chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Fatigue, Gait disturbance, Immediate post-injection reaction, Laboratory test abnormal, Mobility decreased
Clinical narrative: ID: 37yo F previously healthy radiology tech developed progressive muscle weakness and SOB after the 2nd dose of COVID vaccine. HPI: Patient was previously healthy and physically active prior to COVID vaccines. No prior COVId infection. No prior MSK pain, arthritis, arthralgias. No prior rash. No dry eye / dry mouth. She received the first dose of Pfizer COVID vaccine at the end of Dec 2020 and experienced achiness and fatigue that resolved after a few days. For the first time, her fingertips and toes also started turning white, numb and painful when cold. She received a second dose on Jan 12, 2021 and immediately experienced heart palpitations while at the vaccination site, and later heartburn and vomiting when she went back to work. The following week, she developed sore throat for 2 days, took leftover amoxicillin at home. All of these symptoms resolved after a few days. She However, she developed gradual SOB, muscle ache and fatigue, initially mild but worsened over a few weeks. She noticed feeling out of breath, arms giving out, legs burning when pushing stretchers to patient rooms. One morning while she was getting up for work, she couldn't lift up leg, but had to pick up her legs so she get into her car. She also had to pick up her leg with arms to get into shower. "It felt like waking up every morning having run a marathon." On 2/13 she went to ER, got admitted for CK 30,000 for rhabdo treatment for 4 days. She denied having done extreme sports or increased physical activity that might have caused rhabdo. On discharge home, she could barely walk and continued SOB. She also developed additional rash on left arm, chest and shoulders. A physician ordered lab work and found her CK to be 50K, so she was admitted again on March 6 for 8 days, discharged on 3/14/2021. Denies fever since COVID vaccination.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Muscular weakness, Myalgia, Myopathy, Oropharyngeal pain, Palpitations
Clinical narrative: ID: 37yo F previously healthy radiology tech developed progressive muscle weakness and SOB after the 2nd dose of COVID vaccine. HPI: Patient was previously healthy and physically active prior to COVID vaccines. No prior COVId infection. No prior MSK pain, arthritis, arthralgias. No prior rash. No dry eye / dry mouth. She received the first dose of Pfizer COVID vaccine at the end of Dec 2020 and experienced achiness and fatigue that resolved after a few days. For the first time, her fingertips and toes also started turning white, numb and painful when cold. She received a second dose on Jan 12, 2021 and immediately experienced heart palpitations while at the vaccination site, and later heartburn and vomiting when she went back to work. The following week, she developed sore throat for 2 days, took leftover amoxicillin at home. All of these symptoms resolved after a few days. She However, she developed gradual SOB, muscle ache and fatigue, initially mild but worsened over a few weeks. She noticed feeling out of breath, arms giving out, legs burning when pushing stretchers to patient rooms. One morning while she was getting up for work, she couldn't lift up leg, but had to pick up her legs so she get into her car. She also had to pick up her leg with arms to get into shower. "It felt like waking up every morning having run a marathon." On 2/13 she went to ER, got admitted for CK 30,000 for rhabdo treatment for 4 days. She denied having done extreme sports or increased physical activity that might have caused rhabdo. On discharge home, she could barely walk and continued SOB. She also developed additional rash on left arm, chest and shoulders. A physician ordered lab work and found her CK to be 50K, so she was admitted again on March 6 for 8 days, discharged on 3/14/2021. Denies fever since COVID vaccination.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Polymyositis, Rash, Vomiting
Clinical narrative: ID: 37yo F previously healthy radiology tech developed progressive muscle weakness and SOB after the 2nd dose of COVID vaccine. HPI: Patient was previously healthy and physically active prior to COVID vaccines. No prior COVId infection. No prior MSK pain, arthritis, arthralgias. No prior rash. No dry eye / dry mouth. She received the first dose of Pfizer COVID vaccine at the end of Dec 2020 and experienced achiness and fatigue that resolved after a few days. For the first time, her fingertips and toes also started turning white, numb and painful when cold. She received a second dose on Jan 12, 2021 and immediately experienced heart palpitations while at the vaccination site, and later heartburn and vomiting when she went back to work. The following week, she developed sore throat for 2 days, took leftover amoxicillin at home. All of these symptoms resolved after a few days. She However, she developed gradual SOB, muscle ache and fatigue, initially mild but worsened over a few weeks. She noticed feeling out of breath, arms giving out, legs burning when pushing stretchers to patient rooms. One morning while she was getting up for work, she couldn't lift up leg, but had to pick up her legs so she get into her car. She also had to pick up her leg with arms to get into shower. "It felt like waking up every morning having run a marathon." On 2/13 she went to ER, got admitted for CK 30,000 for rhabdo treatment for 4 days. She denied having done extreme sports or increased physical activity that might have caused rhabdo. On discharge home, she could barely walk and continued SOB. She also developed additional rash on left arm, chest and shoulders. A physician ordered lab work and found her CK to be 50K, so she was admitted again on March 6 for 8 days, discharged on 3/14/2021. Denies fever since COVID vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test normal, Chest X-ray normal, Condition aggravated, Dizziness
Clinical narrative: Event at time of dose: vasovagal syncope, left/right hands/arms paralysis, mid and lower stomach/intestines start of paralysis; treatment: 50 m Benadryl shot, visit to ER; event approximately 2 weeks after dose: both calves tingling, left leg tingling/pain, left forearm tingling, left pinky and ring finger numbness; treatment: doctor visit, MRI, heart EKG, stress test, echocardiogram.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Hypotension, Muscle spasms, Paraesthesia
Clinical narrative: Event at time of dose: vasovagal syncope, left/right hands/arms paralysis, mid and lower stomach/intestines start of paralysis; treatment: 50 m Benadryl shot, visit to ER; event approximately 2 weeks after dose: both calves tingling, left leg tingling/pain, left forearm tingling, left pinky and ring finger numbness; treatment: doctor visit, MRI, heart EKG, stress test, echocardiogram.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Event at time of dose: vasovagal syncope, left/right hands/arms paralysis, mid and lower stomach/intestines start of paralysis; treatment: 50 m Benadryl shot, visit to ER; event approximately 2 weeks after dose: both calves tingling, left leg tingling/pain, left forearm tingling, left pinky and ring finger numbness; treatment: doctor visit, MRI, heart EKG, stress test, echocardiogram.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram, Electrocardiogram ambulatory, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Event at time of dose: vasovagal syncope, left/right hands/arms paralysis, mid and lower stomach/intestines start of paralysis; treatment: 50 m Benadryl shot, visit to ER; event approximately 2 weeks after dose: both calves tingling, left leg tingling/pain, left forearm tingling, left pinky and ring finger numbness; treatment: doctor visit, MRI, heart EKG, stress test, echocardiogram.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monoplegia, Pain in extremity, Paraesthesia, Paralysis, Syncope
Clinical narrative: Event at time of dose: vasovagal syncope, left/right hands/arms paralysis, mid and lower stomach/intestines start of paralysis; treatment: 50 m Benadryl shot, visit to ER; event approximately 2 weeks after dose: both calves tingling, left leg tingling/pain, left forearm tingling, left pinky and ring finger numbness; treatment: doctor visit, MRI, heart EKG, stress test, echocardiogram.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: diagnosed with shingles; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients. This is 1st of two reports. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient noticed a rash on her upper left thigh; it was a rash like she had never seen before. It was further reported that the patient was then diagnosed with shingles by her healthcare provider on an unspecified date. It was reported that the patient wanted to know if she can get the second dose. Outcome of event was unknown.  No follow-up attempts needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361732 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Discomfort, Herpes zoster, Rash, Rash pruritic, Rash vesicular
Clinical narrative: diagnosed with shingles; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients. This is 1st of two reports. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient noticed a rash on her upper left thigh; it was a rash like she had never seen before. It was further reported that the patient was then diagnosed with shingles by her healthcare provider on an unspecified date. It was reported that the patient wanted to know if she can get the second dose. Outcome of event was unknown.  No follow-up attempts needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361732 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients. This is 1st of two reports. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient noticed a rash on her upper left thigh; it was a rash like she had never seen before. It was further reported that the patient was then diagnosed with shingles by her healthcare provider on an unspecified date. It was reported that the patient wanted to know if she can get the second dose. Outcome of event was unknown.  No follow-up attempts needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361732 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blister, Discomfort, Erythema, Herpes zoster, Rash
Clinical narrative: diagnosed with shingles; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients. This is 1st of two reports. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient noticed a rash on her upper left thigh; it was a rash like she had never seen before. It was further reported that the patient was then diagnosed with shingles by her healthcare provider on an unspecified date. It was reported that the patient wanted to know if she can get the second dose. Outcome of event was unknown.  No follow-up attempts needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361732 same reporter/drug/event, different patient
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Ultrasound scan
Clinical narrative: Within 24 hours of the first shot I awoke with severe tinnitus; This is a spontaneous report from a contactable consumer. A 65-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in left arm on 22Jan2021 as single dose for COVID-19 immunization. The patient had known allergies of Thiomersal and Gadolinium. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) via an unspecified route of administration in right arm on 10Feb2021 as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX [CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE]), ubidecarenone (COQ10), ciclosporin (RESTASIS) and multivitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 23Jan2021 03:30 (also reported as within 24hours of first shot) the patient awakens with severe tinnitus. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received the treatment for the event. Approximately on an unknown date in 2021, the patient underwent lab tests and procedures which included hearing check, magnetic resonance imaging and ultrasound however the results were not reported. The outcome of the event recovered with lasting effects approximately on unknown date in 2021.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Magnetic resonance imaging, Tinnitus, Ultrasound scan
Clinical narrative: Within 24 hours of the first shot I awoke with severe tinnitus; This is a spontaneous report from a contactable consumer. A 65-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in left arm on 22Jan2021 as single dose for COVID-19 immunization. The patient had known allergies of Thiomersal and Gadolinium. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) via an unspecified route of administration in right arm on 10Feb2021 as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX [CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE]), ubidecarenone (COQ10), ciclosporin (RESTASIS) and multivitamin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 23Jan2021 03:30 (also reported as within 24hours of first shot) the patient awakens with severe tinnitus. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received the treatment for the event. Approximately on an unknown date in 2021, the patient underwent lab tests and procedures which included hearing check, magnetic resonance imaging and ultrasound however the results were not reported. The outcome of the event recovered with lasting effects approximately on unknown date in 2021.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Obstructive airways disorder, Swollen tongue
Clinical narrative: ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) 1 total dose was not reported, administered on right arm 18-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid.  On 18-MAR-2021, the patient received the shot and felt the room was coming in and out. she was probably just nervous, sat in room for duration of waiting period, felt like she had to throw up and felt hot and sweaty. She got a trash can, wanted to get some fresh air, everything and face went numb and unable to recall details, can recall nurse asking for recovery kit and oxygen. On same date, she was transported to ER (emergency room) and tongue swelling and hanging out of her mouth and was blue in color and throat was swollen Nurse assisted in lifting her head to open her airway to assist in breathing. It was diagnosed as anaphylactic reaction. Epi, steroid and benadryl received prior to transport. She was discharged on 19-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anaphylactic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210503257-JANSSEN COVID-19 VACCINE-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) 1 total dose was not reported, administered on right arm 18-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid.  On 18-MAR-2021, the patient received the shot and felt the room was coming in and out. she was probably just nervous, sat in room for duration of waiting period, felt like she had to throw up and felt hot and sweaty. She got a trash can, wanted to get some fresh air, everything and face went numb and unable to recall details, can recall nurse asking for recovery kit and oxygen. On same date, she was transported to ER (emergency room) and tongue swelling and hanging out of her mouth and was blue in color and throat was swollen Nurse assisted in lifting her head to open her airway to assist in breathing. It was diagnosed as anaphylactic reaction. Epi, steroid and benadryl received prior to transport. She was discharged on 19-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anaphylactic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210503257-JANSSEN COVID-19 VACCINE-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 02Mar2021 at around 12:00 to 14:00 (Batch/Lot Number: EN6203) as the 1st dose, single for COVID-19 immunization. The vaccination facility type was reported as a drive through clinic; the vaccine was not administered at the military facility. Relevant medical history included neonatal lupus, from an unknown date and unknown if ongoing. Concomitant medication included hydroxychloroquine tablet taken for neonatal lupus from 2019 to an unspecified stop date. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on the same date of the Pfizer suspect vaccine. The patient had no prior vaccinations (within 4 weeks). The patient had no adverse event (AE) following prior vaccinations. The patient had no family medical history and no relevant test. On 06Mar2021 at 12:00, four days after receiving the first vaccine on 02Mar2021, the patient started having burning and itching in the area where one would have shingles. It was on her right side torso front and back and random burning and itching on top of thigh and foot. Ten days after that, which would be 14Mar2021, the patient saw first bumps on side of right torso and was not sure what it was. The rash on side of torso below bra line on right side came out on Sunday, 14Mar2021 at 10:00. It wasn't until 18Mar2021, when she had a teleconference with the physician, took pictures and was on video, that she thought it was shingles. They gave the patient the number to Pfizer to ask what to do about 2nd dose, which was supposed to be as the time of the report (23Mar2021). The patient waited for an in person appointment (appt) with a dermatologist before she took the valacyclovir and the day prior reporting, she confirmed it was shingles, so she took the first dose of that last night. It was a 2 day prescription, but the problem was, she was due for the second dose of the Pfizer COVID vaccine. Both the physician who she had teleconference with, the dermatologist and pharmacist, did not advise taking 2nd dose until the shingles cleared up. The patient was asked to ask Pfizer the recommendation for the window for receiving the second dose after being diagnosed with shingles and taking valacyclovir. The event did require a physician's teleconference visit with primary care office on 17Mar2021 at 19:00, then a dermatologist appointment to confirm shingles on 22Mar2021 at 09:00 AM. The patient's healthcare provider (HCP) recommended not to receive the second dose until the shingles was over. Therapeutic measures were taken as a result of shingles, which included valacyclovir. The patient was recovering from the event.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 02Mar2021 at around 12:00 to 14:00 (Batch/Lot Number: EN6203) as the 1st dose, single for COVID-19 immunization. The vaccination facility type was reported as a drive through clinic; the vaccine was not administered at the military facility. Relevant medical history included neonatal lupus, from an unknown date and unknown if ongoing. Concomitant medication included hydroxychloroquine tablet taken for neonatal lupus from 2019 to an unspecified stop date. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on the same date of the Pfizer suspect vaccine. The patient had no prior vaccinations (within 4 weeks). The patient had no adverse event (AE) following prior vaccinations. The patient had no family medical history and no relevant test. On 06Mar2021 at 12:00, four days after receiving the first vaccine on 02Mar2021, the patient started having burning and itching in the area where one would have shingles. It was on her right side torso front and back and random burning and itching on top of thigh and foot. Ten days after that, which would be 14Mar2021, the patient saw first bumps on side of right torso and was not sure what it was. The rash on side of torso below bra line on right side came out on Sunday, 14Mar2021 at 10:00. It wasn't until 18Mar2021, when she had a teleconference with the physician, took pictures and was on video, that she thought it was shingles. They gave the patient the number to Pfizer to ask what to do about 2nd dose, which was supposed to be as the time of the report (23Mar2021). The patient waited for an in person appointment (appt) with a dermatologist before she took the valacyclovir and the day prior reporting, she confirmed it was shingles, so she took the first dose of that last night. It was a 2 day prescription, but the problem was, she was due for the second dose of the Pfizer COVID vaccine. Both the physician who she had teleconference with, the dermatologist and pharmacist, did not advise taking 2nd dose until the shingles cleared up. The patient was asked to ask Pfizer the recommendation for the window for receiving the second dose after being diagnosed with shingles and taking valacyclovir. The event did require a physician's teleconference visit with primary care office on 17Mar2021 at 19:00, then a dermatologist appointment to confirm shingles on 22Mar2021 at 09:00 AM. The patient's healthcare provider (HCP) recommended not to receive the second dose until the shingles was over. Therapeutic measures were taken as a result of shingles, which included valacyclovir. The patient was recovering from the event.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral haematoma, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache
Clinical narrative: COMPUTERISED TOMOGRAM HEAD ABNORMAL; VENOUS SINUS THROMBOSIS; INTRACEREBRAL HAEMATOMA; THROMBOCYTOPENIA; EXPERIENCING HEADACHES 1 WEEK AGO; This spontaneous report received from a healthcare professional via VAERS (Vaccine Adverse Event Reporting System) (VAERS reference number 1133212) and concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin allergy.  The patient, age 38, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the patient was "experiencing headaches 1 week ago", and also had aphasia later in the week.  On 24-MAR-2021, the patient went to an outside hospital and was found to have intraparenchymal hemorrhage in addition to venous sinus thrombosis and developed intracerebral haematoma.  On 25-MAR-2021, Computerized tomography (CT) of the head without contrast showed parenchymal hemorrhage and persistent hyperdensity in the left transverse sinus, consistent with known venous sinus thrombosis. The patient was being treated for the venous sinus thrombosis with heparin. On an unknown date, platelet count was 78,000 (thrombocytopenia). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events thrombocytopenia, intracerebral haematoma, venous sinus thrombosis, experiencing headaches 1 week ago, and computerized tomogram head abnormal was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).  Version 3 was created on 26-APR-2021 for the purpose of quality improvement. The following corrections were made: platelet count was added as the event of thrombocytopenia.; Sender's Comments: V2: Follow up added additional laboratory information. This report received via VAERs database (ID# 1133212) concerned a 38-year-old female patient who experienced intraparenchymal hemorrhage and venous sinus thrombosis 16 days after vaccination. Diagnosis was confirmed on computerized tomography (CT) of the head. Platelet count was 78,000.   Medical history and concomitant medications were not reported. Presenting symptoms included headache and aphasia. Treatment included heparin.  Outcome was not reported.   Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS), the low platelet count and temporal relationship to vaccination (Criteria level 2), the events are assessed to have a plausible relationship with vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral haematoma, Cerebral venous sinus thrombosis, Computerised tomogram head, Computerised tomogram head abnormal, Headache
Clinical narrative: COMPUTERISED TOMOGRAM HEAD ABNORMAL; VENOUS SINUS THROMBOSIS; INTRACEREBRAL HAEMATOMA; THROMBOCYTOPENIA; EXPERIENCING HEADACHES 1 WEEK AGO; This spontaneous report received from a healthcare professional via VAERS (Vaccine Adverse Event Reporting System) (VAERS reference number 1133212) and concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin allergy.  The patient, age 38, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the patient was "experiencing headaches 1 week ago", and also had aphasia later in the week.  On 24-MAR-2021, the patient went to an outside hospital and was found to have intraparenchymal hemorrhage in addition to venous sinus thrombosis and developed intracerebral haematoma.  On 25-MAR-2021, Computerized tomography (CT) of the head without contrast showed parenchymal hemorrhage and persistent hyperdensity in the left transverse sinus, consistent with known venous sinus thrombosis. The patient was being treated for the venous sinus thrombosis with heparin. On an unknown date, platelet count was 78,000 (thrombocytopenia). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events thrombocytopenia, intracerebral haematoma, venous sinus thrombosis, experiencing headaches 1 week ago, and computerized tomogram head abnormal was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).  Version 3 was created on 26-APR-2021 for the purpose of quality improvement. The following corrections were made: platelet count was added as the event of thrombocytopenia.; Sender's Comments: V2: Follow up added additional laboratory information. This report received via VAERs database (ID# 1133212) concerned a 38-year-old female patient who experienced intraparenchymal hemorrhage and venous sinus thrombosis 16 days after vaccination. Diagnosis was confirmed on computerized tomography (CT) of the head. Platelet count was 78,000.   Medical history and concomitant medications were not reported. Presenting symptoms included headache and aphasia. Treatment included heparin.  Outcome was not reported.   Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS), the low platelet count and temporal relationship to vaccination (Criteria level 2), the events are assessed to have a plausible relationship with vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: COMPUTERISED TOMOGRAM HEAD ABNORMAL; VENOUS SINUS THROMBOSIS; INTRACEREBRAL HAEMATOMA; THROMBOCYTOPENIA; EXPERIENCING HEADACHES 1 WEEK AGO; This spontaneous report received from a healthcare professional via VAERS (Vaccine Adverse Event Reporting System) (VAERS reference number 1133212) and concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin allergy.  The patient, age 38, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the patient was "experiencing headaches 1 week ago", and also had aphasia later in the week.  On 24-MAR-2021, the patient went to an outside hospital and was found to have intraparenchymal hemorrhage in addition to venous sinus thrombosis and developed intracerebral haematoma.  On 25-MAR-2021, Computerized tomography (CT) of the head without contrast showed parenchymal hemorrhage and persistent hyperdensity in the left transverse sinus, consistent with known venous sinus thrombosis. The patient was being treated for the venous sinus thrombosis with heparin. On an unknown date, platelet count was 78,000 (thrombocytopenia). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events thrombocytopenia, intracerebral haematoma, venous sinus thrombosis, experiencing headaches 1 week ago, and computerized tomogram head abnormal was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).  Version 3 was created on 26-APR-2021 for the purpose of quality improvement. The following corrections were made: platelet count was added as the event of thrombocytopenia.; Sender's Comments: V2: Follow up added additional laboratory information. This report received via VAERs database (ID# 1133212) concerned a 38-year-old female patient who experienced intraparenchymal hemorrhage and venous sinus thrombosis 16 days after vaccination. Diagnosis was confirmed on computerized tomography (CT) of the head. Platelet count was 78,000.   Medical history and concomitant medications were not reported. Presenting symptoms included headache and aphasia. Treatment included heparin.  Outcome was not reported.   Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS), the low platelet count and temporal relationship to vaccination (Criteria level 2), the events are assessed to have a plausible relationship with vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Tinnitus
Clinical narrative: Shortly after receiving the vaccine I experienced the flu like symptoms identified as typical.  I also experienced tinnitus about two hours after the shot that is continuing to today.  Related to the autoimmune flare that I believe is related to the vaccine, I first began experiencing bone/joint pain in my wrist (never had this before) and then over the days this has progressed to significant symptoms of flare of autoimmune today.  Pain/ache in all joints now, muscle pain as well, along with vision blurriness at times, fatigue and autoimmune rash on my hands and in my groin.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Condition aggravated, Fatigue, Immune system disorder
Clinical narrative: Shortly after receiving the vaccine I experienced the flu like symptoms identified as typical.  I also experienced tinnitus about two hours after the shot that is continuing to today.  Related to the autoimmune flare that I believe is related to the vaccine, I first began experiencing bone/joint pain in my wrist (never had this before) and then over the days this has progressed to significant symptoms of flare of autoimmune today.  Pain/ache in all joints now, muscle pain as well, along with vision blurriness at times, fatigue and autoimmune rash on my hands and in my groin.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Myalgia, Rash, Tinnitus, Vision blurred
Clinical narrative: Shortly after receiving the vaccine I experienced the flu like symptoms identified as typical.  I also experienced tinnitus about two hours after the shot that is continuing to today.  Related to the autoimmune flare that I believe is related to the vaccine, I first began experiencing bone/joint pain in my wrist (never had this before) and then over the days this has progressed to significant symptoms of flare of autoimmune today.  Pain/ache in all joints now, muscle pain as well, along with vision blurriness at times, fatigue and autoimmune rash on my hands and in my groin.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: red sore very painful fingers. clinically appears as chilbalins.  patient described reaction beginning 5 minutes after receiving the vaccine. reaction persisted for 2 months.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chillblains, Erythema, Pain in extremity
Clinical narrative: red sore very painful fingers. clinically appears as chilbalins.  patient described reaction beginning 5 minutes after receiving the vaccine. reaction persisted for 2 months.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under the age of 18 received Moderna vaccine. No reactions reported.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under the age of 18 received Moderna vaccine. No reactions reported.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Electromyogram, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Symptoms began 4/9 of weakness, presented to ED on 4/11 and was diagnosed with Guillain-Barre Syndrome. Patient received treatment with IVIG x 5 doses and was discharged to Rehab facility on 4/19. Patient with worsening dysphagia and facial nerve paralysis on 5/6 requiring readmission to hospital. Patient required intubation and transfer to ICU on 5/7 where he currently remains. Plasmapheresis was started on 5/7 for additional management of Guillain-Barre Syndrome.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal
Clinical narrative: Symptoms began 4/9 of weakness, presented to ED on 4/11 and was diagnosed with Guillain-Barre Syndrome. Patient received treatment with IVIG x 5 doses and was discharged to Rehab facility on 4/19. Patient with worsening dysphagia and facial nerve paralysis on 5/6 requiring readmission to hospital. Patient required intubation and transfer to ICU on 5/7 where he currently remains. Plasmapheresis was started on 5/7 for additional management of Guillain-Barre Syndrome.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Symptoms began 4/9 of weakness, presented to ED on 4/11 and was diagnosed with Guillain-Barre Syndrome. Patient received treatment with IVIG x 5 doses and was discharged to Rehab facility on 4/19. Patient with worsening dysphagia and facial nerve paralysis on 5/6 requiring readmission to hospital. Patient required intubation and transfer to ICU on 5/7 where he currently remains. Plasmapheresis was started on 5/7 for additional management of Guillain-Barre Syndrome.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dysphagia, Endotracheal intubation, Facial paralysis, Guillain-Barre syndrome
Clinical narrative: Symptoms began 4/9 of weakness, presented to ED on 4/11 and was diagnosed with Guillain-Barre Syndrome. Patient received treatment with IVIG x 5 doses and was discharged to Rehab facility on 4/19. Patient with worsening dysphagia and facial nerve paralysis on 5/6 requiring readmission to hospital. Patient required intubation and transfer to ICU on 5/7 where he currently remains. Plasmapheresis was started on 5/7 for additional management of Guillain-Barre Syndrome.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Intensive care, Plasmapheresis
Clinical narrative: Symptoms began 4/9 of weakness, presented to ED on 4/11 and was diagnosed with Guillain-Barre Syndrome. Patient received treatment with IVIG x 5 doses and was discharged to Rehab facility on 4/19. Patient with worsening dysphagia and facial nerve paralysis on 5/6 requiring readmission to hospital. Patient required intubation and transfer to ICU on 5/7 where he currently remains. Plasmapheresis was started on 5/7 for additional management of Guillain-Barre Syndrome.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Electrocardiogram, Headache, Palpitations
Clinical narrative: Reporting April 7 first Covid vaccination with Pzier vaccine, Lot EW0150. States on April 8 had palpitations, chills, headache. On 9th went to UC and diagnosed with PVC's. Went to ER 3x, saw cardiologist on 12th, wore monitor x 72 hours and on the 13th echocardiogram showed slight pericardial effusion. Placed on beta blockers, antinflammatory and colchicine. Still having palpitations and chest pain. FMLA 9 weeks. Will see cardiologist June 11 and may be released. Increasing abdominal and join pain for last week, will see PCP tomorrow or proceed to ER if worsens. Complains of being so tired.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Cardiac monitoring, Chest pain, Chills
Clinical narrative: Reporting April 7 first Covid vaccination with Pzier vaccine, Lot EW0150. States on April 8 had palpitations, chills, headache. On 9th went to UC and diagnosed with PVC's. Went to ER 3x, saw cardiologist on 12th, wore monitor x 72 hours and on the 13th echocardiogram showed slight pericardial effusion. Placed on beta blockers, antinflammatory and colchicine. Still having palpitations and chest pain. FMLA 9 weeks. Will see cardiologist June 11 and may be released. Increasing abdominal and join pain for last week, will see PCP tomorrow or proceed to ER if worsens. Complains of being so tired.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Fatigue, Headache, Impaired work ability, Palpitations
Clinical narrative: Reporting April 7 first Covid vaccination with Pzier vaccine, Lot EW0150. States on April 8 had palpitations, chills, headache. On 9th went to UC and diagnosed with PVC's. Went to ER 3x, saw cardiologist on 12th, wore monitor x 72 hours and on the 13th echocardiogram showed slight pericardial effusion. Placed on beta blockers, antinflammatory and colchicine. Still having palpitations and chest pain. FMLA 9 weeks. Will see cardiologist June 11 and may be released. Increasing abdominal and join pain for last week, will see PCP tomorrow or proceed to ER if worsens. Complains of being so tired.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericardial effusion, Ventricular extrasystoles
Clinical narrative: Reporting April 7 first Covid vaccination with Pzier vaccine, Lot EW0150. States on April 8 had palpitations, chills, headache. On 9th went to UC and diagnosed with PVC's. Went to ER 3x, saw cardiologist on 12th, wore monitor x 72 hours and on the 13th echocardiogram showed slight pericardial effusion. Placed on beta blockers, antinflammatory and colchicine. Still having palpitations and chest pain. FMLA 9 weeks. Will see cardiologist June 11 and may be released. Increasing abdominal and join pain for last week, will see PCP tomorrow or proceed to ER if worsens. Complains of being so tired.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Herpes zoster, SARS-CoV-2 test
Clinical narrative: became symptomatic with Shingles; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 16Mar2021 at 13:45 (Batch/Lot Number: EN6202) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included Pre-diabetic, Hazelnuts, penicillins, statins allergy and high cholesterol. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3247) on 15Feb2021 for COVID-19 immunization. On 20Mar2021, the patient became symptomatic with shingles. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Mar2021 and sars-cov-2 test: negative on 10Mar2021. The patient did not received treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  No follow up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: became symptomatic with Shingles; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 16Mar2021 at 13:45 (Batch/Lot Number: EN6202) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included Pre-diabetic, Hazelnuts, penicillins, statins allergy and high cholesterol. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3247) on 15Feb2021 for COVID-19 immunization. On 20Mar2021, the patient became symptomatic with shingles. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Mar2021 and sars-cov-2 test: negative on 10Mar2021. The patient did not received treatment for the event. The outcome of the event was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  No follow up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Pharmacy received fax requesting medical records request for Covid-19 vaccine recipient.  Pharmacy unaware of VAERS for this patient, and contacted patient phone number on file.  Patient's wife returned call, stated patient was deceased, occurred a week after getting the vaccine.  Patient stated the Department of Health was notified.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain, Vomiting
Clinical narrative: Pharmacy received fax requesting medical records request for Covid-19 vaccine recipient.  Pharmacy unaware of VAERS for this patient, and contacted patient phone number on file.  Patient's wife returned call, stated patient was deceased, occurred a week after getting the vaccine.  Patient stated the Department of Health was notified.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Nausea, vomiting, diarrhea, headache, body aches
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, headache, body aches