05Jul2021 (as reported). No treatment was received for the events. The outcome of the events was recovered in Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 0.08
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Unevaluable event
Clinical narrative: Caller reports no symptoms from injection/no reaction/No additional AEs or PQC reported; VAQTA was administered to a one month old.; This spontaneous report has been received from a nurse and a health care professional, concerning a 1-month-old male patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 07-JUL-2021, the patient was vaccinated with a dose of Hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) administered intramuscularly (IM) in his right vastus lateralis (vaccine scheme was not reported; lot number T035721 has been verified to be a valid lot number, expiration date reported and established as 15-APR-2022 (also reported as 15-AUG-2022)), as prophylaxis, at the age of 1 month (product administered to patient of inappropriate age). The caller reported no symptoms from injection. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035721; expirationdate: 15-APR-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 0.08
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller reports no symptoms from injection/no reaction/No additional AEs or PQC reported; VAQTA was administered to a one month old.; This spontaneous report has been received from a nurse and a health care professional, concerning a 1-month-old male patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 07-JUL-2021, the patient was vaccinated with a dose of Hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) administered intramuscularly (IM) in his right vastus lateralis (vaccine scheme was not reported; lot number T035721 has been verified to be a valid lot number, expiration date reported and established as 15-APR-2022 (also reported as 15-AUG-2022)), as prophylaxis, at the age of 1 month (product administered to patient of inappropriate age). The caller reported no symptoms from injection. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035721; expirationdate: 15-APR-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: 30 minutes post-COVID vaccine, patient complained of shortness of breath, tingles all over body, lightheadedness, chest tightness, and difficulty swallowing. Epinephrine was given at clinic where she received the vaccine and was then taken to the ED>
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dysphagia, Dyspnoea, Paraesthesia
Clinical narrative: 30 minutes post-COVID vaccine, patient complained of shortness of breath, tingles all over body, lightheadedness, chest tightness, and difficulty swallowing. Epinephrine was given at clinic where she received the vaccine and was then taken to the ED>
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: URINARY RETENTION; I WANT TO KILL SELF; I CAN BARELY WALK; NUMBNESS OF THE SKIN; HARD TO BREATH BECAUSE OF THE PAIN; WEIGHT LOSS; EXTREME WEAKNESS IN LEGS; EXTREME BILATERAL MUSCLE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included back problem since she was 20 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20sA21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 18-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient experienced side effects, it had been a month (JUN-2021) and described as had extreme pain, bilateral, could barely walk, in so much pain, and symptoms mimic GBS (Guillain-Barre syndrome). The patient asked if it could just kill her, was horrifying and was getting scared. The patient thought she would not going to make it. The patient wanted kill self, was in incredible pain and had numbness on the skin. The patient could not deal with pain, took 2 extra strength Tylenol (paracetamol), also took Advil (ibuprofen) and it was not working. The patient could not even vacuum, had extreme weakness in legs, and it sounded like GBS. The patient had urinary retention. The symptoms were not rising, not progressed on eye, hand, arm and face. The pain was from feet to hips, little bit in the back, below knee cap, inner thigh, and bilateral. It was hurting, it was muscle and not joint pain (extreme bilateral muscle pain). The patient did not know when it was started and the pain had been degenerative. The pain got worst every day, nothing was working and it was hard to breath because of the pain. The patient was dealing with this and no one was caring and it was disgusting. The patient lost 40 pounds (weight loss). The patient could not stand to do dish or to do anything. The patient ate 1 frozen meal a day. The patient did not know if it was from the vaccine or not and it was absolute insane. The patient had everything other than above the waist. The patient's doctor did not call back and she could not get medical attention. The patient did not go to emergency room.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme bilateral muscle pain, I can barely walk, urinary retention, numbness of the skin, extreme weakness in legs, hard to breath because of the pain, and weight loss, and the outcome of I want to kill self was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745505-COVID-19 VACCINE AD26.COV2.S-Urinary retention. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: URINARY RETENTION; I WANT TO KILL SELF; I CAN BARELY WALK; NUMBNESS OF THE SKIN; HARD TO BREATH BECAUSE OF THE PAIN; WEIGHT LOSS; EXTREME WEAKNESS IN LEGS; EXTREME BILATERAL MUSCLE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included back problem since she was 20 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20sA21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 18-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient experienced side effects, it had been a month (JUN-2021) and described as had extreme pain, bilateral, could barely walk, in so much pain, and symptoms mimic GBS (Guillain-Barre syndrome). The patient asked if it could just kill her, was horrifying and was getting scared. The patient thought she would not going to make it. The patient wanted kill self, was in incredible pain and had numbness on the skin. The patient could not deal with pain, took 2 extra strength Tylenol (paracetamol), also took Advil (ibuprofen) and it was not working. The patient could not even vacuum, had extreme weakness in legs, and it sounded like GBS. The patient had urinary retention. The symptoms were not rising, not progressed on eye, hand, arm and face. The pain was from feet to hips, little bit in the back, below knee cap, inner thigh, and bilateral. It was hurting, it was muscle and not joint pain (extreme bilateral muscle pain). The patient did not know when it was started and the pain had been degenerative. The pain got worst every day, nothing was working and it was hard to breath because of the pain. The patient was dealing with this and no one was caring and it was disgusting. The patient lost 40 pounds (weight loss). The patient could not stand to do dish or to do anything. The patient ate 1 frozen meal a day. The patient did not know if it was from the vaccine or not and it was absolute insane. The patient had everything other than above the waist. The patient's doctor did not call back and she could not get medical attention. The patient did not go to emergency room.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme bilateral muscle pain, I can barely walk, urinary retention, numbness of the skin, extreme weakness in legs, hard to breath because of the pain, and weight loss, and the outcome of I want to kill self was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745505-COVID-19 VACCINE AD26.COV2.S-Urinary retention. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Urinary retention, Weight, Weight decreased
Clinical narrative: URINARY RETENTION; I WANT TO KILL SELF; I CAN BARELY WALK; NUMBNESS OF THE SKIN; HARD TO BREATH BECAUSE OF THE PAIN; WEIGHT LOSS; EXTREME WEAKNESS IN LEGS; EXTREME BILATERAL MUSCLE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included back problem since she was 20 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20sA21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 18-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient experienced side effects, it had been a month (JUN-2021) and described as had extreme pain, bilateral, could barely walk, in so much pain, and symptoms mimic GBS (Guillain-Barre syndrome). The patient asked if it could just kill her, was horrifying and was getting scared. The patient thought she would not going to make it. The patient wanted kill self, was in incredible pain and had numbness on the skin. The patient could not deal with pain, took 2 extra strength Tylenol (paracetamol), also took Advil (ibuprofen) and it was not working. The patient could not even vacuum, had extreme weakness in legs, and it sounded like GBS. The patient had urinary retention. The symptoms were not rising, not progressed on eye, hand, arm and face. The pain was from feet to hips, little bit in the back, below knee cap, inner thigh, and bilateral. It was hurting, it was muscle and not joint pain (extreme bilateral muscle pain). The patient did not know when it was started and the pain had been degenerative. The pain got worst every day, nothing was working and it was hard to breath because of the pain. The patient was dealing with this and no one was caring and it was disgusting. The patient lost 40 pounds (weight loss). The patient could not stand to do dish or to do anything. The patient ate 1 frozen meal a day. The patient did not know if it was from the vaccine or not and it was absolute insane. The patient had everything other than above the waist. The patient's doctor did not call back and she could not get medical attention. The patient did not go to emergency room.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme bilateral muscle pain, I can barely walk, urinary retention, numbness of the skin, extreme weakness in legs, hard to breath because of the pain, and weight loss, and the outcome of I want to kill self was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745505-COVID-19 VACCINE AD26.COV2.S-Urinary retention. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Eye swelling, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFTER I GO HOME I FELT WEIRD SO I SAT DOWN AND WAS JUST SITTING DOWN, AFTER ABOUT 3 HOURS HAD PASSED I COULDN'T EVEN WALK TO THE RESTROOM ON MY OWN, SO MY SON HAD TO TAKE ME, AFTER COMING OUT OF THE BATHROOM I WENT TO LAY DOWN ON THE BED AROUND 8PM, BY THEN I WAS SWELLING UP ALL OVER AND ITICHING AND FEELING HORRIBLE LIKE IF SOMETHNG WAS KEEPING DOWN, I WAS IN SO SO MY PAIN AND FELT MY LUNG SO TIGHT THE I WAS HAVING DIFFICULT BREATHING, THIS IS WHO I WAS ALL NIGHT, HAVING CHILLS AND ACHING EVERY INCH OF MY BODY, NEXT DAY I HAD TO GO INTO THE ER AND I WAS TOLD I HAD A ALLERGY REACTION TO THE PFIZER VACCINE AND RECOMMENDED I DON'T TAKE THE SECOND DOSE ON AUGUST 2, 2021, THEN AFTER THIS ER VISIT I HAD TO GO AGAIN ON THE 15 OF JULY AS I GOT WORSE AND WAS TOLD THE SAME ALLERGIC TO COVID 19 VACCINE
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Swelling face
Clinical narrative: AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFTER I GO HOME I FELT WEIRD SO I SAT DOWN AND WAS JUST SITTING DOWN, AFTER ABOUT 3 HOURS HAD PASSED I COULDN'T EVEN WALK TO THE RESTROOM ON MY OWN, SO MY SON HAD TO TAKE ME, AFTER COMING OUT OF THE BATHROOM I WENT TO LAY DOWN ON THE BED AROUND 8PM, BY THEN I WAS SWELLING UP ALL OVER AND ITICHING AND FEELING HORRIBLE LIKE IF SOMETHNG WAS KEEPING DOWN, I WAS IN SO SO MY PAIN AND FELT MY LUNG SO TIGHT THE I WAS HAVING DIFFICULT BREATHING, THIS IS WHO I WAS ALL NIGHT, HAVING CHILLS AND ACHING EVERY INCH OF MY BODY, NEXT DAY I HAD TO GO INTO THE ER AND I WAS TOLD I HAD A ALLERGY REACTION TO THE PFIZER VACCINE AND RECOMMENDED I DON'T TAKE THE SECOND DOSE ON AUGUST 2, 2021, THEN AFTER THIS ER VISIT I HAD TO GO AGAIN ON THE 15 OF JULY AS I GOT WORSE AND WAS TOLD THE SAME ALLERGIC TO COVID 19 VACCINE
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Cough, Drug hypersensitivity, Dyspnoea
Clinical narrative: AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFTER I GO HOME I FELT WEIRD SO I SAT DOWN AND WAS JUST SITTING DOWN, AFTER ABOUT 3 HOURS HAD PASSED I COULDN'T EVEN WALK TO THE RESTROOM ON MY OWN, SO MY SON HAD TO TAKE ME, AFTER COMING OUT OF THE BATHROOM I WENT TO LAY DOWN ON THE BED AROUND 8PM, BY THEN I WAS SWELLING UP ALL OVER AND ITICHING AND FEELING HORRIBLE LIKE IF SOMETHNG WAS KEEPING DOWN, I WAS IN SO SO MY PAIN AND FELT MY LUNG SO TIGHT THE I WAS HAVING DIFFICULT BREATHING, THIS IS WHO I WAS ALL NIGHT, HAVING CHILLS AND ACHING EVERY INCH OF MY BODY, NEXT DAY I HAD TO GO INTO THE ER AND I WAS TOLD I HAD A ALLERGY REACTION TO THE PFIZER VACCINE AND RECOMMENDED I DON'T TAKE THE SECOND DOSE ON AUGUST 2, 2021, THEN AFTER THIS ER VISIT I HAD TO GO AGAIN ON THE 15 OF JULY AS I GOT WORSE AND WAS TOLD THE SAME ALLERGIC TO COVID 19 VACCINE
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Fibrin D dimer, Full blood count, Gait disturbance
Clinical narrative: AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFTER I GO HOME I FELT WEIRD SO I SAT DOWN AND WAS JUST SITTING DOWN, AFTER ABOUT 3 HOURS HAD PASSED I COULDN'T EVEN WALK TO THE RESTROOM ON MY OWN, SO MY SON HAD TO TAKE ME, AFTER COMING OUT OF THE BATHROOM I WENT TO LAY DOWN ON THE BED AROUND 8PM, BY THEN I WAS SWELLING UP ALL OVER AND ITICHING AND FEELING HORRIBLE LIKE IF SOMETHNG WAS KEEPING DOWN, I WAS IN SO SO MY PAIN AND FELT MY LUNG SO TIGHT THE I WAS HAVING DIFFICULT BREATHING, THIS IS WHO I WAS ALL NIGHT, HAVING CHILLS AND ACHING EVERY INCH OF MY BODY, NEXT DAY I HAD TO GO INTO THE ER AND I WAS TOLD I HAD A ALLERGY REACTION TO THE PFIZER VACCINE AND RECOMMENDED I DON'T TAKE THE SECOND DOSE ON AUGUST 2, 2021, THEN AFTER THIS ER VISIT I HAD TO GO AGAIN ON THE 15 OF JULY AS I GOT WORSE AND WAS TOLD THE SAME ALLERGIC TO COVID 19 VACCINE
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test, Laboratory test, Metabolic function test, Pain, Pregnancy test urine
Clinical narrative: AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFTER I GO HOME I FELT WEIRD SO I SAT DOWN AND WAS JUST SITTING DOWN, AFTER ABOUT 3 HOURS HAD PASSED I COULDN'T EVEN WALK TO THE RESTROOM ON MY OWN, SO MY SON HAD TO TAKE ME, AFTER COMING OUT OF THE BATHROOM I WENT TO LAY DOWN ON THE BED AROUND 8PM, BY THEN I WAS SWELLING UP ALL OVER AND ITICHING AND FEELING HORRIBLE LIKE IF SOMETHNG WAS KEEPING DOWN, I WAS IN SO SO MY PAIN AND FELT MY LUNG SO TIGHT THE I WAS HAVING DIFFICULT BREATHING, THIS IS WHO I WAS ALL NIGHT, HAVING CHILLS AND ACHING EVERY INCH OF MY BODY, NEXT DAY I HAD TO GO INTO THE ER AND I WAS TOLD I HAD A ALLERGY REACTION TO THE PFIZER VACCINE AND RECOMMENDED I DON'T TAKE THE SECOND DOSE ON AUGUST 2, 2021, THEN AFTER THIS ER VISIT I HAD TO GO AGAIN ON THE 15 OF JULY AS I GOT WORSE AND WAS TOLD THE SAME ALLERGIC TO COVID 19 VACCINE