chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: getting stuffed; runny nose; little cold; She had been exposed to Covid-19; She had been exposed to Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 10:30 (Lot number: FF2589) as dose 3  booster ,single for covid-19 immunisation. Relevant medical history included: "Anorexia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Time: Approx. 10:30 AM, Anatomical Site of injection: Right Arm, Batch/Lot No: ER8731), administration date: 16Jul2021, when the patient was 13 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Time: Approx. 11:00 AM, Anatomical Site of injection: Right Arm, Batch/Lot No: EW0171), administration date: 06Aug2021, when the patient was 13 years old, for COVID-19 Immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "She had been exposed to Covid-19"; FEELING ABNORMAL (non-serious) with onset 15Jan2022, outcome "unknown", described as "getting stuffed"; RHINORRHOEA (non-serious) with onset 15Jan2022, outcome "unknown", described as "runny nose"; NASOPHARYNGITIS (non-serious) with onset 15Jan2022, outcome "unknown", described as "little cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive.  Additional Information:Vaccine was not administered at military Facility.No prior vaccinations were done.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: getting stuffed; runny nose; little cold; She had been exposed to Covid-19; She had been exposed to Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 10:30 (Lot number: FF2589) as dose 3  booster ,single for covid-19 immunisation. Relevant medical history included: "Anorexia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Time: Approx. 10:30 AM, Anatomical Site of injection: Right Arm, Batch/Lot No: ER8731), administration date: 16Jul2021, when the patient was 13 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Time: Approx. 11:00 AM, Anatomical Site of injection: Right Arm, Batch/Lot No: EW0171), administration date: 06Aug2021, when the patient was 13 years old, for COVID-19 Immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "She had been exposed to Covid-19"; FEELING ABNORMAL (non-serious) with onset 15Jan2022, outcome "unknown", described as "getting stuffed"; RHINORRHOEA (non-serious) with onset 15Jan2022, outcome "unknown", described as "runny nose"; NASOPHARYNGITIS (non-serious) with onset 15Jan2022, outcome "unknown", described as "little cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive.  Additional Information:Vaccine was not administered at military Facility.No prior vaccinations were done.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: pt developed a large CVA -5 hours after getting the vaccine dose; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Feb2022 08:00 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant) with onset 24Feb2022 12:00, outcome "not recovered", described as "pt developed a large CVA -5 hours after getting the vaccine dose". The event "pt developed a large cva -5 hours after getting the vaccine dose" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical summary: Patient underwent CVA treatment. It was unknown whether the patient took other vaccine in four weeks. It was unknown whether patient had covid prior vaccination. The patient was not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event cerebrovascular accident and the suspect drug BNT162B2 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Incorrect dose administered, Pain, Pyrexia
Clinical narrative: Receive their 4th dose of the Pfizer Covid-19 vaccine; Fever; Chills; Headache; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2022 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, Got the booster , Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 24Feb2022, outcome "unknown", described as "Receive their 4th dose of the Pfizer Covid-19 vaccine"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset Feb2022, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the vaccine in March or April last year and then I got Covid pretty bad in August; the vaccine in March or April last year and then I got Covid pretty bad in August; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "the vaccine in March or April last year and then I got Covid pretty bad in August". The patient was concerned, had the shot, the vaccine in March or April last year & then got Covid pretty bad in August & then had the booster in October and now all of a sudden smell burning all the time, for like two months now had been smelling burning in house and searched everywhere & then all whatever the clothes wear whatever under arm started swelling up and today whole chest was swollen almost like it was like it was fluid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Chest Pains; Extreme cough and congestion; Extreme cough and congestion; Hard to breath; Fatigue and Weak; Fatigue and Weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 15:00 (Lot number: FE5180) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 13Aug2021, when the patient was 16 years old, for COVID-19 Immunization.  The following information was reported: CHEST PAIN (non-serious) with onset 03Sep2021 19:00, outcome "not recovered", described as "Chest Pains"; COUGH (non-serious), NASAL CONGESTION (non-serious) all with onset 03Sep2021 19:00, outcome "not recovered" and all described as "Extreme cough and congestion"; DYSPNOEA (non-serious) with onset 03Sep2021 19:00, outcome "not recovered", described as "Hard to breath"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 03Sep2021 19:00, outcome "not recovered" and all described as "Fatigue and Weak". The events "chest pains", "extreme cough and congestion", "extreme cough and congestion", "hard to breath", "fatigue and weak" and "fatigue and weak" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, cough, nasal congestion, dyspnoea, fatigue, asthenia.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Since vaccination, the patient tested for COVID-19. The patient has no known allergies.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test
Clinical narrative: Chest Pains; Extreme cough and congestion; Extreme cough and congestion; Hard to breath; Fatigue and Weak; Fatigue and Weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 15:00 (Lot number: FE5180) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 13Aug2021, when the patient was 16 years old, for COVID-19 Immunization.  The following information was reported: CHEST PAIN (non-serious) with onset 03Sep2021 19:00, outcome "not recovered", described as "Chest Pains"; COUGH (non-serious), NASAL CONGESTION (non-serious) all with onset 03Sep2021 19:00, outcome "not recovered" and all described as "Extreme cough and congestion"; DYSPNOEA (non-serious) with onset 03Sep2021 19:00, outcome "not recovered", described as "Hard to breath"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 03Sep2021 19:00, outcome "not recovered" and all described as "Fatigue and Weak". The events "chest pains", "extreme cough and congestion", "extreme cough and congestion", "hard to breath", "fatigue and weak" and "fatigue and weak" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, cough, nasal congestion, dyspnoea, fatigue, asthenia.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Since vaccination, the patient tested for COVID-19. The patient has no known allergies.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Feb2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Feb2022) neg, notes: Neg ag test 23Feb and 24Feb; (24Feb2022) neg, notes: Neg ag test 23Feb and 24Feb; (25Feb2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient was diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. The patient was exposed at dinner party 17Feb then cough 22Feb then neg ag test 23Feb and 24Feb and positive AG on 25Feb.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia oral
Clinical narrative: Strange taste; Severe itching inside throat; Numb lips; Skin rash; Dizziness; Nauseous; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Wheezing; Full body rash; Stomach pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 15:00 (Lot number: FM0698) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: TASTE DISORDER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Strange taste"; THROAT IRRITATION (medically significant) with onset 25Feb2022, outcome "unknown", described as "Severe itching inside throat"; HYPOAESTHESIA ORAL (medically significant) with onset 25Feb2022, outcome "unknown", described as "Numb lips"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Skin rash"; DIZZINESS (medically significant) with onset 25Feb2022, outcome "unknown", described as "Dizziness"; NAUSEA (medically significant) with onset 25Feb2022, outcome "unknown", described as "Nauseous"; DYSPNOEA (medically significant), DYSPHAGIA (medically significant), SPEECH DISORDER (medically significant) all with onset 25Feb2022, outcome "unknown" and all described as "Difficulty breathing, swallowing and talking"; WHEEZING (medically significant) with onset 25Feb2022, outcome "unknown", described as "Wheezing"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Full body rash"; ABDOMINAL PAIN UPPER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Stomach pain". The events "strange taste", "severe itching inside throat", "numb lips", "skin rash", "dizziness", "nauseous", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "wheezing", "full body rash" and "stomach pain" were evaluated at the emergency room visit or department of urgent care. As the therapeutic measures IV Benadryl and IV steroids were taken as a result of taste disorder, throat irritation, hypoaesthesia oral, rash, dizziness, nausea, dyspnoea, dysphagia, speech disorder, wheezing, rash, abdominal pain upper. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Speech disorder, Taste disorder, Throat irritation
Clinical narrative: Strange taste; Severe itching inside throat; Numb lips; Skin rash; Dizziness; Nauseous; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Wheezing; Full body rash; Stomach pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 15:00 (Lot number: FM0698) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: TASTE DISORDER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Strange taste"; THROAT IRRITATION (medically significant) with onset 25Feb2022, outcome "unknown", described as "Severe itching inside throat"; HYPOAESTHESIA ORAL (medically significant) with onset 25Feb2022, outcome "unknown", described as "Numb lips"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Skin rash"; DIZZINESS (medically significant) with onset 25Feb2022, outcome "unknown", described as "Dizziness"; NAUSEA (medically significant) with onset 25Feb2022, outcome "unknown", described as "Nauseous"; DYSPNOEA (medically significant), DYSPHAGIA (medically significant), SPEECH DISORDER (medically significant) all with onset 25Feb2022, outcome "unknown" and all described as "Difficulty breathing, swallowing and talking"; WHEEZING (medically significant) with onset 25Feb2022, outcome "unknown", described as "Wheezing"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Full body rash"; ABDOMINAL PAIN UPPER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Stomach pain". The events "strange taste", "severe itching inside throat", "numb lips", "skin rash", "dizziness", "nauseous", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "wheezing", "full body rash" and "stomach pain" were evaluated at the emergency room visit or department of urgent care. As the therapeutic measures IV Benadryl and IV steroids were taken as a result of taste disorder, throat irritation, hypoaesthesia oral, rash, dizziness, nausea, dyspnoea, dysphagia, speech disorder, wheezing, rash, abdominal pain upper. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Strange taste; Severe itching inside throat; Numb lips; Skin rash; Dizziness; Nauseous; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Wheezing; Full body rash; Stomach pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 15:00 (Lot number: FM0698) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: TASTE DISORDER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Strange taste"; THROAT IRRITATION (medically significant) with onset 25Feb2022, outcome "unknown", described as "Severe itching inside throat"; HYPOAESTHESIA ORAL (medically significant) with onset 25Feb2022, outcome "unknown", described as "Numb lips"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Skin rash"; DIZZINESS (medically significant) with onset 25Feb2022, outcome "unknown", described as "Dizziness"; NAUSEA (medically significant) with onset 25Feb2022, outcome "unknown", described as "Nauseous"; DYSPNOEA (medically significant), DYSPHAGIA (medically significant), SPEECH DISORDER (medically significant) all with onset 25Feb2022, outcome "unknown" and all described as "Difficulty breathing, swallowing and talking"; WHEEZING (medically significant) with onset 25Feb2022, outcome "unknown", described as "Wheezing"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Full body rash"; ABDOMINAL PAIN UPPER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Stomach pain". The events "strange taste", "severe itching inside throat", "numb lips", "skin rash", "dizziness", "nauseous", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "wheezing", "full body rash" and "stomach pain" were evaluated at the emergency room visit or department of urgent care. As the therapeutic measures IV Benadryl and IV steroids were taken as a result of taste disorder, throat irritation, hypoaesthesia oral, rash, dizziness, nausea, dyspnoea, dysphagia, speech disorder, wheezing, rash, abdominal pain upper. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Haematemesis
Clinical narrative: I was trying to vomit blood twice; Having a lot of pain in the site that I was taken in; both arms that began to hurt; my back began to hurt; Tiredness; Headache; Muscle pain; Chills; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset Feb2022, outcome "unknown", described as "I was trying to vomit blood twice"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Having a lot of pain in the site that I was taken in"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "both arms that began to hurt"; BACK PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "my back began to hurt"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle pain"; CHILLS (non-serious) with onset Feb2022, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain". Clinical course: The patient stated that  was having a side effect from the (Pfizer Covid-19 Vaccine) that  patient had taken because was having a lot of pain in the site that patient was taken in. It was both arms that began to hurt and patient's back began to hurt and had been having tiredness, headache, muscle pain, chills and joint pain and occasionally and a couple of days ago patient was trying to vomit blood twice.Patient stated that patient had excruciating amount of pain and had been taking a lot of pain from it (vaccine) lately but don't have the pain always, it just off and on pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: I was trying to vomit blood twice; Having a lot of pain in the site that I was taken in; both arms that began to hurt; my back began to hurt; Tiredness; Headache; Muscle pain; Chills; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset Feb2022, outcome "unknown", described as "I was trying to vomit blood twice"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Having a lot of pain in the site that I was taken in"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "both arms that began to hurt"; BACK PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "my back began to hurt"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle pain"; CHILLS (non-serious) with onset Feb2022, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain". Clinical course: The patient stated that  was having a side effect from the (Pfizer Covid-19 Vaccine) that  patient had taken because was having a lot of pain in the site that patient was taken in. It was both arms that began to hurt and patient's back began to hurt and had been having tiredness, headache, muscle pain, chills and joint pain and occasionally and a couple of days ago patient was trying to vomit blood twice.Patient stated that patient had excruciating amount of pain and had been taking a lot of pain from it (vaccine) lately but don't have the pain always, it just off and on pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Headache
Clinical narrative: I was trying to vomit blood twice; Having a lot of pain in the site that I was taken in; both arms that began to hurt; my back began to hurt; Tiredness; Headache; Muscle pain; Chills; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset Feb2022, outcome "unknown", described as "I was trying to vomit blood twice"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Having a lot of pain in the site that I was taken in"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "both arms that began to hurt"; BACK PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "my back began to hurt"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle pain"; CHILLS (non-serious) with onset Feb2022, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain". Clinical course: The patient stated that  was having a side effect from the (Pfizer Covid-19 Vaccine) that  patient had taken because was having a lot of pain in the site that patient was taken in. It was both arms that began to hurt and patient's back began to hurt and had been having tiredness, headache, muscle pain, chills and joint pain and occasionally and a couple of days ago patient was trying to vomit blood twice.Patient stated that patient had excruciating amount of pain and had been taking a lot of pain from it (vaccine) lately but don't have the pain always, it just off and on pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Myalgia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: I was trying to vomit blood twice; Having a lot of pain in the site that I was taken in; both arms that began to hurt; my back began to hurt; Tiredness; Headache; Muscle pain; Chills; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset Feb2022, outcome "unknown", described as "I was trying to vomit blood twice"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Having a lot of pain in the site that I was taken in"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "both arms that began to hurt"; BACK PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "my back began to hurt"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle pain"; CHILLS (non-serious) with onset Feb2022, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain". Clinical course: The patient stated that  was having a side effect from the (Pfizer Covid-19 Vaccine) that  patient had taken because was having a lot of pain in the site that patient was taken in. It was both arms that began to hurt and patient's back began to hurt and had been having tiredness, headache, muscle pain, chills and joint pain and occasionally and a couple of days ago patient was trying to vomit blood twice.Patient stated that patient had excruciating amount of pain and had been taking a lot of pain from it (vaccine) lately but don't have the pain always, it just off and on pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Respiratory rate increased, Vomiting
Clinical narrative: I was trying to vomit blood twice; Having a lot of pain in the site that I was taken in; both arms that began to hurt; my back began to hurt; Tiredness; Headache; Muscle pain; Chills; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: HAEMATEMESIS (medically significant) with onset Feb2022, outcome "unknown", described as "I was trying to vomit blood twice"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "Having a lot of pain in the site that I was taken in"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "both arms that began to hurt"; BACK PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "my back began to hurt"; FATIGUE (non-serious) with onset Feb2022, outcome "unknown", described as "Tiredness"; HEADACHE (non-serious) with onset Feb2022, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Muscle pain"; CHILLS (non-serious) with onset Feb2022, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "unknown", described as "Joint pain". Clinical course: The patient stated that  was having a side effect from the (Pfizer Covid-19 Vaccine) that  patient had taken because was having a lot of pain in the site that patient was taken in. It was both arms that began to hurt and patient's back began to hurt and had been having tiredness, headache, muscle pain, chills and joint pain and occasionally and a couple of days ago patient was trying to vomit blood twice.Patient stated that patient had excruciating amount of pain and had been taking a lot of pain from it (vaccine) lately but don't have the pain always, it just off and on pain.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cold type haemolytic anaemia, Haemolytic anaemia, SARS-CoV-2 test
Clinical narrative: Hemolytic anemia; Cold agglutinin disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: FH8030) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medication(s) included: SERTRALINE, within 2 weeks of vaccination. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. 016B21A, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 42 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 029A21A, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: HAEMOLYTIC ANAEMIA (hospitalization, medically significant) with onset 05Dec2021, outcome "not recovered", described as "Hemolytic anemia"; COLD TYPE HAEMOLYTIC ANAEMIA (hospitalization, medically significant) with onset 05Dec2021, outcome "not recovered", described as "Cold agglutinin disease". The patient was hospitalized for haemolytic anaemia, cold type haemolytic anaemia (hospitalization duration: 14 day(s)). The events "hemolytic anemia" and "cold agglutinin disease" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Since the vaccination, the patient has been tested for COVID-19, sars-cov-2 test: (22Dec2021) negative. Therapeutic measures were taken as a result of haemolytic anaemia, cold type haemolytic anaemia included Blood transfusion, IVIG.   Reported Event: After the 3rd booster COVID vaccine with Pfizer, I developed haemolytic anaemia, cold agglutinin disease. I am still suffering from this illness and doctors have no much information about it. The patient did not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Severe headache; Fever; Chills; Weakness; Muscle pain; Joint pain; Extreme exhaustion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2022 (Lot number: FF2590) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC. Past drug history included: Bactrim, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: ER8736, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Batch/Lot number: EW0178, Location of injection: Arm Left), administration date: 22May2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Severe headache", "fever", "chills", "weakness", "muscle pain", "Joint pain". The following information was reported: HEADACHE (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Severe headache"; PYREXIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Fever"; CHILLS (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Chills"; ASTHENIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Weakness"; MYALGIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Joint pain"; FATIGUE (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Extreme exhaustion". Therapeutic measures were taken as a result of headache, pyrexia, chills, asthenia, myalgia, arthralgia, fatigue.  Additional information: Treatment received: Pain pills (unspecified). Events were reported as non-serious. No other vaccines received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe headache; Fever; Chills; Weakness; Muscle pain; Joint pain; Extreme exhaustion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2022 (Lot number: FF2590) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC. Past drug history included: Bactrim, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: ER8736, Location of injection: Arm Left), administration date: 30Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Batch/Lot number: EW0178, Location of injection: Arm Left), administration date: 22May2021, when the patient was 64 years old, for COVID-19 Immunization, reaction(s): "Severe headache", "fever", "chills", "weakness", "muscle pain", "Joint pain". The following information was reported: HEADACHE (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Severe headache"; PYREXIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Fever"; CHILLS (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Chills"; ASTHENIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Weakness"; MYALGIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Joint pain"; FATIGUE (non-serious) with onset 18Feb2022 02:00, outcome "recovered with sequelae" (2022), described as "Extreme exhaustion". Therapeutic measures were taken as a result of headache, pyrexia, chills, asthenia, myalgia, arthralgia, fatigue.  Additional information: Treatment received: Pain pills (unspecified). Events were reported as non-serious. No other vaccines received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Hypersensitivity, Muscular weakness, Peripheral swelling
Clinical narrative: Swelling in her hands/the swelling went down mostly, but not completely/left arm had the more intense swelling; experiencing redness, like a glove effect where the redness cuts off at the wrist; Burning and when using her hands a lot she experiences hypersensitivity and loss of strength; Burning and when using her hands a lot she experiences hypersensitivity and loss of strength; Burning and when using her hands a lot she experiences hypersensitivity and loss of strength; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-022222-4609.  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RESTYLANE, start date: 2013. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Swelling in her hands/the swelling went down mostly, but not completely/left arm had the more intense swelling"; ERYTHEMA (non-serious), outcome "not recovered", described as "experiencing redness, like a glove effect where the redness cuts off at the wrist"; BURNING SENSATION (non-serious), HYPERSENSITIVITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "not recovered" and all described as "Burning and when using her hands a lot she experiences hypersensitivity and loss of strength". Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient reported the day after her injection with Restylane in the hands she developed swelling in her hands and after a few days was started on a prednisone dose pack and antibiotics fearing an infection. Patient stated the prednisone helped the swelling but now since the swelling went down mostly, but not completely, she had been experiencing redness, like a glove effect where the redness cuts off at the wrist, burning and when using her hands a lot she experienced hypersensitivity and loss of strength, and that all symptoms were still ongoing since Oct. Patient reported that she got the first dose of Covid 19 vaccine by Pfizer the day before she was injected with Restylane. NP stated she believed this reaction was since she got the Covid vaccine and not as much from the Restylane because she had Restylane in the past, several times since 2013, as well as Juvederm and Sculptra all with no problems. She got the Covid vaccine in her left arm and her left arm had the more intense swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID case confirmed by PCR; Breakthrough COVID case confirmed by PCR; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Dec2021 (Lot number: FD7218) as dose 3 (booster), single, administration date 12Apr2021 (Lot number: EL3247) as dose 2, single and administration date 22Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 18Feb2022, outcome "recovering" and all described as "Breakthrough COVID case confirmed by PCR". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.