chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Fall, Fatigue, Full blood count, Pain in extremity
Clinical narrative: Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization.  Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated.  Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA).  The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization.  Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated.  Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA).  The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm ruptured, Behaviour disorder, Computerised tomogram, Headache, Sensory loss
Clinical narrative: loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Walking disability
Clinical narrative: loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Cardio-respiratory arrest, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Paraesthesia oral, Resuscitation, Seizure like phenomena, Ultrasound scan abnormal
Clinical narrative: passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Aphasia, Cerebrovascular accident, Headache, Intracranial aneurysm
Clinical narrative: stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced  Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm  (hospitalization, disability, life threatening),  Treatment was given for the events of stroke, a thunder clap headache,  limbs stiffened up, eyes crossed, lost speech, and  brain aneurysm.  The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm  not recovered, while Mood Swings, Anger and Pain was unknown.  Information on Lot has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mood swings, Musculoskeletal stiffness, Pain, Strabismus
Clinical narrative: stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced  Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm  (hospitalization, disability, life threatening),  Treatment was given for the events of stroke, a thunder clap headache,  limbs stiffened up, eyes crossed, lost speech, and  brain aneurysm.  The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm  not recovered, while Mood Swings, Anger and Pain was unknown.  Information on Lot has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received Covid 19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization.The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter was calling about the Covid 19 Vaccine. Reporter stated that she gets information every day from the nursing home. Reporter stated that she will provide the name of the Nursing home, she just forgot to put it down. The patient, within 2 days dead from it, he was perfectly healthy. The patient died on an unspecified date. It was not reported if an autopsy was performed.   Information on Lot/batch number has been requested.; Reported Cause(s) of Death: Death
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Investigation, SARS-CoV-2 test
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized  due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all.  The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Transient ischaemic attack
Clinical narrative: Repetitive episodes of tingling; numbness occurring in left side of body including side of face; Possible TIA; This is a spontaneous report from a contactable consumer reporting for himself.  A 73-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262), via an unspecified route of administration in the left arm on 02Feb2021 16:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included amlodipine (unknown manufacturer). On 02Feb2021 16:00 the patient experienced repetitive episodes of tingling and numbness occurring in left side of body including side of face; possible TIA with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient was hospitalized for 3 days due to the events. The events were serious as life-threatening and due to hospitalization. It was unknown if the patient received treatments for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood osmolarity, Blood pressure measurement, Blood urea, Monocyte count
Clinical narrative: Thrombocytopenia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombocytopenia on an unspecified date, the seriousness of the event reported as death. The patient died two weeks after receiving a COVID-19 vaccine. Patient's wife said that he died from a condition known as thrombocytopenia, marked by a shortage of the blood platelets that help stop bleeding, after he received BNT162B2. The patient underwent lab tests and procedures which included blood bilirubin: 1.50, blood osmolarity: 297, blood pressure measurement: 159/106, blood urea: 22.3, monocyte count: 12.1 %, platelet count: thrombocytopenia, platelet count: platelet count decreased again to 0 on 21Dec2020. The patient died on an unspecified date.  It was unknown if an autopsy was performed. The outcome of the events was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: Thrombocytopenia; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombocytopenia on an unspecified date, the seriousness of the event reported as death. The patient died two weeks after receiving a COVID-19 vaccine. Patient's wife said that he died from a condition known as thrombocytopenia, marked by a shortage of the blood platelets that help stop bleeding, after he received BNT162B2. The patient underwent lab tests and procedures which included blood bilirubin: 1.50, blood osmolarity: 297, blood pressure measurement: 159/106, blood urea: 22.3, monocyte count: 12.1 %, platelet count: thrombocytopenia, platelet count: platelet count decreased again to 0 on 21Dec2020. The patient died on an unspecified date.  It was unknown if an autopsy was performed. The outcome of the events was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood blister, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Blood blister; hands, feet, torso are covered and painful/soreness and tenderness of palms; has trouble with ambulation; torso are covered and painful; This is a spontaneous report from a contactable nurse (patient's daughter). An 86-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021), intramuscular in the left upper arm on 25Jan2021 13:30 at a single dose for protection against virus. Medical history included COVID from 18Nov2020 and ongoing (recovering/resolving). The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021) intramuscular in the left arm on 04Jan2021 for protection against virus with no problem. On 26Jan2021, patient had one tiny blood blister but now was covered in them. Her hands, feet, and torso are covered and are painful. The patient has trouble with ambulation and using her walker since. The palms of her hands are covered front and back too. The patient was also covered on her toes and areas of the abdomen around the umbilicus area. Had the first dose on 04Jan2021 and the second on 25Jan2021. Her mother has an appointment on 03Feb2021, and caller wanted to know if this is uncommon or a rare side effect. The reporter has found a couple of articles, but most of them refer to pediatrics and rashes and she didn't see any side effects about blood blisters for her mother's age group. Further stated that areas covered are progressively worse and disabling since her mother was using a walker to ambulate. Has not been able to really use the walker due to the soreness and tenderness of palms. Her mother had the disease (COVID) back on 18Nov2020 and was symptomatic and was mild. No other vaccines received the same time. No history of problems with vaccines in past. They can't think of nothing that was new, no new medications, lotions, creams, or detergents, nothing new. The events did not require a visit to emergency room nor a physician office. Onset date of events reported was on 26Jan2021 with outcome of not recovered. The reporter assessed the seriousness of events as disability. The events were assessed as related to vaccines.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister
Clinical narrative: Blood blister; hands, feet, torso are covered and painful/soreness and tenderness of palms; has trouble with ambulation; torso are covered and painful; This is a spontaneous report from a contactable nurse (patient's daughter). An 86-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021), intramuscular in the left upper arm on 25Jan2021 13:30 at a single dose for protection against virus. Medical history included COVID from 18Nov2020 and ongoing (recovering/resolving). The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021) intramuscular in the left arm on 04Jan2021 for protection against virus with no problem. On 26Jan2021, patient had one tiny blood blister but now was covered in them. Her hands, feet, and torso are covered and are painful. The patient has trouble with ambulation and using her walker since. The palms of her hands are covered front and back too. The patient was also covered on her toes and areas of the abdomen around the umbilicus area. Had the first dose on 04Jan2021 and the second on 25Jan2021. Her mother has an appointment on 03Feb2021, and caller wanted to know if this is uncommon or a rare side effect. The reporter has found a couple of articles, but most of them refer to pediatrics and rashes and she didn't see any side effects about blood blisters for her mother's age group. Further stated that areas covered are progressively worse and disabling since her mother was using a walker to ambulate. Has not been able to really use the walker due to the soreness and tenderness of palms. Her mother had the disease (COVID) back on 18Nov2020 and was symptomatic and was mild. No other vaccines received the same time. No history of problems with vaccines in past. They can't think of nothing that was new, no new medications, lotions, creams, or detergents, nothing new. The events did not require a visit to emergency room nor a physician office. Onset date of events reported was on 26Jan2021 with outcome of not recovered. The reporter assessed the seriousness of events as disability. The events were assessed as related to vaccines.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Feeling abnormal, Mental impairment
Clinical narrative: vaccine is really taking a big toll on her brain function; feels just weird, like everything is in slow motion/feeling really weird; dizzy/lightheaded; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left deltoid on 02Feb2021 at single dose for COVID-19 immunization. The patient's medical history was not reported.  There were no concomitant medications. The patient got the COVID vaccine a couple hours ago on 02Feb202 and was very lightheaded. When the patient was asked to provide her mailing address, she stated she was feeling really weird, the vaccine was really taking a big toll on her brain function, she was super dizzy and feels just weird, like everything is in slow motion. Lightheadedness started probably about 20 minutes after she had the shot, they made her wait for 15 minutes, now she just feels really weird. The patient was healthy, she just got blood tests back and everything said she is healthy. She thought they said to call if she was having a side effect of dizziness or weakness, as they are more serious, but she called her doctor and they said to call Pfizer. The outcome of the events was unknown. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Death
Clinical narrative: approxmately 1:30 Pm the resident passed away; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a female patient of an unspecified age (reported as 85 without unit) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular at left arm on 29Dec2020 11:29 at single dose for COVID-19 immunization. Medical history included dementia, aphasia, type 2 diabetes mellitus (DM), iron deficiency, asthenia, osteoporosis, polyneuropathy, anxiety, Major depressive disorder (MDD). Concomitant medication included gabapentin, memantine. The patient had allergies to codiene, phenobarbital, penicillin. The vaccine was administrated with no immediate adverse reaction at 11:29. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 13:30 on 29Dec2020, the resident passed away.  It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: approxmately 1:30 Pm the resident passed away
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal wall haematoma, Abdominal wall haemorrhage, Acute respiratory failure, COVID-19 pneumonia, Death
Clinical narrative: Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure, COVID pneumonia; acute resp failure, COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist.  A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure, COVID pneumonia, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit, then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events death, COVID-19 pneumonia, acute respiratory failure, hypotension, abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.; Reported Cause(s) of Death: Pt passed soon after
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure, COVID pneumonia; acute resp failure, COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist.  A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure, COVID pneumonia, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit, then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events death, COVID-19 pneumonia, acute respiratory failure, hypotension, abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.; Reported Cause(s) of Death: Pt passed soon after
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hallucination, visual, Poor quality sleep
Clinical narrative: stayed up all night, slept all day; Hallucinations/ just saw people but never heard voices; stayed up all night, slept all day; This is a spontaneous report from a contactable consumer (patient's daughter). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EN5318, expiration date unknown) via an unspecified route of administration on the right arm on 01Feb2021 at a single dose as vaccine for COVID-19. The patient had no medical history and no concomitant medications.  On 01Feb2021 23:00, the patient experienced hallucinations. It was reported that patient started hallucinating on 01Feb2021 23:00 and just saw people but never heard voices. The reporter stated that her mom never had hallucinations ever. The patient feared people were in the house and stayed up all night (from 01Feb2021 23:00), slept all day (on 02Feb2021). The reporter wanted to know if they have ever heard of this happening. She has made an appointment with the patient's doctor. The outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Developed Shingles on his face; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported for a 32-year-old male patient (her fiance). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration at the right arm on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2  on 08Jan2021 for COVID-19 immunization. The patient developed shingles on his face on 31Jan2021 and swollen lymph nodes on 01Feb2021. The events were reported as serious (medically significant) and worsened. There were no investigation assessment. The patient had not recovered from the events at the time of the report.    Information on the batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the Company considers the event swollen lymph nodes is possibly related to suspect vaccine BNT162B2. Other than a temporal association, there is no evidence or argument to suggest a causal relationship between BNT162B2 and the event shingles, which is likely an intercurrent condition. 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: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Vision blurred, Visual field tests
Clinical narrative: Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering.  No follow-up activities are needed. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; an expired dose of M-M-R II was given to a patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-JAN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # R035704, expiration date:09-DEC-2020 (dose, route of administration and anatomical location were not reported) for prophylaxis. There were no know temperature excursions. No adverse event was reported.
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE; Improperly stored dose was administered; This spontaneous report was received from a nurse and refers to a 13-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 01-FEB-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot number: T013205, expiration date: 03-DEC-2021 (strength, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 48 (unit not reported) for 24 hours and 45 minutes. Digital data logger was involved. There was no previous temperature excursion noted. There was no additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Headache, Hypersensitivity
Clinical narrative: autoimmune disorder; hypersensitivity; headaches; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 12-DEC-2011 (at approximately 67 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a health care provider (reported as provider) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: autoimmune disorder, hypersensitivity and headaches. The outcome of the events was unknown.  Upon internal review, autoimmune disorder was determined to be medically significant.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Influenza virus test negative, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: she has a fever of 101.5; headache; nausea; This spontaneous report was received from a company employee (also reported as the patient's grandmother) and the patient's mother, referring to a 17 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter.  On 11-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis.  On 12-FEB-2021, the patient had a fever of 101.5 (units not provided), headache and nausea. The patient sought medical attention by seeing the administering physician in afternoon and was tested for flu, strep, and Covid, all of which were negative. The patient was diagnosed that her symptoms were an adverse reaction to the vaccine. The outcome of fever of 101.5 (units not provided), headache and nausea were unknown. It was reported that the patient would not be receiving the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The reporter considered the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was related.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Streptococcus test negative
Clinical narrative: she has a fever of 101.5; headache; nausea; This spontaneous report was received from a company employee (also reported as the patient's grandmother) and the patient's mother, referring to a 17 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter.  On 11-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis.  On 12-FEB-2021, the patient had a fever of 101.5 (units not provided), headache and nausea. The patient sought medical attention by seeing the administering physician in afternoon and was tested for flu, strep, and Covid, all of which were negative. The patient was diagnosed that her symptoms were an adverse reaction to the vaccine. The outcome of fever of 101.5 (units not provided), headache and nausea were unknown. It was reported that the patient would not be receiving the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The reporter considered the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was related.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: shingles - like rash / Rash is painful; shingles - like rash; This case was reported by a other health professional via interactive and described the occurrence of painful rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced painful rash and vesicular rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the painful rash and vesicular rash were unknown.   It was unknown if the reporter considered the painful rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles like rash. The rash was painful and patient received valacyclovir 1 g BID was helpful.  The reporter asked was it possible to get shingles from the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 100°temp; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 2nd dose of Shingrix and got 100 degree F body temperature. The patient was asking how long will the fever last.