chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood glucose, Blood test, Dizziness, Haemoglobin
Clinical narrative: permanent pupil dilation; loss of peripheral vision - able to see straight forward but was fuzzy; extreme lightheadedness; severe headache/complicated migraines; Extreme aphasia; This is a spontaneous report from a contactable nurse, the patient. This 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an intramuscular of administration in the left arm on 27Feb2021 14:30 (at the age of 24-year-old) as single dose for COVID-19 immunization. Medical history included mitral valve prolapse, asthma, attention deficit hyperactivity disorder, Crohn's disease, tachycardia and pernicious anemia. Concomitant medications included adalimumab (HUMIRA), propranolol (manufacturer unknown), escitalopram (manufacturer unknown), ethinylestradiol/ norgestimate (SPRINTEC) and amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL XR). The patient previously took ibuprofen and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 10:30, the patient reported experiencing "extreme aphasia, loss of simple understanding, inability to comprehend normally, permanent pupil dilation, loss of peripheral vision - able to see straight forward but was fuzzy, body felt fuzzy, extreme lightheadedness, frustration due to not being able to comprehend my own words, and severe headache afterwards. Checked hemoglobin and glucose through finger stick, both were normal. Symptoms subsided after a few hours but reoccurred for about an hour that same day. Since this occurred, I still have trouble at times finding the words to say. 4 days after this happened, I was hospitalized and put on stroke precautions: 4 MRIs and blood work show no sign of stroke and discharged with a diagnosis of complicated migraines." The patient was placed on prochlorperazine maleate and nortriptyline as events treatments. Since the vaccination, the patient had been tested negative for COVID-19 on the BINAX test via nasal swab on 04Mar2021. The patient was hospitalized for 2 days on unspecified dates in Mar2021. The patient had recovered with lasting effects.; Sender's Comments: The causal association between the reported events and vaccine administered cannot be excluded at this time. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Migraine, Pupil fixed, SARS-CoV-2 test, Visual field defect
Clinical narrative: permanent pupil dilation; loss of peripheral vision - able to see straight forward but was fuzzy; extreme lightheadedness; severe headache/complicated migraines; Extreme aphasia; This is a spontaneous report from a contactable nurse, the patient. This 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an intramuscular of administration in the left arm on 27Feb2021 14:30 (at the age of 24-year-old) as single dose for COVID-19 immunization. Medical history included mitral valve prolapse, asthma, attention deficit hyperactivity disorder, Crohn's disease, tachycardia and pernicious anemia. Concomitant medications included adalimumab (HUMIRA), propranolol (manufacturer unknown), escitalopram (manufacturer unknown), ethinylestradiol/ norgestimate (SPRINTEC) and amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL XR). The patient previously took ibuprofen and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 10:30, the patient reported experiencing "extreme aphasia, loss of simple understanding, inability to comprehend normally, permanent pupil dilation, loss of peripheral vision - able to see straight forward but was fuzzy, body felt fuzzy, extreme lightheadedness, frustration due to not being able to comprehend my own words, and severe headache afterwards. Checked hemoglobin and glucose through finger stick, both were normal. Symptoms subsided after a few hours but reoccurred for about an hour that same day. Since this occurred, I still have trouble at times finding the words to say. 4 days after this happened, I was hospitalized and put on stroke precautions: 4 MRIs and blood work show no sign of stroke and discharged with a diagnosis of complicated migraines." The patient was placed on prochlorperazine maleate and nortriptyline as events treatments. Since the vaccination, the patient had been tested negative for COVID-19 on the BINAX test via nasal swab on 04Mar2021. The patient was hospitalized for 2 days on unspecified dates in Mar2021. The patient had recovered with lasting effects.; Sender's Comments: The causal association between the reported events and vaccine administered cannot be excluded at this time. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Bradycardia, Dyspnoea, Tachycardia
Clinical narrative: runs of Brady; B/P shooting through the roof.; Tachycardia; shortness of breath; wheezing; extreme weakness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient reported for herself that she received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route in the left arm on 29Mar2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included fibromyalgia. Allergies to medications, food, or other products included cefazolin (ANCEF), penicillin, and bandage tape. Prior to 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 medications included pregabalin (LYRICA) for fibromyalgia and BalanceMD (candida supplement). On 31Mar2021 at 09:00, the patient experienced runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof. These events resulted in emergency room/department or urgent care via squad hospital transport and were reported as non-serious. There was no treatment received for runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof. The clinical outcomes of runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: runs of Brady; B/P shooting through the roof.; Tachycardia; shortness of breath; wheezing; extreme weakness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient reported for herself that she received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route in the left arm on 29Mar2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included fibromyalgia. Allergies to medications, food, or other products included cefazolin (ANCEF), penicillin, and bandage tape. Prior to 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 medications included pregabalin (LYRICA) for fibromyalgia and BalanceMD (candida supplement). On 31Mar2021 at 09:00, the patient experienced runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof. These events resulted in emergency room/department or urgent care via squad hospital transport and were reported as non-serious. There was no treatment received for runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof. The clinical outcomes of runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling hot, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: Tightening; heating up; swelling of throat; swelling of throat and chest; throat closing; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosis in May2020, COVID-19 test taken via nasal swab on 01May2020 was positive.  The patient had never had an allergic reaction in her life and she was not allergic to anything that she knew of. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine.The patient received her first vaccine on 10Apr2021. After the shot she felt her throat closing. She experienced Tightening, heating up, swelling of throat and chest within 10 minutes of vaccine administration, also reported as at 14:15. They called the Paramedics, who gave her Benadryl injection when they picked her up from the site where she received her vaccination, which was a drug store. She was then transported to the emergency department. She was hospitalized and treated with Benadryl injection for the Tightening, heating up, swelling of throat and chest. She was monitored for 3-4 hours, and her symptoms were not worsening and she was able to leave the hospital. Ever since, this is the 9th day, everyday she had severe shortness of breath. She had no wheezing. Her chest clenches. It scared her so she had gone to the Emergency Department 2 more times for it. She had gone there 3 times in total. She had been to the Emergency Room a few times and saw doctors there. Her throat closing stopped later that evening and had come back about 4 times. Since then, she was not sure if it was just the sensation of the throat closing because it is coupled with shortness of breath. She had the sensation of throat closing about 4 times. She was short of breath every day since receiving the vaccine and up to 4 times each day. Sometimes it was worse than others. She had it while on the call (19Apr2021) and rated it 4/10. On 14Apr2021 she went to the Emergency Department in the middle of the night. She rated that episode as 9/10. Episodes of symptoms had been ongoing and reoccurring since the day of vaccine administration. She had a COVID-19 test post vaccination in Apr2021 (unknown results). The outcome of  Tightening/ Chest tightness, heating up, swelling of throat and chest, throat closing and severe shortness of breath was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Throat tightness
Clinical narrative: Tightening; heating up; swelling of throat; swelling of throat and chest; throat closing; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosis in May2020, COVID-19 test taken via nasal swab on 01May2020 was positive.  The patient had never had an allergic reaction in her life and she was not allergic to anything that she knew of. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine.The patient received her first vaccine on 10Apr2021. After the shot she felt her throat closing. She experienced Tightening, heating up, swelling of throat and chest within 10 minutes of vaccine administration, also reported as at 14:15. They called the Paramedics, who gave her Benadryl injection when they picked her up from the site where she received her vaccination, which was a drug store. She was then transported to the emergency department. She was hospitalized and treated with Benadryl injection for the Tightening, heating up, swelling of throat and chest. She was monitored for 3-4 hours, and her symptoms were not worsening and she was able to leave the hospital. Ever since, this is the 9th day, everyday she had severe shortness of breath. She had no wheezing. Her chest clenches. It scared her so she had gone to the Emergency Department 2 more times for it. She had gone there 3 times in total. She had been to the Emergency Room a few times and saw doctors there. Her throat closing stopped later that evening and had come back about 4 times. Since then, she was not sure if it was just the sensation of the throat closing because it is coupled with shortness of breath. She had the sensation of throat closing about 4 times. She was short of breath every day since receiving the vaccine and up to 4 times each day. Sometimes it was worse than others. She had it while on the call (19Apr2021) and rated it 4/10. On 14Apr2021 she went to the Emergency Department in the middle of the night. She rated that episode as 9/10. Episodes of symptoms had been ongoing and reoccurring since the day of vaccine administration. She had a COVID-19 test post vaccination in Apr2021 (unknown results). The outcome of  Tightening/ Chest tightness, heating up, swelling of throat and chest, throat closing and severe shortness of breath was not recovered.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Cough, Rheumatoid arthritis, Wheezing
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 79-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 12Mar2021 at 12:00 (at the age of 79-years-old)  (Batch/Lot number was not reported) as a single dose and dose 2 via an unspecified route of administration on 14Apr2021 (at the age of 79-years-old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included ongoing asthma, ongoing rheumatoid arthritis and allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. With both vaccine inoculations, the next day and for at least 8 days afterwards, the patient's asthma was very much increased. The patient had constant coughing and wheezing. In addition, for 3 days their RA pain was much increased. The events started on 12 Mar2021. No treatment was given. The outcome of asthma increased, coughing, wheezing and RA pain increased was recovering.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, SARS-CoV-2 test
Clinical narrative: Large DVT in leg femoral popliteal; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date  (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162b2 on 18Jan2021 at 12:00 (Lot Number: Unknown) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced large DVT in leg femoral popliteal without other cause on 24Mar2021, diagnosed 3-4 weeks after the 2nd vaccine.  The patient underwent lab tests and procedures which included PCR COVID test on 24Mar2021 (post vaccination), which was negative. Therapeutic measures included rivaroxaban (XARELTO) as a result of large DVT in leg femoral popliteal (deep vein thrombosis). The patient was recovering from the event, large DVT in leg femoral popliteal.   No follow up attempts are possible; Information about Lot and batch number could not be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Mental impairment, Scan brain
Clinical narrative: brain hemorrhage; general comprehension has gone downhill; This is a spontaneous report from a contactable consumer (non-healthcare professional reporting for a patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the right arm on 17Mar2021 at 14:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included Type 1 diabetes mellitus from an unknown date and unknown if ongoing (not controlled). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication) included insulin for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 30Mar2021 at 14:30, the patient experienced brain hemorrhage, and general comprehension has gone downhill; both considered to be disabilities for which the patient was hospitalized for 2 days. Clinical course: One week after immunization, on 30Mar2021 at 14:30, the patient started screaming his head hurt. They had to medicate him to get him into ambulance because he was confused. A brain scan was performed on 30Mar2021 which revealed a small brain hemorrhage. They then transferred patient. His general comprehension has gone downhill. No treatment for the event was given. The patient had not recovered from the events, brain hemorrhage, and general comprehension has gone downhill.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: hearing loss in the right ear; This is a spontaneous report from a contactable consumer, the patient, and a non-contactable consumer, the patient's sister. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 23Mar2021 between 13:00 and 13:30 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history includes ringing in ears, problem with hearing out of the other (left) ear. Concomitant medications were none. There were no additional vaccines administered on the same date, or within 4 weeks of BNT162B2. On 24Mar2021, the patient experienced hearing loss in the right ear and sometime between 19:00 - 20:00, the patient could not hear out of the right ear for a day. The patient never had a problem with this ear. No emergency room or physician's office visit was required. The patient got up the next morning and her hearing was back. The clinical outcome of hearing loss in the right ear and could not hear out of the right ear was resolved on 25Mar2021.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid 19; This is a spontaneous report from a contactable consumer patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient reported he got the first dose of the Pfizer COVID vaccine on 28Jan2021 and tested positive for COVID-19 on 05Feb2021. He was hospitalized from an unspecified date for 21 days and now he is looking to get his second dose. He mentioned that the vaccination site where he got the first one is not having vaccine administration anymore and he is looking for a place where he can get the second dose. Outcome of the event was unknown.  Information on the lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: tested positive for covid 19; This is a spontaneous report from a contactable consumer patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient reported he got the first dose of the Pfizer COVID vaccine on 28Jan2021 and tested positive for COVID-19 on 05Feb2021. He was hospitalized from an unspecified date for 21 days and now he is looking to get his second dose. He mentioned that the vaccination site where he got the first one is not having vaccine administration anymore and he is looking for a place where he can get the second dose. Outcome of the event was unknown.  Information on the lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid 19; This is a spontaneous report from a contactable consumer patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient reported he got the first dose of the Pfizer COVID vaccine on 28Jan2021 and tested positive for COVID-19 on 05Feb2021. He was hospitalized from an unspecified date for 21 days and now he is looking to get his second dose. He mentioned that the vaccination site where he got the first one is not having vaccine administration anymore and he is looking for a place where he can get the second dose. Outcome of the event was unknown.  Information on the lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Amnesia, Aphasia, Balance disorder, Clumsiness
Clinical narrative: Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself.  A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Decreased appetite, Disturbance in attention, Hallucination, Headache
Clinical narrative: Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself.  A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Migraine, Musculoskeletal stiffness, Personality change, Photosensitivity reaction
Clinical narrative: Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself.  A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Speech disorder, Thinking abnormal, Vertigo
Clinical narrative: Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself.  A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dystonia, Headache, Malaise, Sinusitis, Systemic lupus erythematosus
Clinical narrative: started going through one of her cycles of lupus where she had headaches and dystonia; dystonia in her shoulders and neck; Malaise; headache; sinus infection; This is a spontaneous report from a contactable consumer.   A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included Attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing, lupus from an unknown date and unknown if ongoing.    She got her first Pfizer covid vaccine and for 5 days after, had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck and these symptoms will last for 15 days.  The headache then turned into a sinus infection and as a result of all this, she missed her second dose.  Her doctor told her to reschedule and told her to schedule two weeks away which would be today but she is about to start a new medication for her ADHD and to do that she has to come off of her other one which is a stimulant.  She doesn't want to start a new medication right now with the problems that might come up along with getting the second shot and any side effects that she might have.  She is frozen, just not sure what to do.  She has heard if you only get one dose, it is 80% effective. She is concerned if she only gets one dose, she'll be prevented from flying or doing other things because having the vaccine might be required but she has missed the window for getting the second shot so she doesn't know what to do. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Diverticulitis, Faeces discoloured, Pain, Scan
Clinical narrative: severe pain in lower left side.; diarrhea; diverticulitis; Had black liquid stool.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 23Mar2021 07:15 as single dose for covid-19 immunization in a pharmacy. Medical history was reported as none. No known allergies. The patient was taking an unspecified antibiotic between 1-2 weeks. No other vaccinations were done in four weeks. The patient has not had COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. On 24Mar2021, 1 day after vaccination the patient had diarrhea. On 25Mar2021, 2 days after, the patient had severe pain in lower left side. The patient was diagnosed with diverticulitis on an unspecified date in Mar2021. The patient also reported black liquid stools in Mar2021. The patient ended up in the ER on an unspecified date and got a scan and was sent home with antibiotics as treatment. The patient was getting better but not yet 100%. The patient underwent lab tests and procedures which included scan: unknown results on an unspecified date. The outcome of the events was recovering.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Anxiety, Dyspnoea, Frustration tolerance decreased, Heart rate
Clinical narrative: Had difficulties thinking clearly; Flu like symptoms; Feel lots of anxiety and frustration; Feel lots of anxiety and frustration; Feel aggressive; Irritability; Had issues breathing with my lungs; Felt like my heart beat was a little bit off; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 13Apr2021 17:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunization. The patient had history of depression and allergies with prednisone and penicillin. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication and therapy dates and serum allergy shots. The patient had no other vaccine in four weeks. On 13Apr2021 21:00,  the patient had flu like symptoms. He also started to feel lots of anxiety and frustration. He felt aggressive and had difficulties thinking clearly. He became confrontational with his partner and ended up jumping out of the moving vehicle, at a slow speed. He did have a long day, but he felt like irritability was a big factor. He also had issues breathing with his lungs and felt like his heartbeat was a little bit off. He did not have COVID-19 prior to vaccination and not tested post vaccination. The patient did not receive any treatment for the events and recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Influenza like illness, Irritability, Mental impairment
Clinical narrative: Had difficulties thinking clearly; Flu like symptoms; Feel lots of anxiety and frustration; Feel lots of anxiety and frustration; Feel aggressive; Irritability; Had issues breathing with my lungs; Felt like my heart beat was a little bit off; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 13Apr2021 17:00 (Batch/Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunization. The patient had history of depression and allergies with prednisone and penicillin. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication and therapy dates and serum allergy shots. The patient had no other vaccine in four weeks. On 13Apr2021 21:00,  the patient had flu like symptoms. He also started to feel lots of anxiety and frustration. He felt aggressive and had difficulties thinking clearly. He became confrontational with his partner and ended up jumping out of the moving vehicle, at a slow speed. He did have a long day, but he felt like irritability was a big factor. He also had issues breathing with his lungs and felt like his heartbeat was a little bit off. He did not have COVID-19 prior to vaccination and not tested post vaccination. The patient did not receive any treatment for the events and recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Ear pain, Facial pain, Headache
Clinical narrative: hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination.   Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nausea, Rash, Vomiting
Clinical narrative: hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blue toe syndrome, Deep vein thrombosis, Imaging procedure, Oedema peripheral, Pain in extremity
Clinical narrative: he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old.  Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported.  The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering.  Information on the lot number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Peripheral swelling, SARS-CoV-2 antibody test
Clinical narrative: he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old.  Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported.  The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering.  Information on the lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Intervertebral disc protrusion
Clinical narrative: disc herniations; back pain/ pain; This is a spontaneous report from a contactable consumer (patient's husband) via the medical information team and Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 09Apr2021 (lot number and expiration date were not reported) as single dose for COVID-19 immunization. Medical history included autoimmune diabetes: pancreas no longer produces insulin and is nothing but cysts; immunocompromised person; and precancerous. The patient uses a DEXCOM 6 to monitor her blood sugar. Concomitant medication included three unspecified insulins and the machine (DEXCOM 6) tells her how much to take. On an unspecified date, the patient had disc herniations and lots of pain. She was seen by a doctor yesterday (13Apr2021) for her back pain and was asked if she had a vaccine yet. The doctor gave her a local shot, maybe a corticosteroid injection, in her back. She was also prescribed with prednisone 20 mg, twice daily. The patient's husband was concerned that even without the prednisone she would already have a lower response to the vaccine and wanted to know if that was correct. The outcome of the events was unknown.