chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having  a hard time to get a sentence out (felt like his motor skills were affected); having  a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021.  Information about lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint stiffness, Motor dysfunction, Muscle tightness, Pain
Clinical narrative: he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having  a hard time to get a sentence out (felt like his motor skills were affected); having  a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021.  Information about lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Speech disorder, Transient ischaemic attack, Vision blurred
Clinical narrative: he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having  a hard time to get a sentence out (felt like his motor skills were affected); having  a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthropathy, Decreased appetite, Mental disorder, Pyrexia
Clinical narrative: He felt like he was getting Covid again; A slight fever; Stomach was bothering him; Appetite wasn't there; mental trauma; after receiving the vaccine it went into his hips; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  Medical history included hip problems (bone on bone on both hips-scheduled surgery for 11June2021), pulmonary embolism from Feb2021 to an unknown date (hospitalized for three days due to a pulmonary embolism) ,Covid-19 from Feb2021 to an unknown date (in February he tested positive for Covid)  The patient's concomitant medications were not reported.  The patient experienced he felt like he was getting covid again,  a slight fever,  stomach was bothering him,  appetite wasn't there, mental trauma, bone on bone on both hips.  he feels like when he got covid it went into his hips and after receiving the vaccine. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on Feb2021.  The clinical course was reported as follows Male patient aged 62, received first dose of the Pfizer BioNTech Covid 19 vaccine approximately 3 weeks ago (date unspecified) from his place of employment.  In February he tested positive for Covid and was hospitalized for three days due to a pulmonary embolism.  Two days after receiving his first dose of the vaccine, he started developing symptoms, he felt like he was getting Covid again.  He experienced a slight fever, stomach was bothering him, appetite wasn't there and it took two weeks to recover.  'He has hip problems, bone on bone on both hips.  He feels like when he got Covid it went into his hips and after receiving the vaccine it went into his hips'. He has a scheduled surgery for 11June2021.   He reports mental trauma from having covid and when he got side effects from the vaccine it felt like he was getting Covid all over again.  Callers wife inquired Can you wait six weeks to get second dose? Caller inquired Does he have to get his second dose of the vaccine or does he have enough coverage from having covid and having the first dose? The clinical outcome of the event after receiving the vaccine it went into his hips was unknown while the remaining events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Suspected COVID-19
Clinical narrative: He felt like he was getting Covid again; A slight fever; Stomach was bothering him; Appetite wasn't there; mental trauma; after receiving the vaccine it went into his hips; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  Medical history included hip problems (bone on bone on both hips-scheduled surgery for 11June2021), pulmonary embolism from Feb2021 to an unknown date (hospitalized for three days due to a pulmonary embolism) ,Covid-19 from Feb2021 to an unknown date (in February he tested positive for Covid)  The patient's concomitant medications were not reported.  The patient experienced he felt like he was getting covid again,  a slight fever,  stomach was bothering him,  appetite wasn't there, mental trauma, bone on bone on both hips.  he feels like when he got covid it went into his hips and after receiving the vaccine. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on Feb2021.  The clinical course was reported as follows Male patient aged 62, received first dose of the Pfizer BioNTech Covid 19 vaccine approximately 3 weeks ago (date unspecified) from his place of employment.  In February he tested positive for Covid and was hospitalized for three days due to a pulmonary embolism.  Two days after receiving his first dose of the vaccine, he started developing symptoms, he felt like he was getting Covid again.  He experienced a slight fever, stomach was bothering him, appetite wasn't there and it took two weeks to recover.  'He has hip problems, bone on bone on both hips.  He feels like when he got Covid it went into his hips and after receiving the vaccine it went into his hips'. He has a scheduled surgery for 11June2021.   He reports mental trauma from having covid and when he got side effects from the vaccine it felt like he was getting Covid all over again.  Callers wife inquired Can you wait six weeks to get second dose? Caller inquired Does he have to get his second dose of the vaccine or does he have enough coverage from having covid and having the first dose? The clinical outcome of the event after receiving the vaccine it went into his hips was unknown while the remaining events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID; The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID; 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 an unspecified date (also reported as around 10 weeks ago) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 1 of Pfizer vaccine on an unspecified date (also reported as around 10 weeks ago) and the patient contracted COVID on an unspecified date (for clarification). The patient underwent Covid-19 test and became negative on an unspecified date (reported as 2 1/2 weeks ago). The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Tinnitus
Clinical narrative: some nerve issues, hands and feet; tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient saw her neurologist and reported tinnitus on an unspecified date, it stayed the same as she reported it. Her neurologist that she saw at 7:30 this morning. They were going to do nerve testing. He wanted her to hold off on getting the second dose. He said that it's 80% efficacy. She had already gone past 4 weeks and he said that she could wait longer. She was having some nerve issues, hands and feet, nothing to do with the vaccine as they didn't think so. He didn't think it's related to the vaccine. He told her that she didn't have to get it right away because he said that it was 80% now, from reports that they heard. The patient wanted to know the timing information on the second dose and what was the efficacy of one dose. The patient stated that she would definitely be getting it past 42 days, not even know if I was going to get the second dose. The outcome of events, some nerve issues, hands and feet and tinnitus was unknown. The patient stated that her husband was a superintendent and he talked to health department once week.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Neuropathy peripheral and tinnitus due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cellulitis, Chest pain, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E11283) via an unspecified route of administration on 19Dec2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included "HTH GERD" and sulfa allergy, both from unspecified dates and unspecified if ongoing  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within two weeks of the vaccination) included pantoprazole sodium sesquihydrate (PROTONIX), losartan and anastrazole, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received demerol for an unspecified indication on an unspecified date and experienced allergy (reported as "known allergies: Eli sulfa demerol"). On 08Jan2021 at 12:00 the patient experienced severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain. All events were serious for hospitalization on an unspecified date, for 5 days. All events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The events required treatment with antibiotics for 6 weeks. The clinical outcomes of the events severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain were all recovered/resolved with sequel (recovered with lasting effects) on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available the reported events more likely represent intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E11283) via an unspecified route of administration on 19Dec2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included "HTH GERD" and sulfa allergy, both from unspecified dates and unspecified if ongoing  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within two weeks of the vaccination) included pantoprazole sodium sesquihydrate (PROTONIX), losartan and anastrazole, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received demerol for an unspecified indication on an unspecified date and experienced allergy (reported as "known allergies: Eli sulfa demerol"). On 08Jan2021 at 12:00 the patient experienced severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain. All events were serious for hospitalization on an unspecified date, for 5 days. All events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The events required treatment with antibiotics for 6 weeks. The clinical outcomes of the events severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain were all recovered/resolved with sequel (recovered with lasting effects) on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available the reported events more likely represent intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Epistaxis, Thrombosis
Clinical narrative: clots were coming out; nose bleed; blood pressure went up; This is a spontaneous report from a contactable consumer (classmate's sister). This is the second of two reports. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. On an unspecified date (almost a month after receiving the second COVID-19 vaccine) the patient experienced clots were coming out, nosebleed and blood pressure went up. The reporter called to report that she had received a phone call from an old classmate, who had a sister, who experienced the same reaction after getting the Pfizer vaccine. This patient experienced the same nosebleeds after the COVID-19 vaccine. This person's nosebleeds started almost a month after she received the second dose of the COVID-19 vaccine. That was when the reporter started trying to figure out where these nosebleeds were coming from. She did not have any further information on the person that she mentioned. The clinical outcomes of the events clots were coming out, nosebleed and blood pressure went up were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476256 same reporter/drug/event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Vaginal haemorrhage
Clinical narrative: bleeding heavily with small clots; has not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 08Apr2021 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunization. Medical history included endometriosis diagnosed in 1993 and subsequently she had laparoscopy twice by the age of 26-year-old; and ongoing menopause since 2018. History of Parity 1: the patient was pregnant with her daughter and have her naturally at 27 years old and never had another pregnancy again. The patient's concomitant medications were only women multi-vitamins. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she has not had menstrual cycle since 2018. On 23Apr2021, the patient started spotting. Since 26Apr2021, she has been bleeding heavily with small clots. All day today (on 28Apr2021) she has been bleeding very very heavy with clots. She was planning to go to her doctor by morning, but she was following through with her second dose tomorrow (29Apr2021). The clinical outcome of the events "have not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots" were not resolved.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Cerebral thrombosis, Confusional state, Fall, Flushing
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (Patient's relative) reported for a female patient of an unspecified age received BNT162B2 (PFIZER COVID 19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at unknown dose number, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received the Pfizer Covid vaccine. The patient was fine and healthy after the shot. Subsequently she fell down, hurt her hip and broke her wrist. Last Monday, she went for a steroid shot that was given in her wrist. On Tuesday, she was flushed and threw up. They took her to the hospital, and she was diagnosed with blood clots in her brain. She has been in the hospital since that Tuesday (unspecified date) due to the reported events. She has since been admitted to the hospital with a swelling of her brain, and confusion. The events happened on unspecified dates. She is scheduled for a magnetic resonance imaging (MRI). The outcome of the events was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Vomiting
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (Patient's relative) reported for a female patient of an unspecified age received BNT162B2 (PFIZER COVID 19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at unknown dose number, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received the Pfizer Covid vaccine. The patient was fine and healthy after the shot. Subsequently she fell down, hurt her hip and broke her wrist. Last Monday, she went for a steroid shot that was given in her wrist. On Tuesday, she was flushed and threw up. They took her to the hospital, and she was diagnosed with blood clots in her brain. She has been in the hospital since that Tuesday (unspecified date) due to the reported events. She has since been admitted to the hospital with a swelling of her brain, and confusion. The events happened on unspecified dates. She is scheduled for a magnetic resonance imaging (MRI). The outcome of the events was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hyperhidrosis, Hypotension, Incoherent, Pallor
Clinical narrative: they were concerned about blood clot; shaking uncontrollably; pouring sweat; sheet white with no color to skin at all; blood pressure 68/30; not particularly coherent; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated his wife had adverse event to the COVID vaccine last week. He stated that they both got the vaccine. At 3 AM on unspecified date, the reporter woke up because his wife (patient) was shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and had blood pressure 68/30. They had to call an ambulance and she was brought to the hospital. They were able to get her blood pressure up and stabilized her after 8 hours. They were concerned about blood clot and did other scans. Lab data included blood pressure 68/30 (units unspecified) and scans with unknown results; both on unspecified date. The clinical outcomes of shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and blood clot were unknown, while of blood pressure 68/30 was recovering.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Scan, Thrombosis, Tremor
Clinical narrative: they were concerned about blood clot; shaking uncontrollably; pouring sweat; sheet white with no color to skin at all; blood pressure 68/30; not particularly coherent; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated his wife had adverse event to the COVID vaccine last week. He stated that they both got the vaccine. At 3 AM on unspecified date, the reporter woke up because his wife (patient) was shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and had blood pressure 68/30. They had to call an ambulance and she was brought to the hospital. They were able to get her blood pressure up and stabilized her after 8 hours. They were concerned about blood clot and did other scans. Lab data included blood pressure 68/30 (units unspecified) and scans with unknown results; both on unspecified date. The clinical outcomes of shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and blood clot were unknown, while of blood pressure 68/30 was recovering.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 01:00 (Batch/Lot Number: EW0164) (at the age of 48 years old) at 1st dose, single for COVID-19 immunization. Medical history included low iron, Bell's palsy in Jan2020 and patient had no known allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications within 2 weeks of vaccination. On 25Apr2021 08:00 (after receiving the vaccine 2 days later), the patient had Bells Palsy symptoms started along with a head ache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The outcome of the events was not recovered.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cellulitis, Chills, Decreased appetite, Decreased immune responsiveness
Clinical narrative: Cellulitis; immune system being weakened; fevers which came and went; chills; sweats; nausea; loss of appetite; light headedness; lack of energy; This is a spontaneous report from a contactable consumer (the patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in left arm on 06Apr2021 12:30 at age of 36-year-old at single dose for COVID-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) via an unspecified route of administration in left arm from 16Mar2021 12:30 at age of 36-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was very sick for 4 days: fevers which came and went, chills, sweats, nausea, loss of appetite, light headedness, lack of energy. As a result of his immune system being weakened, he wound up with Cellulitis which he was still fighting over 3 weeks after the shot. As the patient was normally a healthy male, it was strange that he would wind up with a bacterial infection. The patient also stated that after the second dose he experienced cellulitis in his left leg to thigh area. He went to emergency room for scan and to rule out clot. He thought he was immunocompromised and that was why he got the cellulitis in the leg. Caller wanted to get the compensation information to help with the bills. The events onset date was 06Apr2021 17:00. 2 rounds of antibiotics was received for the events. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included ultrasound with unknown result. The outcome of the events was recovering.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pyrexia, Ultrasound scan
Clinical narrative: Cellulitis; immune system being weakened; fevers which came and went; chills; sweats; nausea; loss of appetite; light headedness; lack of energy; This is a spontaneous report from a contactable consumer (the patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in left arm on 06Apr2021 12:30 at age of 36-year-old at single dose for COVID-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) via an unspecified route of administration in left arm from 16Mar2021 12:30 at age of 36-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was very sick for 4 days: fevers which came and went, chills, sweats, nausea, loss of appetite, light headedness, lack of energy. As a result of his immune system being weakened, he wound up with Cellulitis which he was still fighting over 3 weeks after the shot. As the patient was normally a healthy male, it was strange that he would wind up with a bacterial infection. The patient also stated that after the second dose he experienced cellulitis in his left leg to thigh area. He went to emergency room for scan and to rule out clot. He thought he was immunocompromised and that was why he got the cellulitis in the leg. Caller wanted to get the compensation information to help with the bills. The events onset date was 06Apr2021 17:00. 2 rounds of antibiotics was received for the events. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included ultrasound with unknown result. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Chills, Contusion, Inflammatory carcinoma of the breast
Clinical narrative: diagnosed her with inflammatory breast cancer; experienced chills and such that started in the middle of the night; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; This is a spontaneous report a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in the left arm on 04Mar2021 (Lot number: UNKNOWN) as single dose for COVID-19 immunisation. Medical history included ovarian cancer (12 years ago and she survived). Concomitant medication included ibuprofen. The patient reported after 1st dose she was diagnosed her with inflammatory breast cancer. The patient experienced chills and such that started in the middle of the night. She had no real aches and pains in that first couple of days. The patient reported that a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling. She noticed some unusual things happening with her breast and at first she thought that she didn't know if it was from the COVID vaccine or if maybe she had hit something. But within a week or two she had severe breast swelling and noticed other bruising. After that first COVID vaccine she thought that it was an unusual thing that happened so she called her doctor and they have now diagnosed her with inflammatory breast cancer which comes up quickly and can't always be diagnosed on a mammogram. It wasn't with a lump that they decided to see if she had this, it was because of the swelling and bruising. The doctor said well it could be coincidental with the COVID vaccine but it is awfully strange that this came up shortly after the first vaccine. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Heart rate increased, Nausea, Pallor
Clinical narrative: Seizure; Felt dizzy; Eye sight was blurry; Shake and jerk; Shake and jerk; Skin turned pale; Heart rate was high; Nauseous; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 16:00 as unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil; magnesium [magnesium citrate]; vitamin d [vitamin d nos]; probiotic [bifidobacterium lactis]; vitamin b complex (VITAMIN B). The consumer stated, approximately 20 minutes after receiving the vaccine (28Apr2021 16:15) the patient felt dizzy, eyesight was blurry, and he began to shake and jerk. It resembled a seizure. His skin turned pale, heart rate was high, and he felt nauseous. It took him approximately 5-10 minutes to feel "normal" again. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in emergency room/department or urgent care. There is no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.  Information about Batch/Lot no. has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Tremor, Vision blurred
Clinical narrative: Seizure; Felt dizzy; Eye sight was blurry; Shake and jerk; Shake and jerk; Skin turned pale; Heart rate was high; Nauseous; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 16:00 as unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil; magnesium [magnesium citrate]; vitamin d [vitamin d nos]; probiotic [bifidobacterium lactis]; vitamin b complex (VITAMIN B). The consumer stated, approximately 20 minutes after receiving the vaccine (28Apr2021 16:15) the patient felt dizzy, eyesight was blurry, and he began to shake and jerk. It resembled a seizure. His skin turned pale, heart rate was high, and he felt nauseous. It took him approximately 5-10 minutes to feel "normal" again. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in emergency room/department or urgent care. There is no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.  Information about Batch/Lot no. has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Migraine, Paraesthesia
Clinical narrative: 12 hours post vaccination blacked out. Post regaining consciousness both hands and arms became numb; Mild migrane; Forehead felt numb for 3 d/Post regaining consciousness both hands and arms became numb; slight tingling in fingers; This is a spontaneous report from a non-contactable other hcp (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Apr2021 19:00 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient felt okay after vaccine. 12 hours post vaccination (24Apr2021 08:00) blacked out. Post regaining consciousness both hands and arms became numb. Felt slight tingling in fingers. Mild migrane. Forehead felt numb for 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no known allergies and other medical history. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported event of Loss of consciousness and BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: My period started two weeks early. This was already strange because my periods are very regular. I was bleeding very heavily; My period started two weeks early. This was already strange because my periods are very regular.; lightheaded; My period started two weeks early. This was already strange because my periods are very regular. I was bleeding very heavilynoticed several blood clots; This is a spontaneous report from a contactable consume (patient). A 22-years-old non pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 07Apr2021 (at the age of 22 years old) (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. The patients medical history and  concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Apr2021 the patient experienced  period started two weeks early, bleeding very heavily (medically significant), noticed several blood clots as well and lightheaded. The clinical course was reported as follows ' My period started two weeks early. This was already strange because my periods are very regular. I was bleeding very heavily and I considered going to urgent care but I was light headed and decided against driving. I noticed several blood clots as well. No Treatment was given for the events. The clinical outcome of the events was recovered. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Single dose, Lot number EW0170 on 28Apr2021     No follow-up attempts are needed. No further information is expected.