chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: COVID-19 Infection. Experienced COVID-19 symptoms and tested positive on PCR Test; COVID-19 Infection. Experienced COVID-19 symptoms and tested positive on PCR Test; dose 1 and dose 2 both 25Jan2021; dose 1 and dose 2 both 25Jan2021; This is a spontaneous report from a non-contactable consumer. A non-pregnant 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm (Batch/Lot Number: EL9262) as 1st dose, single dose, dose 2 via an unspecified route of administration (Batch/Lot Number: EM9810) as 2nd dose, single dose, both on 25Jan2021 for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced COVID-19 symptoms and tested positive on PCR Test (nasal swab) on 13May2021. The patient does not receive treatment. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chills, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Fainting spell; Loss of feeling in hands and feet; Dangerously low blood pressure; Sweating profusely; Chills; Overall weakness; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 14May2021 08:00 (at the age of 29 years) (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included penicillin allergy. The patient previously received the 1ST DOSE of BNT162B2 administered on the left arm on 16Apr2021 at 08:00 (at the age of 29 years) for COVID-19 immunization. On 14May2021 08:00, the patient experienced fainting spell, loss of feeling in hands and feet, dangerously low blood pressure, sweating profusely, chills, overall weakness and "nautilus". The event fainting was assessed as serious (medically significant). Therapeutic measures were taken as a result of all the events. The outcome of the events was recovering.  No follow-up attempts are possible, information about the batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Syncope
Clinical narrative: Fainting spell; Loss of feeling in hands and feet; Dangerously low blood pressure; Sweating profusely; Chills; Overall weakness; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 14May2021 08:00 (at the age of 29 years) (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included penicillin allergy. The patient previously received the 1ST DOSE of BNT162B2 administered on the left arm on 16Apr2021 at 08:00 (at the age of 29 years) for COVID-19 immunization. On 14May2021 08:00, the patient experienced fainting spell, loss of feeling in hands and feet, dangerously low blood pressure, sweating profusely, chills, overall weakness and "nautilus". The event fainting was assessed as serious (medically significant). Therapeutic measures were taken as a result of all the events. The outcome of the events was recovering.  No follow-up attempts are possible, information about the batch number cannot be obtained.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough positive case of COVID 19; Breakthrough positive case of COVID 19; This is a spontaneous report from a contactable other healthcare professional. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 1ST DOSE, SINGLE and 2ND DOSE, SINGLE, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. Medical history included atrial fibrillation (A-fib). It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19. The patient's concomitant medications were not reported. It was reported that the patient experienced breakthrough positive case of COVID 19 on an unspecified date. It was noted that the patient was tested positive to COVID test post vaccination. The event resulted in hospitalization. Treatment was received for the adverse event (unspecified medication). The event was considered serious due to Caused/prolonged hospitalization. The outcome of the events was recovered.   Information on lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypersensitivity, Lip swelling, Swelling face
Clinical narrative: an allergic reaction to the Pfizer; face swelling/She says she was like a actor doing the clump. She says her lip and jaw looked just like that; She says she was like a actor doing the clump. She says her lip and jaw looked just like that.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 11:00 (at the age of 50-year-old) as 1st dose, single for covid-19 immunisation.  Medical history included ongoing high blood pressure, blood clot on her right kidney from 2016, high cholesterol from 2016. Concomitant medications included warfarin; cholesterol. The patient was calling about the Pfizer COVID-19 vaccine. She says she had both of them. She says she had an allergic reaction to the Pfizer; she is assuming it was the Pfizer. She says the 15th through the 19th she was like a actor doing the clump. She says her lip and jaw looked just like that. She says it was at a the pharmacy. She says she went to Urgent Care, they gave her Benadryl, and admitted her to the hospital because they thought her throat was going to close(it started 20Apr2021 or 21Apr2021 and ended on 21Apr2021). The patient stated she was started on a high blood pressure medication after the first time of being in the hospital with face swelling. Prior Vaccinations (within 4 weeks) there is no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There is no AE following prior vaccinations. The patient says she has no allergies and was not sick at the time of either vaccination. There is no Family Medical History Relevant to AE. The outcome of the events was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This is a spontaneous report from a contactable Pharmacist reported for a patient that: a 68-year-old male patient received first dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (at 68 years old) (Lot Number: EN6204) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Reporter reported that the patient was last vaccination listed was a Tdap in 2010 for immunization.  Reporter reported that reporting for adults was not mandatory, but was done out of courtesy, so the reporter cannot say for certain that the patient did not receive prior vaccinations within 4 weeks of the Covid-19 vaccine. Reporter reported that the patient was hospitalized for Covid-19 on 09Mar2021.  Reporter reported that she assumed the patient was tested for Covid-19 on 09Mar2021 but did not know the actual date.  Reporter reported that she did not know what type of Covid-19 test was performed. Reporter reported that she would assume that the patient received a positive Covid-19 diagnosis when he was admitted to the hospital on 09Mar2021. She did not know the date of the patient was Covid-19 diagnosis, when the patient developed symptoms, or which symptoms the patient had. The patient received additional therapies for COVID-19 included: Convalescent plasma on 09Mar2021 and Remdesivir from an unknown date to 13Mar2021. Reporter reported that the patient took his last dose of Remdesivir on 13Mar2021.  Reporter reported that she did not know when the patient started Remdesivir, but she thinks that it was a 5 day treatment. Reporter reported that she did not know when the patient was discharged from the hospital. The patient was not still hospitalized. Reporter reported that the patient was not displaying clinical signs at rest indicative of severe systemic illness yesterday, 13May2021, but she die not know if he did previously. Reporter reported that the patient came into her pharmacy to get his second dose of the Covid-19 vaccine.  Reporter reported that the patient got the first dose of the Covid-19 vaccine at a different place. The patient underwent lab tests and procedures which included COVID-19 virus test: Positive on 09Mar2021. The outcome of the event was recovered in Mar2021.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of COVID-19 cannot be excluded. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Syncope
Clinical narrative: she has syncope and migraine; she has syncope and migraine; she did not feel good after the first shot.; This is a spontaneous report from a contactable consumer for herself.  A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose  for covid-19 immunisation.  Medical history included cataract .  The patient's concomitant medications were not reported.  The patient experienced  syncope  on an unspecified date with outcome of unknown , migraine  on an unspecified date with outcome of unknown , she did not feel good after the first shot on an unspecified date with outcome of unknown.    No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Blood clots - DVT; This is a spontaneous report from a contactable consumer (patient) reported that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171), via an unspecified route of administration, administered in arm left on 07May2021 08:15 (at the age of 34-years-old) as 2nd dose, single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included covid-19 prior vaccination. The patient had no known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP8737), via an unspecified route of administration, administered in arm left on 16Apr2021 08:00 AM (at the age of 34-years-old) as 1st dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levonorgestrel (PILL 72) taken for birth control, start and stop date were not reported. On 12May2021, the patient experienced blood clots - DVT. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of blood clots - DVT as patient received blood thinners. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report received from a contactable physician. This physician reported similar events for 11 patients. This is the 2nd of the 11 reports.  A 39-year-old male patient received bnt162b2 (BNT162B2) intramuscular, first dose administered in Deltoid Right on 23Dec2020 (Batch/Lot number EH9899), second dose intramuscular, administered in Deltoid Right on 13Jan2021 (Batch/Lot number EK9231), bot at single dose for COVID-19 immunization. The patient medical history and patient's concomitant medications were none. The patient had a positive test for SARS-CoV2: Sars CoV-2 RNA PCR (Test for SARS-CoV-2 by PCR, or other commercial or public health assay) on 03Feb2021 (as reported): positive, new infection. The patient was not hospitalized, was not admitted to an intensive care unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. No new or worsened symptoms/signs during the COVID-19 illness experienced. The event did not require the initiation of new medication or other treatment or procedure. The patient was not taking any medications routinely prior to the event being reported. No pre-existing diseases was worsened during the SARS-CoV2 infection (please specify). No Prior Vaccination (within 4 weeks). Patient received COVID 19 vaccination on 23Dec2020 and 13Jan2021. Patient had an exposure to a symptomatic COVID 19. This patient was exposed to COVID by his child's caretaker prior to testing positive. infected individual who then tested positive for COVID 19 on 03Jan2021. This patient went for post exposure testing on 03Mar2021, tested positive for COVID 19, then developed symptoms of loss of taste and smell, headache, muscle aches, congestion. The outcome of the events was recovered on an unspecified date.; Sender's Comments: The 39-year-old male patient received bnt162b2 (BNT162B2), first dose on 23Dec2020, and second dose on 13Jan2021. On 03Mar2021, the patient tested positive for COVID 19, then developed symptoms of loss of taste and smell, headache, muscle aches and congestion.  Based on information available, Vaccination failure cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021389615 same reporter/vaccine, similar events, different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid infection with symptoms; Breakthrough Covid infection with symptoms; This is a spontaneous report from a contactable nurse and a physician. The nurse reported similar events for 11 patients. This is 6th of the 11 reports. A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in deltoid left on 23Dec2020 (Lot Number: EH9899) as single dose, second dose of BNT162B2 intramuscular in deltoid left on 12Jan2021 (Lot Number: EK9231) as single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient was not current smoker and unknown if former smoker. There were no Prior vaccinations. The patient experienced breakthrough COVID infection on 27Mar2021. The patient underwent lab tests and procedures which included Covid PCR nasopharyngeal swab on 30Mar2021 was positive and Covid PCR nasopharyngeal swab 31Mar2021 was positive. The patient was not hospitalized and not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not experience multiorgan failure, cardiovascular, gastrointestinal/hepatic, vascular, renal, neurological, altered consciousness, dermatological and other symptoms. The patient experienced respiratory and dyspnea. The patient experienced Slight SOB (short of breath) and sinus congestion on 27Mar2021. SOB was resolved on 30Mar2021. Sinus congestion was resolved on 01Apr2021. No treatment received. The outcome of the events was resolved in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently the lack of efficacy (Vaccination failure) of the vaccine BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021389615 Same reporter/ drug, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Condition aggravated, Cough
Clinical narrative: health has been getting worse; have pains in her chest and back; have pains in her chest and back; making it difficult to move, breathe and cough; making it difficult to move, breathe and cough; coughing; coughing up bloody phlegm; constant waves of fever; cold chills; swollen lymph nodes; earache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09May2021 09:30 (Lot Number: EURO182) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that for the last 6 days her health has been getting worse, she have pains in her chest and back, making it difficult to move, breathe and cough. She's coughing up bloody phlegm and go through constant waves of fever and cold chills. She have swollen lymph nodes right side with a terrible earache. The events started on 11May2021 08:00. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Haemoptysis, Lymphadenopathy, Movement disorder
Clinical narrative: health has been getting worse; have pains in her chest and back; have pains in her chest and back; making it difficult to move, breathe and cough; making it difficult to move, breathe and cough; coughing; coughing up bloody phlegm; constant waves of fever; cold chills; swollen lymph nodes; earache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09May2021 09:30 (Lot Number: EURO182) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that for the last 6 days her health has been getting worse, she have pains in her chest and back, making it difficult to move, breathe and cough. She's coughing up bloody phlegm and go through constant waves of fever and cold chills. She have swollen lymph nodes right side with a terrible earache. The events started on 11May2021 08:00. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: health has been getting worse; have pains in her chest and back; have pains in her chest and back; making it difficult to move, breathe and cough; making it difficult to move, breathe and cough; coughing; coughing up bloody phlegm; constant waves of fever; cold chills; swollen lymph nodes; earache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09May2021 09:30 (Lot Number: EURO182) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that for the last 6 days her health has been getting worse, she have pains in her chest and back, making it difficult to move, breathe and cough. She's coughing up bloody phlegm and go through constant waves of fever and cold chills. She have swollen lymph nodes right side with a terrible earache. The events started on 11May2021 08:00. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Dizziness, Gait disturbance
Clinical narrative: Weird side effect that felt like my brain was jiggling inside my head; dizziness; slight trouble walking; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 24 years of age), via an unspecified route of administration, administered in arm left on 30Apr2021 16:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The patient experienced weird side effect that felt like her brain was jiggling inside her head, dizziness, and slight trouble walking, all on 01May2021. Further ADR description stated that the patient had weird side effect that felt like her brain was jiggling inside her head. This lasted for two days after her second dosage. It caused dizziness and slight trouble walking sometimes.  The outcome of 'felt like her brain was jiggling inside her head' was recovered on 03May2021 (for 2 days) while outcome of other events was recovered on an unspecified date.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gastrointestinal pain, Hypoaesthesia, Insomnia
Clinical narrative: lot of dizziness / felt that patient is going to faint; Having lot of trouble getting out of the bed and not having somewhat balance; Nauseous / pretty severe nausea; Trouble sleeping; numbness; ache sometimes in the colon and it feels that I am going to faint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Lot number was not reported) as unknown, single dose for COVID-19 immunisation. Medical history included anaphylactic shock syndrome and allergies to some chemicals and fluids. The patient's concomitant medications were not reported. Patient stated, "I am having, I do get anaphylactic shock syndrome or symptoms with certain allergies to some chemicals and fluids." Patient had the vaccine on an unspecified date. On an unspecified date, patient had a lot of nausea and had trouble sleeping, Patient was so nauseous in the morning with pretty severe nausea that has ease somewhat. Patient also a had lot of dizziness. Patient was having lot of trouble getting out of the bed and not having somewhat balance. Patient claimed that these are usual signs that some kind of reaction patient experiences but patient doesn't consider it even though these are on the verge to be anaphylaxis problem usually. Patient stated "When I am actually on the road, I get numbness and ache sometimes in the colon and it feels that I am going to faint and I have not had that." Patient felt slightly better at the time of report. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: lot of dizziness / felt that patient is going to faint; Having lot of trouble getting out of the bed and not having somewhat balance; Nauseous / pretty severe nausea; Trouble sleeping; numbness; ache sometimes in the colon and it feels that I am going to faint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Lot number was not reported) as unknown, single dose for COVID-19 immunisation. Medical history included anaphylactic shock syndrome and allergies to some chemicals and fluids. The patient's concomitant medications were not reported. Patient stated, "I am having, I do get anaphylactic shock syndrome or symptoms with certain allergies to some chemicals and fluids." Patient had the vaccine on an unspecified date. On an unspecified date, patient had a lot of nausea and had trouble sleeping, Patient was so nauseous in the morning with pretty severe nausea that has ease somewhat. Patient also a had lot of dizziness. Patient was having lot of trouble getting out of the bed and not having somewhat balance. Patient claimed that these are usual signs that some kind of reaction patient experiences but patient doesn't consider it even though these are on the verge to be anaphylaxis problem usually. Patient stated "When I am actually on the road, I get numbness and ache sometimes in the colon and it feels that I am going to faint and I have not had that." Patient felt slightly better at the time of report. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Migraine
Clinical narrative: headaches; migraine; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; This is spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 36 years, on 08Apr2021 13:30 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not had other vaccines in four weeks prior to the COVID vaccine. Patient had no other medications in two weeks. The patient historically took the first dose of BNT162B2 (Batch/lot number: ER2613) on 17Mar2021 at 02:00 PM on the left arm COVID-19 immunization. Adverse event start date and time was 09Apr2021 at 06:00AM. Patient reported having continuing and persistent headaches since his vaccine. After his second vaccine, he experienced his first ever migraine and it was very intense. Maximum intensity lasted for about 6-8 hours. His endurance has also been greatly impacted and has not been be able to exert himself for any extended period of time. Ten minutes of light activity is about all that he could manage. At the time of report, patient was still experiencing headaches more frequently than ever before. No treatment was received for the events. The adverse events resulted in disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.     Information on Lot/Batch number has been obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspepsia, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: headaches; migraine; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; This is spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 36 years, on 08Apr2021 13:30 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not had other vaccines in four weeks prior to the COVID vaccine. Patient had no other medications in two weeks. The patient historically took the first dose of BNT162B2 (Batch/lot number: ER2613) on 17Mar2021 at 02:00 PM on the left arm COVID-19 immunization. Adverse event start date and time was 09Apr2021 at 06:00AM. Patient reported having continuing and persistent headaches since his vaccine. After his second vaccine, he experienced his first ever migraine and it was very intense. Maximum intensity lasted for about 6-8 hours. His endurance has also been greatly impacted and has not been be able to exert himself for any extended period of time. Ten minutes of light activity is about all that he could manage. At the time of report, patient was still experiencing headaches more frequently than ever before. No treatment was received for the events. The adverse events resulted in disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.     Information on Lot/Batch number has been obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Migraine, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: headaches; migraine; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; This is spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 36 years, on 08Apr2021 13:30 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not had other vaccines in four weeks prior to the COVID vaccine. Patient had no other medications in two weeks. The patient historically took the first dose of BNT162B2 (Batch/lot number: ER2613) on 17Mar2021 at 02:00 PM on the left arm COVID-19 immunization. Adverse event start date and time was 09Apr2021 at 06:00AM. Patient reported having continuing and persistent headaches since his vaccine. After his second vaccine, he experienced his first ever migraine and it was very intense. Maximum intensity lasted for about 6-8 hours. His endurance has also been greatly impacted and has not been be able to exert himself for any extended period of time. Ten minutes of light activity is about all that he could manage. At the time of report, patient was still experiencing headaches more frequently than ever before. No treatment was received for the events. The adverse events resulted in disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.     Information on Lot/Batch number has been obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: headaches; migraine; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; My endurance has also been greatly impacted and I have not been be able to exert myself for any extended period of time. Ten minutes of light activity is about all I manage.; This is spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 36 years, on 08Apr2021 13:30 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not had other vaccines in four weeks prior to the COVID vaccine. Patient had no other medications in two weeks. The patient historically took the first dose of BNT162B2 (Batch/lot number: ER2613) on 17Mar2021 at 02:00 PM on the left arm COVID-19 immunization. Adverse event start date and time was 09Apr2021 at 06:00AM. Patient reported having continuing and persistent headaches since his vaccine. After his second vaccine, he experienced his first ever migraine and it was very intense. Maximum intensity lasted for about 6-8 hours. His endurance has also been greatly impacted and has not been be able to exert himself for any extended period of time. Ten minutes of light activity is about all that he could manage. At the time of report, patient was still experiencing headaches more frequently than ever before. No treatment was received for the events. The adverse events resulted in disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.     Information on Lot/Batch number has been obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blister, Hypersensitivity, Investigation, Pain of skin
Clinical narrative: Chronic rash/ Break out; first, my skin has evaluated into a blisters; the blisters are so severe and they are unbearable; skin is hurting; Allergic reactions; This is a spontaneous report from a contactable consumer (patient). This 33-year-old female patient received  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172), via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 33-year-old) as single dose for COVID-19 immunization. Medical history included migraine, seasonal allergy, and ongoing asthma. Concomitant medications included sumatriptan succinate (IMITREX) taken for severe migraine, diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy, salbutamol (ALBUTEROL) taken for asthma, and acetylsalicylic acid/ caffeine/ paracetamol (EXCEDRIN MIGRANA) taken for mild migraine. The patient previously received the first dose of BNT162b2 (Lot number: ER8733) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 33-year-old) for COVID-19 immunization and experienced breakout onset on 08Apr2021, she went to emergency room, received antibiotics & recovered on 13Apr2021. The patient reported, "This breakout I experienced is way worsened. First, my skin has evaluated (erupted) into blisters (on 11May2021). I was fine until 2 days ago and I couldn't take the itching and scratches. The blisters are so severe, and they are unbearable. So, I went to the emergency room yesterday (13May2021), they had to do biopsy of my skin to test the skin; they cut two holes to do Pin test to make sure there was not a chronic rash. I have been prescribed medications for allergic reactions (May2021) and they gave me some ointment to put on my skin because my skin is hurting (May2021)" also reported as "an ointment to rub on the blisters that are the worse". Then she came home yesterday (13May2021). The patient also stated, "They gave me some prescriptions when I went to the emergency room to help with the allergic reactions: One of them is called cetirizine and that one is 10 mg tablet that they told me to take one tablet everyday by now and the other one is prednisone this one is 20 mg tablet to be taken three times daily by now." Referring to the result of the lab test (skin biopsy), she stated, "There was a nothing, there was chronic rash. The dermatologist she is the one who gave me these prescriptions that I just read up to you and I have to follow up with her on Monday (17May2021). The clinical outcome of the allergic reactions, skin blisters, chronic rash/ break out and skin is hurting was not resolved.  Additional information has been requested and will be provided as it becomes available.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550697 same patient, different vaccine dose/event
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Chronic rash/ Break out; first, my skin has evaluated into a blisters; the blisters are so severe and they are unbearable; skin is hurting; Allergic reactions; This is a spontaneous report from a contactable consumer (patient). This 33-year-old female patient received  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172), via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 33-year-old) as single dose for COVID-19 immunization. Medical history included migraine, seasonal allergy, and ongoing asthma. Concomitant medications included sumatriptan succinate (IMITREX) taken for severe migraine, diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy, salbutamol (ALBUTEROL) taken for asthma, and acetylsalicylic acid/ caffeine/ paracetamol (EXCEDRIN MIGRANA) taken for mild migraine. The patient previously received the first dose of BNT162b2 (Lot number: ER8733) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 33-year-old) for COVID-19 immunization and experienced breakout onset on 08Apr2021, she went to emergency room, received antibiotics & recovered on 13Apr2021. The patient reported, "This breakout I experienced is way worsened. First, my skin has evaluated (erupted) into blisters (on 11May2021). I was fine until 2 days ago and I couldn't take the itching and scratches. The blisters are so severe, and they are unbearable. So, I went to the emergency room yesterday (13May2021), they had to do biopsy of my skin to test the skin; they cut two holes to do Pin test to make sure there was not a chronic rash. I have been prescribed medications for allergic reactions (May2021) and they gave me some ointment to put on my skin because my skin is hurting (May2021)" also reported as "an ointment to rub on the blisters that are the worse". Then she came home yesterday (13May2021). The patient also stated, "They gave me some prescriptions when I went to the emergency room to help with the allergic reactions: One of them is called cetirizine and that one is 10 mg tablet that they told me to take one tablet everyday by now and the other one is prednisone this one is 20 mg tablet to be taken three times daily by now." Referring to the result of the lab test (skin biopsy), she stated, "There was a nothing, there was chronic rash. The dermatologist she is the one who gave me these prescriptions that I just read up to you and I have to follow up with her on Monday (17May2021). The clinical outcome of the allergic reactions, skin blisters, chronic rash/ break out and skin is hurting was not resolved.  Additional information has been requested and will be provided as it becomes available.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550697 same patient, different vaccine dose/event
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Eye irritation, Pain
Clinical narrative: Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; Body aches, chills, cold sweats, eyes burn.; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 13May2021 12:00 (Lot number was not reported) as single dose (at age of 34-year-old) for covid-19 immunisation. Medical history was reported as none. First dose of bnt162b2 (BNT162B2) was administered on 22Apr2021 12:00 PM in right arm (at age of 34-year-old) for covid-19 immunisation. Concomitant medication received within 2 weeks of vaccination included ibuprofen (IBUPROFEN). Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. On 13May2021 16:30 patient experienced body aches, chills, cold sweats, eyes burn. Patient had not recovered from the events at the time of the report. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Disorientation, Dizziness, Hypoaesthesia
Clinical narrative: Severe Nausea; Diarrhea; Light-headed / Dizziness; Weakness; got weak legs; Weakness; got weak legs; Numbness in legs; Mild disorientation every now and then; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170), via an unspecified route of administration on 06May2021 (at the age of 36-years-old) at 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included bupropion, citalopram, and propranolol. Historical vaccine included first dose of BNT162B2 (lot number: EW0153) taken on 15Apr2021 at the age of 36-years-old for COVID-19 immunization. The reporter stated that 5 hours after the second shot of BNT162B2, on May2021, the patient experienced severe nausea, diarrhea, light-headedness, and dizziness. The patient also had weakness, weak legs, numbness in her legs, and mild disorientation every now and then. The patient was brought to the hospital twice at the emergency room for these. The reporter stated that in the emergency room, the patient was only given anti-nausea medication, like ondansetron (ZOFRAN), and nothing else. Outcome of all the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea
Clinical narrative: Severe Nausea; Diarrhea; Light-headed / Dizziness; Weakness; got weak legs; Weakness; got weak legs; Numbness in legs; Mild disorientation every now and then; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0170), via an unspecified route of administration on 06May2021 (at the age of 36-years-old) at 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included bupropion, citalopram, and propranolol. Historical vaccine included first dose of BNT162B2 (lot number: EW0153) taken on 15Apr2021 at the age of 36-years-old for COVID-19 immunization. The reporter stated that 5 hours after the second shot of BNT162B2, on May2021, the patient experienced severe nausea, diarrhea, light-headedness, and dizziness. The patient also had weakness, weak legs, numbness in her legs, and mild disorientation every now and then. The patient was brought to the hospital twice at the emergency room for these. The reporter stated that in the emergency room, the patient was only given anti-nausea medication, like ondansetron (ZOFRAN), and nothing else. Outcome of all the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Started to have hives all over my body, extra over in my chest and stomach area.; it was so kind of itching this morning; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Apr2021 (Lot Number: EW0169) (at 23-year-old) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included dormant asthma when she was kid. There's other products (unspecified). The patient reported she had been having some vaccine reaction she believed, but she went to the doctor today and they believed it to an environmental reaction but, she got the vaccine on "Sunday" (18Apr2021), the evening before around 11 pm, she started to have hives all over my body, extra over in chest and stomach area and then she called like UCM App which was registered doctor provider. They told me to take antihistamine so, took two diphenhydramine hydrochloride (BENADRYL) and the "last night" around 11 o' clock it came back still like around 24 hours and she took couple of more diphenhydramine and it was so kind of itching this morning, she took one more, but she was concern she went to the doctor, they said she reported these kind of symptoms. She had like reaction before (further clarification unknown) but this probably the most severe but she didn't believe that was an environmental was just the correlation between she getting the vaccine. The outcome of event hives was unknown, of event itching was resolving. (the second dose and further course refer to AER 2021552482)