chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Nausea, Vertigo
Clinical narrative: awakened at 4 am with severe vertigo, faded within a few hours.; Then 5 days later, awakened at 5am with severe vertigo and nausea; Then 5 days later, awakened at 5am with severe vertigo and nausea; felt drained and unstable all day; and sense of " falling up " in bed- had drained feeling and headache all day.; felt drained and unstable all day; This is a spontaneous report received from a contactable Nurse (patient reported for self). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: ER8729), via an unspecified route of administration, administered in arm left on 08Apr2021 at 15:00 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization at Public Health Clinic/Veterans Administration facility. The patient medical history included known allergies to penicillin and latex. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Demerol and vancomycin and experienced allergy (drug hypersensitivity). Prior vaccinations within 4 weeks were reported as none. The patient did not have COVID prior vaccination. Reported as, first dose on 4/8- no side effects until 5 days later, on 13Apr2021 at 04:00 the patient reported to have awakened at 4 am with severe vertigo, faded within a few hours. Then 5 days later (also reported as 7 days later), awakened at 5am (unspecified date) with severe vertigo and nausea lasting several hours, felt drained and unstable all day and sense of "falling up" in bed- had drained feeling and headache all day. Patient stated to have NEVER had vertigo before, patient had no symptoms of any vestibular disorder- this is a random, bizarre side effect that is happening to others getting the Pfizer Covid vaccine. Adverse events required physician office visit. Therapeutic measures were taken as a result of the events which included treatment with meclizine, ondansetron, rest and chiropractic. Since the vaccination, patient was not tested for COVID. The outcome of the event Vertigo was recovering; outcome of the other events was unknown.  No follow-up attempts are required. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Vertigo
Clinical narrative: awakened at 4 am with severe vertigo, faded within a few hours.; Then 5 days later, awakened at 5am with severe vertigo and nausea; Then 5 days later, awakened at 5am with severe vertigo and nausea; felt drained and unstable all day; and sense of " falling up " in bed- had drained feeling and headache all day.; felt drained and unstable all day; This is a spontaneous report received from a contactable Nurse (patient reported for self). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: ER8729), via an unspecified route of administration, administered in arm left on 08Apr2021 at 15:00 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization at Public Health Clinic/Veterans Administration facility. The patient medical history included known allergies to penicillin and latex. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Demerol and vancomycin and experienced allergy (drug hypersensitivity). Prior vaccinations within 4 weeks were reported as none. The patient did not have COVID prior vaccination. Reported as, first dose on 4/8- no side effects until 5 days later, on 13Apr2021 at 04:00 the patient reported to have awakened at 4 am with severe vertigo, faded within a few hours. Then 5 days later (also reported as 7 days later), awakened at 5am (unspecified date) with severe vertigo and nausea lasting several hours, felt drained and unstable all day and sense of "falling up" in bed- had drained feeling and headache all day. Patient stated to have NEVER had vertigo before, patient had no symptoms of any vestibular disorder- this is a random, bizarre side effect that is happening to others getting the Pfizer Covid vaccine. Adverse events required physician office visit. Therapeutic measures were taken as a result of the events which included treatment with meclizine, ondansetron, rest and chiropractic. Since the vaccination, patient was not tested for COVID. The outcome of the event Vertigo was recovering; outcome of the other events was unknown.  No follow-up attempts are required. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0179) via an unspecified route of administration in the left arm on 13May2021 at 13:00 (at the age of 13-years-old), as a DOSE 1, SINGLE for COVID-19 immunisation. The patient had no relevant medical history and concomitant medications. The patient had no known allergies to medications, food or other products. The patient was not pregnant at time of vaccination. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18May2021 at 09:00, the patient experienced urticaria. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of urticaria and included treatment with antihistamines and topical steroids. The clinical outcome of the event urticaria was not recovered at the time of this report.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo; This is a spontaneous report from a contactable consumer(patient). A 56-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: EN6201), via an unspecified route, administered in Arm Left on 05Mar2021 at 14:30 (at the age of 53years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included addison's disease, ankylosing spondylitis, type 2 diabetes mellitus, alopecia scarring, and knee arthroplasty (just had 2 knee replacements), hypersensitivity (Known allergies: Yes), were from an unknown date and unknown if ongoing just had 2 knee replacements. Concomitant medications included hydrocortisone (CORTEF [HYDROCORTISONE]); metoprolol tartrate (LOPRESSOR); empagliflozin (JARDIANCE); venlafaxine hydrochloride (EFFEXOR), were taken for an unspecified indication, start and stop date were not reported. The patient received no other vaccine in four weeks. The covid prior vaccination and covid tested post vaccination was no. On 07Mar2021 at 18:00, the patient experienced severe vertigo (3 days after 1st dose). The patient was treated with meclizine. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263996 same reporter/drug/event, different patient
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: severe diarrhea; sick to her stomach; sore throat; congestion; runny nose; severe headache; dizziness; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA7484), via an unspecified route of administration, administered in right arm on 29Jul2021 11:55 (at the age of 12 years) as dose 1, single for COVID-19 immunization. The patient medical history included kidney contusion since she was 2 years; weak immune system, asthma and allergies diagnosed around 4 years old; urinary tract infection. Her little brother has asthma and allergies too. The patient's concomitant medications included over the counter medications for allergies. History of all previous immunization with the pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. On 29Jul2021 12:10 (immediately after receiving the vaccine, within 15 minutes) the patient experienced a severe headache and dizziness. On 30Jul2021 01:00 (Last night) she woke up with severe diarrhea, sick to her stomach, sore throat, congestion with runny nose. All the symptoms were persisting. The events did not require emergency room or physician office visit. The reporter would like to know if this was normal for her daughter to experience side effects after the first dose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Headache, Nasal congestion
Clinical narrative: severe diarrhea; sick to her stomach; sore throat; congestion; runny nose; severe headache; dizziness; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA7484), via an unspecified route of administration, administered in right arm on 29Jul2021 11:55 (at the age of 12 years) as dose 1, single for COVID-19 immunization. The patient medical history included kidney contusion since she was 2 years; weak immune system, asthma and allergies diagnosed around 4 years old; urinary tract infection. Her little brother has asthma and allergies too. The patient's concomitant medications included over the counter medications for allergies. History of all previous immunization with the pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. On 29Jul2021 12:10 (immediately after receiving the vaccine, within 15 minutes) the patient experienced a severe headache and dizziness. On 30Jul2021 01:00 (Last night) she woke up with severe diarrhea, sick to her stomach, sore throat, congestion with runny nose. All the symptoms were persisting. The events did not require emergency room or physician office visit. The reporter would like to know if this was normal for her daughter to experience side effects after the first dose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: severe diarrhea; sick to her stomach; sore throat; congestion; runny nose; severe headache; dizziness; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA7484), via an unspecified route of administration, administered in right arm on 29Jul2021 11:55 (at the age of 12 years) as dose 1, single for COVID-19 immunization. The patient medical history included kidney contusion since she was 2 years; weak immune system, asthma and allergies diagnosed around 4 years old; urinary tract infection. Her little brother has asthma and allergies too. The patient's concomitant medications included over the counter medications for allergies. History of all previous immunization with the pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations (within 4 weeks) were none. AE(s) following prior vaccinations were none. On 29Jul2021 12:10 (immediately after receiving the vaccine, within 15 minutes) the patient experienced a severe headache and dizziness. On 30Jul2021 01:00 (Last night) she woke up with severe diarrhea, sick to her stomach, sore throat, congestion with runny nose. All the symptoms were persisting. The events did not require emergency room or physician office visit. The reporter would like to know if this was normal for her daughter to experience side effects after the first dose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Trigeminal neuralgia
Clinical narrative: Dizziness; Trigeminal neuralgia on left side of neck and face; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 25Mar2021 at 13:15 (age at vaccination: 62 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history included blood pressure increased (elevated blood pressure) and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 08May2021 at 20:00, the patient experienced dizziness and trigeminal neuralgia on left side of neck and face. The events had resulted in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events which included treatment with steroid (MANUFACTURER UNKNOWN). It was a 7day prescription. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and trigeminal neuralgia on left side of neck and face was recovering at the time of report.   The lot number for the vaccine [BNT162b2] was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Chills, Facial pain
Clinical narrative: Severe hip and lower back pain; Severe hip and lower back pain; severe chills; face ache; sharp stabbing in arms and legs; T 100.0; This is a spontaneous report from contactable old female Nurse (Patient) who reported for herself.  A 62-years-old non-pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was FF2589) via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at 16:30) (age at time of vaccination was 62-years-old) as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EX9231) via an unspecified route of administration, administered in Arm Left on 12Jan2021 (at 14:00) as a DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EJ1685) via an unspecified route of administration, administered in Arm Left on 22Dec2020 (at 14:00) as a DOSE 1, SINGLE for COVID-19 immunization. On 02Oct2021 (at 03:30), the patient experienced Severe hip and lower back pain, severe chills, face ache, sharp stabbing in arms and legs and T 100.0. Additional Information: Severe hip and lower back pain started after the second dose and was unable to get relief from going to the Chiropractor. Pains became worst after the third dose (could not bend or sit with excruciating pain), severe chills, face ache, sharp stabbing in arms and legs and T 100.0. All symptoms lasted for one day Saturday, 02Oct2021, however lower back and hip pain still persisted. The patient received Chiropractor as a treatment medication for adverse events. The clinical outcome of severe chills, face ache, sharp stabbing in arms and legs and T 100.0 was recovered, while the clinical outcome of Severe hip and lower back pain was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe hip and lower back pain; Severe hip and lower back pain; severe chills; face ache; sharp stabbing in arms and legs; T 100.0; This is a spontaneous report from contactable old female Nurse (Patient) who reported for herself.  A 62-years-old non-pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was FF2589) via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at 16:30) (age at time of vaccination was 62-years-old) as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EX9231) via an unspecified route of administration, administered in Arm Left on 12Jan2021 (at 14:00) as a DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EJ1685) via an unspecified route of administration, administered in Arm Left on 22Dec2020 (at 14:00) as a DOSE 1, SINGLE for COVID-19 immunization. On 02Oct2021 (at 03:30), the patient experienced Severe hip and lower back pain, severe chills, face ache, sharp stabbing in arms and legs and T 100.0. Additional Information: Severe hip and lower back pain started after the second dose and was unable to get relief from going to the Chiropractor. Pains became worst after the third dose (could not bend or sit with excruciating pain), severe chills, face ache, sharp stabbing in arms and legs and T 100.0. All symptoms lasted for one day Saturday, 02Oct2021, however lower back and hip pain still persisted. The patient received Chiropractor as a treatment medication for adverse events. The clinical outcome of severe chills, face ache, sharp stabbing in arms and legs and T 100.0 was recovered, while the clinical outcome of Severe hip and lower back pain was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Facial pain, Pain in extremity
Clinical narrative: Severe hip and lower back pain; Severe hip and lower back pain; severe chills; face ache; sharp stabbing in arms and legs; T 100.0; This is a spontaneous report from contactable old female Nurse (Patient) who reported for herself.  A 62-years-old non-pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was FF2589) via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at 16:30) (age at time of vaccination was 62-years-old) as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EX9231) via an unspecified route of administration, administered in Arm Left on 12Jan2021 (at 14:00) as a DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EJ1685) via an unspecified route of administration, administered in Arm Left on 22Dec2020 (at 14:00) as a DOSE 1, SINGLE for COVID-19 immunization. On 02Oct2021 (at 03:30), the patient experienced Severe hip and lower back pain, severe chills, face ache, sharp stabbing in arms and legs and T 100.0. Additional Information: Severe hip and lower back pain started after the second dose and was unable to get relief from going to the Chiropractor. Pains became worst after the third dose (could not bend or sit with excruciating pain), severe chills, face ache, sharp stabbing in arms and legs and T 100.0. All symptoms lasted for one day Saturday, 02Oct2021, however lower back and hip pain still persisted. The patient received Chiropractor as a treatment medication for adverse events. The clinical outcome of severe chills, face ache, sharp stabbing in arms and legs and T 100.0 was recovered, while the clinical outcome of Severe hip and lower back pain was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Severe hip and lower back pain; Severe hip and lower back pain; severe chills; face ache; sharp stabbing in arms and legs; T 100.0; This is a spontaneous report from contactable old female Nurse (Patient) who reported for herself.  A 62-years-old non-pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was FF2589) via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at 16:30) (age at time of vaccination was 62-years-old) as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EX9231) via an unspecified route of administration, administered in Arm Left on 12Jan2021 (at 14:00) as a DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EJ1685) via an unspecified route of administration, administered in Arm Left on 22Dec2020 (at 14:00) as a DOSE 1, SINGLE for COVID-19 immunization. On 02Oct2021 (at 03:30), the patient experienced Severe hip and lower back pain, severe chills, face ache, sharp stabbing in arms and legs and T 100.0. Additional Information: Severe hip and lower back pain started after the second dose and was unable to get relief from going to the Chiropractor. Pains became worst after the third dose (could not bend or sit with excruciating pain), severe chills, face ache, sharp stabbing in arms and legs and T 100.0. All symptoms lasted for one day Saturday, 02Oct2021, however lower back and hip pain still persisted. The patient received Chiropractor as a treatment medication for adverse events. The clinical outcome of severe chills, face ache, sharp stabbing in arms and legs and T 100.0 was recovered, while the clinical outcome of Severe hip and lower back pain was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, Migraine, Nausea, SARS-CoV-2 test negative
Clinical narrative: Severe debilitating migraine type headache with nausea and vomiting; Severe debilitating migraine type headache with nausea and vomiting; Severe debilitating migraine type headache with nausea and vomiting; This is a spontaneous report from a contactable pharmacist. This 65-year-old female Pharmacist (patient) reported for herself. A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 intramuscular, administered in Arm Left on 13Oct2021 14:00 (at the age of 65 years) (Batch/Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included none from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for an unspecified indication; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 on dose 1 intramuscular, administered in Arm Left on 23Jan2021 11:30 (Batch/Lot Number: EL3246); dose 2 intramuscular, administered in Arm Left on 13Feb2021 (Batch/Lot Number: EL8982) (at the age of 65 years) for covid-19 immunisation. On 17Oct2021 06:00 the patient experienced severe debilitating migraine type headache with nausea and vomiting. It was also reported that Symptoms started on 17Oct2021 in early morning and continued until treated with methylprednisolone. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Oct2021 Post vaccination: Nasal Swab. The patient received the treatment as Methylprednisolone 4mg for the adverse events. Device date was 23Oct2021. The clinical outcome of the events was recovered on 19Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Severe debilitating migraine type headache with nausea and vomiting; Severe debilitating migraine type headache with nausea and vomiting; Severe debilitating migraine type headache with nausea and vomiting; This is a spontaneous report from a contactable pharmacist. This 65-year-old female Pharmacist (patient) reported for herself. A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 intramuscular, administered in Arm Left on 13Oct2021 14:00 (at the age of 65 years) (Batch/Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included none from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for an unspecified indication; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 on dose 1 intramuscular, administered in Arm Left on 23Jan2021 11:30 (Batch/Lot Number: EL3246); dose 2 intramuscular, administered in Arm Left on 13Feb2021 (Batch/Lot Number: EL8982) (at the age of 65 years) for covid-19 immunisation. On 17Oct2021 06:00 the patient experienced severe debilitating migraine type headache with nausea and vomiting. It was also reported that Symptoms started on 17Oct2021 in early morning and continued until treated with methylprednisolone. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Oct2021 Post vaccination: Nasal Swab. The patient received the treatment as Methylprednisolone 4mg for the adverse events. Device date was 23Oct2021. The clinical outcome of the events was recovered on 19Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Severe debilitating migraine type headache with nausea and vomiting; Severe debilitating migraine type headache with nausea and vomiting; Severe debilitating migraine type headache with nausea and vomiting; This is a spontaneous report from a contactable pharmacist. This 65-year-old female Pharmacist (patient) reported for herself. A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 intramuscular, administered in Arm Left on 13Oct2021 14:00 (at the age of 65 years) (Batch/Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included none from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for an unspecified indication; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 on dose 1 intramuscular, administered in Arm Left on 23Jan2021 11:30 (Batch/Lot Number: EL3246); dose 2 intramuscular, administered in Arm Left on 13Feb2021 (Batch/Lot Number: EL8982) (at the age of 65 years) for covid-19 immunisation. On 17Oct2021 06:00 the patient experienced severe debilitating migraine type headache with nausea and vomiting. It was also reported that Symptoms started on 17Oct2021 in early morning and continued until treated with methylprednisolone. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Oct2021 Post vaccination: Nasal Swab. The patient received the treatment as Methylprednisolone 4mg for the adverse events. Device date was 23Oct2021. The clinical outcome of the events was recovered on 19Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: fainting; Dizziness; booster; This is a spontaneous report from a contactable consumer (patient). This 33-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 08Nov2021 16:00 (Lot Number: FH8028) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.  Medical history included irritable bowel syndrome (IBS), gastrooesophageal reflux disease (GERD), Lichen sclerosus, Known allergies: Food dye. Concomitant medications included macrogol 3350 (GLYCOLAX); dicyclomine; omeprazole; famotidine (PEPCID); plantago ovata (METAMUCIL). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 01Apr2021 (lot number: ER8730) in Left arm at age of 33-years-old for COVID-19 Immunization, dose 2 on 22Apr2021 (lot number: EW0162) in Left arm at age of 33-years-old for COVID-19 Immunization. No other vaccine in four weeks. The patient experienced dizziness and fainting the morning after on 09Nov2021 06:00. No treatment received. The outcome of the events dizziness and fainting was recovered on an unspecified date, of event booster was unknown. No covid prior vaccination. No covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Immunisation, Syncope
Clinical narrative: fainting; Dizziness; booster; This is a spontaneous report from a contactable consumer (patient). This 33-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 08Nov2021 16:00 (Lot Number: FH8028) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.  Medical history included irritable bowel syndrome (IBS), gastrooesophageal reflux disease (GERD), Lichen sclerosus, Known allergies: Food dye. Concomitant medications included macrogol 3350 (GLYCOLAX); dicyclomine; omeprazole; famotidine (PEPCID); plantago ovata (METAMUCIL). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 01Apr2021 (lot number: ER8730) in Left arm at age of 33-years-old for COVID-19 Immunization, dose 2 on 22Apr2021 (lot number: EW0162) in Left arm at age of 33-years-old for COVID-19 Immunization. No other vaccine in four weeks. The patient experienced dizziness and fainting the morning after on 09Nov2021 06:00. No treatment received. The outcome of the events dizziness and fainting was recovered on an unspecified date, of event booster was unknown. No covid prior vaccination. No covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Brain natriuretic peptide normal, Cardiac disorder, Cardiomegaly
Clinical narrative: shortness of breath; dyspnea on exertion; pleuritic chest pain; Have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes; This is a spontaneous report from a contactable physician. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 05Nov2021 (Lot Number: 33026BD) at age of 44 years old as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypertension, obstructive sleep apnea, chronic migraines, asthma, mitral valve prolapse and Covid. Concomitant medication(s) included eszopiclone; gabapentin; fluticasone propionate, salmeterol xinafoate (FLUTICASONE + SALMETEROL); naproxen; sumatriptan; hydrochlorothiazide; cholecalciferol; cyclobenzaprine; diclofenac; magnesium oxide; riboflavin; pantoprazole; lisinopril. The patient previously took the first dose of BNT162B2 (lot number: FH8020) Intramuscular in left arm on 15Oct2021 for COVID-19 immunization. The patient acutely developed shortness of breath and dyspnea on exertion within 24 hours following the 2nd dose of the vaccine which progressively worsened with subsequent development of pleuritic chest pain. Presented to the hospital approximately 6 days later and was found to have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes. Patient was subsequently started on therapeutic anticoagulation with enoxaparin and plan for transition to rivaroxaban. Events started on 06Nov2021 and resulted in hospitalization. The patient was hospitalized for 3 days. Lab test included Nasal Swab/Cepheid RT-PCR on 11Nov2021 with Negative Covid test result. The outcome was recovering.; Sender's Comments: Based on current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Dyspnoea, Dyspnoea exertional, Pleuritic pain, Pulmonary embolism. The case will be reassessed further upon receipt of additional information.  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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Dyspnoea exertional, Fibrin D dimer, Osteopenia
Clinical narrative: shortness of breath; dyspnea on exertion; pleuritic chest pain; Have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes; This is a spontaneous report from a contactable physician. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 05Nov2021 (Lot Number: 33026BD) at age of 44 years old as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypertension, obstructive sleep apnea, chronic migraines, asthma, mitral valve prolapse and Covid. Concomitant medication(s) included eszopiclone; gabapentin; fluticasone propionate, salmeterol xinafoate (FLUTICASONE + SALMETEROL); naproxen; sumatriptan; hydrochlorothiazide; cholecalciferol; cyclobenzaprine; diclofenac; magnesium oxide; riboflavin; pantoprazole; lisinopril. The patient previously took the first dose of BNT162B2 (lot number: FH8020) Intramuscular in left arm on 15Oct2021 for COVID-19 immunization. The patient acutely developed shortness of breath and dyspnea on exertion within 24 hours following the 2nd dose of the vaccine which progressively worsened with subsequent development of pleuritic chest pain. Presented to the hospital approximately 6 days later and was found to have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes. Patient was subsequently started on therapeutic anticoagulation with enoxaparin and plan for transition to rivaroxaban. Events started on 06Nov2021 and resulted in hospitalization. The patient was hospitalized for 3 days. Lab test included Nasal Swab/Cepheid RT-PCR on 11Nov2021 with Negative Covid test result. The outcome was recovering.; Sender's Comments: Based on current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Dyspnoea, Dyspnoea exertional, Pleuritic pain, Pulmonary embolism. The case will be reassessed further upon receipt of additional information.  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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleuritic pain, Pulmonary embolism, Troponin increased
Clinical narrative: shortness of breath; dyspnea on exertion; pleuritic chest pain; Have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes; This is a spontaneous report from a contactable physician. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 05Nov2021 (Lot Number: 33026BD) at age of 44 years old as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypertension, obstructive sleep apnea, chronic migraines, asthma, mitral valve prolapse and Covid. Concomitant medication(s) included eszopiclone; gabapentin; fluticasone propionate, salmeterol xinafoate (FLUTICASONE + SALMETEROL); naproxen; sumatriptan; hydrochlorothiazide; cholecalciferol; cyclobenzaprine; diclofenac; magnesium oxide; riboflavin; pantoprazole; lisinopril. The patient previously took the first dose of BNT162B2 (lot number: FH8020) Intramuscular in left arm on 15Oct2021 for COVID-19 immunization. The patient acutely developed shortness of breath and dyspnea on exertion within 24 hours following the 2nd dose of the vaccine which progressively worsened with subsequent development of pleuritic chest pain. Presented to the hospital approximately 6 days later and was found to have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes. Patient was subsequently started on therapeutic anticoagulation with enoxaparin and plan for transition to rivaroxaban. Events started on 06Nov2021 and resulted in hospitalization. The patient was hospitalized for 3 days. Lab test included Nasal Swab/Cepheid RT-PCR on 11Nov2021 with Negative Covid test result. The outcome was recovering.; Sender's Comments: Based on current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Dyspnoea, Dyspnoea exertional, Pleuritic pain, Pulmonary embolism. The case will be reassessed further upon receipt of additional information.  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: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Pleuritic pain, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: shortness of breath; dyspnea on exertion; pleuritic chest pain; Have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes; This is a spontaneous report from a contactable physician. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 05Nov2021 (Lot Number: 33026BD) at age of 44 years old as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypertension, obstructive sleep apnea, chronic migraines, asthma, mitral valve prolapse and Covid. Concomitant medication(s) included eszopiclone; gabapentin; fluticasone propionate, salmeterol xinafoate (FLUTICASONE + SALMETEROL); naproxen; sumatriptan; hydrochlorothiazide; cholecalciferol; cyclobenzaprine; diclofenac; magnesium oxide; riboflavin; pantoprazole; lisinopril. The patient previously took the first dose of BNT162B2 (lot number: FH8020) Intramuscular in left arm on 15Oct2021 for COVID-19 immunization. The patient acutely developed shortness of breath and dyspnea on exertion within 24 hours following the 2nd dose of the vaccine which progressively worsened with subsequent development of pleuritic chest pain. Presented to the hospital approximately 6 days later and was found to have large saddle pulmonary embolism with emboli extending into segmental and subsegmental branches of all lobes. Patient was subsequently started on therapeutic anticoagulation with enoxaparin and plan for transition to rivaroxaban. Events started on 06Nov2021 and resulted in hospitalization. The patient was hospitalized for 3 days. Lab test included Nasal Swab/Cepheid RT-PCR on 11Nov2021 with Negative Covid test result. The outcome was recovering.; Sender's Comments: Based on current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Dyspnoea, Dyspnoea exertional, Pleuritic pain, Pulmonary embolism. The case will be reassessed further upon receipt of additional information.  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: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Immunisation, SARS-CoV-2 test
Clinical narrative: BOOSTER; He could not see out of his eye; Has floaters but they have expanded and he could not see out of his left eye; Headache/head is killing him; All of a sudden he got a hot flash go up his head/there was a lot of pressure in his head; This is a spontaneous report received from a contactable consumer. This consumer reported for 56-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 56 years old.  The patient medical history was not reported. Concomitant medications included an unknown anxiety medication. The patient previously received first and second dose of bnt162b2 on unspecified dates for COVID-19 immunisation. In Nov2021, the patient got a Headache and has floaters but they have expanded and he could not see out of his left eye and that went away but he still has a headache. It was reported that when he got the shot, he was sitting in #, states it was really weird, all of a sudden he got a hot flash go up his head, states he got the shot in left arm, his left eye got floaters and there was a lot of pressure in his head and after a couple of seconds it went away. States today he reported that he was at work and someone was talking to him and all of a sudden he got a dull headache, saw floaters again in his left eye, more profound, states he could not see out of his eye, head is killing him, same kind of headache that he had last week. Slight headache. The patient is not one to usually get headaches, or have any issue with his eyes. The outcome of hot flash go up his head/there was a lot of pressure in his head was recovered in Nov2021, outcome of booster, could not see out of his eye was unknown, outcome of other events was not recovered.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.