chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Malaise, Off label use, Rhinorrhoea
Clinical narrative: Covid exposure; Runny nose, after booster shot; Caller started sneezing, after booster shot; Felt out of sorts, after booster shot; felt tired; Booster; off label use; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 09Sep2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced covid exposure on an unspecified date, runny nose, after booster shot on an unspecified date, caller started sneezing, after booster shot on an unspecified date, felt out of sorts, after booster shot on an unspecified date, felt tired on an unspecified date, booster on 09Sep2021, off label use on 09Sep2021. Caller stated that she was exposed from her friend, and she just wanted to relay her experience to support the booster dose. The outcome of the events exposure to sars-cov-2, rhinorrhoea, sneezing, malaise, fatigue was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Covid exposure; Runny nose, after booster shot; Caller started sneezing, after booster shot; Felt out of sorts, after booster shot; felt tired; Booster; off label use; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 09Sep2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced covid exposure on an unspecified date, runny nose, after booster shot on an unspecified date, caller started sneezing, after booster shot on an unspecified date, felt out of sorts, after booster shot on an unspecified date, felt tired on an unspecified date, booster on 09Sep2021, off label use on 09Sep2021. Caller stated that she was exposed from her friend, and she just wanted to relay her experience to support the booster dose. The outcome of the events exposure to sars-cov-2, rhinorrhoea, sneezing, malaise, fatigue was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, Ovarian cyst, Uterine spasm
Clinical narrative: I had uterine cramping within five minutes of administration; Then I missed my menstrual cycle for two months directly following administration.; I also developed a large painful ovarian cyst on my right ovary; This is a spontaneous report from a non-contactable consumer (Patient reported for herself).   A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EU10181), via unspecified route of administration, in left arm on 29Jun2021 (at the age of 32-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 29Jun2021 the patient had uterine cramping within five minutes of administration. Then patient missed menstrual cycle for two months directly following administration. Patient also developed a large painful ovarian cyst on right ovary. The patient receives ultrasound treatment and had a physician office visit. Outcome of all the reported events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiomegaly, Microembolism, Pulmonary embolism
Clinical narrative: Microembolisms on her right side blocking flow to lungs; Enlarged heart that is most likely caused by the pulmonary embolism; Pulmonary embolism; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from another Manufacturer.   A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 71-years-old) as dose 2, single for COVID-19 immunisation; treprostinil sodium (Batch/Lot number was not reported), nasal from an unspecified date to an unspecified date, at 18-54 mcg (3-9 breaths), qid, inhalation for secondary pulmonary (pulmonary arterial hypertension). Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included apixaban (ELIQUIS) and amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date (at the age of 71-years-old) for COVID-19 immunisation. The patient experienced pulmonary embolism on May2021, micro embolisms on her right-side blocking flow to lungs and an enlarged heart that is most likely caused by the pulmonary embolism on an unspecified date. The clinical course was as follows: The patient reported that she had a pulmonary embolism in May. She stated that she thought it was a result of the second Pfizer Covid vaccine dose. She also had micro embolisms on her right-side blocking flow to lungs. She also had an enlarged heart that was most likely caused by the pulmonary embolism. The events pulmonary embolism and microembolism were assessed as serious and medically significant. The action taken in response to the events for TREPROSTINIL SODIUM was unknown. The outcome of the events was unknown.    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 reported information ,a causal relationship between the events and suspected drug cannot be 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: Arthralgia, Asthenia, Headache, Pain, Pyrexia
Clinical narrative: she was so much pain; head was sore; Joint pain; Slight fever; Feels so weak; This is spontaneous report from contactable consumer. A contactable female consumer (patient) of an unspecified age reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 18Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and When she took the first dose, she did not experience any of that. Investigation assessment was not provided. Received call from consumer regarding the Pfizer COVID Vaccine. She took the second dose on 18Sep2021 afternoon. She felt ok, but on 19Sep2021 morning, she was so much pain and her head was sore. She had joint pain, a slight fever and felt so weak also. She would like to know if she could take Tylenol for the pain. Her head was hurting her so bad and felt weak and her joints was hurting her, so she did not wish to complete report. She would contact her pharmacy, where she got the vaccine, to see if they could advise her if she could take Tylenol. The outcome of events was unknown.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ankylosing spondylitis, Joint stiffness, Tendon disorder, Tendonitis
Clinical narrative: Ankylosing spondylitis flare up; Tendons thick/ ridged from inflammation; Tendon thickening/ Tendons thick/ ridged from inflammation; Joint stiffness; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer from Facilitating Company from a contactable male consumer reporting for himself.  A 53-year-old male subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 01May2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date and ongoing (Batch/Lot number was not reported), at unspecified dose for ankylosing spondylitis.  Medical history included surgery for spinal cord stimulator from Feb2021 and ongoing, ongoing ankylosing spondylitis. The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 01Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation and experienced fatigue. The subject experienced ankylosing spondylitis flare up on an unspecified date with outcome of not recovered, tendons thick/ ridged from inflammation on an unspecified date with outcome of not recovered, tendon thickening/ tendons thick/ridged from inflammation on an unspecified date with outcome of not recovered and joint stiffness on 02May2021 with outcome of unknown.  The action taken in response to the events for adalimumab was dose not changed. The reporter's causality for the events tendons thick/ridged from inflammation unknown onset, tendons thick/ridged from inflammation unknown onset and ankylosing spondylitis flare up with adalimumab (HUMIRA) was a reasonable possibility. The reporter's causality for the event stiff joints with adalimumab (HUMIRA) was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 available information and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the reported events Ankylosing spondylitis flare up, Tendonitis, Tendon thickening, and Joint stiffness cannot be completely excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pneumonia, SARS-CoV-2 antibody test
Clinical narrative: Had a terrible cough starting 2 days after first dose. Continued to get worse and was diagnosed with pneumonia 1 week after my 1st dose; Had a terrible cough starting 2 days after first dose. Continued to get worse and was diagnosed with pneumonia 1 week after my 1st dose; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in left arm on 10Sep2021 12:30 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. The patient experienced a terrible cough starting 2 days after first dose which continued to get worse and was diagnosed with pneumonia 1 week after first dose in Sep2021. The patient underwent lab tests and procedures which included Nasal swab: negative on 17Sep2021. Therapeutic measures taken as a result of the events included antibiotics. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hypoaesthesia, Muscle tightness
Clinical narrative: fainting sensation but she didn't pass out; fainting sensation/dizziness; flushing; numbing sensation on her jaw; tingling; weakness; jaw became heavy for a short time; experienced sore arms; This is a spontaneous report from a Contactable Nurse (patient).A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Aug2021 (Batch/Lot number was not reported) (at the age 46-years-old) as dose 1, single for covid-19 immunization. Medical history and concomitant were none. The patient was healthy person. On 14Aug2021, the patient experienced fainting, dizziness, flushing, numbness facial, tingling, weakness, tightness in jaw and pain in arm. The patient reported that she experienced side effects after getting the first dose last 14Aug2021. She specified she had it at the moment while on site. She experienced dizziness, had a fainting sensation but did not actually pass out, flushing, numbing sensation on her jaw, tingling all over the body but most especially on her jaw, jaw became heavy for a short time, and had sore arms. She mentioned that those that she mentioned did not last as she was able to walk out of the establishment. She added that she still experienced overall weakness after she left the vaccination site and a mild tingling sensation for 24 hours. The overall weakness and the mild tingling sensation only lasted for 24 hours that then they both went away, she does not have any side effects to now. The tingling sensation for the most part was kind of mild and she would say that the flushing was moderate because she felt like she had been standing under the sun for hours. The Causality reported as all related because they happened right after the vaccine. On 14Aug2021, the patient recovered from fainting, dizziness, flushing, numbness facial, tightness in jaw, pain in arm and on 15Aug2021, the patient recovered from tingling and weakness.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Syncope, Dizziness, Flushing, Hypoaesthesia, Paraesthesia, Asthenia, muscle tightness, Pain in extremity and suspect drug BNT162B2 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Presyncope
Clinical narrative: fainting sensation but she didn't pass out; fainting sensation/dizziness; flushing; numbing sensation on her jaw; tingling; weakness; jaw became heavy for a short time; experienced sore arms; This is a spontaneous report from a Contactable Nurse (patient).A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Aug2021 (Batch/Lot number was not reported) (at the age 46-years-old) as dose 1, single for covid-19 immunization. Medical history and concomitant were none. The patient was healthy person. On 14Aug2021, the patient experienced fainting, dizziness, flushing, numbness facial, tingling, weakness, tightness in jaw and pain in arm. The patient reported that she experienced side effects after getting the first dose last 14Aug2021. She specified she had it at the moment while on site. She experienced dizziness, had a fainting sensation but did not actually pass out, flushing, numbing sensation on her jaw, tingling all over the body but most especially on her jaw, jaw became heavy for a short time, and had sore arms. She mentioned that those that she mentioned did not last as she was able to walk out of the establishment. She added that she still experienced overall weakness after she left the vaccination site and a mild tingling sensation for 24 hours. The overall weakness and the mild tingling sensation only lasted for 24 hours that then they both went away, she does not have any side effects to now. The tingling sensation for the most part was kind of mild and she would say that the flushing was moderate because she felt like she had been standing under the sun for hours. The Causality reported as all related because they happened right after the vaccine. On 14Aug2021, the patient recovered from fainting, dizziness, flushing, numbness facial, tightness in jaw, pain in arm and on 15Aug2021, the patient recovered from tingling and weakness.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Syncope, Dizziness, Flushing, Hypoaesthesia, Paraesthesia, Asthenia, muscle tightness, Pain in extremity and suspect drug BNT162B2 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable pharmacist. A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 10Sep2021 (at the age of 24-years-old) (Batch/Lot Number: FD0809) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included irritable bowel syndrome. The patient's concomitant medications were not reported. On 13Sep2021, the patient experienced hives (medically significant). The Hives were noticed to be first experienced on the torso on Monday 13Sep2021. The Xifaxan was started on 17Sep2021. On an unspecified date, irritable bowel syndrome disorder. The outcome of the events was unknown.; Sender's Comments: Based on the temporal relation, the association between the event of Urticaria and the suspect product of BNT162B2 cannot be completely ruled out. 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: M
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Hypertension, Overdose, Product preparation error
Clinical narrative: headache; high blood pressure; administered a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine; administered a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine; administered a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine; This is a spontaneous report from a contactable lawyer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Aug2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was administered with a non-diluted version of vaccine, injected him with 6 times of the medically recommended amount of the vaccine on 22Aug2021. As a result of improper injection, patient was hospitalized with high blood pressure, headaches, and other such extreme side effect. The reporter stated that this will hereafter be referred to as the incident. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Renal disorder, Type 2 diabetes mellitus, Weight decreased
Clinical narrative: Reports that she initially got her first Pfizer Covid vaccine dose on April 24th but afterwards got Covid and was hospitalized; Reports that she initially got her first Pfizer Covid vaccine dose on April 24th but afterwards got Covid and was hospitalized; has kidney issues/ Covid it attacked her kidneys; She tested positive for Covid it attacked her kidneys and put her into Type 2 diabetes; She lost 44 pounds.; This is a spontaneous report from a contactable consumer or other non hcp.   A 55-years-old female patient received first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown), via an unspecified route of administration in Arm Left on 24Apr2021 at 10:00 (age at time of vaccination was 55-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported.  The reporter  stated patient initially got her first Pfizer Covid vaccine dose on 24Apr2021 but afterwards got COVID positive on 14May2021 and had to quarantine in the hospital. she was admitted on 21May2021 and discharged on 27May2021. The patient recovered fully and everything and moving forward she would go every month to get tests, she underwent lab test in Jun2021, Jul2021 and Aug2021, that the patient was tested for COVID and all the tests shown negative. The patient was on her way to get the 2nd COVID shot on 15May2021 and when she tested positive for COVID it attacked her kidneys and put her into Type 2 diabetes and she was working with her doctor to get back to good health with her kidneys. The patient also lost 44 pounds. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14May2021 resuls in covid test positive ,sars-cov-2 test: negative on Jun2021 resulted covid  test negative ,sars-cov-2 test: negative on Jul2021 resulted covid  test negative , sars-cov-2 test: negative on Aug2021 covid  resulted test negative. The outcome of the event COVID-19 was recovered, Type 2 diabetes mellitus was not recovered and other events was unknown.  Follow-up attempts completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, C-reactive protein increased, Dyspnoea, Hyperhidrosis
Clinical narrative: prolonged palpatations; tachycardia; SOA; sweats; fevers; anxiety; abdominal pain; lymphadenopathy axialla; elevated sed rate  and crp; elevated sed rate  and crp; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 05May2021 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had prolonged palpitations, tachycardia, shortness of air (SOA), sweats ,fevers, anxiety, abdominal pain lymphadenopathy axilla, elevated erythrocyte sedimentation rate and C-reactive protein (CRP) on 06May2021. These events were lasting for 2 to 3 months without other explanation with extensive workup basically a prolonged immune response to the vaccine. These events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment with beta-blockers for palpitations and tachycardia and had a close monitoring with extensive work ups. This case was considered as serious but not specified. The outcome of the events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Palpitations, Pyrexia, Red blood cell sedimentation rate increased, Tachycardia
Clinical narrative: prolonged palpatations; tachycardia; SOA; sweats; fevers; anxiety; abdominal pain; lymphadenopathy axialla; elevated sed rate  and crp; elevated sed rate  and crp; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 05May2021 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had prolonged palpitations, tachycardia, shortness of air (SOA), sweats ,fevers, anxiety, abdominal pain lymphadenopathy axilla, elevated erythrocyte sedimentation rate and C-reactive protein (CRP) on 06May2021. These events were lasting for 2 to 3 months without other explanation with extensive workup basically a prolonged immune response to the vaccine. These events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment with beta-blockers for palpitations and tachycardia and had a close monitoring with extensive work ups. This case was considered as serious but not specified. The outcome of the events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Skin disorder, Vitamin D
Clinical narrative: has an autoimmune condition of her skin and a flare up of the condition; has an autoimmune condition of her skin and a flare up of the condition; has an autoimmune condition of her skin and a flare up of the condition; This is a spontaneous report from a contactable consumer (parent).  A 38-year-old (also the age at vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 28Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization.  Medical history included vitamin D deficiency diagnosed last year (2020) and ongoing which her level was 16. She also had ongoing autoimmune skin disorder which she used to having flare up and initially received DUPLICIT (as reported) and tried other antibiotics which nothing seems to work. She also mentioned that got large lymph nodes because of her skin condition (ongoing), had breast cancer and a carcinoid tumor in left lung which she had radiation and chemo a while ago prior to COVID shots.  The patient also had birth control as she doesn't get her period every month, sores in her mouth due to acne medicine and iron deficiency. Concomitant medications included ustekinumab (STELARA) taken for autoimmune skin disorder from an unspecified start date to Aug2021 and unspecified birth control.  The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 07Mar2021 (Batch/Lot number was not reported) at the age of 38-year-old as for COVID-19 immunization. Then, received the 2nd dose on 28Mar2021. A couple weeks after, she had a mild flare up of the condition (has an autoimmune condition of her skin). The flare up that doesn't seem to be going away which her doctor give her steroids because she's not sleeping due to the flare up. Outcome of the events were not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Endocarditis
Clinical narrative: Patient developed documented endocarditis on day 7 post administration; This is a spontaneous report from a contactable pharmacist.  An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 intramuscular, administered in left arm on 13Sep2021 (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on an unspecified date (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient experienced patient developed documented endocarditis on day 7 post administration on 19Sep2021. The event led to hospitalization.  Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of endocarditis cannot be fully 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Influenza like illness, Muscular weakness
Clinical narrative: Minor flu like symptoms; Low-grade fever; Headache; Fatigue; Muscle weakness in my right hand and arm; Swelling in my right foot; I have a neuromuscular disease that affects the right side of my body, and the vaccine seems to have made the disease worse; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Sep2021 14:30 (at the age of 41-year-old) (Lot Number: EW0167) as dose 2, single for COVID-19 immunization. Medical history included unknown neuromuscular disease - possibly Charcot Marie tooth or a rare form of muscular dystrophy. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included lysine (LYSINE) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop dates were not reported. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Aug2021 14:00 (at the age of 41-year-old) (Lot Number: EW0167) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Sep2021 14:00, the patient had had minor flu like symptoms including low-grade fever, headache, fatigue. The most concerning side effects as reported by the patient were a daily headache that does not respond to OTC pain meds, muscle weakness in her right hand and arm, and swelling in her right foot. The patient had a neuromuscular disease that affects the right side of her body, and the vaccine seemed to have made the disease worse. The patient received treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Minor flu like symptoms; Low-grade fever; Headache; Fatigue; Muscle weakness in my right hand and arm; Swelling in my right foot; I have a neuromuscular disease that affects the right side of my body, and the vaccine seems to have made the disease worse; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Sep2021 14:30 (at the age of 41-year-old) (Lot Number: EW0167) as dose 2, single for COVID-19 immunization. Medical history included unknown neuromuscular disease - possibly Charcot Marie tooth or a rare form of muscular dystrophy. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included lysine (LYSINE) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop dates were not reported. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Aug2021 14:00 (at the age of 41-year-old) (Lot Number: EW0167) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Sep2021 14:00, the patient had had minor flu like symptoms including low-grade fever, headache, fatigue. The most concerning side effects as reported by the patient were a daily headache that does not respond to OTC pain meds, muscle weakness in her right hand and arm, and swelling in her right foot. The patient had a neuromuscular disease that affects the right side of her body, and the vaccine seemed to have made the disease worse. The patient received treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Very very severe menstrual cramping, heavy bleeding with clots.; Very very severe menstrual cramping; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 17Sep2021 at 11:30 AM (Batch/Lot number was not reported) (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. Facility type vaccine was pharmacy or drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant. The patient's medical history included allergies to penicillin and shellfish. Concomitant medications included estradiol, progesterone (PROGESTIN), ascorbic acid (VITAMIN C), vitamin D NOS (VITAMIN D), and probiotic; all taken for unspecified indications, start and stop dates were not reported. On 18Sep2021 18:00 (06:00 PM), the patient experienced very very severe menstrual cramping, heavy bleeding with clots. The patient was not tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Investigation
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. The patient experienced stroke 17 hours later of vaccination of second dose, on an unknown date in Feb2021. The patient went through extensive testing which revealed no other cause, tied the shot directly to the stroke. The patient also reported that on 05Jan2021, the patient was extensive and perfect physical. It was also reported that the patient recovered somewhat but will have to live with symptoms for a lifetime. The outcome was recovered with sequel for the reported event.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Swelling, Urticaria
Clinical narrative: angioedema; welts/hives; random swelling over different areas; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on an unknown date for Covid-19 immunisation. Concomitant medication included adalimumab (HUMIRA) taken for immune suppressed, start and stop date were not reported. The patient reported that since receiving the second dose of the vaccine, he/she developed angioedema on an unspecified date and believed to be caused by the vaccine. Patient also had welts/hives and random swelling over different areas on an unspecified date. The symptoms were somewhat under control with a Claritin once a day. Patient was on Humira therefore immune suppressed. Although patient take steroids when having flare, he/she takes steroids and rest. Patient was prescribed Epi pens as well as a precaution. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report based on information received by Pfizer from a Facilitating Company. A contactable consumer (patient) reported that a 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), intramuscular on an unspecified date as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose (reported as CF) for moderate to severe hidradenitis suppurativa. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced COVID-19. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of the events was not recovered.  Causality of COVID-19 and adalimumab as per reporter (Drug/Vaccine) was not reported. Causuality of COVID-19 and BNT162B2 as per reporter (Drug/Vaccine) was Possible.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of event covid19 and drug ineffective cannot be totally excluded.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Immunisation, Nausea, Off label use
Clinical narrative: balance problems where I have to hold on to walls, door knobs, or any fixed item; nausea; I my THIRD Booster Covid Vaccine; I my THIRD Booster Covid Vaccine; the shoulder was sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Sep2021 (Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. Medical history included crohn's disease for 52 years. The patient's concomitant medications were not reported. Immediately after third booster covid vaccine on 08Sep2021, patient's left arm at the shoulder was sore and no problem. But, after 5 days on 13Sep2021 and continuing to date of 19Sep2021, when patient got up in the morning (slowly), patient had balance problems where patient had to hold on to walls, doorknobs, or any fixed item to hold on to, to get to the bathroom. At the same time, patient had bad nausea which continues for hours, or until a 20mg Nausea Pill was taken as a treatment. The outcome of all events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: I haven't had menstrual cramps since I have been a teenager. These have been entry month since the shot.; This is a spontaneous report from a contactable consumer. This 46-Year-old female consumer (patient) reported that: A 46-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: EN5318), via an unspecified route of administration, administered in left arm as dose 2, single on 13Feb2021 13:00 (at the age of 45-year-old) for COVID-19 immunization at Pharmacy. Patient had no medical history and had no known allergies. Historical vaccine included patient previously took first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: EL3246), via an unspecified route of administration, administered in left arm as dose 1, single on 14Jan2021 13:45 (at the age of 45-year-old) for covid-19 immunisation. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); vitamin D nos (VITAMIN D NOS); vitamin B nos (VITAMIN B NOS) and bupropion hydrochloride (WELLBUTRIN) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received any other medications with Vitamin E, D and B. Wellbutrin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 21Feb2021 14:00, the patient had severe menstrual cramps and didn't have menstrual cramps since she was a teenager. These have been entry month since the shot. No treatment was received for the adverse events. At the time of this report, the outcome of event was unknown.  Follow-Up (23Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bell's palsy, Eye movement disorder, Facial paralysis, Feeling abnormal, Hypoaesthesia
Clinical narrative: Bell's Palsy symptoms; Right sided facial paralysis; Inability to close the right eye; Right sided facial numbness; Lop-sided smile; Patient received Pfizer COVID vaccine 01Mar2021,15Mar2021; This is a spontaneous report from a contactable Nurse. A 45-year-old female patient received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for COVID-19 immunization and received POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 26Jul2021. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 on 01Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. On 30Jul2021, patient experienced Bells Palsy symptoms, right sided facial paralysis, inability to close the right eye, right sided facial numbness, and lop-sided smile. The patient was treated with Valacyclovir 1000mg TID for 5 days, and Medrol dose pack 4 mg X 6 days. The outcome of event Inappropriate schedule of vaccine administered was unknown and for other events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the event bells palsy and facial paralysis and the suspect drug BNT162B2  cannot be ruled out. 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.