chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Feel like Im on fire on the inside - top 1/2 of body; shakes; trouble comprehending paragraphs of text, trouble driving car; can't concentrate; neck tightness; extreme fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, pre-NASH from an unknown date and unknown if ongoing, known allergies to possibly excipients in tablets, latex and more from an unknown date and unknown if ongoing. Concomitant medication(s) included LEVOTHYROXINE; paracetamol (TYLENOL) and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took sudafed [guaifenesin;pseudoephedrine hydrochloride] and nickel and experienced known allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Hospital. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, patient experienced feel like Im on fire on the inside - top 1/2 of body, shakes, chills, extreme fatigue, trouble comprehending paragraphs of text, trouble driving car, can't concentrate, neck tightness. Patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care for the adverse events. Treatment was not received for the adverse events. The events were assessed as serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, caused disabling/incapacitating, did not cause congenital anomaly/birth defect. Patient received second dose of BNT162B2 (lot number: EN6203), administered in Left arm on 19Apr2021 for COVID-19 immunization. The patient underwent lab tests and procedures which included COVID-19: negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disturbance in attention, Fatigue, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: Feel like Im on fire on the inside - top 1/2 of body; shakes; trouble comprehending paragraphs of text, trouble driving car; can't concentrate; neck tightness; extreme fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, pre-NASH from an unknown date and unknown if ongoing, known allergies to possibly excipients in tablets, latex and more from an unknown date and unknown if ongoing. Concomitant medication(s) included LEVOTHYROXINE; paracetamol (TYLENOL) and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took sudafed [guaifenesin;pseudoephedrine hydrochloride] and nickel and experienced known allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Hospital. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, patient experienced feel like Im on fire on the inside - top 1/2 of body, shakes, chills, extreme fatigue, trouble comprehending paragraphs of text, trouble driving car, can't concentrate, neck tightness. Patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care for the adverse events. Treatment was not received for the adverse events. The events were assessed as serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, caused disabling/incapacitating, did not cause congenital anomaly/birth defect. Patient received second dose of BNT162B2 (lot number: EN6203), administered in Left arm on 19Apr2021 for COVID-19 immunization. The patient underwent lab tests and procedures which included COVID-19: negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, SARS-CoV-2 test, Tremor
Clinical narrative: Feel like Im on fire on the inside - top 1/2 of body; shakes; trouble comprehending paragraphs of text, trouble driving car; can't concentrate; neck tightness; extreme fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, pre-NASH from an unknown date and unknown if ongoing, known allergies to possibly excipients in tablets, latex and more from an unknown date and unknown if ongoing. Concomitant medication(s) included LEVOTHYROXINE; paracetamol (TYLENOL) and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took sudafed [guaifenesin;pseudoephedrine hydrochloride] and nickel and experienced known allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Hospital. Prior to vaccination, patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, patient experienced feel like Im on fire on the inside - top 1/2 of body, shakes, chills, extreme fatigue, trouble comprehending paragraphs of text, trouble driving car, can't concentrate, neck tightness. Patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care for the adverse events. Treatment was not received for the adverse events. The events were assessed as serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, caused disabling/incapacitating, did not cause congenital anomaly/birth defect. Patient received second dose of BNT162B2 (lot number: EN6203), administered in Left arm on 19Apr2021 for COVID-19 immunization. The patient underwent lab tests and procedures which included COVID-19: negative. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Hypoaesthesia, Ocular hyperaemia, Swelling face
Clinical narrative: Left eye got really swollen; Red eye; Itchy eye like an allergic reaction; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On an unspecified date in Mar2021 after the first dose, within 4-8 hours the patient's left eye got really swollen, red and itchy like an allergic reaction. The clinical outcomes of the events, left eye got really swollen, red eye and itchy eye like an allergic reaction were unknown. On 30Mar2021 at 21:00, after the second dose, within 4-8 hours, the patient's left eye got really swollen, red and itchy like an allergic reaction. The clinical outcomes of the events left eye got really swollen, red eye and itchy eye like an allergic reaction were recovering at the time of report. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Left eye got really swollen; Red eye; Itchy eye like an allergic reaction; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On an unspecified date in Mar2021 after the first dose, within 4-8 hours the patient's left eye got really swollen, red and itchy like an allergic reaction. The clinical outcomes of the events, left eye got really swollen, red eye and itchy eye like an allergic reaction were unknown. On 30Mar2021 at 21:00, after the second dose, within 4-8 hours, the patient's left eye got really swollen, red and itchy like an allergic reaction. The clinical outcomes of the events left eye got really swollen, red eye and itchy eye like an allergic reaction were recovering at the time of report. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Bell's palsy, Blood test, Computerised tomogram head, Dry eye
Clinical narrative: When right to ER with stroke like symptoms; Was diagnosed with BELLS PALSY/Paralysis are on my left side/mouth twisted; headache; sleep more; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 58-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 16Mar2021 15:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included Heart Disease, sleep apthy, swelling in left leg and ankle. No known allergies. Concomitant medications included patient took other medications (unspecified) in two weeks.  For Adverse events the patient reported as follows: It all began 10 as after her 1st of 2 vaccines. The Pfizer. She went to work for 2hrs. At 6pm she picked her daughter up and she asked why was your mouth twisted. She had not noticed any difference but called the 24hr nurse. When right to ER with stroke like symptoms. Had a headache that started a few days before and would not go away. She was diagnosed with BELLS PALSY. Paralysis were on her left side. Her left eye had to have eyes every few hrs, she slept more. She was not able to work since this had happen and this was the 3rd month. Eyes were still affected, still headaches and eating or chewing food, or drinking was difficult. The start date of events was 26Mar2021 06:30 PM. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events stroke like symptoms and bells palsy were Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received included steroids for 7 days, (6) pills daily at one time. The outcome of events was not recovered. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired work ability, Magnetic resonance imaging head, Memory impairment, Movement disorder
Clinical narrative: When right to ER with stroke like symptoms; Was diagnosed with BELLS PALSY/Paralysis are on my left side/mouth twisted; headache; sleep more; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 58-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 16Mar2021 15:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included Heart Disease, sleep apthy, swelling in left leg and ankle. No known allergies. Concomitant medications included patient took other medications (unspecified) in two weeks.  For Adverse events the patient reported as follows: It all began 10 as after her 1st of 2 vaccines. The Pfizer. She went to work for 2hrs. At 6pm she picked her daughter up and she asked why was your mouth twisted. She had not noticed any difference but called the 24hr nurse. When right to ER with stroke like symptoms. Had a headache that started a few days before and would not go away. She was diagnosed with BELLS PALSY. Paralysis were on her left side. Her left eye had to have eyes every few hrs, she slept more. She was not able to work since this had happen and this was the 3rd month. Eyes were still affected, still headaches and eating or chewing food, or drinking was difficult. The start date of events was 26Mar2021 06:30 PM. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events stroke like symptoms and bells palsy were Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received included steroids for 7 days, (6) pills daily at one time. The outcome of events was not recovered. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Speech disorder
Clinical narrative: When right to ER with stroke like symptoms; Was diagnosed with BELLS PALSY/Paralysis are on my left side/mouth twisted; headache; sleep more; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 58-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 16Mar2021 15:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included Heart Disease, sleep apthy, swelling in left leg and ankle. No known allergies. Concomitant medications included patient took other medications (unspecified) in two weeks.  For Adverse events the patient reported as follows: It all began 10 as after her 1st of 2 vaccines. The Pfizer. She went to work for 2hrs. At 6pm she picked her daughter up and she asked why was your mouth twisted. She had not noticed any difference but called the 24hr nurse. When right to ER with stroke like symptoms. Had a headache that started a few days before and would not go away. She was diagnosed with BELLS PALSY. Paralysis were on her left side. Her left eye had to have eyes every few hrs, she slept more. She was not able to work since this had happen and this was the 3rd month. Eyes were still affected, still headaches and eating or chewing food, or drinking was difficult. The start date of events was 26Mar2021 06:30 PM. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events stroke like symptoms and bells palsy were Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received included steroids for 7 days, (6) pills daily at one time. The outcome of events was not recovered. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Cerebrovascular accident, Headache, Somnolence
Clinical narrative: When right to ER with stroke like symptoms; Was diagnosed with BELLS PALSY/Paralysis are on my left side/mouth twisted; headache; sleep more; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 58-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 16Mar2021 15:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included Heart Disease, sleep apthy, swelling in left leg and ankle. No known allergies. Concomitant medications included patient took other medications (unspecified) in two weeks.  For Adverse events the patient reported as follows: It all began 10 as after her 1st of 2 vaccines. The Pfizer. She went to work for 2hrs. At 6pm she picked her daughter up and she asked why was your mouth twisted. She had not noticed any difference but called the 24hr nurse. When right to ER with stroke like symptoms. Had a headache that started a few days before and would not go away. She was diagnosed with BELLS PALSY. Paralysis were on her left side. Her left eye had to have eyes every few hrs, she slept more. She was not able to work since this had happen and this was the 3rd month. Eyes were still affected, still headaches and eating or chewing food, or drinking was difficult. The start date of events was 26Mar2021 06:30 PM. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Events stroke like symptoms and bells palsy were Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received included steroids for 7 days, (6) pills daily at one time. The outcome of events was not recovered. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: hardly walk after the first one; This is a spontaneous report from a contactable consumer reporting for himself. This is one of two report from same reporter. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included hips replaced (years ago) and both knees replaced (years ago). The concomitant medications were not reported. On an unknown date in 2021, the patient experienced hardly walk after the first one. The patient reported that he could hardly walk after the first one and had been living on diclofenac anti-inflammatory and ibuprofen and can only take that so much before it starts hurting. He does not know what to do and wondered if there is anything to help him. The patient was referred to HCP and Survey was offered. He went to the doctor about one month ago and got a script for diclofenac, but this was going on too long and it has been months. He does not know if it was going to be permanent now. Almost four months. Therapeutic measures were taken as a result of hardly walk after the first one. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance
Clinical narrative: hardly walk after the first one; This is a spontaneous report from a contactable consumer reporting for himself. This is one of two report from same reporter. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included hips replaced (years ago) and both knees replaced (years ago). The concomitant medications were not reported. On an unknown date in 2021, the patient experienced hardly walk after the first one. The patient reported that he could hardly walk after the first one and had been living on diclofenac anti-inflammatory and ibuprofen and can only take that so much before it starts hurting. He does not know what to do and wondered if there is anything to help him. The patient was referred to HCP and Survey was offered. He went to the doctor about one month ago and got a script for diclofenac, but this was going on too long and it has been months. He does not know if it was going to be permanent now. Almost four months. Therapeutic measures were taken as a result of hardly walk after the first one. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Influenza like illness
Clinical narrative: I read a headline online that said a thirteen year old died in his sleep after taking the Pfizer vaccine and the CDC is investigating. Another article headline may have said it was a boy but; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter read a headline online that said a thirteen-year-old died in his sleep after taking the Pfizer vaccine and the CDC was investigating. Another article headline may have said it was a boy, but reporter can't find that article again. The reporter don't have a subscription to newsweek so could not read the article and get more specifics.The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of event was reported as fatal.   Follow up needed, further information was requested.; Reported Cause(s) of Death: a thirteen year old died in his sleep after taking the Pfizer vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Cardiomegaly, Pericardial effusion, Sudden death
Clinical narrative: I read a headline online that said a thirteen year old died in his sleep after taking the Pfizer vaccine and the CDC is investigating. Another article headline may have said it was a boy but; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter read a headline online that said a thirteen-year-old died in his sleep after taking the Pfizer vaccine and the CDC was investigating. Another article headline may have said it was a boy, but reporter can't find that article again. The reporter don't have a subscription to newsweek so could not read the article and get more specifics.The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of event was reported as fatal.   Follow up needed, further information was requested.; Reported Cause(s) of Death: a thirteen year old died in his sleep after taking the Pfizer vaccine
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: I read a headline online that said a thirteen year old died in his sleep after taking the Pfizer vaccine and the CDC is investigating. Another article headline may have said it was a boy but; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter read a headline online that said a thirteen-year-old died in his sleep after taking the Pfizer vaccine and the CDC was investigating. Another article headline may have said it was a boy, but reporter can't find that article again. The reporter don't have a subscription to newsweek so could not read the article and get more specifics.The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of event was reported as fatal.   Follow up needed, further information was requested.; Reported Cause(s) of Death: a thirteen year old died in his sleep after taking the Pfizer vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Laboratory test normal, Nausea, Neck pain
Clinical narrative: headache, everyday for 90 days since his first Pfizer vaccine; He is in lot of pain.; This is a spontaneous report from a contactable consumer or other Non HCP. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: ER8737), via an unspecified route of administration, administered on 02Apr2021 as single dose for COVID-19 immunisation. Medical history included nausea from an unknown date and unknown if ongoing, weight decreased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced headache, everyday for 90 days since his first vaccine, ever since with no relief. He is in lot of pain on an unspecified date. He is been seeking medical treatment, he is been seeing a neurologist. Neurologist agrees, probably an adverse reaction which is don't know, what to do and we don't know he get him seen what the next step or there is no plan in place on. Reporter stated, he need to talk to someone to get him Medical treatment. What do I do? He need to know how to get in touch with them. What date and time and what option to choose because he have already done that. Therapeutic measures were taken with Tylenol as a result of headache, everyday for 90 days since his first vaccine, he is in lot of pain. The patient underwent lab tests and procedures which included helicobacter test: negative on 10Jun2021. The outcome of events was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: headache, everyday for 90 days since his first Pfizer vaccine; He is in lot of pain.; This is a spontaneous report from a contactable consumer or other Non HCP. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: ER8737), via an unspecified route of administration, administered on 02Apr2021 as single dose for COVID-19 immunisation. Medical history included nausea from an unknown date and unknown if ongoing, weight decreased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced headache, everyday for 90 days since his first vaccine, ever since with no relief. He is in lot of pain on an unspecified date. He is been seeking medical treatment, he is been seeing a neurologist. Neurologist agrees, probably an adverse reaction which is don't know, what to do and we don't know he get him seen what the next step or there is no plan in place on. Reporter stated, he need to talk to someone to get him Medical treatment. What do I do? He need to know how to get in touch with them. What date and time and what option to choose because he have already done that. Therapeutic measures were taken with Tylenol as a result of headache, everyday for 90 days since his first vaccine, he is in lot of pain. The patient underwent lab tests and procedures which included helicobacter test: negative on 10Jun2021. The outcome of events was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Helicobacter test, Pain
Clinical narrative: headache, everyday for 90 days since his first Pfizer vaccine; He is in lot of pain.; This is a spontaneous report from a contactable consumer or other Non HCP. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: ER8737), via an unspecified route of administration, administered on 02Apr2021 as single dose for COVID-19 immunisation. Medical history included nausea from an unknown date and unknown if ongoing, weight decreased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced headache, everyday for 90 days since his first vaccine, ever since with no relief. He is in lot of pain on an unspecified date. He is been seeking medical treatment, he is been seeing a neurologist. Neurologist agrees, probably an adverse reaction which is don't know, what to do and we don't know he get him seen what the next step or there is no plan in place on. Reporter stated, he need to talk to someone to get him Medical treatment. What do I do? He need to know how to get in touch with them. What date and time and what option to choose because he have already done that. Therapeutic measures were taken with Tylenol as a result of headache, everyday for 90 days since his first vaccine, he is in lot of pain. The patient underwent lab tests and procedures which included helicobacter test: negative on 10Jun2021. The outcome of events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Upon audit, found that client had received prior doses -- 2/24/2021 and 5/20/2021
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle contractions involuntary, Pain, Pyrexia, Sleep disorder
Clinical narrative: Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; felt feverish.; Next day woke up sore and have a decent headache; This is a spontaneous report from a contactable consumer (patient himself). A 22-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Ewolfe) via an unspecified route of administration in left arm on 22Jun2021 14:00 as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Facility where the most recent COVID-19 vaccine was administered was reported pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19, prior to vaccination. Patient was not been tested for COVID-19, since the vaccination. On 23Jun2021 at 02:30 patient woke up from sleep shaking. Shaking turned uncontrollable/convulsions. Lasted for about 25 minutes before it resided and felt feverish. Next day woke up sore and have a decent headache. The patient did not receive any treatment for the adverse events. The outcome of the event was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; felt feverish.; Next day woke up sore and have a decent headache; This is a spontaneous report from a contactable consumer (patient himself). A 22-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Ewolfe) via an unspecified route of administration in left arm on 22Jun2021 14:00 as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Facility where the most recent COVID-19 vaccine was administered was reported pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19, prior to vaccination. Patient was not been tested for COVID-19, since the vaccination. On 23Jun2021 at 02:30 patient woke up from sleep shaking. Shaking turned uncontrollable/convulsions. Lasted for about 25 minutes before it resided and felt feverish. Next day woke up sore and have a decent headache. The patient did not receive any treatment for the adverse events. The outcome of the event was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia, Seizure, Sleep disorder, Tremor
Clinical narrative: Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; Woke up from sleep shaking. Shaking turned uncontrollable/convulsions.; felt feverish.; Next day woke up sore and have a decent headache; This is a spontaneous report from a contactable consumer (patient himself). A 22-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Ewolfe) via an unspecified route of administration in left arm on 22Jun2021 14:00 as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Facility where the most recent COVID-19 vaccine was administered was reported pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19, prior to vaccination. Patient was not been tested for COVID-19, since the vaccination. On 23Jun2021 at 02:30 patient woke up from sleep shaking. Shaking turned uncontrollable/convulsions. Lasted for about 25 minutes before it resided and felt feverish. Next day woke up sore and have a decent headache. The patient did not receive any treatment for the adverse events. The outcome of the event was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Angiogram pulmonary abnormal, Chest pain, Dyspnoea, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Symptoms began with pain on side on 6/17/2021. Reports feeling heaviness on chest that same night. Was taken to ER and had x-ray where PE was detected. She was transferred to another hospital and admitted for 5 days.
Age: 15.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Blood test, Chest X-ray abnormal, Chest discomfort, Flank pain, Pulmonary embolism
Clinical narrative: Symptoms began with pain on side on 6/17/2021. Reports feeling heaviness on chest that same night. Was taken to ER and had x-ray where PE was detected. She was transferred to another hospital and admitted for 5 days.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Chest pain, Face oedema, Pruritus, Urticaria
Clinical narrative: auto immune disorder; allergies; face started swelling up; getting hives like on head and on face; behind leg also kind of hot; throat started swollen up; cannot swallow; This is a spontaneous report from a contactable consumer (patient). A 50-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 23Jun2021 13:00 (Lot Number: EW0161) as dose number unknown, single for covid-19 immunisation. No prior vaccination within 4 weeks of getting the Pfizer vaccination. The patient's medical history and concomitant medications were not reported. The patient had an adverse reaction to BNT162B2 and had to go to the hospital to juiced up to counter act that. Approximately couple of hours after taking the shot, the patient's face started swelling up and started getting hives like on head and on face, behind leg also kind of hot and then about another hour went by the patient decided to go to emergency room and on the way there the patient's throat started swollen up and cannot swallow. The patient was being check for auto immune disorder and allergies. Treatment included cetirizine and took another pill omeprazole at 20 mg. Getting the Pfizer shot here or like the patient was gave all kind of medicine to counter act it so there was chance when medicine go away that the patient was going to have another relapse swollen up an everything. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: auto immune disorder; allergies; face started swelling up; getting hives like on head and on face; behind leg also kind of hot; throat started swollen up; cannot swallow; This is a spontaneous report from a contactable consumer (patient). A 50-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 23Jun2021 13:00 (Lot Number: EW0161) as dose number unknown, single for covid-19 immunisation. No prior vaccination within 4 weeks of getting the Pfizer vaccination. The patient's medical history and concomitant medications were not reported. The patient had an adverse reaction to BNT162B2 and had to go to the hospital to juiced up to counter act that. Approximately couple of hours after taking the shot, the patient's face started swelling up and started getting hives like on head and on face, behind leg also kind of hot and then about another hour went by the patient decided to go to emergency room and on the way there the patient's throat started swollen up and cannot swallow. The patient was being check for auto immune disorder and allergies. Treatment included cetirizine and took another pill omeprazole at 20 mg. Getting the Pfizer shot here or like the patient was gave all kind of medicine to counter act it so there was chance when medicine go away that the patient was going to have another relapse swollen up an everything. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Autoimmune disorder, Dysphagia, Feeling hot, Pharyngeal swelling
Clinical narrative: auto immune disorder; allergies; face started swelling up; getting hives like on head and on face; behind leg also kind of hot; throat started swollen up; cannot swallow; This is a spontaneous report from a contactable consumer (patient). A 50-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 23Jun2021 13:00 (Lot Number: EW0161) as dose number unknown, single for covid-19 immunisation. No prior vaccination within 4 weeks of getting the Pfizer vaccination. The patient's medical history and concomitant medications were not reported. The patient had an adverse reaction to BNT162B2 and had to go to the hospital to juiced up to counter act that. Approximately couple of hours after taking the shot, the patient's face started swelling up and started getting hives like on head and on face, behind leg also kind of hot and then about another hour went by the patient decided to go to emergency room and on the way there the patient's throat started swollen up and cannot swallow. The patient was being check for auto immune disorder and allergies. Treatment included cetirizine and took another pill omeprazole at 20 mg. Getting the Pfizer shot here or like the patient was gave all kind of medicine to counter act it so there was chance when medicine go away that the patient was going to have another relapse swollen up an everything. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: auto immune disorder; allergies; face started swelling up; getting hives like on head and on face; behind leg also kind of hot; throat started swollen up; cannot swallow; This is a spontaneous report from a contactable consumer (patient). A 50-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 23Jun2021 13:00 (Lot Number: EW0161) as dose number unknown, single for covid-19 immunisation. No prior vaccination within 4 weeks of getting the Pfizer vaccination. The patient's medical history and concomitant medications were not reported. The patient had an adverse reaction to BNT162B2 and had to go to the hospital to juiced up to counter act that. Approximately couple of hours after taking the shot, the patient's face started swelling up and started getting hives like on head and on face, behind leg also kind of hot and then about another hour went by the patient decided to go to emergency room and on the way there the patient's throat started swollen up and cannot swallow. The patient was being check for auto immune disorder and allergies. Treatment included cetirizine and took another pill omeprazole at 20 mg. Getting the Pfizer shot here or like the patient was gave all kind of medicine to counter act it so there was chance when medicine go away that the patient was going to have another relapse swollen up an everything. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Heart Palpitations; This is a spontaneous report from a contactable nurse (patient reported for herself). A 28-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EK5730), via an intramuscular route of administration, administered in Arm Right on 16Jan2021 (at the age of 28-year-old), as single for covid-19 immunisation. The patient was non-pregnant at the time of vaccination. The patient had no other medical history. The patient had no known allergies. Concomitant medication included Ethinylestradiol, norgestimate (SPRINTEC) taken for birth control, start and stop date were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection,Lot Number: EL3246), via an intramuscular route of administration, administered in Arm Right on 26Dec2020 (at the age of 28-year-old), as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19Prior to vaccination. No other vaccine received in four weeks. On 17Jan2021, 1 day post second injection, the patient experienced heart palpitations. It was Intermittent that day and on and off since then. On 09Jun2021, the patient underwent Rapid, Nasal Swab test, which was Negative for covid-19. No treatment was received to treat the event. The event assessed as medically significant. The outcome of the event was unknown at the time of this report.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  palpitations. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate