chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 (Lot number: EW0196) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EL3247), administration date: 03Mar2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 2, Lot Number: EL3247), administration date: 24Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "Body aches"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; AXILLARY PAIN (non-serious), outcome "unknown", described as "sore underarm"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills". No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Capillary leak syndrome
Clinical narrative: Severe exacerbations of systemic capillary leak syndrome;  entitled Severe exacerbations of systemic capillary leak syndrome after COVID-19 vaccination: A case series. The full publication has been requested.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CAPILLARY LEAK SYNDROME (medically significant), outcome "unknown", described as "Severe exacerbations of systemic capillary leak syndrome". Exacerbations of rare systemic capillary leak syndromes have been reported, but the patient had no evidence of a prior leak.; Sender's Comments: Based on possible temporal relationship the causal role of the BNT162B2 Vaccination cannot be excluded for reported event.  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: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Product administered to patient of inappropriate age
Clinical narrative: patient age 8 years old; The shot was given at 2:30pm.  By 4pm we noticed significant eye swelling and irritation.  Gave him a full adult dose of Benadryl (25mil) and contacted our pediatrician.  By 5 eyes were nearly swelled; The shot was given at 2:30pm.  By 4pm we noticed significant eye swelling and irritation.  Gave him a full adult dose of Benadryl (25mil) and contacted our pediatrician.  By 5 eyes were nearly swelled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 14:30 (Lot number: FK5127) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Egg" (unspecified if ongoing), notes: Egg; "Known allergies: peanuts" (unspecified if ongoing), notes: peanuts; "Known allergies: tree nuts" (unspecified if ongoing), notes: tree nuts. There were no concomitant medications. The following information was reported: EYE SWELLING (medically significant), EYE IRRITATION (medically significant) all with onset 18Nov2021 16:00, outcome "recovered" (Nov2021) and all described as "The shot was given at 2:30pm.  By 4pm we noticed significant eye swelling and irritation.  Gave him a full adult dose of Benadryl (25mil) and contacted our pediatrician.  By 5 eyes were nearly swelled". The event "the shot was given at 2:30pm.  by 4pm we noticed significant eye swelling and irritation.  gave him a full adult dose of benadryl (25mil) and contacted our pediatrician.  by 5 eyes were nearly swelled" and "the shot was given at 2:30pm.  by 4pm we noticed significant eye swelling and irritation.  gave him a full adult dose of benadryl (25mil) and contacted our pediatrician.  by 5 eyes were nearly swelled" was evaluated at the physician office visit. Therapeutic measures were taken as a result of eye swelling, eye irritation.  Additional information: After first dose of Benadryl it took approximately 18 hours (and a second and third dose of Benadryl) for his eye swelling to completely go away. The patient did not have any other vaccine in 4 weeks. The patient did not have any other medication in two weeks. The patient did not have covid-19 prior vaccination and the patient did not tested for covid-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Hemiparesis, Hypoaesthesia, Paraesthesia
Clinical narrative: right sidedness weakness; numbing in her arms and legs; tingling in her arms and legs; she couldn't feel the right side of her face or her tongue; crushing stomach pain; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter nurse from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPARESIS, outcome "unknown", described as "right sidedness weakness"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing in her arms and legs"; PARAESTHESIA (non-serious), outcome "unknown", described as " tingling in her arms and legs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she couldn't feel the right side of her face or her tongue"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "crushing stomach pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Hemiparesis, hypoaesthesia, Paraesthesia, Feeling abnormal, Abdominal pain upper 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: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: right sidedness weakness; numbing in her arms and legs; tingling in her arms and legs; she couldn't feel the right side of her face or her tongue; crushing stomach pain; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter nurse from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPARESIS, outcome "unknown", described as "right sidedness weakness"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing in her arms and legs"; PARAESTHESIA (non-serious), outcome "unknown", described as " tingling in her arms and legs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she couldn't feel the right side of her face or her tongue"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "crushing stomach pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Hemiparesis, hypoaesthesia, Paraesthesia, Feeling abnormal, Abdominal pain upper 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: COVID19
Symptoms: Chest pain, Fatigue, Hemiparesis, Muscular weakness
Clinical narrative: hemiparesis on the right side she couldn't feel the entire side of her body including tongue her face and her nose; crushing chest pain; bilateral weakness of the hands and arms weakness on the legs; extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  An 8 year-old female patient (age from 6-10) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEMIPARESIS (medically significant), outcome "unknown", described as "hemiparesis on the right side she couldn't feel the entire side of her body including tongue her face and her nose"; CHEST PAIN (non-serious), outcome "unknown", described as "crushing chest pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "bilateral weakness of the hands and arms weakness on the legs"; FATIGUE (non-serious), outcome "unknown", described as "extreme exhaustion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event Hemiparesis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Lot number: FF8P41) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single, lot number:EL3247, expiry date was not reported, at left arm), administration date: 19Feb2021, when the patient was 23 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, lot number:EL3247, expiry date not reported, at left arm), administration date: 29Jan2021, when the patient was 23 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Third injection/booster"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "feverish"; PAIN (non-serious) with onset 19Nov2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 19Nov2021, outcome "recovering", described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome "recovering", described as "sore injection site". Therapeutic measures were not taken as a result of pyrexia, pain, chills, vaccination site pain. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Recurring periods of increased chest pain and fluttering; Recurring periods of increased chest pain and fluttering/Sustained dull ache in chest; Chest discomfort increases at night and in morning; Experiencing some shortness of breath when chest discomfort peaks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Nov2021 (Lot number: FF8839) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, product=COVID 19, brand=Pfizer - COVID 19 - Sanford (SNF-PFIZER-COVID19), lot number=FF8839, administrator route=Intramuscular, vaccine location=Left arm), administration date: 20Oct2021, when the patient was 28 years old, for COVID-19 Immunization. Sustained dull ache in chest starting a few days after second dose; recurring periods of increased chest pain and fluttering. Chest discomfort increases at night and in morning, wanes during the day. Experiencing some shortness of breath when chest discomfort peaks. As of 22Nov2021 symptoms continue. Have waited to see if symptoms subside before seeking medical treatment. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 16Nov2021 06:00, outcome "not recovered", described as "Recurring periods of increased chest pain and fluttering"; CHEST PAIN (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Recurring periods of increased chest pain and fluttering/Sustained dull ache in chest"; CHEST DISCOMFORT (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Chest discomfort increases at night and in morning"; DYSPNOEA (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Experiencing some shortness of breath when chest discomfort peaks". Therapeutic measures were not taken as a result of cardiac flutter, chest pain, chest discomfort, dyspnoea.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 08May2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 17Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 12Jul2021 at 14:00, the patient experienced cold feet and legs, cold arms and shooting pain in arms for over a month. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events Cold feet and legs/ cold arms and shooting pain in arms were resolved with sequelae on an unknown date in 2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration on an unknown date (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included reflex sympathetic dystrophy syndrome (RSD). The patient had known allergies to soy and nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date both as single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced arm pain at the site of injection. The event arm pain at the site of injection did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event arm pain at the site of injection. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm pain at the site of injection was resolving at the time of the report.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old patient of unspecified gender received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration on 09Nov2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient previously received the first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date and the second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date; both as a single dose for COVID-19 immunisation. On 11Nov2021 at 07:00, after the booster shot, the patient experienced arm pain, tiredness, headache, muscle pain, fever and chills; which started 2 days after the vaccination. The patient was fine on 12Nov2021 (reported as Friday). On an unknown date in Nov2021, few days after, the patient came down with an upper respiratory cold. The patient started to feel better as of 24Nov2021 (reported as today). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 21Nov2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events arm pain, tiredness, headache, muscle pain, fever and chills was resolved on 12Nov2021; while that of upper respiratory cold was resolving at the time of this report.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old patient of unspecified gender received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration on 09Nov2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient previously received the first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date and the second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date; both as a single dose for COVID-19 immunisation. On 11Nov2021 at 07:00, after the booster shot, the patient experienced arm pain, tiredness, headache, muscle pain, fever and chills; which started 2 days after the vaccination. The patient was fine on 12Nov2021 (reported as Friday). On an unknown date in Nov2021, few days after, the patient came down with an upper respiratory cold. The patient started to feel better as of 24Nov2021 (reported as today). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 21Nov2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events arm pain, tiredness, headache, muscle pain, fever and chills was resolved on 12Nov2021; while that of upper respiratory cold was resolving at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin discolouration, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ff2593) via an unspecified route of administration in the left arm on 21Nov2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The medical history included abnormal blood pressure. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified blood pressure medications within two weeks of vaccination. On 22Nov2021 at 10:15, the patient's left middle finger first joint with fingernail was swollen for two days. It was red and then turned purple and was sore to touch and was tender. The patient felt like she had slammed it in a car door but did not. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the reported events. The clinical outcome of the events left middle finger first joint with fingernail was swollen for two days then it was red and then turned to purple, sore to touch, tender were not resolved at the time of this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Gastrointestinal pain, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 23Nov2021 at 00:00 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and, known allergies to pineapple and thermasil. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration on 11Mar2021 at 13:15 (at the age of 77-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 77-year-old); both as single dose for COVID-19 immunisation. On 23Nov2021 at 20:30, the patient experienced injection site pain, headache, chills, fever, diarrhea, arm pain, dehydration and intestinal cramps. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, headache, chills, fever, diarrhea, arm pain, dehydration and intestinal cramps was resolving at the time of this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 23Nov2021 at 00:00 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and, known allergies to pineapple and thermasil. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration on 11Mar2021 at 13:15 (at the age of 77-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 77-year-old); both as single dose for COVID-19 immunisation. On 23Nov2021 at 20:30, the patient experienced injection site pain, headache, chills, fever, diarrhea, arm pain, dehydration and intestinal cramps. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, headache, chills, fever, diarrhea, arm pain, dehydration and intestinal cramps was resolving at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3781) via an unspecified route of administration in the left arm on 21Aug2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN) and unspecified condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified prescriptions within two weeks of vaccination, from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 29Jul2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 15Sep2021 at 15:00 (since getting the second Pfizer vaccine), the patient's left arm at injection site felt like something was pinching sticking her. Sometimes that feeling radiated down to her left forearm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm at injection site felt like something was pinching sticking her, sometimes that feeling radiated down to her left forearm was not resolved at the time of this report.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Gait inability, Inappropriate schedule of product administration, Pain in extremity, SARS-CoV-2 test
Clinical narrative: extreme leg pain; unable to walk; Dose: 1=02Sep2021/ Dose: 2= 20Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 11:30 (Lot number: fh8028) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose lot number=fc3183,, prev dose lot unknown=False,, prev dose administration date=02Sep2021,, prev dose administration time=14:00, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 02Sep2021, when the patient was 14 years old, for Covid-19 immunization, reaction(s): "Initially had slight pain at injection site", "extreme leg pain in both legs below the knees", "Both the front of the leg and the calf were experiencing pain". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Nov2021 11:30, outcome "unknown", described as "Dose: 1=02Sep2021/ Dose: 2= 20Nov2021"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021, outcome "unknown", described as "extreme leg pain"; GAIT INABILITY (non-serious) with onset 23Nov2021, outcome "unknown", described as "unable to walk". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, gait inability.  Additional information: Patient took tylenol to deal with pain. It took almost 10 weeks from initial dose for extreme pain to subside. Advised by pediatrician to not receive 2nd dose of pfizer until test result came back and constant leg pain subsided. Patient did not receive any other vaccine in four weeks. Patient was tested for blood panel test as negative (Leg pain had diminished to uncomfortable instead of extreme pain) on 08Nov2021 and COVID-19 (test name post vaccination was Binax, test type post vaccination Nasal Swab) with result as negative on 16Nov2021.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: same affliction in different past of the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "same affliction in different past of the body".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: same affliction in different past of the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "same affliction in different past of the body". Caller said just as caller got around a little better and his physical therapist apologized for papooing reporter in regard to complaints about the neuropathy. The therapist informed caller four other patients had the same affliction in different past of the body.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died after taking the second dose of the vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died after taking the second dose of the vaccines". The patient date of death was unknown. The reported cause of death was "Died after taking the second dose of the vaccines". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Died after taking the second dose of the vaccines
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Nov2021 at 09:45 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D), ascorbic acid (VITAMIN C) and biotin (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 45-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 10:00 (at the age of 45-years-old); both as single dose for COVID-19 immunisation. On 23Nov2021 at 17:00, the patient experienced swelling and soreness of lymph node in left arm pit toward the front of body. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling and soreness of lymph node in left arm pit toward the front of body was not resolved at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Nov2021 at 20:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of COVID-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA; Lot Number: UNKNOWN) via an unspecified route of administration on 18Jan2021 (at the age of 27-years-old) and the second dose of COVID -19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA; Lot Number: UNKNOWN) via an unspecified route of administration on 17Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 24Nov2021 at 20:00, the patient experienced lymph node swelling in left under arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph node swelling in left under arm was resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: For the past month "I" have had a menstrual cycle every 2 weeks which is very abnormal for "me"; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via intramuscular route of administration in the right arm on 09Oct2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via intramuscular route of administration in the right arm on 08Sep2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Since the past month from the time of this report, from 14Oct2021, the patient experienced menstrual cycle every 2 weeks which was very abnormal for her. The patient had regular menstrual cycles before receiving her second dose of the Pfizer vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle every 2 weeks which was very abnormal was unknown at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration on 26Oct2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration on 26Sep2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 26Oct2021, the patient experienced frequent moderate headaches. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event frequent moderate headaches was not resolved at the time of this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: He received 2 doses of Pfizer COVID 19 vaccine and has just received a positive PCR test.  A breakthrough case.; He received 2 doses of Pfizer COVID 19 vaccine and has just received a positive PCR test.  A breakthrough case.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 80 year-old male patient received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 80 years as dose 2, single and (Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "He received 2 doses of Pfizer COVID 19 vaccine and has just received a positive PCR test. A breakthrough case.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (02Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, sars-cov-2 test positive. No covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Immunisation, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via intramuscular route of administration in the right arm on 23Nov2021 at 12:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the right arm on 22Feb2021 at 13:00 (at the age of 51-year-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the right arm on 15Mar2021 at 13:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 24Nov2021 at 09:00, the patient experienced swelling under right armpit, dizzy and change of voice which she hadn't realized the first times when she received the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling under right armpit, dizzy and change of voice was not resolved at the time of this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 24Nov2021 at 14:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 20Apr2021 (at the age of 56-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 (at the age of 56-years-old); both as single dose for COVID-19 immunisation. On 24Nov2021, the patient experienced severe fever each day since shot, chills, headaches, body aches and fatigue that prevented everyday activities. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fever each day since shot, chills, headaches, body aches and fatigue that prevented everyday activities were unknown at the time of this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 24Nov2021 at 14:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 20Apr2021 (at the age of 56-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 (at the age of 56-years-old); both as single dose for COVID-19 immunisation. On 24Nov2021, the patient experienced severe fever each day since shot, chills, headaches, body aches and fatigue that prevented everyday activities. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe fever each day since shot, chills, headaches, body aches and fatigue that prevented everyday activities were unknown at the time of this report.