chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Hypopnoea, Sneezing
Clinical narrative: Chills; Sharp pain under ribcage; Shallow breathing; could not sneeze; Could not lift chest and shoulders due to pain; This is a spontaneous report received from a contactable consumer (reporting on herself). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737; Expiration Date was not reported), via an unspecified route of administration in Arm Left on 31Mar2021 as single dose for COVID-19 immunization. Medical history included histoplasmosis, calcification metastatic, arthritis all from an unknown date and unknown if ongoing. No history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient states she was diagnosed with this at about 10 years of age. On an x-ray she had years ago it said that the infection was cleared, there was signs of the prior infection, calcifications on her lungs are permanent, and there was some arthritis noted. Patient states that she has a question related to the first dose of the Covid Vaccine. States she received the first dose about 3 weeks ago on 31Mar2021. Says that during that day she experienced no side effects and did not expect to have any. The next day throughout the day she was okay. On 01Apr2021 at around 18:00 or 19:00, States then she had some chills, which she states was to be expected. Says then something odd happened, she had a pain on her right side under her ribcage; a sharp pain. She states that the night before she had done some mild exercise and stretching, does not know if that was a factor in her pain. She states that it was very painful. She had to breath shallow because it was less painful when she breathed shallow. Says it stifled her ability to sneeze because the pain wouldn't allow her to lift her chest and shoulders. States the pain stayed the same degree. About 6 days later it subsided and went away completely, but she believes it was gone completely after 4-5 and a half days. States there was no remnants of the pain. A lung x-ray had a black spot on it indicating that. States she had another x-ray years ago that showed that the infection was cleared, there was signs of the prior infection, calcifications on her lungs are permanent, and there was some arthritis not-ed. Patient was wondering if given her history of histoplasmosis and her side effects from the first dose of the vaccine if she should get the second dose. Says it was scheduled for the day after to-morrow Patients weight reports as 112-116 pounds, states that it varies at times. The outcome of the events was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, X-ray
Clinical narrative: Chills; Sharp pain under ribcage; Shallow breathing; could not sneeze; Could not lift chest and shoulders due to pain; This is a spontaneous report received from a contactable consumer (reporting on herself). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737; Expiration Date was not reported), via an unspecified route of administration in Arm Left on 31Mar2021 as single dose for COVID-19 immunization. Medical history included histoplasmosis, calcification metastatic, arthritis all from an unknown date and unknown if ongoing. No history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient states she was diagnosed with this at about 10 years of age. On an x-ray she had years ago it said that the infection was cleared, there was signs of the prior infection, calcifications on her lungs are permanent, and there was some arthritis noted. Patient states that she has a question related to the first dose of the Covid Vaccine. States she received the first dose about 3 weeks ago on 31Mar2021. Says that during that day she experienced no side effects and did not expect to have any. The next day throughout the day she was okay. On 01Apr2021 at around 18:00 or 19:00, States then she had some chills, which she states was to be expected. Says then something odd happened, she had a pain on her right side under her ribcage; a sharp pain. She states that the night before she had done some mild exercise and stretching, does not know if that was a factor in her pain. She states that it was very painful. She had to breath shallow because it was less painful when she breathed shallow. Says it stifled her ability to sneeze because the pain wouldn't allow her to lift her chest and shoulders. States the pain stayed the same degree. About 6 days later it subsided and went away completely, but she believes it was gone completely after 4-5 and a half days. States there was no remnants of the pain. A lung x-ray had a black spot on it indicating that. States she had another x-ray years ago that showed that the infection was cleared, there was signs of the prior infection, calcifications on her lungs are permanent, and there was some arthritis not-ed. Patient was wondering if given her history of histoplasmosis and her side effects from the first dose of the vaccine if she should get the second dose. Says it was scheduled for the day after to-morrow Patients weight reports as 112-116 pounds, states that it varies at times. The outcome of the events was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain
Clinical narrative: headache; tiredness; chills; pain around neck; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number is not reported), via an unspecified route of administration on 12Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patients historical vaccine included first dose of bnt162b2 for covid-19 immunisation. Concomitant medications included ibuprofen, pseudoephedrine hydrochloride (MOTRIN COLD & FLU), paracetamol (TYLENOL). She had both doses of covid vaccine and after each dose she had tiredness and chills. She was experiencing headache and pain around the neck since she got the Pfizer 1st shot. With second dose had those symptoms and still have the headache that would not go away. Wondering if it is a delayed reaction. She Read somewhere that headache can be fatal within 6 months. She was taking motrin and tylenol someone told her ephedrine is better. Her sister thinks she might have diabetes. Also has eye problems and Dr told her might have arthritis in her neck. The events assessed as non-serious with outcome of not recovered.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got tested positive on Covid virus; in between the 1st and 2nd dose she got tested positive on Covid virus; This is a spontaneous report from Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: unknown), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient was scheduled for 2nd dose. On an unspecified date, the patient got tested positive on Covid virus in between the 1st and 2nd dose and she finished the quarantine last 19Apr2021.The lab test included Covid test, results: positive. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (the patient) reported that a 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 22Apr2021 at age of 60-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the vaccine today (22Apr2021), she was currently (22Apr2021) experiencing soreness in the arm but not severe. She would like to confirm if she can take Tylenol to have a nice sleep tonight. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for coronavirus; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was scheduled for the second dose on 06May2021 (exactly 21 days apart). However, he was tested positive for coronavirus on 20Apr2021. He was asking if he should still take the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Apr2021. The outcome of event is unknown. No treatment information was provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient scheduled for the 2nd dose on 23Apr2021 (exactly 21 days apart). The patient currently has a sore throat that started a couple hours ago (Apr2021). She was asking if her daughter can proceed with the 2nd dose scheduled tomorrow. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable female consumer (reported for son).  A male patient of an unknown age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on an unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On 16Apr2021, the patient experienced shingles. It was reported that the patient had first dose of vaccine 3 week ago. Caller is calling on behalf of her son who has been diagnosed with shingles last Monday, 19Apr2021. Caller said that her son had the symptoms of shingles since Friday, 16Apr2021. Caller also stated that her son has the 1st dose of Pfizer Vaccine 3 weeks ago but caller could not recall the exact date. The 2nd dose of the vaccine is scheduled on 27Apr2021. Caller asked if her son can proceed to get the 2nd dose of the vaccine as scheduled. Provided contact details of PMI. The outcome of the event was unknown.    It was unknown whether reporter was a healthcare professional or prescribing HCP. The reporter's contact information available to a sub-contracted party.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss after vaccines; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer of an unspecified age reported that received bnt162b2 (Covid 19 Vaccine, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had both doses of Covid vaccine. The patient would like to know if her side effect has been reported by anyone else. The patient said having hair loss after vaccines. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of event was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was due to get her second dose of Pfizer Covid-19 vaccine however she had gotten pneumonia 2 weeks after getting the first dose and she's currently on antibiotics. She wanted to know if it's safe for her to take the second dose. The outcome of the event was unknown. The event was assessed as serious-medically significant.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death, Rash, Syncope
Clinical narrative: fainted; rash; died 2 weeks ago after receiving the covid vaccine/ passed away;This is a spontaneous report received from a non-contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first and second dose, both via unspecified route of administration on unspecified dates (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter mentioned that she had a friend that died 2 weeks ago after receiving the COVID vaccine. They are going to search for the cause of death (autopsy) because after the vaccine she had a rash, fainted, and went to the hospital, and she recovered (unspecified dates). But after a month or so, she passed away. The reporter mentioned that the patient was born very unhealthy person.  Outcome of rash and fainted was recovered on unspecified dates. The patient died in Apr2021.  It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died 2 weeks ago after receiving the covid vaccine/ passed away
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in arm where shot was administered; This is a spontaneous report from a non-contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose on arm for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation.  The patient experienced swollen lymph node in arm where shot was administered on an unspecified date with outcome of unknown.  Was given antibiotics. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Heart rate, Pulse absent, SARS-CoV-2 test
Clinical narrative: episodes of 4.5 seconds with non pulse; she experienced a basal artery blood clot stroke; lightheaded; This is a spontaneous report from a contactable consumer (patient's son). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 14:30 (at the age of 100years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history was not reported. Concomitant medication included furosemide taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had medical issues starting within hours of the first dose of Covid vaccine. Prior, the patient was in independent living, no medications (as reported), walking about 1/2 daily and completely lucid. Immediately thereafter (after the vaccine, 11Jan2021 16:00), she experienced lightheaded, a hospital stay, and episodes of 4.5 seconds with non-pulse. A pacemaker was installed. During rehab, the patient experienced a basal artery blood clot stroke. The patient is still in rehab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized on an unspecified date for 8 days. Treatment received included pacemaker, numerous medicines (e.g. AFIB). The patient had Covid test post vaccination: Nasal Swab on 15Jan2021 with negative result. The outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed as Covid-19 positive 04Apr2021; Diagnosed as Covid-19 positive 04Apr2021; This is a spontaneous report from a contactable consumer reporting for a patient (grand mother). A 95-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination 95 years old. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient was diagnosed with covid-19 positive on 04apr2021. She is currently in the ICU (Apr2021) and end of life planning is currently under discussion. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Apr2021. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: racing heartbeat; This is a spontaneous report from a contactable consumer via Medical information team. A female patient of an unspecified age (reported as age: 55, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died a few days later after getting vaccinated from a racing heartbeat. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about batch/lot number has been requested.; Reported Cause(s) of Death: racing heartbeat
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died after the 2nd dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 39-year-old female patient received the second dose of 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 single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient died after the 2nd dose on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed.  Information on the batch/lot number has been requested.; Reported Cause(s) of Death: died after the 2nd dose
Sex: M
Vaccine: COVID19
Symptoms: Nerve compression
Clinical narrative: Pinched Nerve; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. The patient had his first dose on 15Mar2021 and second dose on 06Apr2021. He was asking if he can start taking the Prednisone since this was prescribed to him due to Pinched Nerve. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable female consumer(patient) reported for herself.  A unspecified age female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection) via unspecified route of administration on 05Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On10Apr2021 patient tested negative for COVID-19 but on 13Apr2021 patient started showing signs of COVID-19. On 18Apr2021 again tested and resulted positive for COVID-19. The patient second dose would be on 26Apr2021. The Health department had stated that she could go back at normal routine on (24Apr2021) and wanted to know if that's too soon to get her 2nd dose of Vaccine. The outcome of the event reported was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain
Clinical narrative: Pain; feeling of heaviness in the arms.; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported for himself that a male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot number, Expiration date: unknown) as single dose for covid-19 immunisation. The patient received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Lot number, Expiration date: unknown) for covid-19 immunisation. Concomitant medications were not reported. The patient experienced pain on an unspecified date, feeling of heaviness in the arms on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Balance disorder, Cardiac stress test, Disorientation, Dizziness
Clinical narrative: cardiac arrhythmia; mental disorientation; dizziness; loss of balance; This is a spontaneous report from a contactable physician (patient). This 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 07Jan2021 14:30 for COVID-19 immunisation. The first dose was on 10Dec2020, 02:30 PM in left arm. Medical history was not reported. There was no known allergies. There was no covid prior vaccination, no covid tested post vaccination. There was no concomitant medication taken. There was no other vaccine in four weeks, no other medications in two weeks. Patient was healthy with no medical issues. Within 2 weeks of second shot, patient developed a cardiac arrhythmia on 21Jan2021 10:30 when she was at work. Patient had continued symptoms of irregular heart beat since then. Patient had had to go to the ED 2 times. Patient was now following with EP cardiology, treated with beta blockers. About 3 weeks after vaccine (in 2021), patient also developed mental disorientation, dizziness and loss of balance. Patient had had MRI brain, Holter monitoring, event monitoring, stress test and cardiac MRI, all with unknown results. Finally patient was on medications and 3 months later beginning to feel a bit better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care; assessed as life threatening illness (immediate risk of death from the event), disability or permanent damage. The outcome of events was resolved with sequel.  Information about lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Heart rate, Investigation, Magnetic resonance imaging head, Magnetic resonance imaging heart
Clinical narrative: cardiac arrhythmia; mental disorientation; dizziness; loss of balance; This is a spontaneous report from a contactable physician (patient). This 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 07Jan2021 14:30 for COVID-19 immunisation. The first dose was on 10Dec2020, 02:30 PM in left arm. Medical history was not reported. There was no known allergies. There was no covid prior vaccination, no covid tested post vaccination. There was no concomitant medication taken. There was no other vaccine in four weeks, no other medications in two weeks. Patient was healthy with no medical issues. Within 2 weeks of second shot, patient developed a cardiac arrhythmia on 21Jan2021 10:30 when she was at work. Patient had continued symptoms of irregular heart beat since then. Patient had had to go to the ED 2 times. Patient was now following with EP cardiology, treated with beta blockers. About 3 weeks after vaccine (in 2021), patient also developed mental disorientation, dizziness and loss of balance. Patient had had MRI brain, Holter monitoring, event monitoring, stress test and cardiac MRI, all with unknown results. Finally patient was on medications and 3 months later beginning to feel a bit better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care; assessed as life threatening illness (immediate risk of death from the event), disability or permanent damage. The outcome of events was resolved with sequel.  Information about lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Blood test, Cardiac stress test, Dyspnoea, Echocardiogram
Clinical narrative: cardiac arrhythmia; mental disorientation; dizziness; loss of balance; This is a spontaneous report from a contactable physician (patient). This 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 07Jan2021 14:30 for COVID-19 immunisation. The first dose was on 10Dec2020, 02:30 PM in left arm. Medical history was not reported. There was no known allergies. There was no covid prior vaccination, no covid tested post vaccination. There was no concomitant medication taken. There was no other vaccine in four weeks, no other medications in two weeks. Patient was healthy with no medical issues. Within 2 weeks of second shot, patient developed a cardiac arrhythmia on 21Jan2021 10:30 when she was at work. Patient had continued symptoms of irregular heart beat since then. Patient had had to go to the ED 2 times. Patient was now following with EP cardiology, treated with beta blockers. About 3 weeks after vaccine (in 2021), patient also developed mental disorientation, dizziness and loss of balance. Patient had had MRI brain, Holter monitoring, event monitoring, stress test and cardiac MRI, all with unknown results. Finally patient was on medications and 3 months later beginning to feel a bit better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care; assessed as life threatening illness (immediate risk of death from the event), disability or permanent damage. The outcome of events was resolved with sequel.  Information about lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Magnetic resonance imaging heart, Palpitations
Clinical narrative: cardiac arrhythmia; mental disorientation; dizziness; loss of balance; This is a spontaneous report from a contactable physician (patient). This 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 07Jan2021 14:30 for COVID-19 immunisation. The first dose was on 10Dec2020, 02:30 PM in left arm. Medical history was not reported. There was no known allergies. There was no covid prior vaccination, no covid tested post vaccination. There was no concomitant medication taken. There was no other vaccine in four weeks, no other medications in two weeks. Patient was healthy with no medical issues. Within 2 weeks of second shot, patient developed a cardiac arrhythmia on 21Jan2021 10:30 when she was at work. Patient had continued symptoms of irregular heart beat since then. Patient had had to go to the ED 2 times. Patient was now following with EP cardiology, treated with beta blockers. About 3 weeks after vaccine (in 2021), patient also developed mental disorientation, dizziness and loss of balance. Patient had had MRI brain, Holter monitoring, event monitoring, stress test and cardiac MRI, all with unknown results. Finally patient was on medications and 3 months later beginning to feel a bit better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care; assessed as life threatening illness (immediate risk of death from the event), disability or permanent damage. The outcome of events was resolved with sequel.  Information about lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: intense tingling in her hands and feet; This case was reported by a consumer via other manufacturer and described the occurrence of tingling feet/hands in a 60-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine (received 1st dose on 23rd February 2021) and Covid-19 vaccine (received 2nd dose on 15th March 2021).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tingling feet/hands. On an unknown date, the outcome of the tingling feet/hands was unknown.   It was unknown if the reporter considered the tingling feet/hands to be related to Shingles vaccine.  Additional details provided were as follows: The patient herself was the reporter for this case. The age at the vaccination was not reported. The reporter called for information about the symptoms she experienced after the administration of the Pfizer's COVID-19 vaccine immunization. The patient reports that she received her first dose and the second dose on around 8 weeks ago. The patient reported that 7 weeks after the administration of the second dose of the Pfizer's COVID-19 vaccine she started experiencing an intense tingling in her hands and feet that lasted for a week. The reporter reported that she had a similar symptom after she received the first dose of the Shingles vaccine and her physician recommended her to interrupt the immunization for Shingles. The reporter reported that she was going to contact her Physician.
Age: 4.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: patient had fever, after the second dose and again ran a high fever-104 Fahrenheit, after the third dose; Initial information was received on 16-Apr-2021 regarding an unsolicited valid non-serious case received from a physician (Pediatrician).  This case involves a 4 year-old female patient who experienced fever after the second dose and again high fever-104 Fahrenheit, after the third dose (pyrexia), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history included animal bite [was scratched and possibly bitten by an animal]. The patient's past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 07-Apr-2021, on 10-Apr-2021 and on 14-Apr-2021, the patient received first, second and third dose of suspect RABIES (HDC) VACCINE [Injection] (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 10-APR-2021, the patient developed non-serious fever, after the second dose and again high fever-104 Fahrenheit, after the third dose (pyrexia) on the same day following the administration of second dose RABIES (HDC) VACCINE.  Physician wanted to know if it was safe to continue the series. It was also mentioned the child received the first dose without problem. Her fourth (day 14) dose was due on 21-Apr-2021, and her parents were concerned regarding the elevated fever.  No other relevant laboratory data was reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event.  Result of assessment was not reported.  There will be no information available on batch number for this case.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: A patient received  the sterile diluent and its states on the bottle not to give it alone, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00557535) and transmitted to Sanofi on 12-Apr-2021.  This case involves a two-month-old female patient who received 0.5 mL of the sterile diluent and its states on the bottle not to give it alone of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ340AA and expiry date: 21-Jun-2022) via an intramuscular route in the left thigh for prophylactic vaccination on 09-Apr-2021 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination.  The caller would like to know the reason that why the Dtap and IPV variants cannot be given alone.  This was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional and a consumer/ non-health care professional via Medical Information (MI) (Reference number- 00559372) and transmitted to Sanofi on 13-Apr-2021.  This case involves a 01-year old male patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered) (lot number: UJ182AAA and expiration date: unknown and lot number: U6685AA and expiration date: 08-Mar-2021] at 0.5 ml dose via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  It was an actual medication error due to expired vaccine used (latency: unknown).  At the time of reporting, patient had no adverse event.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose was administered, with no AE; Initial information received on 14-Apr-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a 3 years old male patient who was given an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (fifth dose, frequency: once, strength: standard, lot C5611BA and expiration date: 03-Apr-2021) via intramuscular route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication were given.  It was a case of an actual medication error due to expired vaccine used (same day latency).  Nurse asks for follow-up information after expired product was administered and reports potential adverse event. Nurse stated she thinks this may have already been reported but no other report found.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, IPV, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered 0.5ml of expired Ipol with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Agency (Reference number- 00563648) and transmitted to Sanofi on 15-Apr-2021.  This case involves a 12 years old female patient who experienced was administered with an expired 0.5ml dose of IPV (VERO) [IPOL] (lot R1B251M and expiration date: 13-Mar-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 15-Apr-2021.  Medical history, medical treatments, past vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know if it needs to be re-administered or does she need to watch out for anything.   At the time of reporting, the patient experienced no specific adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 month old male patient inadvertently administered expired dose of Pentacel with no reported adverse event; Initial information received on 20-Apr-2021 regarding an unsolicited valid non-serious case received from a physician via nurse.  This case involves a two month old male patient who was inadvertently administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 07-Apr-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ216AA and expiry date: 06-Apr-2021) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Caller with question on whether dose need repeating at only one day past expiration. Reporter relationship: (HCP) health care professional Product used: not Applicable  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired MENACTRA with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Global Medical Information (GMI) (Reference number- 00571643) and transmitted to Sanofi on 21-Apr-2021.  This case involves an 11 years old male patient received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6543AA and expiry date: 23-Feb-2021) via intramuscular route in the right deltoid (expired product administered) for prophylactic vaccination on 20-Apr-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter stated that the mother was concerned about what possible adverse outcomes could come from this. Mother is aware that patient will need need to be revaccinated. Initial response provided: Provided response from the SRD, however, physician assistant was not satisfied. Offered to escalate to TA for the question on what possible adverse outcomes could come from receiving an expired vaccine. Physician assistant requested a response by the end of the week.    At the time of reporting, the patient experienced no specific adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.