chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Hyperacusis, Influenza like illness, Pain, Pyrexia
Clinical narrative: moderate hearing loss; hyperacusis; tinnitus; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 10Mar2021 13:00 at single dose for covid-19 immunisation. The patient's medical history included hypertension. The patient was not pregnant at time of vaccination. The patient's concomitant medications included desvenlafaxine, candesartan, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and azelastine.  The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264) via an unspecified route of administration, administered in Arm Left first dose on 17Feb2021 for covid-19 immunisation. On 11Mar2021 14:00, the patient experienced moderate hearing loss confirmed by doctor hyperacusiss and tinnitus. The patient was treated with oral steroids. The events cause physician office visit. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden hearing loss
Clinical narrative: moderate hearing loss; hyperacusis; tinnitus; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 10Mar2021 13:00 at single dose for covid-19 immunisation. The patient's medical history included hypertension. The patient was not pregnant at time of vaccination. The patient's concomitant medications included desvenlafaxine, candesartan, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and azelastine.  The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264) via an unspecified route of administration, administered in Arm Left first dose on 17Feb2021 for covid-19 immunisation. On 11Mar2021 14:00, the patient experienced moderate hearing loss confirmed by doctor hyperacusiss and tinnitus. The patient was treated with oral steroids. The events cause physician office visit. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Hyperacusis, Tinnitus
Clinical narrative: moderate hearing loss; hyperacusis; tinnitus; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 10Mar2021 13:00 at single dose for covid-19 immunisation. The patient's medical history included hypertension. The patient was not pregnant at time of vaccination. The patient's concomitant medications included desvenlafaxine, candesartan, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and azelastine.  The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264) via an unspecified route of administration, administered in Arm Left first dose on 17Feb2021 for covid-19 immunisation. On 11Mar2021 14:00, the patient experienced moderate hearing loss confirmed by doctor hyperacusiss and tinnitus. The patient was treated with oral steroids. The events cause physician office visit. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Nausea, Nervousness
Clinical narrative: blood pressure went high to 163/blood pressure was elevated; dizzy; tightness in collar bone area; cold; neck tightness; freezing really cold for 30 to 40 minutes; pain at the bottom of my neck; exhaustion; it sounds like paresthesia; my body started shaking, involuntary shaking for about an hour; Disoriented; confused; my heart beating fast, tachycardia; This is a spontaneous report from a contactable physician, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient had the first Pfizer covid Vaccine 2 weeks ago today, and states, "I felt dizzy within first 5 minutes, my blood pressure went high to 163/, tightness in collar bone area, cold right away. I think I panicked at the same time. Not like a chest pain, but bottom of my neck tightness, it went away in half an hour on its own. I was freezing really cold for 30 to 40 minutes they brought me blanket and orange juice to drink and it went away about 5:30ish it took 45 minutes to feel better. The pain at the bottom of my neck went away the next day or a few hours later, it was at the bottom of my collar of my neck, my blood pressure was elevated, I was cold and freezing. Besides the typical side effects of exhaustion, I went to urgent care near my house, and they said it was vaccine stuff, a week ago Monday was when I went. I spoke with my doctor this Monday on virtual call, and she said it sounds like paresthesia, shaking of the body related to vaccine. My doctor called it paresthesia, my body started shaking, involuntary shaking for about an hour. I was disoriented, confused and my heart beating fast, tachycardia. The outcome of the events neck tightness, freezing really cold for 30 to 40 minutes and pain at the bottom of my neck was recovered on an unknown date in Apr2021 and all other events was unknow.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a temporal association  a causal relationship between the reported events and suspect drug  BNT162B2 is assessed as possible. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: blood pressure went high to 163/blood pressure was elevated; dizzy; tightness in collar bone area; cold; neck tightness; freezing really cold for 30 to 40 minutes; pain at the bottom of my neck; exhaustion; it sounds like paresthesia; my body started shaking, involuntary shaking for about an hour; Disoriented; confused; my heart beating fast, tachycardia; This is a spontaneous report from a contactable physician, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient had the first Pfizer covid Vaccine 2 weeks ago today, and states, "I felt dizzy within first 5 minutes, my blood pressure went high to 163/, tightness in collar bone area, cold right away. I think I panicked at the same time. Not like a chest pain, but bottom of my neck tightness, it went away in half an hour on its own. I was freezing really cold for 30 to 40 minutes they brought me blanket and orange juice to drink and it went away about 5:30ish it took 45 minutes to feel better. The pain at the bottom of my neck went away the next day or a few hours later, it was at the bottom of my collar of my neck, my blood pressure was elevated, I was cold and freezing. Besides the typical side effects of exhaustion, I went to urgent care near my house, and they said it was vaccine stuff, a week ago Monday was when I went. I spoke with my doctor this Monday on virtual call, and she said it sounds like paresthesia, shaking of the body related to vaccine. My doctor called it paresthesia, my body started shaking, involuntary shaking for about an hour. I was disoriented, confused and my heart beating fast, tachycardia. The outcome of the events neck tightness, freezing really cold for 30 to 40 minutes and pain at the bottom of my neck was recovered on an unknown date in Apr2021 and all other events was unknow.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a temporal association  a causal relationship between the reported events and suspect drug  BNT162B2 is assessed as possible. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Bone pain, Confusional state, Disorientation, Dizziness
Clinical narrative: blood pressure went high to 163/blood pressure was elevated; dizzy; tightness in collar bone area; cold; neck tightness; freezing really cold for 30 to 40 minutes; pain at the bottom of my neck; exhaustion; it sounds like paresthesia; my body started shaking, involuntary shaking for about an hour; Disoriented; confused; my heart beating fast, tachycardia; This is a spontaneous report from a contactable physician, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient had the first Pfizer covid Vaccine 2 weeks ago today, and states, "I felt dizzy within first 5 minutes, my blood pressure went high to 163/, tightness in collar bone area, cold right away. I think I panicked at the same time. Not like a chest pain, but bottom of my neck tightness, it went away in half an hour on its own. I was freezing really cold for 30 to 40 minutes they brought me blanket and orange juice to drink and it went away about 5:30ish it took 45 minutes to feel better. The pain at the bottom of my neck went away the next day or a few hours later, it was at the bottom of my collar of my neck, my blood pressure was elevated, I was cold and freezing. Besides the typical side effects of exhaustion, I went to urgent care near my house, and they said it was vaccine stuff, a week ago Monday was when I went. I spoke with my doctor this Monday on virtual call, and she said it sounds like paresthesia, shaking of the body related to vaccine. My doctor called it paresthesia, my body started shaking, involuntary shaking for about an hour. I was disoriented, confused and my heart beating fast, tachycardia. The outcome of the events neck tightness, freezing really cold for 30 to 40 minutes and pain at the bottom of my neck was recovered on an unknown date in Apr2021 and all other events was unknow.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a temporal association  a causal relationship between the reported events and suspect drug  BNT162B2 is assessed as possible. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold, Hypertension, Muscle tightness, Nasopharyngitis
Clinical narrative: blood pressure went high to 163/blood pressure was elevated; dizzy; tightness in collar bone area; cold; neck tightness; freezing really cold for 30 to 40 minutes; pain at the bottom of my neck; exhaustion; it sounds like paresthesia; my body started shaking, involuntary shaking for about an hour; Disoriented; confused; my heart beating fast, tachycardia; This is a spontaneous report from a contactable physician, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient had the first Pfizer covid Vaccine 2 weeks ago today, and states, "I felt dizzy within first 5 minutes, my blood pressure went high to 163/, tightness in collar bone area, cold right away. I think I panicked at the same time. Not like a chest pain, but bottom of my neck tightness, it went away in half an hour on its own. I was freezing really cold for 30 to 40 minutes they brought me blanket and orange juice to drink and it went away about 5:30ish it took 45 minutes to feel better. The pain at the bottom of my neck went away the next day or a few hours later, it was at the bottom of my collar of my neck, my blood pressure was elevated, I was cold and freezing. Besides the typical side effects of exhaustion, I went to urgent care near my house, and they said it was vaccine stuff, a week ago Monday was when I went. I spoke with my doctor this Monday on virtual call, and she said it sounds like paresthesia, shaking of the body related to vaccine. My doctor called it paresthesia, my body started shaking, involuntary shaking for about an hour. I was disoriented, confused and my heart beating fast, tachycardia. The outcome of the events neck tightness, freezing really cold for 30 to 40 minutes and pain at the bottom of my neck was recovered on an unknown date in Apr2021 and all other events was unknow.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a temporal association  a causal relationship between the reported events and suspect drug  BNT162B2 is assessed as possible. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Paraesthesia, Tachycardia, Tremor
Clinical narrative: blood pressure went high to 163/blood pressure was elevated; dizzy; tightness in collar bone area; cold; neck tightness; freezing really cold for 30 to 40 minutes; pain at the bottom of my neck; exhaustion; it sounds like paresthesia; my body started shaking, involuntary shaking for about an hour; Disoriented; confused; my heart beating fast, tachycardia; This is a spontaneous report from a contactable physician, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient had the first Pfizer covid Vaccine 2 weeks ago today, and states, "I felt dizzy within first 5 minutes, my blood pressure went high to 163/, tightness in collar bone area, cold right away. I think I panicked at the same time. Not like a chest pain, but bottom of my neck tightness, it went away in half an hour on its own. I was freezing really cold for 30 to 40 minutes they brought me blanket and orange juice to drink and it went away about 5:30ish it took 45 minutes to feel better. The pain at the bottom of my neck went away the next day or a few hours later, it was at the bottom of my collar of my neck, my blood pressure was elevated, I was cold and freezing. Besides the typical side effects of exhaustion, I went to urgent care near my house, and they said it was vaccine stuff, a week ago Monday was when I went. I spoke with my doctor this Monday on virtual call, and she said it sounds like paresthesia, shaking of the body related to vaccine. My doctor called it paresthesia, my body started shaking, involuntary shaking for about an hour. I was disoriented, confused and my heart beating fast, tachycardia. The outcome of the events neck tightness, freezing really cold for 30 to 40 minutes and pain at the bottom of my neck was recovered on an unknown date in Apr2021 and all other events was unknow.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a temporal association  a causal relationship between the reported events and suspect drug  BNT162B2 is assessed as possible. 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Blood test normal, Blood thyroid stimulating hormone, Body temperature fluctuation, Chest pain
Clinical narrative: Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers and toes, feeling of body vibrating and nerve pain, and hair loss, lasting over a month.  Also a much  heavier than normal period that lasted 8 days (normal length is 4-5 days).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram ambulatory, Fatigue, Full blood count normal, Headache
Clinical narrative: Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers and toes, feeling of body vibrating and nerve pain, and hair loss, lasting over a month.  Also a much  heavier than normal period that lasted 8 days (normal length is 4-5 days).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Metabolic function test, Palpitations
Clinical narrative: Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers and toes, feeling of body vibrating and nerve pain, and hair loss, lasting over a month.  Also a much  heavier than normal period that lasted 8 days (normal length is 4-5 days).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Anaemia, Asthenia, Differential white blood cell count, Fatigue
Clinical narrative: Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers and toes, feeling of body vibrating and nerve pain, and hair loss, lasting over a month.  Also a much  heavier than normal period that lasted 8 days (normal length is 4-5 days).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Heavy menstrual bleeding, Insomnia, Mean cell haemoglobin decreased, Mean cell volume abnormal
Clinical narrative: Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers and toes, feeling of body vibrating and nerve pain, and hair loss, lasting over a month.  Also a much  heavier than normal period that lasted 8 days (normal length is 4-5 days).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms, Neuralgia, Neuropathy peripheral, Palpitations, Serum ferritin decreased
Clinical narrative: Fatigue, exhaustion, heart palpitations, insomnia, weakness, muscle spasms, neuropathy in fingers and toes, feeling of body vibrating and nerve pain, and hair loss, lasting over a month.  Also a much  heavier than normal period that lasted 8 days (normal length is 4-5 days).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Dyspnoea, Headache
Clinical narrative: she is now experiencing a lingering headache, nausea and chills.; she is now experiencing a lingering headache, nausea and chills.; she is now experiencing a lingering headache, nausea and chills.; This is a spontaneous report from a program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer Covid-19 vaccine yesterday 14Apr2021 and she was now experiencing a lingering headache, nausea and chills on 15Apr2021. She wanted to know if she can take Tylenol. She also mentioned that her vaccination card was lost and she wanted to schedule for her second dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: she is now experiencing a lingering headache, nausea and chills.; she is now experiencing a lingering headache, nausea and chills.; she is now experiencing a lingering headache, nausea and chills.; This is a spontaneous report from a program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer Covid-19 vaccine yesterday 14Apr2021 and she was now experiencing a lingering headache, nausea and chills on 15Apr2021. She wanted to know if she can take Tylenol. She also mentioned that her vaccination card was lost and she wanted to schedule for her second dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Severe headaches in the back of her head and would need to lay down; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer  (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included sinus allergies. The patient's concomitant medications were not reported. The patient experienced severe headaches in the back of her head on 25Mar2021 and would need to lay down, stated after taking 2 anacin it would feel better for a while. The outcome of event was unknown. The second dose is scheduled for 23Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Blood bilirubin increased, Blood lactate dehydrogenase increased, Central nervous system lesion, Cerebral thrombosis
Clinical narrative: clots; I received the pfizer vaccine and within 2 weeks had bruising; low platelets; This is a spontaneous report from a contactable consumer, the patient. This patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that he/she received the vaccine and within 2 weeks had bruising, low platelets and clots (unspecified date). Lab data included platelets: low on unspecified date. The clinical outcomes of bruising, low platelets and clots were unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Hepatitis viral test negative, Magnetic resonance imaging head abnormal, Plasmapheresis, Platelet count decreased
Clinical narrative: clots; I received the pfizer vaccine and within 2 weeks had bruising; low platelets; This is a spontaneous report from a contactable consumer, the patient. This patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that he/she received the vaccine and within 2 weeks had bruising, low platelets and clots (unspecified date). Lab data included platelets: low on unspecified date. The clinical outcomes of bruising, low platelets and clots were unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: clots; I received the pfizer vaccine and within 2 weeks had bruising; low platelets; This is a spontaneous report from a contactable consumer, the patient. This patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that he/she received the vaccine and within 2 weeks had bruising, low platelets and clots (unspecified date). Lab data included platelets: low on unspecified date. The clinical outcomes of bruising, low platelets and clots were unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Contusion, Platelet count, Platelet count decreased, Thrombosis
Clinical narrative: clots; I received the pfizer vaccine and within 2 weeks had bruising; low platelets; This is a spontaneous report from a contactable consumer, the patient. This patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that he/she received the vaccine and within 2 weeks had bruising, low platelets and clots (unspecified date). Lab data included platelets: low on unspecified date. The clinical outcomes of bruising, low platelets and clots were unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Menstruation delayed, Mood swings
Clinical narrative: she has not had her period/ missed that period and she had still not yet started her menstrual cycle; worsening anxiety; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Apr2021 (lot number: EW0150, expiration date: 31Jul2021) at single dose for COVID-19 immunization. The relevant medical history included anxiety from unspecified date. Concomitant medications were reported as none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 02Apr2021, her menstrual period should had started 3 days later however she had not had her period. Her doctor told her that her cycle was missed never but she never missed a cycle before. She would like to know if she should receive the second dose of the vaccine this Friday or the recommendations since they were not sure it's related to the vaccine. The patient stated she was due to start her period 3 days after the first dose on 05Apr2021 and she missed that period and she had still not yet started her menstrual cycle, stated she cannot confirm it was linked to the vaccine but wanted to call and ask if had any other cases like this reported. Stated she wanted to know if had a recommendation about what she should do about the second dose. The patient stated that since she received the first dose her anxiety has worsened on 02Apr2021. The patient had taken 2 pregnancy tests, that were negative on an unspecified date. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Menstruation irregular, Pregnancy test
Clinical narrative: she has not had her period/ missed that period and she had still not yet started her menstrual cycle; worsening anxiety; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Apr2021 (lot number: EW0150, expiration date: 31Jul2021) at single dose for COVID-19 immunization. The relevant medical history included anxiety from unspecified date. Concomitant medications were reported as none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 02Apr2021, her menstrual period should had started 3 days later however she had not had her period. Her doctor told her that her cycle was missed never but she never missed a cycle before. She would like to know if she should receive the second dose of the vaccine this Friday or the recommendations since they were not sure it's related to the vaccine. The patient stated she was due to start her period 3 days after the first dose on 05Apr2021 and she missed that period and she had still not yet started her menstrual cycle, stated she cannot confirm it was linked to the vaccine but wanted to call and ask if had any other cases like this reported. Stated she wanted to know if had a recommendation about what she should do about the second dose. The patient stated that since she received the first dose her anxiety has worsened on 02Apr2021. The patient had taken 2 pregnancy tests, that were negative on an unspecified date. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Ultrasound Doppler
Clinical narrative: on 3/8/21 patient describes numbness which starts on left hip which goes down left leg. on 3/21/21  patient complains of 3 days of pain and swelling in left lower leg, calf, edema of the foot and ankle which is painful with movement.  ultrasound negative. on 3/23/21  ultrasound shows Deep vein thrombosis is visualized in the left popliteal vein.  progress note indicates no immobility or long car rides.  No history of DVT or pulmonary embolus.  Begin enoxaparin x5 days and then dabigatran.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Hypoaesthesia, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: on 3/8/21 patient describes numbness which starts on left hip which goes down left leg. on 3/21/21  patient complains of 3 days of pain and swelling in left lower leg, calf, edema of the foot and ankle which is painful with movement.  ultrasound negative. on 3/23/21  ultrasound shows Deep vein thrombosis is visualized in the left popliteal vein.  progress note indicates no immobility or long car rides.  No history of DVT or pulmonary embolus.  Begin enoxaparin x5 days and then dabigatran.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound Doppler, Ultrasound scan abnormal, Ultrasound scan normal
Clinical narrative: on 3/8/21 patient describes numbness which starts on left hip which goes down left leg. on 3/21/21  patient complains of 3 days of pain and swelling in left lower leg, calf, edema of the foot and ankle which is painful with movement.  ultrasound negative. on 3/23/21  ultrasound shows Deep vein thrombosis is visualized in the left popliteal vein.  progress note indicates no immobility or long car rides.  No history of DVT or pulmonary embolus.  Begin enoxaparin x5 days and then dabigatran.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, Skin tightness, Ultrasound scan
Clinical narrative: on 3/8/21 patient describes numbness which starts on left hip which goes down left leg. on 3/21/21  patient complains of 3 days of pain and swelling in left lower leg, calf, edema of the foot and ankle which is painful with movement.  ultrasound negative. on 3/23/21  ultrasound shows Deep vein thrombosis is visualized in the left popliteal vein.  progress note indicates no immobility or long car rides.  No history of DVT or pulmonary embolus.  Begin enoxaparin x5 days and then dabigatran.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for self. Weakness in right hand and right foot;  A 28-years-old female patient received the first dose of   COVID-19 VACCINE via an unspecified route of administration, administered in Arm Left on 16 Apr 2021 09:45  as single dose for Covid-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Crohn's disease, Psoriatic arthritis, psoriasis, diagnosed with COVID-19 prior to vaccination. Concomitant medications included ustekinumab (STELARA), escitalopram, oral birth control within 2 weeks of vaccination. The patient previously took prednisone and experienced prednisone allergy. The patient experienced weakness in right hand and right foot on 16 Apr 2021 11:30 AM. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was not recovered. The case was reported as non-serious. No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer reported for self. Weakness in right hand and right foot;  A 28-years-old female patient received the first dose of   COVID-19 VACCINE via an unspecified route of administration, administered in Arm Left on 16 Apr 2021 09:45  as single dose for Covid-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Crohn's disease, Psoriatic arthritis, psoriasis, diagnosed with COVID-19 prior to vaccination. Concomitant medications included ustekinumab (STELARA), escitalopram, oral birth control within 2 weeks of vaccination. The patient previously took prednisone and experienced prednisone allergy. The patient experienced weakness in right hand and right foot on 16 Apr 2021 11:30 AM. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was not recovered. The case was reported as non-serious. No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Balance disorder, Chills, Dizziness, Migraine
Clinical narrative: Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events.  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 Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances 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 including head CT/MRI, 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: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Panic reaction, Presyncope, Tinnitus, Tremor
Clinical narrative: Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events.  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 Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances 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 including head CT/MRI, 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: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events.  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 Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances 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 including head CT/MRI, 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: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Ear discomfort, Head discomfort, Migraine, Nausea
Clinical narrative: Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events.  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 Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances 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 including head CT/MRI, 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.