chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Headache, Muscular weakness, Neck pain
Clinical narrative: Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Vision blurred
Clinical narrative: Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Neck pain, Product administered at inappropriate site, SARS-CoV-2 test
Clinical narrative: Brain Bleed.; Pain in back of neck; BNT162B2 in right leg; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date not provided), via an unspecified route of administration, in right leg, on 26Mar2021 17:45 (at the age of 63-year-old), at single dose, for COVID-19 immunization. Medical history included high blood pressure. Patient had no known allergies. No COVID prior vaccination. No other vaccine in four weeks. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV6206, expiration date not provided), via an unspecified route of administration, in right arm, on 03Mar2021 17:45  (at the age of 63-year-old), at single dose, for COVID-19 immunization. On 27Mar2021 03:30, the patient experienced pain in back of neck and brain bleed. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient was hospitalized for 19 days. The patient underwent lab tests and procedures, which included COVID test was negative in Apr2021. Therapeutic measures were taken as a result of events and included treatment with observation intensive care unit (ICU) 7 days, tube feed and medication. The outcome of the events "pain in back of neck and brain bleed" was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, Body temperature, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: 102 deg F temp; shivering; abnormal general body fatigue; Atelectasis; double blood clot in left lung lower left lobe; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 17:00 (Batch/Lot number was not reported) at the age of 68-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Inclusion Body Myositis, Sjogren's syndrome and Known allergies included Penicillin, Lamisil, Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included unspecified other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Got up 9:30AM on 14Apr2021. Experienced abnormal general body fatigue. Began shivering at 1:00 PM and went back to bed. 102 degree F temp at 3:00 PM. Called primary care physician, who advised we go to Emergency room (ER). Got into ER about 6:00pm. Covid polymerase chin reaction (PCR) Nasal Swab test negative, full viral panel negative. Chest X-Ray showed some Atelectasis, Computerised tomogram (CAT) scan revealed double blood clot in left lung lower left lobe. Sent to Hospital at about 1:00 AM 15Apr2021. Treatment with 16ml/hr Heparin plus 5mg/day warfarin. Discharged 06:00 PM on16Apr2021. Adverse event resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pulmonary thrombosis, Pyrexia, Respiratory viral panel, SARS-CoV-2 test
Clinical narrative: 102 deg F temp; shivering; abnormal general body fatigue; Atelectasis; double blood clot in left lung lower left lobe; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 17:00 (Batch/Lot number was not reported) at the age of 68-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Inclusion Body Myositis, Sjogren's syndrome and Known allergies included Penicillin, Lamisil, Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included unspecified other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Got up 9:30AM on 14Apr2021. Experienced abnormal general body fatigue. Began shivering at 1:00 PM and went back to bed. 102 degree F temp at 3:00 PM. Called primary care physician, who advised we go to Emergency room (ER). Got into ER about 6:00pm. Covid polymerase chin reaction (PCR) Nasal Swab test negative, full viral panel negative. Chest X-Ray showed some Atelectasis, Computerised tomogram (CAT) scan revealed double blood clot in left lung lower left lobe. Sent to Hospital at about 1:00 AM 15Apr2021. Treatment with 16ml/hr Heparin plus 5mg/day warfarin. Discharged 06:00 PM on16Apr2021. Adverse event resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest, Dizziness, Endoscopy, Gastrointestinal haemorrhage, Haemorrhage
Clinical narrative: unknown bleeding; nausea; lightheaded; GI bleed; cardiac arrest; bleed in small intestine; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Right on 26Feb2021 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Vaccine Administered at Military Facility was no. Patient received the first dose of vaccine on 05Feb2021 at age of 70 years old for covid-19 immunization and experienced rash on face, loss of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock. The patient medical history and concomitant medications were not reported. The patient experienced unknown bleeding (death, hospitalization, medically significant) on 10Mar2021, nausea (hospitalization) in 2021 with outcome of unknown, lightheaded (hospitalization) in 2021 with outcome of unknown, gastrointestinal (GI) bleed (medically significant) in 2021 with outcome of unknown, cardiac arrest (medically significant) in 2021 with outcome of unknown, bleed in small intestine (medically significant) in 2021 with outcome of unknown. Patient went to the hospital on 10Mar2021 with nausea and lightheaded. Endoscopy found GI bleed in 2021. Received blood went into cardiac arrest. Sent to another hospital found bleed in small intestine. Patient experienced unknown bleeding on 10Mar2021, which required visit to Emergency room/ intensive care unit on 18Mar2021 and received treatment, it resulted in death. The patient died on 18Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: unknown bleeding
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Small intestinal haemorrhage
Clinical narrative: unknown bleeding; nausea; lightheaded; GI bleed; cardiac arrest; bleed in small intestine; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Right on 26Feb2021 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Vaccine Administered at Military Facility was no. Patient received the first dose of vaccine on 05Feb2021 at age of 70 years old for covid-19 immunization and experienced rash on face, loss of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock. The patient medical history and concomitant medications were not reported. The patient experienced unknown bleeding (death, hospitalization, medically significant) on 10Mar2021, nausea (hospitalization) in 2021 with outcome of unknown, lightheaded (hospitalization) in 2021 with outcome of unknown, gastrointestinal (GI) bleed (medically significant) in 2021 with outcome of unknown, cardiac arrest (medically significant) in 2021 with outcome of unknown, bleed in small intestine (medically significant) in 2021 with outcome of unknown. Patient went to the hospital on 10Mar2021 with nausea and lightheaded. Endoscopy found GI bleed in 2021. Received blood went into cardiac arrest. Sent to another hospital found bleed in small intestine. Patient experienced unknown bleeding on 10Mar2021, which required visit to Emergency room/ intensive care unit on 18Mar2021 and received treatment, it resulted in death. The patient died on 18Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: unknown bleeding
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: had large bilateral PE; This is a spontaneous report from a contactable nurse. A 72-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Jan2021 (lot number EL1283) on Left arm at single dose for COVID-19 immunization. Facility type vaccine was at urgent care center. Medical history included hypertension. Concomitant medications were not reported. The patient had large bilateral PE (pulmonary embolism) several weeks after vaccine on 18Feb2021. The event resulted in emergency room visit, physician office visit and Hospitalization for 2 days. Serious criteria Life-threatening also reported for the event. The event was treatment with anticoagulation. The outcome of the event was resolved in 2021.; Sender's Comments: A causal relationship between the event "had large bilateral PE" and suspect product BNT162B2 is possible based on the information provided and a temporal association in this 72-year-old female patient with hypertension. This case will be reassessed should additional information become 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: swelling in her right foot and right calf and pain/blood clot was diagnosed in her right calf under her knee; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in left arm on 31Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient previously received the first dose of bnt162b2, at the age of 52-year-old, via an unspecified route of administration, administered in left arm on 10Mar2021 11:15(Lot Number: EN6206) as single dose for covid-19 immunization. Started experiencing swelling in her right foot and right calf and pain 3 days following 2nd injection (03Apr2021). Went to the doctor and blood clot was diagnosed in her right calf under my knee 9 days following 2nd injection (09Apr2021). Event resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The treatment for event was 21 Days Xarelto BID then Pradaxa for 90 days. The patient was not pregnant. The outcome of the event was recovering.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Computerised tomogram, Dyspnoea, Haematemesis
Clinical narrative: Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer.  A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation.  Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00,  the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination.  COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Musculoskeletal chest pain, Neuralgia, Pain, Pulmonary embolism
Clinical narrative: Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer.  A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation.  Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00,  the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination.  COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer.  A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation.  Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00,  the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination.  COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebellar stroke, Computerised tomogram, Echocardiogram, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: Cerebellar Stroke; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via unspecified route of administration in the left arm on 15Apr2021 11:30AM at age of 51-year-old at single dose for COVID-19 immunisation. Medical history included known allergies to Mango. Other Medical history included neuropathy and benign prostatic hyperplasia (BPH). There was no covid prior vaccination. There was no other vaccine in four weeks. There were concomitant medications in two weeks: pregabalin (LYRICA), morniflumate (FLOMAX) and nortriptyline. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) in left arm on 25Mar2021 04:30PM at 51-year-old at single dose for COVID-19 immunisation. Patient experienced adverse event: cerebellar stroke on 18Apr2021 06:45PM. Patient resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 2 days. Patient received treatment included computerised tomogram (CT scan), magnetic resonance imaging (MRI), Echocardiogram (TEE) and MyCare Link. Covid test post vaccination included: Nasal Swab on 18Apr2021: Negative. Patient was recovering from event.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) in the left arm on 30Mar2021 02:00 PM at 60-year-old at single dose for COVID-19 immunisation. Medical history included allergies to orphenadrine citrate (NORFLEX), blue dye. Other medical history included myasthenia gravis (Mg), asthma, hyperbaric oxygen therapy (hbo), glaucoma. There was no covid prior vaccination. There was no other vaccine in four weeks. There were concomitant medications in two weeks (unspecified). Patient experienced adverse event: pulmonary embolism on 14Apr2021 04:00 PM. The adverse events resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Hospitalization for 4 days. Patient received treatment for events included heparin drip. CT scan, respiratory TX, lab, apixaban (ELIQUIS). No covid tested post vaccination. Patient was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Panic attack
Clinical narrative: Panic attacks; Anxiety; Neither him or I have been able to sleep for days.; This is a spontaneous report from a contactable consumer. A male patient (reporter's son) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, Patient has developed anxiety and panic attacks. They had seen a doctor twice. Doctor prescribed the medications to calm him (patient) down. Consumer stated that they ended up calling (emergency number) twice and other two times to urgent care with severe panic attacks. Consumer stated that his son never suffered any of these before. Consumer has been trying to find psychological therapy without any luck and that was not a normal reaction, reported as please help us. neither him nor i have been able to sleep for days. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot in leg; This is a spontaneous report from a non-contactable consumer reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 01Apr2021 02:00 PM at 42-year-old at single dose for COVID-19 immunisation. Patient had known allergies (unspecified) and other medical history (unspecified). There was no covid prior vaccination. There is no other vaccine in four weeks. Other medications in two weeks included antibiotics. Patient experienced adverse event: blood clot in leg on 03Apr2021 02:00 AM. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient received treatment for events included blood thinners. Patient had covid tested post vaccination on 21Apr2021: Nasal Swab: Negative. Patient was not recovered.      No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Thrombosis
Clinical narrative: Blood Clots both legs; had other vaccine same date at 2nd dose in the left arm; had other vaccine same date at 2nd dose in the left arm; This is a spontaneous report from a contactable Consumer (patient). A 69-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 15Apr2021 12:00 PM at single dose for COVID-19 immunization. Medical history was unknown. The patient had no known allergies. The patient had no covid prior vaccination, no covid tested post vaccination. The patient had no other vaccine in four weeks or other medications in two weeks. Concomitant medications were none. The patient had other vaccine same date at 2nd dose in the left arm. The patient experienced blood clots both legs on 15Apr2021 12:15 PM. The patient had extensive dvt IVC and both legs as treatment for event. Outcome of the event blood clots both legs was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (duration: 5 days), Life threatening illness (immediate risk of death from the event).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 39-years, via an unspecified route of administration in right arm on 19Mar2021 14:00 at single dose for COVID-19 immunization. Medical history was not reported. No COVID-19 prior vaccination, no other vaccine in four weeks. There were other medications in two weeks. The patient previously took zaleplon (SONOTA) and experienced allergy to it. On 23Mar2021 08:00 AM, the patient developed transverse myelitis following the first vaccination. The patient went to ER and was admitted and treated there for the following week for the condition transverse myelitis. The event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 7 days, life threatening illness (immediate risk of death from the event). The patient received 5-day course of IV steroids as treatment. Outcome of the event was not recovered. The patient underwent lab tests and procedures, which included COVID-19 virus test (nasal swab) was negative on 10Apr2021.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Product administered at inappropriate site
Clinical narrative: died; administered in Left leg; This is a spontaneous report from a contactable consumer reported for patient (mother). A 93-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Mar2021 administered in Left leg at single dose for COVID-19 immunisation. No other vaccine in four weeks. Medical history included COPD, aortic stenosis, mild dementia, no known allergies. Concomitant medications in two weeks included donepezil, acetylsalicylic acid (ASPIRIN), ascorbic acid/ergocalciferol/nicotinamide/retinol/riboflavin/thiamine hydrochloride (VITAMINS), Blood Pressure Meds. Historical Vaccine included the first dose of BNT162B2 (lot number EL1283) in the right arm on 26Jan2021 09:15 (at the age of 93-years-old) as a single dose for COVID-19 immunization and experienced prolonged tiredness, increased weakness, dragging right foot when walks, little more trouble swallowing pills than before on 27Jan2021.  The patient died three weeks later on 29Mar2021, she received treatment included ambulance. Care providers thought rapid decline after vaccine. The death cause was unknown, no autopsy was performed. No COVID prior vaccination, no COVID tested post vaccination.     Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died
Sex: F
Vaccine: COVID19
Symptoms: Foot fracture, Peripheral swelling, Skin discolouration
Clinical narrative: I broke my toe; My whole foot is black and blue and swollen up; My whole foot is black and blue and swollen up; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry not reported) via unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medications and past drug history were not reported. On an unspecified date in Apr2021, the patient reported that she broke her toe. Her whole foot was black and blue and swollen up. Also reported that it had nothing to do with her vaccine though. She provided no further information. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship reported events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Death, Injury
Clinical narrative: who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial; who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial; This is a spontaneous report from a contactable consumer or other non hcp. A child patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the consumer had searched the website and cannot find anywhere that states who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Mom Passed away last Tuesday; This is a spontaneous report from a Pfizer from a contactable consumer reported (patient's child). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported.  Patient passed away on an unspecified date in Apr2021 (reported as last tuesday). It was reported that patient's child and entire family were scheduled to get second dose of Covid Vaccine on 29Apr2021. Clarified that they tested postive after first (1 st) dose. Patient (Mom) passed away last Tuesday. She was wondering about getting the second dose. The patient died on an unspecified date in Apr2021.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Mom Passed away last Tuesday
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pharyngeal swelling
Clinical narrative: Anaphylaxis, after the second dose.; Throat swelling, after second dose.; This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158, expiration date: 31Jul2021) via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization, experienced tingling in throat, after first vaccine.  The reporter stated the throat swelling was resolved and she was given Benadryl IM and transferred to the emergency department. There, she was given Epinephrine, and she had an increased heart rate. The reporter was not sure if that was a complication, but did not know for sure. The reporter did not have any information specifically. Eventually the patient improved. Anaphylaxis was resolved after treatment in the emergency room, but was unsure exactly. The reporter stated that 14 prime, or first doses were given and 21 boosters, or second doses were given. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  The patient required visit to the Emergency Room for events. About the medical intervention, the reporter stated that a Rapid Response was called at the site of the vaccination, and an intravenous line was started and the patient was given Solumedrol. In the emergency room, the patient was given Benadryl intramuscularly and Epinephrine was given. The heart rate increased after the Epinephrine, and then the employee had a good outcome. The patient was hospitalized. There was no multiorgan involvement, respiratory involved. Outcome of the events was recovered. Reporter seriousness for Throat swelling and anaphylaxis was Life threatening. Event relatedness was reported as related.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events throat swelling and anaphylaxis based on the known safety profile.   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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received expired dose of ACT-HIB vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (Reference number- 00559739) and transmitted to Sanofi on 13-Apr-2021.   This case involves a 1-year-4-month-3 week male patient who received vaccine 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with expired diluent (single dose vials, frequency: once, strength: standard, batch number: U6573AA,expiry date: 22-Mar-2021 via intramuscular route in left thigh) (expired product administered) on 24-Mar-2021 for prophylactic vaccination.   The patient's medical history, past medical treatment, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021.   At the time of reporting, No specific adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Lip swelling, Ocular hyperaemia, Periorbital swelling, Swelling face
Clinical narrative: some sort of liquid coming out of her eyes periodically; face was swelling; swelling under her eyes; lips swelling; eyes were red; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case from a non health care professional in courtesy from Pfizer.  This case involves 82 years old female patient who experienced some sort of liquid coming out of her eyes periodically (eye discharge), face was swelling (face oedema), swelling under her eyes (periorbital swelling), lips swelling (lip swelling) and eyes were red (ocular hyperaemia), while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment, vaccination, concomitant medication and family history were not provided.  In 2017, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In 2017 the patient developed a non-serious some some sort of liquid coming out of her eyes periodically (eye discharge), face was swelling (face oedema), swelling under her eyes (periorbital swelling), lips swelling (lip swelling) and eyes were red (ocular hyperaemia), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was also reported that PFIZER-BIONTECH VACCINE Question: Consumer stated she is 82 year old and interested in receiving the Pfizer-bioNTech COVID-1g (coronavirus diseaes) Vaccine; however, first she wants to compare the ingredients of this vaccine with the ingredients in Fluzone High- Dose, specifically the following: Sodium phosphate-buffered isotonic sodium chloride solution, Octylphenol ethoxylate, Formaldehyde. She repored: In 2017, received Fluzone High-Dose by Sanofi and had some kind of reaction, question have you heard of Oculorespiratory syndrome to the shot.  It was not reported if the patient received a corrective treatment for the events.  It was unknown if there were lab data/results available.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: ActHIB mixed/ reconstituted with diluent that expired on 22Mar2021 and administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00559563) and transmitted to Sanofi on 13-Apr-2021.  This case is linked to case 2021SA124250 and 2021SA133014 (same reporter).  This case involves a 1 years old female patient who was administered with expired 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiry date: 22-Mar-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 08-Apr-2021.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021.   At the time of reporting, No specific adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ActHIB mixed/ reconstituted with diluent that expired on 22Mar2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00559740) and transmitted to Sanofi on 13-Apr-2021.  This case is linked to cases 2021SA124061 and 2021SA133014 (same reporter).  This case involves an 1 years old female patient who was administered with expired 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiry date: 22-Mar-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 02-Apr-2021.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021.   At the time of reporting, No specific adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired Ipol vaccine was administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00561142) and transmitted to Sanofi on 14-Apr-2021.  This case involves a 1 years old female patient who was administered with an expired 0.5 mL dose of suspect IPV (VERO) [IPOL] (Injection, lot R1D252M and expiry date : 13-Apr-2021) via unknown route in right leg (expired product administered) for prophylactic vaccination on 14-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was actual medication error due to expired vaccine used (on same day).  It was reported wanted to know if the patient needs to be revaccinated.  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.