chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: it started falling out into my hands/ My hair is very thin now; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 19Mar2021 07:15 (Batch/Lot Number: Ep7534) as SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at time of vaccination. Medical history included HBP and Pre-Diab both from an unknown date and unknown if ongoing (reported as Other medical history: HBP, pre-Diab). The patient had no Covid prior vaccination and not tested for Covid post vaccination. No other vaccine in four weeks. The patient was vaccinated at a clinic. Concomitant medication (reported as other medications in two weeks) included sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), metformin (METFORMIN), asa (reported as 325), colecalciferol (VIT D3), metoprolol (METOPROLOL), famotidine (FAMACE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 for COVID-19 immunization first dose (lot: EL8982) on 27Feb2021 at 08:00 am administered in left Arm. It was reported that "Within a few days of my 2nd shot, I was in the shower washing my hair and it started falling out into my hands. I haven't changed any hair products. I've always had nice thick hair. I told my Dr during a visit 06Apr2021, he didn't note any bald patches. My hair is very thin now, Im hoping this is temporary." It was reported that the event occurred on 21Mar2021 at 08:00 am. The outcome of the event was not recovered. The events resulted in Disability or permanent damage.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event alopecia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Nausea
Clinical narrative: loss of consciousness; slumped on the floor/going down; nausea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (COVID 19 Pfizer), dose 2 via an unspecified route of administration, administered in right arm on 10Apr2021 13:00 (Lot Number: ER8729) as single dose for COVID-19 immunisation; and trazodone, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 50 mg for insomnia. Medical history included high blood pressure and low thyroid from an unknown date and unknown if ongoing. The patient had unspecified medication for high blood pressure and low thyroid. The patient previously received codeine and experienced allergies. The patient previously received 1st dose of BNT162B2 COVID19 Pfizer, lot = EN6207, on 16Mar2021, 06:30 pm, in the left arm for covid-19 immunization. About 36 hours after injection of 2nd dose and about six hours after taking 50mg of Trazodone for insomnia, awoke to get a drink of water. Experienced sudden onset of nausea so he didn't take the drink but went to the bathroom to urinate instead. Came to (regained consciousness) finding self slumped on the floor. No advance feeling of lightheadedness. No memory of going down. Out for an unknown period of time. Hadn't had a lot to drink after receiving the injection. No prior occurrences of loss of consciousness. Onset of events was 12Apr2021 01:00 am. Outcome of events recovered with no treatment. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. The action taken in response to the events for trazodone was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: PE; This is a spontaneous report from a contactable Nurse. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ek9231), via an unspecified route of administration, administered on the left arm, at the age of 28 years, on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma, angiolipoma, labral surgery to hip, drug hypersensitivity to penicillins; all from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity, bactrium ds and experienced drug hypersensitivity, doxycycline and experienced drug hypersensitivity. The patient received first dose of COVID vaccine BNT162B2 (lot number= Ej1685) at the age of 28 years on 22Dec2020 on the left arm at single dose for COVID-19 immunization. The patient reported that 2 weeks after the second vaccine, she underwent hip labral surgery and suffered a PE on 22Feb2021. She was not sure if the vaccine could have contributed to the PE or just the surgery but wanted to report just incase. She was taking aspirin to prevent DVT's. The patient was hospitalized for pe (pulmonary embolism) for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Feb2021. Therapeutic measures (DOAC) were taken as a result of pe (pulmonary embolism). The outcome of the event was recovering.; Sender's Comments: The event pulmonary embolism is likely an intercurrent medical condition and unrelated to BNT162B2. Patient's hip surgery two weeks after the vaccine might have contributed to the event onset. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased, Heart rate irregular
Clinical narrative: Heartbeat was erratic at times - fluttering very fast.; Heartbeat was erratic at times - fluttering very fast.; Heartbeat was erratic at times - fluttering very fast.; This is a spontaneous report from a non-contactable consumer. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced heartbeat was erratic at times - fluttering very fast. The outcome of the event was unknown.     No follow up attempts are possible; information about lot number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Vaccination site hypoaesthesia
Clinical narrative: Instant allergic reaction to injection; itchy; arm is numb where they injected the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ew0162, first dose) solution for injection intramuscular in the left arm on 10Apr2021 at 11:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included sulfa allergy. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had an instant allergic reaction to injection, it's still very itchy, also my arm was numb where they injected the vaccine on 10Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included diphenhydramine (BENADRYL). The outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accident, Injury
Clinical narrative: he had a bad accident; he had a bad injury; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 23Mar2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was trying to reschedule his second COVID-19 Vaccine dose that was due on 13Apr2021 because he was in a bad accident and still in the hospital. He can't take the second dose today because he had a bad injury, he wants to know how to reschedule his second dose. The patient reported he had his first COVID-19 Vaccine shot 3 weeks ago, and he was supposed to get his second COVID-19 Vaccine shot today. The patient was hospitalized for he had a bad accident (accident) from an unknown date to 13Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Injury, Product dose omission issue
Clinical narrative: he had a bad accident; he had a bad injury; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 23Mar2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was trying to reschedule his second COVID-19 Vaccine dose that was due on 13Apr2021 because he was in a bad accident and still in the hospital. He can't take the second dose today because he had a bad injury, he wants to know how to reschedule his second dose. The patient reported he had his first COVID-19 Vaccine shot 3 weeks ago, and he was supposed to get his second COVID-19 Vaccine shot today. The patient was hospitalized for he had a bad accident (accident) from an unknown date to 13Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Pain in extremity
Clinical narrative: felt funny in his chest, like a really weird, really warm and heavy feeling; Sore Arm; This is a spontaneous report from a contactable nurse. The nurse reported similar events for herself and her husband. This is the second of two cases.   A 62-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 10Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril (manufacturer unknown) taken for high blood pressure, start and stop date were not reported (reported as for over 5 years). The patient did not have prior vaccinations within 4 weeks from the the COVID vaccine. On 10Mar2021, the patient felt funny in his chest, like a really weird, really warm and heavy feeling. The patient did not freak out and didn't want to appear weak. It lasted 5 minutes and then it went away. It was a warm feeling in the chest and not being able to breathe. The patient also had a sore arm on 10Mar2021. The outcome of the event felt funny in his chest, like a really weird, really warm and heavy feeling was recovered on 10Mar2021 and the outcome of the event sore arm was recovered on 11Mar2021. The event felt funny in his chest, like a really weird, really warm and heavy feeling was reported as medically significant. The patient received the second dose of the vaccine on 31Mar2021. Relatedness of the suspect drug with the reaction 'felt funny in his chest, like a really weird, really warm and heavy feeling' from the Primary Source Reporter (method of assessment) is unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Chest discomfort and BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-2021408430 same reporter and drug, similar events, different patient
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Atrial fibrillation, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 (Batch/Lot Number: el1284) as single dose for covid-19 immunisation at a hospital. Medical history included hypertension. The patient has no covid prior to vaccination and no known allergies. Concomitant medications included bisoprolol fumarate (CONCOR), amlodipine and metformin. The patient has no other vaccine in four weeks. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: eh8899) on 18Dec2020 in the left arm for Covid-19 immunization. On 03Feb2021 (also reported as "21 days after vaccination"; pending clarification), the patient had Afib episode and ACS needed a coronary stent. The patient was hospitalized for 2 days. The patient was tested for covid post vaccination via nasal swab on 06Mar2021 which was negative. The outcome of the events was recovered with sequel.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Areflexia, Blood test, Facial paralysis, Hypokinesia, Lumbar puncture
Clinical narrative: Initially he was diagnosed with Bell's palsy/face drooling; did not have a knee reflex or any feeling in his hands; did not have a knee reflex or any feeling in his hands; severe muscle pain all over his body to the extent he can't move; severe muscle pain all over his body to the extent he can't move; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 06Mar2021 09:45 (lot number: EN6205) at the age of 32 years old, as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported. Initially the patient was diagnosed with Bell's palsy, his diagnosis was changed to rare reaction to a vaccine as per ER report in the hospital. They changed the diagnosis because it was not only his face drooping (reported as drooling) but he did not have a knee reflex or any feeling in his hands, and severe muscle pain all over his body to the extent he can't move. At the hospital they excluded Lyme disease by blood work and stroke and spinal infection by spinal tapping. Then he was discharged. All events occurred on 12Mar2021 at 09:00 AM. AEs resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (COVID-19 PCR test): negative on 13Mar2021; and on unspecified date, blood work which excluded Lyme disease and stroke and spinal tapping which excluded spinal infection. Corticosteroid was given as treatment for the events. The patient has not recovered from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and an implied temporal association, the reported events are considered possibly related to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test, Sensory loss
Clinical narrative: Initially he was diagnosed with Bell's palsy/face drooling; did not have a knee reflex or any feeling in his hands; did not have a knee reflex or any feeling in his hands; severe muscle pain all over his body to the extent he can't move; severe muscle pain all over his body to the extent he can't move; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 06Mar2021 09:45 (lot number: EN6205) at the age of 32 years old, as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported. Initially the patient was diagnosed with Bell's palsy, his diagnosis was changed to rare reaction to a vaccine as per ER report in the hospital. They changed the diagnosis because it was not only his face drooping (reported as drooling) but he did not have a knee reflex or any feeling in his hands, and severe muscle pain all over his body to the extent he can't move. At the hospital they excluded Lyme disease by blood work and stroke and spinal infection by spinal tapping. Then he was discharged. All events occurred on 12Mar2021 at 09:00 AM. AEs resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (COVID-19 PCR test): negative on 13Mar2021; and on unspecified date, blood work which excluded Lyme disease and stroke and spinal tapping which excluded spinal infection. Corticosteroid was given as treatment for the events. The patient has not recovered from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and an implied temporal association, the reported events are considered possibly related to BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body height, Body height decreased, Computerised tomogram, Deafness
Clinical narrative: He is shrinking a little; patient has gained weight; completely deaf in his left ear/hearing loss; wife thinks the patient is not hearing well out of his right ear; he had walked straight into half of a wall because he was so off kilted; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A 71-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration on 26Mar2021 09:00 as SINGLE DOSE for covid-19 immunization (Age at vaccination: 71 years). Medical history included transidential Global Amnesiatic Episode from Mar2021, blocked carotid artery on his left side and tinnitus (had a history of Tinnitus in his left ear for about 4 years but he could hear). Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN) for carotid artery blockage. The reporter stated that the patient was completely deaf in his left ear and had hearing loss on 10Apr2021. The reporter also stated that he had walked straight into half of a wall because he was so off kilted on 27Mar2021 . The wife thinks the patient is not hearing well out of his right ear on 10Apr2021. The reporter also stated that he is shrinking a little and the patient has gained weight on an unspecified date. The reporter also says that she thought that her husband's side effects started a little late after the vaccine date, has that been reported? Her husband had made the mistake of getting on the internet even though she said not to do that. She jokingly says that her husband is like a medical manual and he thinks that he is going to die from everything. The patient underwent lab tests and procedures which included height: shrinking and weight: gained on an unspecified date and CAT scan and MRI: Transidential Global Amnesiatic Episode on Mar2021. Outcome of the event deafness and hearing decreased was not recovered while outcome of the remaining events was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Magnetic resonance imaging, Weight, Weight increased
Clinical narrative: He is shrinking a little; patient has gained weight; completely deaf in his left ear/hearing loss; wife thinks the patient is not hearing well out of his right ear; he had walked straight into half of a wall because he was so off kilted; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A 71-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration on 26Mar2021 09:00 as SINGLE DOSE for covid-19 immunization (Age at vaccination: 71 years). Medical history included transidential Global Amnesiatic Episode from Mar2021, blocked carotid artery on his left side and tinnitus (had a history of Tinnitus in his left ear for about 4 years but he could hear). Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN) for carotid artery blockage. The reporter stated that the patient was completely deaf in his left ear and had hearing loss on 10Apr2021. The reporter also stated that he had walked straight into half of a wall because he was so off kilted on 27Mar2021 . The wife thinks the patient is not hearing well out of his right ear on 10Apr2021. The reporter also stated that he is shrinking a little and the patient has gained weight on an unspecified date. The reporter also says that she thought that her husband's side effects started a little late after the vaccine date, has that been reported? Her husband had made the mistake of getting on the internet even though she said not to do that. She jokingly says that her husband is like a medical manual and he thinks that he is going to die from everything. The patient underwent lab tests and procedures which included height: shrinking and weight: gained on an unspecified date and CAT scan and MRI: Transidential Global Amnesiatic Episode on Mar2021. Outcome of the event deafness and hearing decreased was not recovered while outcome of the remaining events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Blood pressure measurement, Dyspnoea, Pulmonary thrombosis
Clinical narrative: blood clot in her lung; Shortness of breath; blood pressure dropped extremely low; blood pressure fluctuates; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in the left arm on 17Mar2021 at the age of 69-years-old as single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on 24Feb2021 (Batch/Lot number was not reported) at the age of 69-years-old for COVID-19 immunization. On 07Apr2021, the patient experienced shortness of breath and blood dropped extremely low. On 08Apr2021, the patient experienced blood clot in her lung. And on Apr2021, the patient experienced blood pressure fluctuates. The patient had her final Pfizer Covid vaccine on 17Mar2021. The patient reported that she had to go to the hospital for shortness of breath and her blood pressure dropped extremely low. She stated that they did tests and found out she had a blood clot in her lung. The patient reported that she came home Sunday evening and took the drip thing out and started her on blood thinner that started with an E (as reported). The patient stated that she was told her cardiologist told her to report this. The patient wanted to know if there have been any other reports called in about people calling in with blood clots. The patient was hospitalized due to events shortness of breath, blood dropped extremely low, and blood clot in her lung from 08Apr2021 to 11Apr2021. The patient reported that her blood pressure fluctuates. She stated that it was better than when she was in the hospital. They gave her the drip. The patient reported that her values did come down and this was the only thing they could go by. The outcome of the events shortness of breath and blood pressure dropped extremely low was recovering. The outcome of the events blood clot in her lung and blood pressure fluctuates was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 11Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced Bell's Palsy on 28Mar2021 and was diagnosed on 29Mar2021. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered. The event resulted in emergency room/department or urgent care and disability or permanent damage.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Had severe vertigo; This is a spontaneous report from a contactable health care professional (patient). A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9269), via an unspecified route of administration, administered in the right arm on 24Feb2021 at 10:00 as a single dose for COVID-19 immunization.  Medical history included autoimmune disorders and allergy to sulfa both from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (manufacturer unknown); pramipexole (manufacturer unknown); amlodipine (manufacturer unknown); esomeprazole sodium (NEXIUM) and rosuvastatin calcium (ROSUVA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took Augmentin and experienced allergies. The patient previously received the first dose of BNT162B2 on 03Feb2021 at 10:00 (lot number: EN5318) on the right arm for COVID-19 immunization.  The patient did not have COVID prior to vaccination and has not been tested for COVID post vaccination. On 04Mar2021 at 04:30, the patient experienced severe vertigo. The patient went to visit specialists due to the event namely an ophthalmologist and an ENT specialist.  The patient went to the emergency room due to the events and was hospitalized on an unspecified date for two days. The patient received treatment (unspecified) for the events. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event vertigo cannot be excluded. Etiology or diagnosis was not provided; the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Pain in extremity, X-ray
Clinical narrative: pain in his left leg, very severe; he can hardly walk now; he could hardly stand on his feet for 5 minutes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 (Lot Number: EN6205) (at the age of 62-year-old) as single dose for COVID-19 immunisation.  Medical history included ongoing high blood pressure. Concomitant medication included lisinopril oral at 10 mg once a day taken for high blood pressure, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 18Feb2021 (Lot Number: EN6201) for COVID-19 immunization.  The patient reported that he experienced: "pain in his left leg, very severe, he can hardly walk; he went to work, he could hardly stand on his feet for 5 minutes" on 05Apr2021. Caller stated that: "the pain goes from his ankle to his hip on his left leg". The patient due to the events visited the emergency department on 07Apr2021. Therapeutic measures were taken as a result of the events and included injection of some pain medication (not specified) but hasn't seen any improvement. The patient underwent lab test and procedure which included X-ray (left leg): unknown results on an unspecified date. The patient outcome of pain in his left leg was not recovered and unknown for the other events.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram, Nervous system disorder, Pain in extremity, Thrombosis
Clinical narrative: Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left leg and to her ankle; had the worst pain through her side that ran down her left leg and to her ankle; nerves are all tangled up; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:50 (at 76-years-old) as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. It was not administered at a military facility. Medical history included hip replacement four years ago in 2017 (First right then 2 months later left) and knee replacement six years ago in 2015 (both 2 months apart). There were no concomitant medications. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), administered in Left Arm on 25Feb2021 (at 76-years-old) for COVID-19 immunisation and experienced bad headaches. The patient received the second dose of vaccine on 17Mar2021. On 29Mar2021, she was not hurting and went to brunch with friends. Afterwards (on the same date, 29Mar2021), she was sitting and got the worst pain through her side that ran down her left leg and to her ankle. She drove herself home but was in such misery. She went to the emergency room the next day, on 30Mar2021, wherein she had a CT (computerized tomography) scan that showed a blood clot in her lower abdominal area. She was taking pain medication every 6 hours, or she could hardly stand it. On 08Apr2021, she went back to the emergency room because she could hardly stand it. She was kept in observation status but was not admitted. She was scheduled to have another CT scan on 06May2021. She is not sure what they will do because the nerves are wrapped around it. She also mentioned that her doctor wants to do a biopsy. The pain was also running down to her ankle. She stated that she has had both of her hips replaced in the past. She added that her doctor will do an MRI (magnetic resonance imaging). He will put in a drain if it has not shrunk. The doctor can't do anything because the nerves are all tangled up (2021). As corrective treatment, the patient was taking pain medication for the blood clot and pain through her side that ran down her left leg and to her ankle. Outcome of nerves are all tangled up was unknown, while outcome of the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient experienced brief (15-30 second) episode of syncope; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Lot number: EW0150) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 06Apr2021, immediately following injection of 1st dose of vaccine, patient experienced brief (15-30 second) episode of syncope. She was sitting in chair and slumped forward momentarily. It was unknown if patient had Covid prior vaccination and unknown if tested for Covid post vaccination. No treatment received for the event. The outcome of the event syncope was recovered.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Myocardial infarction, Pain in extremity, Vital signs measurement, Weight
Clinical narrative: Heart attack; a little bit of a sore arm after the first dose; This is a spontaneous report from a contactable pharmacist. An 87-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3302; Expiration Date: Jul2021), via an unspecified route of administration on 27Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing cancer, ongoing chronic obstructive pulmonary disease (COPD), and diabetes. The patient's concomitant medications were not reported. In Feb2021, the patient experienced heart attack. On an unspecified date, the patient experienced a little bit of a sore arm after the first dose. The patient stated the sore arm was mild. The patient was hospitalized due to heart attach on an unspecified date. The reporter wanted to know if the patient needed to restart the vaccine series. The patient had no prior Vaccinations (within 4 weeks) and no events following prior vaccinations. Patient was not overweight and probably 5'8" or 5'9". The reporter guessed the patient was around 160 pounds. Patient's vital signs were stable on 13Apr2021. The patient received second dose on 13Apr2021, 11:50, right arm. The reporter confirmed that the heart attack occurred before the second dose. Outcome of events was unknown.; Sender's Comments: The event myocardial infarction is likely due to an intercurrent condition given the patient's ongpoing medical history and age and not related to BNT162B2.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Diarrhoea, Erythema, Joint swelling, Nodule
Clinical narrative: Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tenderness, Thrombosis
Clinical narrative: Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Vaccination site bruising
Clinical narrative: 4 days later minor blood clot in my finger (not sure it is drug related); Bruise at site of injection; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  On 13Apr2021, the patient had bruise at site of injection and 4 days later (17Apr2021) minor blood clot in her finger was noted (not sure it was drug related). The patient had no COVID-19 prior vaccination and not tested post vaccination. The patient requires doctor or other healthcare professional office/clinic visit for the events and unknown if treatment was received. The patient had not yet recovered from the events.   No follow up attempts are possible. information about lot/batch number cannot be obtained
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Hyperhidrosis, Hypoaesthesia oral, Loss of consciousness, Vaccination site paraesthesia
Clinical narrative: Woke up sweaty; was cold for about 30 minutes after; Mild tingling in left arm for about a minute after passing out; Mild numbness in lips for a few minutes after passing out; Passed out 25 mins after receiving vaccination; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 13Apr2021 09:15 (32-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not have covid prior vaccination and not tested for covid post vaccination. The patient passed out 25 mins after receiving vaccination (13Apr2021 09:40). Lasted a few seconds. Woke up sweaty (13Apr2021 09:45), was cold for about 30 minutes after (13Apr2021 09:45). Mild tingling in left arm for about a minute after passing out (13Apr2021 09:45). Mild numbness in lips for a few minutes after passing out (13Apr2021 09:45). Patient had no treatment for events. The outcome of the event passed out 25 mins after receiving vaccination and mild numbness in lips for a few minutes after passing out was recovered on 13Apr2021, woke up sweaty was recovering, was cold for about 30 minutes after was recovered on 13Apr2021 10:15, mild tingling in left arm for about a minute after passing out was recovered on 13Apr2021 09:46.