chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Peroneal nerve palsy
Clinical narrative: severe allergic reaction; has a drop foot that felt rubbery; Dizziness; Dry mouth; This is a spontaneous report received from two contactable consumers (once is patient himself). A 79-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection and Lot Number: EN6208), via an unspecified route of administration in the left arm on 15MAR2021 15:15 (at the age of 79-years-old) at a single dose for COVID-19 immunization. Patient medical history included Diabetes ongoing, patient has had three heart attacks. The first was over 20 years ago. He is waiting to have a stress test prior to having an angioplasty and Heart condition ongoing. Concomitant medications were reported as none. Lab data includes patient had all kinds of testing at the emergency room, test results that he had at the emergency room were all negative. They checked his heart and did a CT scan on 15Mar2021. Patient received the first dose of the COVID-19 vaccine on 15Mar2021. He received the vaccine at 3:15 pm. Within a minute after getting the vaccine he was getting dizzy. He was monitored for 15 minutes. He thought the dizziness went along with it. On the way home the dizziness was really hard to explain. He has never gotten this dizzy. It took his whole head over. It wasn't a spinning dizziness. He is 79 years old and has a lot of physical problems. He has a drop foot on his good leg. When he got home his drop foot felt rubbery. It is not usually like this. He also had a dry mouth. The papers said this is under the severe allergic reaction. Patient's daughter called the doctor and was told to go to the emergency room. He had all kinds of testing at the emergency room. 3-4 hours later the dizziness dry mouth went away. His foot was back to normal. He is wondering about the second dose. He is asking if the second dose will be stronger than the first. Patient received first dose of vaccine on 15Mar2021 and experienced dizziness, he believes it was a severe allergic reaction. His symptoms subsided a few hours later. He has a history of diabetes and heart issues. Event has already been reported to Pfizer. Patient has a Nuclear cardiac stress test on 01Apr2021. His second dose is schedule for 06Ap2021. He would like to know is it safe to get second dose considering his side effects. Outcome of event (severe allergic reaction) was unknown and recovered on 15Mar2021.   No follow-up attempts are possible and no further information was provided
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Increased seizures after 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 12Mar2021 09:30 as single dose for COVID-19 immunisation. Medical history included cerebral palsy and seizure and covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medications included baclofen, rufinamide (BANZEL), levothyroxine sodium (SYNTHROID), and clobazam (ONFI) and valero acid syrup. In Mar2021, the patient experienced increased seizures after 12 hours. Had to call ambulance, and went to the emergency room (ER) at a hospital. The patient received Ativan, and Depakote and IV fluids. The patient had no other vaccine in 4 weeks and was not covid tested post vaccination. Outcome of event was recovered in Mar2021.  Information about Lot/Batch number is requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Facial paralysis, Fatigue, Feeling abnormal
Clinical narrative: Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation.  Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR).  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis.  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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Lacrimation increased, Magnetic resonance imaging, Memory impairment, Pain
Clinical narrative: Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation.  Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR).  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis.  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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Somnolence, Speech disorder, Tremor, Visual impairment
Clinical narrative: Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation.  Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR).  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis.  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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Bleeding with stool; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in Left arm, on 15Mar2021 at 12:30 (at the age of 66 years old) as a single dose, for COVID-19 immunisation. Medical history included moderate high blood pressure. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included lisinopril, montelukast, vitamin C and vitamin D. The patient did not receive other vaccines in the four weeks prior to receiving the BNT162b2 vaccine. The patient experienced bleeding with stool on 18Mar2021 at 09:00am. The patient did not receive treatment for the event. The event resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcome of the event bleeding with stool was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dementia, Drug ineffective, Gait disturbance
Clinical narrative: had COVID; had COVID; She is in the early stages of dementia; she can't walk; This is a spontaneous report from a contactable consumer (patient's husband). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), at unknown vaccination age via an unspecified route of administration on 05Jan2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. He reported that she got the first dose of Pfizer's COVID-19 vaccine on 05Jan2021. Right after, she ended up having surgery, then was in rehab, and had COVID. She was discharged 2 weeks ago (unspecified date in 2021). He inquired if she can still get the second dose. She is in the early stages of dementia, she had trouble from the second night, she can't walk, she's in a wheelchair all the time. The outcome of the events was unknown.  Information on the Lot/ batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Nausea, Pyrexia
Clinical narrative: Bleeding during bowel movements; Nausea; fever; This is a spontaneous report from a contactable other health professional (HCP). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 which was prior to vaccination. There were no concomitant medications. On 08Mar2021, the patient experienced bleeding during bowel movements, nausea and fever. The patient was hospitalized for 4 days. The patient had colonoscopy as treatment for the event. The outcome of the events was recovering. The patient was not tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea and fever and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect. Conversely, the reported bleeding during bowel movements is unlikely related to the suspect vaccine. More information on the patient's medical history, concurrent medical conditions would be helpful for the Company to provide a more meaningful causality assessment.   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 RA, IEC, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Multiple sclerosis, Oropharyngeal pain, Pyrexia
Clinical narrative: MS; fever; chills; head soreness; sore throat; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 12Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer vaccine on 12Mar2021. He's had fever, chills and head soreness on an unspecified date. He's had a sore throat on an unspecified date. He has MS (multiple sclerosis) and is on dialysis on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL3302, COVID 19) administered in left arm via an unspecified route of administration on 25Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included Sarcoma cancer (amputated hand), heart failure, patient was allergic to Morphine, nitroglycerin, pertussis, walnuts, corn and bees. Concomitant medications were not reported. On 04Feb2021 at 12:30 PM, patient received first dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL0142) administered in left arm for covid-19 immunization. No other vaccine was given in four weeks. It was reported that patient was given other medications in two weeks: 15 meds too many to list. On 25Feb2021 at 22:00, patient experienced fever, headache, redness, stiffness, bruising, neck pain, pain swelling and throbbing which resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment with Meloxicam for 10 days for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL3302, COVID 19) administered in left arm via an unspecified route of administration on 25Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included Sarcoma cancer (amputated hand), heart failure, patient was allergic to Morphine, nitroglycerin, pertussis, walnuts, corn and bees. Concomitant medications were not reported. On 04Feb2021 at 12:30 PM, patient received first dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL0142) administered in left arm for covid-19 immunization. No other vaccine was given in four weeks. It was reported that patient was given other medications in two weeks: 15 meds too many to list. On 25Feb2021 at 22:00, patient experienced fever, headache, redness, stiffness, bruising, neck pain, pain swelling and throbbing which resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment with Meloxicam for 10 days for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: blood in my eye;This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 13:00 (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient is not pregnant. Medical history included a leiden factor a blood disorder. The patient had no known allergies. Concomitant medications included ibuprofen (MOTRIN); ashwagandha; ascorbic acid (VITAMIN C); and an unspecified Pfizer vaccine on 12Mar2021 administered in the left arm. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. On 11Mar2021 12:00 AM, the patient experienced blood in her eye. There was no treatment for the event. No COVID prior vaccination and was not tested with COVID post vaccination. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia oral, Tremor
Clinical narrative: Weakness; shaking; numbness of tongue and face mostly right side; numbness of tongue and face mostly right side; This is a spontaneous report from a contactable consumer, the patient. This 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 via an unspecified route of administration in the left arm (at the age of 29 years-old) on 20Mar2021 at 01:30 PM for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant. Concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 20Mar2021 at 02:00 PM, the patient experienced weakness, shaking and numbness of tongue and face mostly right side and was hospitalized for the events. Treatment was received for weakness, shaking and numbness of tongue and face mostly right side. The clinical outcome of weakness, shaking and numbness of tongue and face mostly right side was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.                     Field Name: NO days hospitalization Field Value: 1  Field Name: Hospital name Field Value: Name  Field Name: Hospital city Field Value: Name Field Name: Hospital state Field Value: Name  Field Name: if patient recovered Field Value: Recovering  Field Name: if treatment ae Field Value: Yes Field Name: Ae treatment  Field Value: Tylenol and fluids with Benadryl  Field Name: if covid prior vaccination Field Value: No   Field Name: If covid tested post vaccination Field Value: No  Field Name Known allergies Field Value: No  Field Name Other medical history Field Value: No  Information about lot and batch number was requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266 and expiration date not reported) via an unspecified route of administration, administered in the left arm on 24Feb2021 16:15 as a single dose for COVID-19 immunisation. Medical history included LBBB, HTN, and high cholesterol. The patient is not pregnant and has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had the first dose of the vaccine on 24Feb2021 and had stroke on 09Mar2021 16:00 with no CVA history. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized on an unspecified date for the event for 1 day. Treatment was given in response to the event which included CT Scan and MRI. The patient underwent COVID test post vaccination via nasal swab on 09Mar2021 and was negative. The outcome of the event was recovering. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6208) on 17Mar2021 for COVID-19 immunization.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: acute appendicitis; This is a spontaneous report from a non-contactable consumer (patient herself). A 62-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the right arm, on 15Mar2021 16:00, at a single dose, for covid-19 immunization. The patient has no medical history. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 22Feb2021 in the right arm for covid-19 immunization at the age of 62-years-old. The vaccine was received at the hospital. The patient did not receive other vaccines within four weeks. The patient has no Covid prior vaccination. The patient incurred acute appendicitis on 16Mar2021 12:30 PM, 20 hours after second dose. There were no indications of difficulty prior. This resulted in surgical removal of appendix. The adverse event resulted in emergency room/department or urgent care visit and, hospitalization for 2 days (from Mar2021 to Mar2021). The patient was recovering from the adverse event at the time of the report. The patient had a Covid-test via nasal swab on 18Mar2021 with results of negative.  No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Dizziness, Drug ineffective
Clinical narrative: tested positive for Covid; tested positive for Covid; loss of strength/ lack of stability/ weakness/he is still very weak; aches; drowsiness; loosing weight; lower leg edema; lethargic; still dizzy; triggered his immune system and his immune system is now one heck of a fight; swelling; loss of appetite; shortness of breath where he cannot walk; unable to walk; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 81, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Oct2020 to an unknown date and was hospitalized for almost a week; chronic lymphocytic leukaemia (CLL) from an unknown date and unknown if ongoing, open heart surgery from an unknown date and unknown if ongoing and 'severe spines' from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 02Feb2021 for COVID-19 immunization and experienced light headiness, chills, dizziness, fever, tired, loss of appetite and very weak. The patient experienced lack of stability/loss of strength, aches, pains, difficulty breathing within 24 hours of the second dose in Feb2021 and was hospitalized. While in the hospital for two days, the patient underwent lab tests which included Sars-Cov-2 test after the second dose which came back positive. The patient had symptoms which included nauseous, very exhausted, shortness of breath and lethargic the evening of the second shot and ended up being transported by ambulance to the hospital. The patient experienced continued weakness, shortness of breath, drowsiness, lost weight, lower leg edema, shortness of breath where he cannot walk, swelling, still is dizzy, lack of appetite after discharge and "have triggered his immune system; his immune system is now in one heck of a fight" on an unknown date, Feb2021. The patient underwent lab tests and procedures which included D-Dimer test (fibrin degradation products): elevated on an unknown date from previous diagnosis of Covid back in Oct2020, was hospitalized for about a week and upon discharge he continued to feel fatigue with elevated D-dimer; fibrin degradation products: unknown results on 17Mar2021, investigation tests after hospitalization on an unknown date and all of his test results were normal. The clinical outcome of the events COVID-19, asthenia, somnolence, weight decreased, lower leg edema, lethargy, and immune system disorder was unknown; for pain, dizziness, swelling, decreased appetite, dyspnea and gait inability was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin degradation products, Gait inability, Immune system disorder, Investigation
Clinical narrative: tested positive for Covid; tested positive for Covid; loss of strength/ lack of stability/ weakness/he is still very weak; aches; drowsiness; loosing weight; lower leg edema; lethargic; still dizzy; triggered his immune system and his immune system is now one heck of a fight; swelling; loss of appetite; shortness of breath where he cannot walk; unable to walk; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 81, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Oct2020 to an unknown date and was hospitalized for almost a week; chronic lymphocytic leukaemia (CLL) from an unknown date and unknown if ongoing, open heart surgery from an unknown date and unknown if ongoing and 'severe spines' from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 02Feb2021 for COVID-19 immunization and experienced light headiness, chills, dizziness, fever, tired, loss of appetite and very weak. The patient experienced lack of stability/loss of strength, aches, pains, difficulty breathing within 24 hours of the second dose in Feb2021 and was hospitalized. While in the hospital for two days, the patient underwent lab tests which included Sars-Cov-2 test after the second dose which came back positive. The patient had symptoms which included nauseous, very exhausted, shortness of breath and lethargic the evening of the second shot and ended up being transported by ambulance to the hospital. The patient experienced continued weakness, shortness of breath, drowsiness, lost weight, lower leg edema, shortness of breath where he cannot walk, swelling, still is dizzy, lack of appetite after discharge and "have triggered his immune system; his immune system is now in one heck of a fight" on an unknown date, Feb2021. The patient underwent lab tests and procedures which included D-Dimer test (fibrin degradation products): elevated on an unknown date from previous diagnosis of Covid back in Oct2020, was hospitalized for about a week and upon discharge he continued to feel fatigue with elevated D-dimer; fibrin degradation products: unknown results on 17Mar2021, investigation tests after hospitalization on an unknown date and all of his test results were normal. The clinical outcome of the events COVID-19, asthenia, somnolence, weight decreased, lower leg edema, lethargy, and immune system disorder was unknown; for pain, dizziness, swelling, decreased appetite, dyspnea and gait inability was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Oedema peripheral, Pain, SARS-CoV-2 test, Somnolence
Clinical narrative: tested positive for Covid; tested positive for Covid; loss of strength/ lack of stability/ weakness/he is still very weak; aches; drowsiness; loosing weight; lower leg edema; lethargic; still dizzy; triggered his immune system and his immune system is now one heck of a fight; swelling; loss of appetite; shortness of breath where he cannot walk; unable to walk; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 81, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Oct2020 to an unknown date and was hospitalized for almost a week; chronic lymphocytic leukaemia (CLL) from an unknown date and unknown if ongoing, open heart surgery from an unknown date and unknown if ongoing and 'severe spines' from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 02Feb2021 for COVID-19 immunization and experienced light headiness, chills, dizziness, fever, tired, loss of appetite and very weak. The patient experienced lack of stability/loss of strength, aches, pains, difficulty breathing within 24 hours of the second dose in Feb2021 and was hospitalized. While in the hospital for two days, the patient underwent lab tests which included Sars-Cov-2 test after the second dose which came back positive. The patient had symptoms which included nauseous, very exhausted, shortness of breath and lethargic the evening of the second shot and ended up being transported by ambulance to the hospital. The patient experienced continued weakness, shortness of breath, drowsiness, lost weight, lower leg edema, shortness of breath where he cannot walk, swelling, still is dizzy, lack of appetite after discharge and "have triggered his immune system; his immune system is now in one heck of a fight" on an unknown date, Feb2021. The patient underwent lab tests and procedures which included D-Dimer test (fibrin degradation products): elevated on an unknown date from previous diagnosis of Covid back in Oct2020, was hospitalized for about a week and upon discharge he continued to feel fatigue with elevated D-dimer; fibrin degradation products: unknown results on 17Mar2021, investigation tests after hospitalization on an unknown date and all of his test results were normal. The clinical outcome of the events COVID-19, asthenia, somnolence, weight decreased, lower leg edema, lethargy, and immune system disorder was unknown; for pain, dizziness, swelling, decreased appetite, dyspnea and gait inability was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Weight decreased
Clinical narrative: tested positive for Covid; tested positive for Covid; loss of strength/ lack of stability/ weakness/he is still very weak; aches; drowsiness; loosing weight; lower leg edema; lethargic; still dizzy; triggered his immune system and his immune system is now one heck of a fight; swelling; loss of appetite; shortness of breath where he cannot walk; unable to walk; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 81, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Oct2020 to an unknown date and was hospitalized for almost a week; chronic lymphocytic leukaemia (CLL) from an unknown date and unknown if ongoing, open heart surgery from an unknown date and unknown if ongoing and 'severe spines' from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 02Feb2021 for COVID-19 immunization and experienced light headiness, chills, dizziness, fever, tired, loss of appetite and very weak. The patient experienced lack of stability/loss of strength, aches, pains, difficulty breathing within 24 hours of the second dose in Feb2021 and was hospitalized. While in the hospital for two days, the patient underwent lab tests which included Sars-Cov-2 test after the second dose which came back positive. The patient had symptoms which included nauseous, very exhausted, shortness of breath and lethargic the evening of the second shot and ended up being transported by ambulance to the hospital. The patient experienced continued weakness, shortness of breath, drowsiness, lost weight, lower leg edema, shortness of breath where he cannot walk, swelling, still is dizzy, lack of appetite after discharge and "have triggered his immune system; his immune system is now in one heck of a fight" on an unknown date, Feb2021. The patient underwent lab tests and procedures which included D-Dimer test (fibrin degradation products): elevated on an unknown date from previous diagnosis of Covid back in Oct2020, was hospitalized for about a week and upon discharge he continued to feel fatigue with elevated D-dimer; fibrin degradation products: unknown results on 17Mar2021, investigation tests after hospitalization on an unknown date and all of his test results were normal. The clinical outcome of the events COVID-19, asthenia, somnolence, weight decreased, lower leg edema, lethargy, and immune system disorder was unknown; for pain, dizziness, swelling, decreased appetite, dyspnea and gait inability was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cancer
Clinical narrative: ovarian cancer; This is a spontaneous report from a contactable consumer (reporting for childhood friend). A 72-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received the first dose BNT162B2 on an unknown date for covid-19 immunisation. On an unspecified date, the patient was diagnosed with ovarian cancer and she has had both shots on an unknown date. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Eye contusion, Eye swelling, Loss of consciousness
Clinical narrative: She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; Blacked out; severe stomach cramps; Nausea; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 09:55 (Lot Number: ER2613, unknown expiration) as a single dose for COVID-19 vaccination.  Medical history and concomitant medications reported as none. The patient received the first shot of COVID-19 vaccine in the morning of 18Mar2021, and after supper, she experienced severe stomach cramps, nausea, diarrhea, vomiting, and stated that she blacked out. She mentioned that she is just taking it slow and eating broth. She confirmed that blacking out has only happened to her 2 other times in her life. She said that it usually happens with the cramping and the vomiting in this same kind of situation. She plans to follow up with the physician. She said that she has a pretty swollen black eye that is really red too (unspecified date). She is putting ice on it. It did not seem like she ate anything that would cause this reaction. She has no other reason to think her reaction could have been caused by anything else. She called the pharmacist and they told her to report it to Pfizer. No additional vaccines administered on the same date of COVID-19 vaccine. No prior vaccinations within 4 weeks.  The patient recovered from events blacked out, severe stomach cramps, diarrhea, and vomiting on 18Mar2021; recovering from nausea; while unknown outcome for the remaining events.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; She said that she has a pretty swollen black eye that is really red too; Blacked out; severe stomach cramps; Nausea; Diarrhea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 09:55 (Lot Number: ER2613, unknown expiration) as a single dose for COVID-19 vaccination.  Medical history and concomitant medications reported as none. The patient received the first shot of COVID-19 vaccine in the morning of 18Mar2021, and after supper, she experienced severe stomach cramps, nausea, diarrhea, vomiting, and stated that she blacked out. She mentioned that she is just taking it slow and eating broth. She confirmed that blacking out has only happened to her 2 other times in her life. She said that it usually happens with the cramping and the vomiting in this same kind of situation. She plans to follow up with the physician. She said that she has a pretty swollen black eye that is really red too (unspecified date). She is putting ice on it. It did not seem like she ate anything that would cause this reaction. She has no other reason to think her reaction could have been caused by anything else. She called the pharmacist and they told her to report it to Pfizer. No additional vaccines administered on the same date of COVID-19 vaccine. No prior vaccinations within 4 weeks.  The patient recovered from events blacked out, severe stomach cramps, diarrhea, and vomiting on 18Mar2021; recovering from nausea; while unknown outcome for the remaining events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Feb2021 as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient rpeorted she got the COVID vaccine shot on 10Feb2021 and was scheduled to go back in 3 weeks but it was cancelled and she had to reschedule to 10Mar2021. She then had diverticulitis and was given antibiotics for it but her doctor wanted her to wait two weeks after completing the antibiotic from 14Mar2021, which would be 28Mar2021. Caller stated her doctor told her she could go ahead and get the COVID shot. The outcome of the event, diverticulitis was unknown.   The lot number for the vaccine, BNT162B2, was not provided and has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Hearing loss with tinnitus to right ear; Hearing loss with tinnitus to right ear; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included DM (diabetes mellitus) and HTN (hypertension) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Jan2021 11:30, the patient experienced hearing loss with tinnitus to right ear. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The events was treated with hyperbaric oxygen therapy. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the event  hearing loss with tinnitus cannot be completely excluded.  This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw, Sialoadenitis
Clinical narrative: salivary gland infection; pain under my jaw on the left side; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 10Mar2021 11:15 AM (at the age of 71-year-old) at single dose for COVID-19 immunization. Medical history included diabetes, hypertension and gout. Concomitant medication included unspecified blood thinner and blood pressure medications. On 11Mar2021 at 10:00 AM, the patient developed salivary gland infection and pain under his jaw on the left side as diagnosed. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed with antibiotics for 7 days. No COVID prior vaccination and the patient was not tested with COVID post vaccination. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Computerised tomogram, Infection, Lymphadenopathy, Pyrexia
Clinical narrative: infectious disease; lymph node which was swollen; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), ), dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included urine analysis. The patient's concomitant medications were not reported. On an unspecified date after getting the first dose she developed fever which continued until today. Patient said it became a daily fever. She had herself to urgent care, developed infectious disease, had urinalysis, CT scan of her abdomen and ultrasound of her lymph node which was swollen. She hasn't got the second dose due to the daily fever. Outcome of event fever was not recovered; the outcome of other events was unknown.  Information on the lot/batch number has been requested.