chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This consumer reported similar events for two patients. This is the first of two reports. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172) via unspecified route in the right arm on 26Aug2021 at about 1:30 -1:40pm (at the age of 52-years-old) as a single dose for COVID-19 immunization. Patient had no medical history and no concomitant medications. No additional vaccines were administered on the same date as the COVID vaccine and no other prior vaccinations (within 4 weeks) of the COVID vaccine were received. The patient and her husband received the first dose of the vaccine from employer on Thursday, 26Aug2021 and before they got home, the lab called and said the company they hired to administered it, instead of giving them the 0.3ml they got 2.1ml which is over 6 times the amount they should have gotten. She also said 7 other patients were involved with incorrect dosing of the vaccine. Patient reported they (she and her husband) haven't had any crazy side effects, just sore (Aug2021) and the 'expected things' (as reported). When she ask the director of the site about the second shot, she was told to go ahead and take the shot. She is going to wait and hear from her primary care doctor but wanted some more information regarding this. The normal things mentioned were described as headache which started that evening (26Aug2021) and is better now, seasonal allergies with runny nose which started on 29Aug2021 and is better today, her arm swelled at the injection site on 26Aug2021 but this has gone down now and this has subsided, body aches including leg cramps (Aug2021) and her neck hurting (the leg hurting started 29Aug2021 and is about the same and the neck hurting started a few days ago (Aug2021) and is about the same). She also reported that the biggest thing has been fatigue which started right away on 26Aug2016, that evening and it is about the same. The reported events did not require ER visit or physician office visit. There were no relevant tests. Treatment for the events included ibuprofen. The outcome of headaches and seasonal allergies with runny nose  was recovering; arm swelled at the injection site was recovered in Aug2021; while body aches including leg cramps, leg hurting, fatigue and neck hurting were not recovered. Follow-up (06Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101132573 same reporter/events/product, different patient.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Neck pain, Overdose
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This consumer reported similar events for two patients. This is the first of two reports. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172) via unspecified route in the right arm on 26Aug2021 at about 1:30 -1:40pm (at the age of 52-years-old) as a single dose for COVID-19 immunization. Patient had no medical history and no concomitant medications. No additional vaccines were administered on the same date as the COVID vaccine and no other prior vaccinations (within 4 weeks) of the COVID vaccine were received. The patient and her husband received the first dose of the vaccine from employer on Thursday, 26Aug2021 and before they got home, the lab called and said the company they hired to administered it, instead of giving them the 0.3ml they got 2.1ml which is over 6 times the amount they should have gotten. She also said 7 other patients were involved with incorrect dosing of the vaccine. Patient reported they (she and her husband) haven't had any crazy side effects, just sore (Aug2021) and the 'expected things' (as reported). When she ask the director of the site about the second shot, she was told to go ahead and take the shot. She is going to wait and hear from her primary care doctor but wanted some more information regarding this. The normal things mentioned were described as headache which started that evening (26Aug2021) and is better now, seasonal allergies with runny nose which started on 29Aug2021 and is better today, her arm swelled at the injection site on 26Aug2021 but this has gone down now and this has subsided, body aches including leg cramps (Aug2021) and her neck hurting (the leg hurting started 29Aug2021 and is about the same and the neck hurting started a few days ago (Aug2021) and is about the same). She also reported that the biggest thing has been fatigue which started right away on 26Aug2016, that evening and it is about the same. The reported events did not require ER visit or physician office visit. There were no relevant tests. Treatment for the events included ibuprofen. The outcome of headaches and seasonal allergies with runny nose  was recovering; arm swelled at the injection site was recovered in Aug2021; while body aches including leg cramps, leg hurting, fatigue and neck hurting were not recovered. Follow-up (06Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101132573 same reporter/events/product, different patient.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Rhinorrhoea, Seasonal allergy, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This consumer reported similar events for two patients. This is the first of two reports. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172) via unspecified route in the right arm on 26Aug2021 at about 1:30 -1:40pm (at the age of 52-years-old) as a single dose for COVID-19 immunization. Patient had no medical history and no concomitant medications. No additional vaccines were administered on the same date as the COVID vaccine and no other prior vaccinations (within 4 weeks) of the COVID vaccine were received. The patient and her husband received the first dose of the vaccine from employer on Thursday, 26Aug2021 and before they got home, the lab called and said the company they hired to administered it, instead of giving them the 0.3ml they got 2.1ml which is over 6 times the amount they should have gotten. She also said 7 other patients were involved with incorrect dosing of the vaccine. Patient reported they (she and her husband) haven't had any crazy side effects, just sore (Aug2021) and the 'expected things' (as reported). When she ask the director of the site about the second shot, she was told to go ahead and take the shot. She is going to wait and hear from her primary care doctor but wanted some more information regarding this. The normal things mentioned were described as headache which started that evening (26Aug2021) and is better now, seasonal allergies with runny nose which started on 29Aug2021 and is better today, her arm swelled at the injection site on 26Aug2021 but this has gone down now and this has subsided, body aches including leg cramps (Aug2021) and her neck hurting (the leg hurting started 29Aug2021 and is about the same and the neck hurting started a few days ago (Aug2021) and is about the same). She also reported that the biggest thing has been fatigue which started right away on 26Aug2016, that evening and it is about the same. The reported events did not require ER visit or physician office visit. There were no relevant tests. Treatment for the events included ibuprofen. The outcome of headaches and seasonal allergies with runny nose  was recovering; arm swelled at the injection site was recovered in Aug2021; while body aches including leg cramps, leg hurting, fatigue and neck hurting were not recovered. Follow-up (06Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101132573 same reporter/events/product, different patient.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: pain in the legs; They received 2.1mLs instead of the 0.3mL recommended dose; fatigue; arm pain at the injection site; neck pain; This is a spontaneous report from a contactable consumer. (patient's wife).  A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Aug2021 13:30 (Batch/Lot Number: EW0172) as a single dose at 2.1 ML SINGLE for covid-19 immunisation. Medical history included ongoing asthma had since he was a kid. There were no concomitant medications.  On 26Aug2021, the patient went to his employer for the first dose and received 2.1mLs instead of the 0.3mL recommended dose. The patient also complained of neck pain and fatigue that day. On 29Aug2021, he had arm pain at the injection site and pain in the legs.The lab that performed the vaccination recommended he receive the second dose.  There was no physician office visit nor emergency room visit. The patient had not received any vaccinations within 4 weeks prior to receiving the vaccine. He was taking ibuprofen. The outcome of the arm pain, pain in the legs and fatigue was not recovered, the neck pain was recovering                 No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Neck pain, Overdose, Pain in extremity, Vaccination site pain
Clinical narrative: pain in the legs; They received 2.1mLs instead of the 0.3mL recommended dose; fatigue; arm pain at the injection site; neck pain; This is a spontaneous report from a contactable consumer. (patient's wife).  A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Aug2021 13:30 (Batch/Lot Number: EW0172) as a single dose at 2.1 ML SINGLE for covid-19 immunisation. Medical history included ongoing asthma had since he was a kid. There were no concomitant medications.  On 26Aug2021, the patient went to his employer for the first dose and received 2.1mLs instead of the 0.3mL recommended dose. The patient also complained of neck pain and fatigue that day. On 29Aug2021, he had arm pain at the injection site and pain in the legs.The lab that performed the vaccination recommended he receive the second dose.  There was no physician office visit nor emergency room visit. The patient had not received any vaccinations within 4 weeks prior to receiving the vaccine. He was taking ibuprofen. The outcome of the arm pain, pain in the legs and fatigue was not recovered, the neck pain was recovering                 No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: pain in the legs; They received 2.1mLs instead of the 0.3mL recommended dose; fatigue; arm pain at the injection site; neck pain; This is a spontaneous report from a contactable consumer. (patient's wife).  A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Aug2021 13:30 (Batch/Lot Number: EW0172) as a single dose at 2.1 ML SINGLE for covid-19 immunisation. Medical history included ongoing asthma had since he was a kid. There were no concomitant medications.  On 26Aug2021, the patient went to his employer for the first dose and received 2.1mLs instead of the 0.3mL recommended dose. The patient also complained of neck pain and fatigue that day. On 29Aug2021, he had arm pain at the injection site and pain in the legs.The lab that performed the vaccination recommended he receive the second dose.  There was no physician office visit nor emergency room visit. The patient had not received any vaccinations within 4 weeks prior to receiving the vaccine. He was taking ibuprofen. The outcome of the arm pain, pain in the legs and fatigue was not recovered, the neck pain was recovering                 No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: UTI; Difficulty breathing; chest pain; rapid heart beat; Fluttering/heart palpitations; Dark veins; Excessive urination; Dizzy; Weakness; Fluttering/heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old nonpregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 10:00 AM (age at vaccination 35-year-old) (Lot Number: FA7484, and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). There were no concomitant medications. The patient did not received other vaccine in four weeks. if covid tested post vaccination :No. known allergies: No The patient experienced on 30Jul2021 at 18:00, Difficulty breathing, chest pain, rapid heartbeat. Fluttering/heart palpitations. Dark veins. Excessive urination. Dizzy. Weakness a few days after. Went to e.r. they told me patient had UTI and patient d-dimer was .92. (Had no symptoms of UTI). The patient received treatment for the events and included Antibiotic for UTI. Going to cardiologist and register Doctor. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as Resolved with Sequel on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, Gait disturbance, Heart rate increased, Palpitations, Pollakiuria
Clinical narrative: UTI; Difficulty breathing; chest pain; rapid heart beat; Fluttering/heart palpitations; Dark veins; Excessive urination; Dizzy; Weakness; Fluttering/heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old nonpregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 10:00 AM (age at vaccination 35-year-old) (Lot Number: FA7484, and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). There were no concomitant medications. The patient did not received other vaccine in four weeks. if covid tested post vaccination :No. known allergies: No The patient experienced on 30Jul2021 at 18:00, Difficulty breathing, chest pain, rapid heartbeat. Fluttering/heart palpitations. Dark veins. Excessive urination. Dizzy. Weakness a few days after. Went to e.r. they told me patient had UTI and patient d-dimer was .92. (Had no symptoms of UTI). The patient received treatment for the events and included Antibiotic for UTI. Going to cardiologist and register Doctor. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as Resolved with Sequel on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection, Urine analysis, Vein discolouration
Clinical narrative: UTI; Difficulty breathing; chest pain; rapid heart beat; Fluttering/heart palpitations; Dark veins; Excessive urination; Dizzy; Weakness; Fluttering/heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old nonpregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 10:00 AM (age at vaccination 35-year-old) (Lot Number: FA7484, and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). There were no concomitant medications. The patient did not received other vaccine in four weeks. if covid tested post vaccination :No. known allergies: No The patient experienced on 30Jul2021 at 18:00, Difficulty breathing, chest pain, rapid heartbeat. Fluttering/heart palpitations. Dark veins. Excessive urination. Dizzy. Weakness a few days after. Went to e.r. they told me patient had UTI and patient d-dimer was .92. (Had no symptoms of UTI). The patient received treatment for the events and included Antibiotic for UTI. Going to cardiologist and register Doctor. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as Resolved with Sequel on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac flutter, Chest pain, Dizziness, Dyspnoea
Clinical narrative: UTI; Difficulty breathing; chest pain; rapid heart beat; Fluttering/heart palpitations; Dark veins; Excessive urination; Dizzy; Weakness; Fluttering/heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old nonpregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 10:00 AM (age at vaccination 35-year-old) (Lot Number: FA7484, and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). There were no concomitant medications. The patient did not received other vaccine in four weeks. if covid tested post vaccination :No. known allergies: No The patient experienced on 30Jul2021 at 18:00, Difficulty breathing, chest pain, rapid heartbeat. Fluttering/heart palpitations. Dark veins. Excessive urination. Dizzy. Weakness a few days after. Went to e.r. they told me patient had UTI and patient d-dimer was .92. (Had no symptoms of UTI). The patient received treatment for the events and included Antibiotic for UTI. Going to cardiologist and register Doctor. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as Resolved with Sequel on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Investigation, Palpitations, Pollakiuria, Urinary tract infection
Clinical narrative: UTI; Difficulty breathing; chest pain; rapid heart beat; Fluttering/heart palpitations; Dark veins; Excessive urination; Dizzy; Weakness; Fluttering/heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old nonpregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 10:00 AM (age at vaccination 35-year-old) (Lot Number: FA7484, and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). There were no concomitant medications. The patient did not received other vaccine in four weeks. if covid tested post vaccination :No. known allergies: No The patient experienced on 30Jul2021 at 18:00, Difficulty breathing, chest pain, rapid heartbeat. Fluttering/heart palpitations. Dark veins. Excessive urination. Dizzy. Weakness a few days after. Went to e.r. they told me patient had UTI and patient d-dimer was .92. (Had no symptoms of UTI). The patient received treatment for the events and included Antibiotic for UTI. Going to cardiologist and register Doctor. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as Resolved with Sequel on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vein discolouration
Clinical narrative: UTI; Difficulty breathing; chest pain; rapid heart beat; Fluttering/heart palpitations; Dark veins; Excessive urination; Dizzy; Weakness; Fluttering/heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old nonpregnant female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 10:00 AM (age at vaccination 35-year-old) (Lot Number: FA7484, and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). There were no concomitant medications. The patient did not received other vaccine in four weeks. if covid tested post vaccination :No. known allergies: No The patient experienced on 30Jul2021 at 18:00, Difficulty breathing, chest pain, rapid heartbeat. Fluttering/heart palpitations. Dark veins. Excessive urination. Dizzy. Weakness a few days after. Went to e.r. they told me patient had UTI and patient d-dimer was .92. (Had no symptoms of UTI). The patient received treatment for the events and included Antibiotic for UTI. Going to cardiologist and register Doctor. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as Resolved with Sequel on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, FLUA3, COVID19, FLUA4
Symptoms: Feeling abnormal, Interchange of vaccine products, Seizure
Clinical narrative: Began to feel bad; Seizures; This spontaneous case was retrieved on 13-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1656372-1), reported by other non-health professional and concerned a 77-year-old female patient.  The patient's concurrent condition included allergy to Accupril (quinapril hydrochloride) and Keflex (cefalexin). It was unknown if the patient was taking any concomitant medications.  On 25-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was 312832.  On the same day, the patient was also vaccinated with a non-company co-suspect vaccine Moderna Covid-19 vaccine (covid-19 vaccine; dose: reported as '3', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 004F21A.  On the same day, after receiving Fluad Quadrivalent and Moderna, in the evening, the patient began to feel bad.  On an unknown date in Aug-2021, the patient was having seizures and was admitted to the hospital. It was unknown if any laboratory analyses were performed.   The outcome of both events was unknown.  The reporter did not provide a causality assessment.  The events of seizures and 'feeling bad' were assessed as serious due to hospitalization. The event of seizures was also considered as medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 77-year-old patient was administered Fluad Quadrivalent on 25-Aug-2021. On the same day, the patient was also vaccinated with a non-company co-suspect vaccine Covid-19 vaccine. On the same day, after vaccination, the patient began to feel bad. On an unknown date in Aug-2021, the patient was having seizures and was admitted to the hospital. Chronology needs more clarification for the event of seizure. More information regarding event feeling bad is also needed. With information available, causality is unassessable for both events.; Sender's Comments: A 77-year-old patient was administered Fluad Quadrivalent on 25-Aug-2021. On the same day, the patient was also vaccinated with a non-company co-suspect vaccine Covid-19 vaccine. On the same day, after vaccination, the patient began to feel bad. On an unknown date in Aug-2021, the patient was having seizures and was admitted to the hospital. Chronology needs more clarification for the event of seizure. More information regarding event feeling bad is also needed. With information available, causality is unassessable for both events.
Age: 77.0
Sex: F
Vaccine: COVID19, FLUA3, COVID19, FLUA4
Symptoms: Feeling abnormal, Seizure
Clinical narrative: Began to feel bad; Seizures; This spontaneous case was retrieved on 13-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1656372-1), reported by other non-health professional and concerned a 77-year-old female patient.  The patient's concurrent condition included allergy to Accupril (quinapril hydrochloride) and Keflex (cefalexin). It was unknown if the patient was taking any concomitant medications.  On 25-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was 312832.  On the same day, the patient was also vaccinated with a non-company co-suspect vaccine Moderna Covid-19 vaccine (covid-19 vaccine; dose: reported as '3', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 004F21A.  On the same day, after receiving Fluad Quadrivalent and Moderna, in the evening, the patient began to feel bad.  On an unknown date in Aug-2021, the patient was having seizures and was admitted to the hospital. It was unknown if any laboratory analyses were performed.   The outcome of both events was unknown.  The reporter did not provide a causality assessment.  The events of seizures and 'feeling bad' were assessed as serious due to hospitalization. The event of seizures was also considered as medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 77-year-old patient was administered Fluad Quadrivalent on 25-Aug-2021. On the same day, the patient was also vaccinated with a non-company co-suspect vaccine Covid-19 vaccine. On the same day, after vaccination, the patient began to feel bad. On an unknown date in Aug-2021, the patient was having seizures and was admitted to the hospital. Chronology needs more clarification for the event of seizure. More information regarding event feeling bad is also needed. With information available, causality is unassessable for both events.; Sender's Comments: A 77-year-old patient was administered Fluad Quadrivalent on 25-Aug-2021. On the same day, the patient was also vaccinated with a non-company co-suspect vaccine Covid-19 vaccine. On the same day, after vaccination, the patient began to feel bad. On an unknown date in Aug-2021, the patient was having seizures and was admitted to the hospital. Chronology needs more clarification for the event of seizure. More information regarding event feeling bad is also needed. With information available, causality is unassessable for both events.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blister, Condition aggravated, Eczema, Nipple disorder
Clinical narrative: Skin rashes that have spread from my arms all the way down to my legs. I have eczema on my hands, specifically dyshidrotic eczema. These rashes however are different never had them prior; Inappropriate schedule of vaccine administered; This is a spontaneous report from a Contactable Consumer (patient). A 20-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 (Batch/Lot Number: EL0203) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 10:30 (Batch/Lot Number: EL9269) as DOSE 1, SINGLE for covid-19 immunisation at the age of 20-year-old. Medical history included allergies to Latex, Dust, Pollen, mice, roaches, cats, dogs; Eczema, IBS, scoliosis, Anxiety, Depression and dyshidrotic eczema (eczema on hands). There were no concomitant medications. The patient experienced skin rashes that have spread from the arms all the way down to the legs on 24Feb2021 with outcome of not recovered, inappropriate schedule of vaccine administered on 17Feb2021 with outcome of unknown. Therapeutic measures were taken as a result of skin included topical steroids, phototherapy, steroid injections. The event resulted in Doctor or other healthcare professional office/clinic visit. No COVID prior vaccination and unknown if COVID tested post vaccination. The clinical course was reported: Skin rashes that have spread from the arms all the way down to the legs. The patient has eczema on the hands, specifically dyshidrotic eczema. These rashes however are different never had them prior and first flare up started the first 2 weeks of the vaccination. Within the last few months, it continues to spread to other parts of the body and flares up.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Skin rashes that have spread from my arms all the way down to my legs. I have eczema on my hands, specifically dyshidrotic eczema. These rashes however are different never had them prior; Inappropriate schedule of vaccine administered; This is a spontaneous report from a Contactable Consumer (patient). A 20-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 (Batch/Lot Number: EL0203) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 10:30 (Batch/Lot Number: EL9269) as DOSE 1, SINGLE for covid-19 immunisation at the age of 20-year-old. Medical history included allergies to Latex, Dust, Pollen, mice, roaches, cats, dogs; Eczema, IBS, scoliosis, Anxiety, Depression and dyshidrotic eczema (eczema on hands). There were no concomitant medications. The patient experienced skin rashes that have spread from the arms all the way down to the legs on 24Feb2021 with outcome of not recovered, inappropriate schedule of vaccine administered on 17Feb2021 with outcome of unknown. Therapeutic measures were taken as a result of skin included topical steroids, phototherapy, steroid injections. The event resulted in Doctor or other healthcare professional office/clinic visit. No COVID prior vaccination and unknown if COVID tested post vaccination. The clinical course was reported: Skin rashes that have spread from the arms all the way down to the legs. The patient has eczema on the hands, specifically dyshidrotic eczema. These rashes however are different never had them prior and first flare up started the first 2 weeks of the vaccination. Within the last few months, it continues to spread to other parts of the body and flares up.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: Skin rashes that have spread from my arms all the way down to my legs. I have eczema on my hands, specifically dyshidrotic eczema. These rashes however are different never had them prior; Inappropriate schedule of vaccine administered; This is a spontaneous report from a Contactable Consumer (patient). A 20-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 (Batch/Lot Number: EL0203) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 10:30 (Batch/Lot Number: EL9269) as DOSE 1, SINGLE for covid-19 immunisation at the age of 20-year-old. Medical history included allergies to Latex, Dust, Pollen, mice, roaches, cats, dogs; Eczema, IBS, scoliosis, Anxiety, Depression and dyshidrotic eczema (eczema on hands). There were no concomitant medications. The patient experienced skin rashes that have spread from the arms all the way down to the legs on 24Feb2021 with outcome of not recovered, inappropriate schedule of vaccine administered on 17Feb2021 with outcome of unknown. Therapeutic measures were taken as a result of skin included topical steroids, phototherapy, steroid injections. The event resulted in Doctor or other healthcare professional office/clinic visit. No COVID prior vaccination and unknown if COVID tested post vaccination. The clinical course was reported: Skin rashes that have spread from the arms all the way down to the legs. The patient has eczema on the hands, specifically dyshidrotic eczema. These rashes however are different never had them prior and first flare up started the first 2 weeks of the vaccination. Within the last few months, it continues to spread to other parts of the body and flares up.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Erythema, Headache
Clinical narrative: Fever; Headache; Dizziness; Blurred vision; extreme swelling at injection site; extreme redness at injection site; warm to touch at the injection site; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female nurse patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Aug2021 at 08:00 at single dose in right arm for COVID-19 immunisation at the age of 63-year-old. Lot number was EW0191. Medical history was none. Concomitant medications were unknown. Vaccine history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Aug2021 at around 11:00 at single dose in left arm for COVID-19 immunisation at the age of 63-year-old (Lot number EW0182). On 31Aug2021 at 08:45, the patient experienced fever, headache, dizziness, vision blurred, extreme swelling and redness at the injection site and was warm to touch, nausea, vomiting, diarrhea; the events were considered medically significant. The patient was not treated for the events. On 31Aug2021, body temperature was 100.9. The patient did not recover from the events. The reporter considered the events were related to suspect vaccine.; Sender's Comments: Based on the available information in the case, the causal association between the events pyrexia, headache, dizziness, vision blurred, vaccination site swelling, vaccination site erythema, vaccination site warmth, nausea, vomiting, diarrhoea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Nausea, Pyrexia, Swelling, Vision blurred
Clinical narrative: Fever; Headache; Dizziness; Blurred vision; extreme swelling at injection site; extreme redness at injection site; warm to touch at the injection site; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female nurse patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Aug2021 at 08:00 at single dose in right arm for COVID-19 immunisation at the age of 63-year-old. Lot number was EW0191. Medical history was none. Concomitant medications were unknown. Vaccine history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Aug2021 at around 11:00 at single dose in left arm for COVID-19 immunisation at the age of 63-year-old (Lot number EW0182). On 31Aug2021 at 08:45, the patient experienced fever, headache, dizziness, vision blurred, extreme swelling and redness at the injection site and was warm to touch, nausea, vomiting, diarrhea; the events were considered medically significant. The patient was not treated for the events. On 31Aug2021, body temperature was 100.9. The patient did not recover from the events. The reporter considered the events were related to suspect vaccine.; Sender's Comments: Based on the available information in the case, the causal association between the events pyrexia, headache, dizziness, vision blurred, vaccination site swelling, vaccination site erythema, vaccination site warmth, nausea, vomiting, diarrhoea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Headache; Dizziness; Blurred vision; extreme swelling at injection site; extreme redness at injection site; warm to touch at the injection site; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female nurse patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Aug2021 at 08:00 at single dose in right arm for COVID-19 immunisation at the age of 63-year-old. Lot number was EW0191. Medical history was none. Concomitant medications were unknown. Vaccine history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Aug2021 at around 11:00 at single dose in left arm for COVID-19 immunisation at the age of 63-year-old (Lot number EW0182). On 31Aug2021 at 08:45, the patient experienced fever, headache, dizziness, vision blurred, extreme swelling and redness at the injection site and was warm to touch, nausea, vomiting, diarrhea; the events were considered medically significant. The patient was not treated for the events. On 31Aug2021, body temperature was 100.9. The patient did not recover from the events. The reporter considered the events were related to suspect vaccine.; Sender's Comments: Based on the available information in the case, the causal association between the events pyrexia, headache, dizziness, vision blurred, vaccination site swelling, vaccination site erythema, vaccination site warmth, nausea, vomiting, diarrhoea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Fever; Headache; Dizziness; Blurred vision; extreme swelling at injection site; extreme redness at injection site; warm to touch at the injection site; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female nurse patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Aug2021 at 08:00 at single dose in right arm for COVID-19 immunisation at the age of 63-year-old. Lot number was EW0191. Medical history was none. Concomitant medications were unknown. Vaccine history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Aug2021 at around 11:00 at single dose in left arm for COVID-19 immunisation at the age of 63-year-old (Lot number EW0182). On 31Aug2021 at 08:45, the patient experienced fever, headache, dizziness, vision blurred, extreme swelling and redness at the injection site and was warm to touch, nausea, vomiting, diarrhea; the events were considered medically significant. The patient was not treated for the events. On 31Aug2021, body temperature was 100.9. The patient did not recover from the events. The reporter considered the events were related to suspect vaccine.; Sender's Comments: Based on the available information in the case, the causal association between the events pyrexia, headache, dizziness, vision blurred, vaccination site swelling, vaccination site erythema, vaccination site warmth, nausea, vomiting, diarrhoea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth, Vision blurred
Clinical narrative: Fever; Headache; Dizziness; Blurred vision; extreme swelling at injection site; extreme redness at injection site; warm to touch at the injection site; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female nurse patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Aug2021 at 08:00 at single dose in right arm for COVID-19 immunisation at the age of 63-year-old. Lot number was EW0191. Medical history was none. Concomitant medications were unknown. Vaccine history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Aug2021 at around 11:00 at single dose in left arm for COVID-19 immunisation at the age of 63-year-old (Lot number EW0182). On 31Aug2021 at 08:45, the patient experienced fever, headache, dizziness, vision blurred, extreme swelling and redness at the injection site and was warm to touch, nausea, vomiting, diarrhea; the events were considered medically significant. The patient was not treated for the events. On 31Aug2021, body temperature was 100.9. The patient did not recover from the events. The reporter considered the events were related to suspect vaccine.; Sender's Comments: Based on the available information in the case, the causal association between the events pyrexia, headache, dizziness, vision blurred, vaccination site swelling, vaccination site erythema, vaccination site warmth, nausea, vomiting, diarrhoea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Erythema, Injection site warmth, Nausea
Clinical narrative: Fever of 100.2; swelling at the injection site; Vomiting; Diarrhea; redness at the injection site; injection site warm to touch; This is a spontaneous report from a contactable Nurse (patient mother). This is the second of four reports. A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration, administered in right arm on 31Aug2021 at 08:00 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number EW0182) on 10Aug2021 at around 11:00 am in the left arm for COVID-19 immunisation. The patient had none with the first dose. Medical history included profoundly autistic and non-verbal and non-communitive since he was 1 year old. The patient's concomitant medications were not reported. On 31Aug2021 at 08:45 the patient experienced fever of 100.2, extreme swelling and redness at the injection site and is warm to touch, vomiting and diarrhea. The events were reported as serious (medically significant) and related to suspect product. No treatments received for the events. The outcome of events was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pyrexia, Vaccination site swelling, Vomiting, Diarrhoea, Vaccination site erythema, and Vaccina-tion site warmth and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Fever of 100.2; swelling at the injection site; Vomiting; Diarrhea; redness at the injection site; injection site warm to touch; This is a spontaneous report from a contactable Nurse (patient mother). This is the second of four reports. A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration, administered in right arm on 31Aug2021 at 08:00 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number EW0182) on 10Aug2021 at around 11:00 am in the left arm for COVID-19 immunisation. The patient had none with the first dose. Medical history included profoundly autistic and non-verbal and non-communitive since he was 1 year old. The patient's concomitant medications were not reported. On 31Aug2021 at 08:45 the patient experienced fever of 100.2, extreme swelling and redness at the injection site and is warm to touch, vomiting and diarrhea. The events were reported as serious (medically significant) and related to suspect product. No treatments received for the events. The outcome of events was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pyrexia, Vaccination site swelling, Vomiting, Diarrhoea, Vaccination site erythema, and Vaccina-tion site warmth and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.