chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Extraocular muscle disorder, Eye inflammation, Eye pain
Clinical narrative: Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; intense pain behind his right eye; headaches that lasted couple days; extraocular muscle movement; Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS); This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route of administration, administered in left arm on 13May2021 15:45 (at the age of 28-years-old) as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0170), via an unspecified route of administration administered in left arm on 21Apr2021 16:00 as first dose, single dose for COVID-19 immunization. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications received within 2 weeks of vaccination; prior to the vaccination, whether the patient was diagnosed with COVID-19 or since the vaccination, whether the patient was tested for COVID-19. It was also unknown whether the patient had covid prior vaccination or covid tested post vaccination. On 27May2021 17:30, the patient had a normal three day flu symptoms. Around 12 days later he rushed to ER with an extremely intense pain behind his right eye and headaches that lasted couple days. His pain was exacerbated by extraocularmuscle movement, particularly when looking to his left. Patient spent one night at the hospital and they did a CT scan and blood work. His CT showed subtle retroocular inflammation, which correlates with his symptoms. Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS). After being seen at the ER and following up with his Ophthalmologist, patient was advised to report his case since it is very unique and unusual. He is very concerned since there is not much information about the syndrome, and since he never experienced eye problems for the past 63 years. The adverse event resulted patient to visit emergency room/department or urgent care, hospitalization and was hospitalized for one day. It was unknown, whether patient receive any treatment for events. The seriousness criteria was considered as caused/prolonged hospitalization by reporter. The outcome of the events was recovering.  Device Date : 09Jun2021.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Idiopathic orbital inflammation, Influenza
Clinical narrative: Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; intense pain behind his right eye; headaches that lasted couple days; extraocular muscle movement; Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS); This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route of administration, administered in left arm on 13May2021 15:45 (at the age of 28-years-old) as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0170), via an unspecified route of administration administered in left arm on 21Apr2021 16:00 as first dose, single dose for COVID-19 immunization. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications received within 2 weeks of vaccination; prior to the vaccination, whether the patient was diagnosed with COVID-19 or since the vaccination, whether the patient was tested for COVID-19. It was also unknown whether the patient had covid prior vaccination or covid tested post vaccination. On 27May2021 17:30, the patient had a normal three day flu symptoms. Around 12 days later he rushed to ER with an extremely intense pain behind his right eye and headaches that lasted couple days. His pain was exacerbated by extraocularmuscle movement, particularly when looking to his left. Patient spent one night at the hospital and they did a CT scan and blood work. His CT showed subtle retroocular inflammation, which correlates with his symptoms. Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS). After being seen at the ER and following up with his Ophthalmologist, patient was advised to report his case since it is very unique and unusual. He is very concerned since there is not much information about the syndrome, and since he never experienced eye problems for the past 63 years. The adverse event resulted patient to visit emergency room/department or urgent care, hospitalization and was hospitalized for one day. It was unknown, whether patient receive any treatment for events. The seriousness criteria was considered as caused/prolonged hospitalization by reporter. The outcome of the events was recovering.  Device Date : 09Jun2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Fatigue, Pain
Clinical narrative: HIGH BLOOD PRESSURE (210/109); This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart surgery, and other pre-existing medical conditions included the patient had no known drug allergies and was on blood thinner. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included metoprolol succinate. On 08-JUN-2021, the subject experienced high blood pressure (210/109). Laboratory data included: Blood pressure (NR: not provided) 210/109 mmHg, 142/80 mmHg. On 11-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 139/90 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high blood pressure (210/109) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210627121-covid-19 vaccine ad26.cov2.s-High blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE (210/109); This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart surgery, and other pre-existing medical conditions included the patient had no known drug allergies and was on blood thinner. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included metoprolol succinate. On 08-JUN-2021, the subject experienced high blood pressure (210/109). Laboratory data included: Blood pressure (NR: not provided) 210/109 mmHg, 142/80 mmHg. On 11-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 139/90 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high blood pressure (210/109) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210627121-covid-19 vaccine ad26.cov2.s-High blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin
Clinical narrative: Chest pain resulting in emergency room visit.  Diagnosis is myocarditis related to Covid-19 vaccine
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Electrocardiogram, Myocarditis, X-ray
Clinical narrative: Chest pain resulting in emergency room visit.  Diagnosis is myocarditis related to Covid-19 vaccine
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE WITHOUT ADVERSE EVENT; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a physician concerned a 17 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 04-AUG-2021) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced off label use without adverse event. On 12-JUN-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use without adverse event and inappropriate age at vaccine administration was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE WITHOUT ADVERSE EVENT; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a physician concerned a 17 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 04-AUG-2021) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced off label use without adverse event. On 12-JUN-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use without adverse event and inappropriate age at vaccine administration was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Death
Clinical narrative: Patient's mother reported patient went into cardiac arrest and deceased on the night of 04/17/2021 around 0200am. Patient had received a second dose of Covid 19 vaccine on 04/16/2021 around 12pm.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient's mother reported patient went into cardiac arrest and deceased on the night of 04/17/2021 around 0200am. Patient had received a second dose of Covid 19 vaccine on 04/16/2021 around 12pm.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, SARS-CoV-2 test
Clinical narrative: Patient's mother reported patient went into cardiac arrest and deceased on the night of 04/17/2021 around 0200am. Patient had received a second dose of Covid 19 vaccine on 04/16/2021 around 12pm.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Lymph node pain
Clinical narrative: Left armpit pain; Left armpit / swollen lymph nodes; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple myeloma.   On 11th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th June 2021, 1 days after receiving Shingrix, the patient experienced axillary pain and axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary pain and axillary lymph nodes enlarged were not recovered/not resolved.   It was unknown if the reporter considered the axillary pain and axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced left armpit pain and left swollen lymph nodes in the same location after receiving the Shingrix vaccine last Friday. The patient gave medical disclaimer and referred to health care professional. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Left armpit pain; Left armpit / swollen lymph nodes; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple myeloma.   On 11th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th June 2021, 1 days after receiving Shingrix, the patient experienced axillary pain and axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary pain and axillary lymph nodes enlarged were not recovered/not resolved.   It was unknown if the reporter considered the axillary pain and axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced left armpit pain and left swollen lymph nodes in the same location after receiving the Shingrix vaccine last Friday. The patient gave medical disclaimer and referred to health care professional. The reporter consented to follow up.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Asthenia, Chest pain, Dizziness
Clinical narrative: Passed out after shot was administered; Extreme heart pain/ Chest pain; Extreme dizziness; Chills; Fatigue; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 36-year-old male patient received bnt162b2 (BNT162B2) at the age of 36-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 12:00PM (Batch/Lot Number: Ew0178) as 1st dose, single for covid-19 immunisation. Medical history was none. Known allergies was none. The patient's concomitant medications were not reported. The patient experienced passed out after shot was administered on 02Jun2021 12:30 with outcome of not recovered, extreme heart pain on 02Jun2021 12:30 with outcome of not recovered, chest pain on 02Jun2021 12:30 with outcome of not recovered , extreme dizziness on 02Jun2021 12:30 with outcome of not recovered, chills on 02Jun2021 12:30 with outcome of not recovered, fatigue on 02Jun2021 12:30 with outcome of not recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chills, Dizziness, Fatigue, Loss of consciousness
Clinical narrative: Passed out after shot was administered; Extreme heart pain/ Chest pain; Extreme dizziness; Chills; Fatigue; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 36-year-old male patient received bnt162b2 (BNT162B2) at the age of 36-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 12:00PM (Batch/Lot Number: Ew0178) as 1st dose, single for covid-19 immunisation. Medical history was none. Known allergies was none. The patient's concomitant medications were not reported. The patient experienced passed out after shot was administered on 02Jun2021 12:30 with outcome of not recovered, extreme heart pain on 02Jun2021 12:30 with outcome of not recovered, chest pain on 02Jun2021 12:30 with outcome of not recovered , extreme dizziness on 02Jun2021 12:30 with outcome of not recovered, chills on 02Jun2021 12:30 with outcome of not recovered, fatigue on 02Jun2021 12:30 with outcome of not recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Constant pain in left arm, cannot lift any thing even small, Ointment from my DR. It is now in my shoulder, cannot raise my arm, very painful, cannot do household chores, cannot sleep, hurts to lay on either side, I get very sharp pain if I try to use this arm. Have a husband that I have to take care of, 2 dogs to take care of. Went to Clinic ordered same med. as my Dr. Yesterday 6-17-21 went to emergency at hospital, did exrays on arm and shoulder, perscribed 2 meds. Oxycodin and a pill pack to take each day with set amount of pills to take at one time. This pain is unbearable. Pain started 3 days after 2nd shot. This has left me with horrible pain. Effecting all parts of my body, including headaches.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Bursitis, Gastrooesophageal reflux disease, Insomnia, Mobility decreased, Muscular weakness
Clinical narrative: Constant pain in left arm, cannot lift any thing even small, Ointment from my DR. It is now in my shoulder, cannot raise my arm, very painful, cannot do household chores, cannot sleep, hurts to lay on either side, I get very sharp pain if I try to use this arm. Have a husband that I have to take care of, 2 dogs to take care of. Went to Clinic ordered same med. as my Dr. Yesterday 6-17-21 went to emergency at hospital, did exrays on arm and shoulder, perscribed 2 meds. Oxycodin and a pill pack to take each day with set amount of pills to take at one time. This pain is unbearable. Pain started 3 days after 2nd shot. This has left me with horrible pain. Effecting all parts of my body, including headaches.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Pain in extremity, Weight decreased
Clinical narrative: Constant pain in left arm, cannot lift any thing even small, Ointment from my DR. It is now in my shoulder, cannot raise my arm, very painful, cannot do household chores, cannot sleep, hurts to lay on either side, I get very sharp pain if I try to use this arm. Have a husband that I have to take care of, 2 dogs to take care of. Went to Clinic ordered same med. as my Dr. Yesterday 6-17-21 went to emergency at hospital, did exrays on arm and shoulder, perscribed 2 meds. Oxycodin and a pill pack to take each day with set amount of pills to take at one time. This pain is unbearable. Pain started 3 days after 2nd shot. This has left me with horrible pain. Effecting all parts of my body, including headaches.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Arthralgia, Joint range of motion decreased, Loss of personal independence in daily activities, Pain in extremity, Paraesthesia
Clinical narrative: Constant pain in left arm, cannot lift any thing even small, Ointment from my DR. It is now in my shoulder, cannot raise my arm, very painful, cannot do household chores, cannot sleep, hurts to lay on either side, I get very sharp pain if I try to use this arm. Have a husband that I have to take care of, 2 dogs to take care of. Went to Clinic ordered same med. as my Dr. Yesterday 6-17-21 went to emergency at hospital, did exrays on arm and shoulder, perscribed 2 meds. Oxycodin and a pill pack to take each day with set amount of pills to take at one time. This pain is unbearable. Pain started 3 days after 2nd shot. This has left me with horrible pain. Effecting all parts of my body, including headaches.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Arthralgia, Headache, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Constant pain in left arm, cannot lift any thing even small, Ointment from my DR. It is now in my shoulder, cannot raise my arm, very painful, cannot do household chores, cannot sleep, hurts to lay on either side, I get very sharp pain if I try to use this arm. Have a husband that I have to take care of, 2 dogs to take care of. Went to Clinic ordered same med. as my Dr. Yesterday 6-17-21 went to emergency at hospital, did exrays on arm and shoulder, perscribed 2 meds. Oxycodin and a pill pack to take each day with set amount of pills to take at one time. This pain is unbearable. Pain started 3 days after 2nd shot. This has left me with horrible pain. Effecting all parts of my body, including headaches.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, CHOL
Symptoms: Pain in extremity, Sleep disorder, X-ray limb
Clinical narrative: Constant pain in left arm, cannot lift any thing even small, Ointment from my DR. It is now in my shoulder, cannot raise my arm, very painful, cannot do household chores, cannot sleep, hurts to lay on either side, I get very sharp pain if I try to use this arm. Have a husband that I have to take care of, 2 dogs to take care of. Went to Clinic ordered same med. as my Dr. Yesterday 6-17-21 went to emergency at hospital, did exrays on arm and shoulder, perscribed 2 meds. Oxycodin and a pill pack to take each day with set amount of pills to take at one time. This pain is unbearable. Pain started 3 days after 2nd shot. This has left me with horrible pain. Effecting all parts of my body, including headaches.
Age: 12.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Blood culture, Blood lactic acid, Blood magnesium, C-reactive protein, Chest X-ray
Clinical narrative: Patient presented with loss of sensation and weakness on bilateral lower extremities (below the knees) 2 days after receiving second dose of Covid19 vaccine. Patient is currently receiving doxycycline and ceftriaxone and is doing passive ROM with physical therapy.
Age: 12.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Diplegia, Epstein-Barr virus test, Full blood count, Influenza virus test, Lumbar puncture
Clinical narrative: Patient presented with loss of sensation and weakness on bilateral lower extremities (below the knees) 2 days after receiving second dose of Covid19 vaccine. Patient is currently receiving doxycycline and ceftriaxone and is doing passive ROM with physical therapy.
Age: 12.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Pregnancy test, SARS-CoV-2 RNA
Clinical narrative: Patient presented with loss of sensation and weakness on bilateral lower extremities (below the knees) 2 days after receiving second dose of Covid19 vaccine. Patient is currently receiving doxycycline and ceftriaxone and is doing passive ROM with physical therapy.
Age: 12.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Streptococcus test, Urine analysis, Viral test
Clinical narrative: Patient presented with loss of sensation and weakness on bilateral lower extremities (below the knees) 2 days after receiving second dose of Covid19 vaccine. Patient is currently receiving doxycycline and ceftriaxone and is doing passive ROM with physical therapy.
Age: 12.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Muscular weakness, Sensory loss
Clinical narrative: Patient presented with loss of sensation and weakness on bilateral lower extremities (below the knees) 2 days after receiving second dose of Covid19 vaccine. Patient is currently receiving doxycycline and ceftriaxone and is doing passive ROM with physical therapy.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy liver, Blood test, Chills, Chromaturia, Feeding disorder
Clinical narrative: severe nausea/vomiting at about 10-12 hours following vaccine, persisted. developed headache on approximately day 4, took 1 day of tylenol 2500mg over 36 hours. on 5/24 saw PCP and had acutely elevated liver enzymes to 600. Sent to ER. Admitted, found to have Hepatitis B flare, started on tenofovir, discharged. Had syncopal episode on 6/1, readmitted, transferred to Medical Center. Switched to Tenofovir alafenamide. Liver biopsy with acute hepatitis. Discharged 6/8. Readmitted 6/12 with worsening nasuea/vomiting and abdominal pain, found to be in acute fulminant liver failure, HBV DNA PCR 144 million, HbCab IgM+, delta negative
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hepatitis B DNA increased, Nausea, Urine analysis, Yellow skin
Clinical narrative: severe nausea/vomiting at about 10-12 hours following vaccine, persisted. developed headache on approximately day 4, took 1 day of tylenol 2500mg over 36 hours. on 5/24 saw PCP and had acutely elevated liver enzymes to 600. Sent to ER. Admitted, found to have Hepatitis B flare, started on tenofovir, discharged. Had syncopal episode on 6/1, readmitted, transferred to Medical Center. Switched to Tenofovir alafenamide. Liver biopsy with acute hepatitis. Discharged 6/8. Readmitted 6/12 with worsening nasuea/vomiting and abdominal pain, found to be in acute fulminant liver failure, HBV DNA PCR 144 million, HbCab IgM+, delta negative
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Acute hepatic failure, Biopsy liver abnormal, Condition aggravated, HBV-DNA polymerase increased
Clinical narrative: severe nausea/vomiting at about 10-12 hours following vaccine, persisted. developed headache on approximately day 4, took 1 day of tylenol 2500mg over 36 hours. on 5/24 saw PCP and had acutely elevated liver enzymes to 600. Sent to ER. Admitted, found to have Hepatitis B flare, started on tenofovir, discharged. Had syncopal episode on 6/1, readmitted, transferred to Medical Center. Switched to Tenofovir alafenamide. Liver biopsy with acute hepatitis. Discharged 6/8. Readmitted 6/12 with worsening nasuea/vomiting and abdominal pain, found to be in acute fulminant liver failure, HBV DNA PCR 144 million, HbCab IgM+, delta negative
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hepatic enzyme increased, Hepatitis B, Hepatitis B core antibody positive, Hepatitis D antibody negative
Clinical narrative: severe nausea/vomiting at about 10-12 hours following vaccine, persisted. developed headache on approximately day 4, took 1 day of tylenol 2500mg over 36 hours. on 5/24 saw PCP and had acutely elevated liver enzymes to 600. Sent to ER. Admitted, found to have Hepatitis B flare, started on tenofovir, discharged. Had syncopal episode on 6/1, readmitted, transferred to Medical Center. Switched to Tenofovir alafenamide. Liver biopsy with acute hepatitis. Discharged 6/8. Readmitted 6/12 with worsening nasuea/vomiting and abdominal pain, found to be in acute fulminant liver failure, HBV DNA PCR 144 million, HbCab IgM+, delta negative
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hepatitis acute, Nausea, Syncope, Vomiting
Clinical narrative: severe nausea/vomiting at about 10-12 hours following vaccine, persisted. developed headache on approximately day 4, took 1 day of tylenol 2500mg over 36 hours. on 5/24 saw PCP and had acutely elevated liver enzymes to 600. Sent to ER. Admitted, found to have Hepatitis B flare, started on tenofovir, discharged. Had syncopal episode on 6/1, readmitted, transferred to Medical Center. Switched to Tenofovir alafenamide. Liver biopsy with acute hepatitis. Discharged 6/8. Readmitted 6/12 with worsening nasuea/vomiting and abdominal pain, found to be in acute fulminant liver failure, HBV DNA PCR 144 million, HbCab IgM+, delta negative
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute hepatic failure, Autoimmune hepatitis, Biopsy liver abnormal, Condition aggravated, Hepatitis B reactivation
Clinical narrative: severe nausea/vomiting at about 10-12 hours following vaccine, persisted. developed headache on approximately day 4, took 1 day of tylenol 2500mg over 36 hours. on 5/24 saw PCP and had acutely elevated liver enzymes to 600. Sent to ER. Admitted, found to have Hepatitis B flare, started on tenofovir, discharged. Had syncopal episode on 6/1, readmitted, transferred to Medical Center. Switched to Tenofovir alafenamide. Liver biopsy with acute hepatitis. Discharged 6/8. Readmitted 6/12 with worsening nasuea/vomiting and abdominal pain, found to be in acute fulminant liver failure, HBV DNA PCR 144 million, HbCab IgM+, delta negative
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Liver function test abnormal, Liver injury, Liver transplant
Clinical narrative: severe nausea/vomiting at about 10-12 hours following vaccine, persisted. developed headache on approximately day 4, took 1 day of tylenol 2500mg over 36 hours. on 5/24 saw PCP and had acutely elevated liver enzymes to 600. Sent to ER. Admitted, found to have Hepatitis B flare, started on tenofovir, discharged. Had syncopal episode on 6/1, readmitted, transferred to Medical Center. Switched to Tenofovir alafenamide. Liver biopsy with acute hepatitis. Discharged 6/8. Readmitted 6/12 with worsening nasuea/vomiting and abdominal pain, found to be in acute fulminant liver failure, HBV DNA PCR 144 million, HbCab IgM+, delta negative
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Two friends of that parent developed Shingles after the Pfizer Covid vaccine.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in left arm on 01May2021 12:00 as 2nd dose, single dose (at the age of 62-years-old); and previously received BNT162B2(Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in left arm on 10Apr2021 14:00 as 1st dose, single dose for COVID-19 immunization. No history of any previous vaccinations within 4 weeks. The patient's medical history and concomitant medications were not reported. Patient reported some people in her family had Chicken-pox. On 18May2021, after second dose, the patient experienced shingles on back which was ongoing at the time of report. Caller states she thought that it wasn't related to the vaccine, until a coworker, was at a game, and another parent, who was sitting next to this coworker, brought up the fact that two friends of that parent developed Shingles after the Pfizer Covid vaccine. Patient developed Shingles and did not think it was related to the vaccine. And patient does not think it was a coincidence that other people are developing Shingles, and maybe the vaccine was activating something inside of their body. No Investigation Assessment. Patient reports she was taking medication for shingles. Patient had a video doctor's visit. The outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021576816 same reporter/drug/event, different patient;US-PFIZER INC-2021576867 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Gait disturbance, Insomnia, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient).  A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported, 44-year-old), via an unspecified route of administration, on 09Jun2021, as first dose, single dose for COVID-19 immunisation. The patient medical history included varicose veins and concomitant medications was not reported. On 09Jun2021 at 17:00, the patient stated that since she got the vaccine, she has a lot of varicose veins on her leg on the same side, in the evening she started to feel like the leg was burning, she couldn't sleep, she had discomfort all night, what can she do. She already had the varicose veins before the vaccine, but she didn't feel like her foot was burning, her foot burns a lot and she feels like her veins are burned, it hurts a lot, she got up since she can't sleep. This started at about 5 pm on the day of the first dose. She got the vaccine on the side where she has the varicose veins on her leg, the right side. She can't even walk. She knows that varicose veins can be dangerous, they can give her thrombosis. Outcome of the events was reported as not recovered.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Discomfort, Disease recurrence, Gait disturbance, Insomnia
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient).  A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported, 44-year-old), via an unspecified route of administration, on 09Jun2021, as first dose, single dose for COVID-19 immunisation. The patient medical history included varicose veins and concomitant medications was not reported. On 09Jun2021 at 17:00, the patient stated that since she got the vaccine, she has a lot of varicose veins on her leg on the same side, in the evening she started to feel like the leg was burning, she couldn't sleep, she had discomfort all night, what can she do. She already had the varicose veins before the vaccine, but she didn't feel like her foot was burning, her foot burns a lot and she feels like her veins are burned, it hurts a lot, she got up since she can't sleep. This started at about 5 pm on the day of the first dose. She got the vaccine on the side where she has the varicose veins on her leg, the right side. She can't even walk. She knows that varicose veins can be dangerous, they can give her thrombosis. Outcome of the events was reported as not recovered.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Varicose vein
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient).  A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported, 44-year-old), via an unspecified route of administration, on 09Jun2021, as first dose, single dose for COVID-19 immunisation. The patient medical history included varicose veins and concomitant medications was not reported. On 09Jun2021 at 17:00, the patient stated that since she got the vaccine, she has a lot of varicose veins on her leg on the same side, in the evening she started to feel like the leg was burning, she couldn't sleep, she had discomfort all night, what can she do. She already had the varicose veins before the vaccine, but she didn't feel like her foot was burning, her foot burns a lot and she feels like her veins are burned, it hurts a lot, she got up since she can't sleep. This started at about 5 pm on the day of the first dose. She got the vaccine on the side where she has the varicose veins on her leg, the right side. She can't even walk. She knows that varicose veins can be dangerous, they can give her thrombosis. Outcome of the events was reported as not recovered.  Information about the Lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neck pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Paraesthesia, Shoulder injury related to vaccine administration
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Panic attack, Paraesthesia, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Additional Details: The patient became dizzy after receiving the vaccine during her 15 minute observation period. She also seemed like she was about to faint. we immediately called paramedics and they arrived on scene. They thought that it was most likely a panic attack. The patient was able to walk out of facility on her own. Someone remained by her side to keep her relaxed and calm the entire even before paramedics arrived.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Panic attack
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Additional Details: The patient became dizzy after receiving the vaccine during her 15 minute observation period. She also seemed like she was about to faint. we immediately called paramedics and they arrived on scene. They thought that it was most likely a panic attack. The patient was able to walk out of facility on her own. Someone remained by her side to keep her relaxed and calm the entire even before paramedics arrived.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache
Clinical narrative: Dizziness, shortness of breath, headache
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Full blood count, Oral herpes
Clinical narrative: Approximately 1-1/2 weeks after vaccination broke out with fever blisters around mouth. Treated once with  Valacyclovir and a MethylPrednisolone decreasing dosage w/o any results. Am now being treated again with a 10 day run of Valacyclovir and  Decrasing Prednisone
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Blood test normal, Headache, Oral mucosal blistering
Clinical narrative: We had our first Pfizer covid shots in March. The morning after my wife developed a blood blister in her mouth. Three weeks later in April we had the second shots. Again my wife developed a blood blister in her mouth the very next day. Since then she has had reoccurring blood blisters accompanied by headaches almost weekly.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Laboratory test, Myalgia, Pain in extremity
Clinical narrative: Received the shot Wednesday 05/05/21 in the afternoon. Flu like symptoms Thursday. Which subsided after 24 hours.  On Friday 05/07/21 I had severe joint and muscle pains. To the point where I could not make a fist with either hand. The pain in my joints and muscles would not be the same each day. Some days it was hands and elbow. Then it was knee and a hand or a foot and a hand. This lasted for 4 weeks. There were times where the pain on the bottom of my feet was so bad I could not walk on them. Pain in my hands to where I could not use them to pick up a cup or open a door. The pain subsided for a week or so until tonight 06/17/21 when my left wrist and fingers are sore with a slight pain.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Lip discolouration, Loss of consciousness, Pallor
Clinical narrative: About 3 minutes after receving the vaccine patient was losing consciousness. Patient looked very pale and lips were turning blue/purple. We laid the patient flat on the ground and gave him some space and called 911 right away. Paramedics arrived within 5-10 minutes and by the time they came patient regained consciousness but was telling them he was feeling very weak and numb.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Pain, Pyrexia
Clinical narrative: I had full body spasms every few seconds for most of the time from 4 am on the15th to 9 pm on the 16th.  They gradually reduced in intensity. They were very intense the first day, making my body jump head to toe.  The second day the intensity was reduced and they seemed to be originating from the stomach area. Still, some of them were strong enough to move my body head to toe.  I did take a prescribed medication, Tizanidine around 9 PM on the 14th, and I think there may have been an interaction with it.  I've never had issue with it other than this event.  The spasms seemed to be directly linked with my recovery from the vaccine, stopping around the time I started to feel better. Tylenol did seem to reduce the intensity, especially the first day.  Other than the spasms, I  had aches and chills start at the same time as the spasms, and a mild fever briefly in the afternoon of the 15th.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: 12 hrs after shot, sharp pain in r side of head, Same in  heart. Could not sit up for 12 hrs, drank only cold water from caregiver.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Vaccinated on 12/18/2020 and 1/8/2021. Tested positive for COVID-19 on 6/1/2021 after symptoms started 5/31/2021 and known exposure on 5/27/2021. Was advised to report on this site.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate irregular, Peripheral swelling
Clinical narrative: Arthritis type pain in all joints that has persisted since the day of the vaccine. Ibuprofen does not help.  Sporadic periods of rapid and irregular heartbeat  since vaccine  Swelling in lower legs since vaccine
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Ongoing intermittent facial swelling of both eyes, lips, and hives and associated itching of forehead, chin and neck. Each episode lasts 4-6 days at intervals of every 15-20 days. Initial symptoms began January 5, 2021 (one week after having reviewed the initial vaccine dose).  Current medications:  Allegra D 360mg BID Pepcid 20mg BID Plaquenil  200mg BID Singular 10mg QD Recently added for breakthrough hives:  Prednisone 40mg  QD x 2 days then 20mg QD x 2 days
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, high temperature (hot) in the vaccine area, swelling, pain and tenderness in the vaccine area, deep exhaustion, headache.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Redness, high temperature (hot) in the vaccine area, swelling, pain and tenderness in the vaccine area, deep exhaustion, headache.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Muscle fatigue, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: I experienced the expected symptoms such as chills, fever, muscle aches, etc - however, since my second dose on May 19, the muscle aches have remained.  Muscles feel weaker/fatigued in back, around joints, and lower body
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dizziness, Immediate post-injection reaction, Nervousness
Clinical narrative: 1625: Received vaccine.  1626: Pt slumped over in chair and was laid down by myself left lateral.  Pt denies loss on consciousness.  Moved pt to back area for observation with EMT.   1628: Pt states that she felt lightheaded and nervous but is breathing unlabored without distress. Pt denied previous reaction to the first dose when he received it in the car. Pt's dad stated that she has no prior medical hx. Pt initial  VS: BP 108/64, HR 84, SpO2  99%, RR 14.  Pt repeat VS was 80/46 pt stated that she was feeling light headed again and that she had some chest tightness. Pt appeared anxious.  SpO2 98% HR 64. Pt stated that she was feeling the same way as before she got dizzy the 1st time.  Pt was laid on the floor and pt stated that she felt better. pt repeat BP 98/58, HR 78, and SpO2 was still 99%. Pt laid on the floor for approximately 5 minutes and given water and snack. Pt sat up slowly and stated that her chest felt better and ate snack.  Pt was kept for approximately 10 more minutes under monitoring. Pt in total was monitored for 34 minutes. Pt was released with father. pt stated that she felt like she was back to normal again. Pt last set of vitals were: BP 116/58 HR 78 SpO2 99. Pt was released to her father.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Brain scan normal, Computerised tomogram normal, Dizziness, Fatigue, Hemiparesis
Clinical narrative: Weakness on the right side of body. Dizziness, tiredness. Occurred the day after taking the vaccine. Had to go to emergency room May 31st after the symptoms worsened . I couldn't move the right side of my body for a week after that incident.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Mobility decreased
Clinical narrative: Weakness on the right side of body. Dizziness, tiredness. Occurred the day after taking the vaccine. Had to go to emergency room May 31st after the symptoms worsened . I couldn't move the right side of my body for a week after that incident.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash approx 5 inch diameter on abdomen only (from navel to lowest rib), consisting of raised red dots with bright pink backgrounds that merged into each other.   Very little to no itching.  No significant fever (less than 1 deg above normal range), and no other reactions.  Rash cleared slowly, about 95% gone 10 days after it began.  A few light pink marks still barely visible 24 days after rash began.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Hot flush, Polymenorrhoea
Clinical narrative: My period began 3 weeks early. I had just finished my cycle prior to the vaccine, and it started by about 5 days after receiving it? And with all the normal period side effects. The period itself was more painful than I usual, as well?paired with hot flashes, which I?ve never had.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular
Clinical narrative: Similar to rash that appeared after 1st dose, except 2nd occurrence was smaller area, lighter in color and lasted a shorter time.  Following 2nd dose, rash appeared on abdomen approx 2 1/2 inch dia above navel, consisting of raised red dots with bright pink backgrounds.  Very little to no itching.  No significant fever (less than 1 deg above normal range), and no other reactions.  Rash cleared to about 95% gone by evening of 6/6/21.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Gait inability, Magnetic resonance imaging normal, Pain in extremity, X-ray limb
Clinical narrative: It band in left leg has been extremely painful for the last 10 weeks.  I can not walk on left leg.  I fall a lot now. I think it is attacking my large nerve connection.  There is no injuries ever on this leg.  Nothing showed in mri.