chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), first dose on 15Jan2021 11:00 (Lot Number: EL3247) and second dose on 03Feb2021 14:00 (Lot Number: EL3247), both via an unspecified route of administration, administered in Arm Left as single dose at the age of 24-year-old for COVID-19 immunisation. The patient medical history was not reported. The patient had no covid prior vaccination. Concomitant medication(s) included ZOLOFT taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. Patient having allergies to Sulphur Drugs. The patient experienced covid since 12Aug2021 12.00AM. Patient underwent covid tested post vaccination (nasal swab) on 13Aug2021 and the result on 14Aug2021 was positive. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for AE. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Frustration tolerance decreased, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 24Mar2021 (at the age of 38-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Other Vaccine as second dose (Batch/Lot Number: EWO 15800 Formulation: Unknown) via unspecified route of administration on 24Mar2021. The patient medical history and concomitant medications were not reported. On 14Aug2021, the patient reported that she did Covid test and was positive and experienced very bad symptoms and had fever, cough, body pain, and lost smell and taste. Patients feel very frustrated. Patient though being vaccinated she would not experience this nightmare. The patient underwent lab tests and procedures which included COVID-19 test, positive on 14Aug2021. Patient had Covid tested post vaccination and Covid prior vaccination was reported as yes. The patient took Tylenol as treatment for the event. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: had aches; chills; low grade fever is the 99's; had diarrhea all day; light headed; not feeling well; not able to stay focused; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 24Feb2021 as UNKNOWN, SINGLE for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Aug2021 the patient experienced had aches, chills, low grade fever is the 99's, had diarrhea all day, light headed, not feeling well, not able to stay focused. On 22-AUG-2021 outcome of events was recovered. The patient underwent lab tests and procedures which included body temperature: 99 on 21Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: had aches; chills; low grade fever is the 99's; had diarrhea all day; light headed; not feeling well; not able to stay focused; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 24Feb2021 as UNKNOWN, SINGLE for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Aug2021 the patient experienced had aches, chills, low grade fever is the 99's, had diarrhea all day, light headed, not feeling well, not able to stay focused. On 22-AUG-2021 outcome of events was recovered. The patient underwent lab tests and procedures which included body temperature: 99 on 21Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dysgeusia, Fatigue, Joint stiffness
Clinical narrative: Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID-acidic mouth; burnt tongue sensation; scratchy throat; mild cold symptoms; cough/ dry hacking cough; Congestion/Nasal stuffiness; joint stiffness; low grade fever; limited taste and smell; limited taste and smell; fatigues; This is a spontaneous report from a contactable consumer or other non-HCP. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) intramuscularly on 28Jan2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) intramuscularly on 18Feb2021 as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination. Vaccination facility type was reported as Pharmacy or Drug Store. It was unknown if patient received any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced break-through COVID-19, COVID/PCR (nasal swab) test with result as positive (COVID-19), breakthrough covid-acidic mouth, burnt tongue sensation, scratchy throat, mild cold symptoms, stuffy nose, cough/dry hacking cough, congestion, joint stiffness, low grade fever, limited taste and smell, fatigue on 15Aug2021 20:00. Patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Sars Cov-2 PCR Test Nasal Test (reported as polymerase chain reaction (Nasal Swab)) with result as positive on an unspecified date in Aug2021. The outcome of events was resolved on an unspecified date in Aug2021.  Follow-up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Parosmia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID-acidic mouth; burnt tongue sensation; scratchy throat; mild cold symptoms; cough/ dry hacking cough; Congestion/Nasal stuffiness; joint stiffness; low grade fever; limited taste and smell; limited taste and smell; fatigues; This is a spontaneous report from a contactable consumer or other non-HCP. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) intramuscularly on 28Jan2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) intramuscularly on 18Feb2021 as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination. Vaccination facility type was reported as Pharmacy or Drug Store. It was unknown if patient received any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced break-through COVID-19, COVID/PCR (nasal swab) test with result as positive (COVID-19), breakthrough covid-acidic mouth, burnt tongue sensation, scratchy throat, mild cold symptoms, stuffy nose, cough/dry hacking cough, congestion, joint stiffness, low grade fever, limited taste and smell, fatigue on 15Aug2021 20:00. Patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Sars Cov-2 PCR Test Nasal Test (reported as polymerase chain reaction (Nasal Swab)) with result as positive on an unspecified date in Aug2021. The outcome of events was resolved on an unspecified date in Aug2021.  Follow-up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Throat irritation, Tongue discomfort, Vaccination failure
Clinical narrative: Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID-acidic mouth; burnt tongue sensation; scratchy throat; mild cold symptoms; cough/ dry hacking cough; Congestion/Nasal stuffiness; joint stiffness; low grade fever; limited taste and smell; limited taste and smell; fatigues; This is a spontaneous report from a contactable consumer or other non-HCP. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) intramuscularly on 28Jan2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) intramuscularly on 18Feb2021 as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination. Vaccination facility type was reported as Pharmacy or Drug Store. It was unknown if patient received any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced break-through COVID-19, COVID/PCR (nasal swab) test with result as positive (COVID-19), breakthrough covid-acidic mouth, burnt tongue sensation, scratchy throat, mild cold symptoms, stuffy nose, cough/dry hacking cough, congestion, joint stiffness, low grade fever, limited taste and smell, fatigue on 15Aug2021 20:00. Patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Sars Cov-2 PCR Test Nasal Test (reported as polymerase chain reaction (Nasal Swab)) with result as positive on an unspecified date in Aug2021. The outcome of events was resolved on an unspecified date in Aug2021.  Follow-up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 26May2021: Dose Number: 1/ 28May2021:Nasal Swab: Positive; This is a spontaneous report from a contactable consumer. A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 17:30 (Age at vaccination 37 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included venlafaxine (VENLAFAXINE); colecalciferol (VITAMIN D [COLECALCIFEROL]). 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 vaccination. Since the vaccination, patient been tested for COVID-19. The patient experienced 26May2021: dose number: 1/ 28May2021 nasal swab positive on an unspecified date. The patient underwent lab tests and procedures which included nasal swab test was positive on 28May2021. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809 and Expiry date was not reported), via intramuscular route of administration on 18Feb2021 (at the age of 65-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9264 and Expiry date was not reported), via Intramuscular route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient received other vaccine in four weeks was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient tested positive for COVID 19. On 13Aug2021, The patient experienced aches, pains, heavy cold symptoms, brief chills, headache, and loss of smell and taste. On 15Aug2021, the patient experienced positive pcr nasal swab. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 15Aug2021. It was unknown if patient received treatment. The outcome for the events positive pcr nasal swab positive was unknown and for the event aches was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable nurse. A 30-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), intramuscular, administered in left arm on 15Feb2021 (at the age of 30-years-old) as DOSE 2, SINGLE and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EL3247), intramuscular, administered in left arm on 25Jan2021 (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced lack of efficacy and tested positive for covid19 with symptoms on 23Aug2021. It was unknown if patient had other vaccine in four weeks or if Covid prior vaccination. The patient underwent lab tests and procedures which included SARS-COV-2 & Influenza A/B PCR molecular test. Nasal swab test positive on 23Aug2021. Treatment for AE was unknown. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) and COVID-19 event cannot be ruled out. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: shoulder got sore the next day; felt blah; This is a spontaneous report from a contactable consumer (patient's family member). This consumer reported similar events for six patients. This is the third of six reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the patient said her shoulder got sore the next day and felt blah but that was it. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101090541 same reporter/drug, same/similar event, different /patient.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Eye pruritus, Off label use
Clinical narrative: her daughter in law had third dose as well, and experienced itching in both eyes.; her daughter in law had third dose as well, and experienced itching in both eyes.; itching in her eyes; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  Historical vaccine included BNT162B2 as dose 1,single and dose 2, single for covid-19 immunization. Patient experienced itching in both eyes a day after the third dose. She read to put ice on the eyes on internet because other people also experienced the same problem. Patient iced her eyes as well. The outcome of the event itching in her eyes was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myositis, Nerve injury
Clinical narrative: nerves started firing in her arm; nerves started firing in her arm. It feels like sticking her fingers in a socket; arm muscle being inflamed; This is a spontaneous report from a contactable consumer or other non hcp.     A 61-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose number unknown, single for covid-19 immunisation. Medical history included surgery, she has had multiple surgeries on her arm She clarified that the multiple surgeries and nerve damage was about 10 years ago, nerve injury. There were no concomitant medications. She has had no reaction in 15 years. She had allergy testing to see if she could get the covid vaccine and everything came back negative. Had allergy testing to see if she could get the covid vaccine and everything came back negative. It was Reported that, the patient experienced nerves started firing in her arm on 20Aug2021 with outcome of recovering, arm muscle being inflamed on 2021 with outcome of unknown, nerves started firing in her arm. it feels like sticking her fingers in a socket on Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included allergy test: negative on 2021    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Fall, Feeling hot, Gait disturbance, Hypokinesia
Clinical narrative: when she turns to her left or right, she falls; equilibrium is off; she now generates heat; paralyzed on her left side; tried to do push ups, but her arms wouldn't push her back up; walking like a child that is just beginning to walk; she has no control over left leg; she was hurting everywhere from being poked for the test; she has no control over left leg; all of her muscles are so tired, she can't do anything anymore; This is a spontaneous report from a contactable consumer. A contactable Nurse reporter different event for two patients. This is 1 of 2 reports. This 66-year-old female Nurse (Patient) reported for herself that:  A 66 year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration, administered on right arm on 19Apr2021 (at the age of 61years) at single dose for COVID-19 immunisation. The patient medical history included Diabetes, blood pressure high, high cholesterol and trigeminal neuralgia (Unspecified To: Ongoing). The patient's concomitant medications were not reported. On an unspecified date, the patient had experienced paralyzed on her left side, tried to do push ups, but her arms wouldn't push her back up walking like a child that is just beginning to walk; she has no control over left leg , when she stoops down, she can't get back up, she now generates heat, all of her muscles are so tired, she can't do anything anymore, when she turns to her left or right, she falls, the palms of her hands are itching, and up past her wrists are tingling; she doesn't have control of her hands and she will urinate all over herself. On an unspecified date, patient had laboratory investigation X-Ray, Blood work, EMG and found to be normal. MRI of brain and spinal column and Result showed previous cervical fusion of C4-C5. Patient did not visit to emergency room. 2nd dose on 10May2021 Lot: EW0158 in morning in her Right arm. States that she wanted it in the right side so she could move it around all day. The clinical outcome of the events paralyzed and equilibrium were unknown and all other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Paralysis and the suspect drug.  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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Muscle fatigue, Pain, Paralysis
Clinical narrative: when she turns to her left or right, she falls; equilibrium is off; she now generates heat; paralyzed on her left side; tried to do push ups, but her arms wouldn't push her back up; walking like a child that is just beginning to walk; she has no control over left leg; she was hurting everywhere from being poked for the test; she has no control over left leg; all of her muscles are so tired, she can't do anything anymore; This is a spontaneous report from a contactable consumer. A contactable Nurse reporter different event for two patients. This is 1 of 2 reports. This 66-year-old female Nurse (Patient) reported for herself that:  A 66 year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration, administered on right arm on 19Apr2021 (at the age of 61years) at single dose for COVID-19 immunisation. The patient medical history included Diabetes, blood pressure high, high cholesterol and trigeminal neuralgia (Unspecified To: Ongoing). The patient's concomitant medications were not reported. On an unspecified date, the patient had experienced paralyzed on her left side, tried to do push ups, but her arms wouldn't push her back up walking like a child that is just beginning to walk; she has no control over left leg , when she stoops down, she can't get back up, she now generates heat, all of her muscles are so tired, she can't do anything anymore, when she turns to her left or right, she falls, the palms of her hands are itching, and up past her wrists are tingling; she doesn't have control of her hands and she will urinate all over herself. On an unspecified date, patient had laboratory investigation X-Ray, Blood work, EMG and found to be normal. MRI of brain and spinal column and Result showed previous cervical fusion of C4-C5. Patient did not visit to emergency room. 2nd dose on 10May2021 Lot: EW0158 in morning in her Right arm. States that she wanted it in the right side so she could move it around all day. The clinical outcome of the events paralyzed and equilibrium were unknown and all other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Paralysis and the suspect drug.  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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Burning sensation, Chest X-ray, Electromyogram
Clinical narrative: when she turns to her left or right, she falls; equilibrium is off; she now generates heat; paralyzed on her left side; tried to do push ups, but her arms wouldn't push her back up; walking like a child that is just beginning to walk; she has no control over left leg; she was hurting everywhere from being poked for the test; she has no control over left leg; all of her muscles are so tired, she can't do anything anymore; This is a spontaneous report from a contactable consumer. A contactable Nurse reporter different event for two patients. This is 1 of 2 reports. This 66-year-old female Nurse (Patient) reported for herself that:  A 66 year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration, administered on right arm on 19Apr2021 (at the age of 61years) at single dose for COVID-19 immunisation. The patient medical history included Diabetes, blood pressure high, high cholesterol and trigeminal neuralgia (Unspecified To: Ongoing). The patient's concomitant medications were not reported. On an unspecified date, the patient had experienced paralyzed on her left side, tried to do push ups, but her arms wouldn't push her back up walking like a child that is just beginning to walk; she has no control over left leg , when she stoops down, she can't get back up, she now generates heat, all of her muscles are so tired, she can't do anything anymore, when she turns to her left or right, she falls, the palms of her hands are itching, and up past her wrists are tingling; she doesn't have control of her hands and she will urinate all over herself. On an unspecified date, patient had laboratory investigation X-Ray, Blood work, EMG and found to be normal. MRI of brain and spinal column and Result showed previous cervical fusion of C4-C5. Patient did not visit to emergency room. 2nd dose on 10May2021 Lot: EW0158 in morning in her Right arm. States that she wanted it in the right side so she could move it around all day. The clinical outcome of the events paralyzed and equilibrium were unknown and all other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Paralysis and the suspect drug.  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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fall, Gait disturbance, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: when she turns to her left or right, she falls; equilibrium is off; she now generates heat; paralyzed on her left side; tried to do push ups, but her arms wouldn't push her back up; walking like a child that is just beginning to walk; she has no control over left leg; she was hurting everywhere from being poked for the test; she has no control over left leg; all of her muscles are so tired, she can't do anything anymore; This is a spontaneous report from a contactable consumer. A contactable Nurse reporter different event for two patients. This is 1 of 2 reports. This 66-year-old female Nurse (Patient) reported for herself that:  A 66 year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration, administered on right arm on 19Apr2021 (at the age of 61years) at single dose for COVID-19 immunisation. The patient medical history included Diabetes, blood pressure high, high cholesterol and trigeminal neuralgia (Unspecified To: Ongoing). The patient's concomitant medications were not reported. On an unspecified date, the patient had experienced paralyzed on her left side, tried to do push ups, but her arms wouldn't push her back up walking like a child that is just beginning to walk; she has no control over left leg , when she stoops down, she can't get back up, she now generates heat, all of her muscles are so tired, she can't do anything anymore, when she turns to her left or right, she falls, the palms of her hands are itching, and up past her wrists are tingling; she doesn't have control of her hands and she will urinate all over herself. On an unspecified date, patient had laboratory investigation X-Ray, Blood work, EMG and found to be normal. MRI of brain and spinal column and Result showed previous cervical fusion of C4-C5. Patient did not visit to emergency room. 2nd dose on 10May2021 Lot: EW0158 in morning in her Right arm. States that she wanted it in the right side so she could move it around all day. The clinical outcome of the events paralyzed and equilibrium were unknown and all other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Paralysis and the suspect drug.  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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Pruritus, Walking aid user
Clinical narrative: when she turns to her left or right, she falls; equilibrium is off; she now generates heat; paralyzed on her left side; tried to do push ups, but her arms wouldn't push her back up; walking like a child that is just beginning to walk; she has no control over left leg; she was hurting everywhere from being poked for the test; she has no control over left leg; all of her muscles are so tired, she can't do anything anymore; This is a spontaneous report from a contactable consumer. A contactable Nurse reporter different event for two patients. This is 1 of 2 reports. This 66-year-old female Nurse (Patient) reported for herself that:  A 66 year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration, administered on right arm on 19Apr2021 (at the age of 61years) at single dose for COVID-19 immunisation. The patient medical history included Diabetes, blood pressure high, high cholesterol and trigeminal neuralgia (Unspecified To: Ongoing). The patient's concomitant medications were not reported. On an unspecified date, the patient had experienced paralyzed on her left side, tried to do push ups, but her arms wouldn't push her back up walking like a child that is just beginning to walk; she has no control over left leg , when she stoops down, she can't get back up, she now generates heat, all of her muscles are so tired, she can't do anything anymore, when she turns to her left or right, she falls, the palms of her hands are itching, and up past her wrists are tingling; she doesn't have control of her hands and she will urinate all over herself. On an unspecified date, patient had laboratory investigation X-Ray, Blood work, EMG and found to be normal. MRI of brain and spinal column and Result showed previous cervical fusion of C4-C5. Patient did not visit to emergency room. 2nd dose on 10May2021 Lot: EW0158 in morning in her Right arm. States that she wanted it in the right side so she could move it around all day. The clinical outcome of the events paralyzed and equilibrium were unknown and all other events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Paralysis and the suspect drug.  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: Blood iron, Blood iron abnormal, Blood test, Haemochromatosis
Clinical narrative: Hemochromatosis; they throw hers (blood) away because it has too much iron; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hemochromatosis in 2021, they throw hers (blood) away because it has too much iron in 2021. Patient reported, She has hemochromatosis, where she has too much iron in her blood, and having that going on she has been going to the Haematologist twice a month for the last month. You know how you go to donate blood; well, they throw hers (blood) away because it has too much iron. They got it down to a safe level and she went to get the shot. After she got the shot and went to have another blood test, in between this to make sure it's going down. She got the Covid shot and a week later got the blood test because it was time for her to go back for a blood withdraw and the results since the shot have gone up again. Her blood levels have gone up again and now she is scared to get the other shot and does not want the blood level to go up even more. Again, mentions that her condition is called Hemochromatosis. The patient underwent lab tests and procedures which included blood iron was too much iron in her blood in 2021, blood test was done, and her blood levels have gone up on 2021. The outcome of event was unknown.  Description of complaint: Declines to provide further report details. Has hemochromatosis and they got her blood levels to a safe level. She got the Covid shot and a week later got the blood test because it was time for her to go back for a blood withdraw and the results since the shot have gone up again. Her blood levels have gone up again and now she is scared to get the other shot and does not want the blood level to go up even more. States she only had the first Covid shot and blood draw was done in between.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced COVID on an unspecified date. Caller also asked if should get the 2nd dose after 42 days from the first dose since they both had COVID. Caller stated that recovered from Covid-19 two weeks ago and was wondering when they can get the Pfizer BioNTech Covid vaccine. She stated that they did not have the monoclonal antibody treatment and was not admitted in the hospital instead just at home. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced COVID on an unspecified date. Caller also asked if should get the 2nd dose after 42 days from the first dose since they both had COVID. Caller stated that recovered from Covid-19 two weeks ago and was wondering when they can get the Pfizer BioNTech Covid vaccine. She stated that they did not have the monoclonal antibody treatment and was not admitted in the hospital instead just at home. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer or non-HCP. This consumer reported for a patient.  A patient of unspecified age and gender received bnt162b2 second dose of (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received bnt162b2 first dose of (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. On unspecified date, the patient who was fully vaccinated tested positive. Reporter declined to provide details and will give them the number to call. Lab tests and procedures which included sars-cov-2 test positive on unspecified date. At the time of this report, outcome of events was unknown.  Follow-up attempts completed. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101095688 same reporter, drug, AE, different patients.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood uric acid, Blood uric acid increased, Gait disturbance, Pain
Clinical narrative: increase in uric acid levels; experienced some of the worst pain; I developed this pain in the right foot, with a little in the left but the right foot; couldn't even walk; pain in my ankle, its like someone took a sledge hammer to my ankle; This is a spontaneous report from a non-contactable consumer(patient) via medical information team. A 70-year-old male patient received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history included gout. Concomitant medications were not reported. Historical vaccine included bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that the patient was asking if his symptoms were a possible side effect from the covid vaccine or if it caused an increase in uric acid levels and if it will go away. The patient received the 2nd dose of the Covid vaccine on the 26th or 27th later clarified it was the 27th, and afterwards he experienced some of the worst pain he has ever experienced with his gout. The patient initially had no symptoms after being vaccinated, but last week, on the 16th or 7th the patient developed pain in the right foot, with a little in the left but the right foot. He could not even walk. The patient had such pain in ankle and it like someone took a sledgehammer to her ankle. Now the patient had gout, but he was watching what he should eat, and did not eat anything on these multiple lists that the doctors provided. The patient not had alcohol in 4 years, which he thought was what used to impact him. The patient stated other than this foot he was feeling fine. The reporter stated that his friends had the shots, some Moderna and Pfizer, and they said that they had chills and all pain, swelling but reported that he didn't have anything initially. The reporter stated that half dozen guys call him that got the shot, 1 guy got Moderna, a double dose, he had a slight rash on his face, he was a 70-year guy, who said his head did not feel right, like he was in the twilight zone. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: increase in uric acid levels; experienced some of the worst pain; I developed this pain in the right foot, with a little in the left but the right foot; couldn't even walk; pain in my ankle, its like someone took a sledge hammer to my ankle; This is a spontaneous report from a non-contactable consumer(patient) via medical information team. A 70-year-old male patient received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history included gout. Concomitant medications were not reported. Historical vaccine included bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that the patient was asking if his symptoms were a possible side effect from the covid vaccine or if it caused an increase in uric acid levels and if it will go away. The patient received the 2nd dose of the Covid vaccine on the 26th or 27th later clarified it was the 27th, and afterwards he experienced some of the worst pain he has ever experienced with his gout. The patient initially had no symptoms after being vaccinated, but last week, on the 16th or 7th the patient developed pain in the right foot, with a little in the left but the right foot. He could not even walk. The patient had such pain in ankle and it like someone took a sledgehammer to her ankle. Now the patient had gout, but he was watching what he should eat, and did not eat anything on these multiple lists that the doctors provided. The patient not had alcohol in 4 years, which he thought was what used to impact him. The patient stated other than this foot he was feeling fine. The reporter stated that his friends had the shots, some Moderna and Pfizer, and they said that they had chills and all pain, swelling but reported that he didn't have anything initially. The reporter stated that half dozen guys call him that got the shot, 1 guy got Moderna, a double dose, he had a slight rash on his face, he was a 70-year guy, who said his head did not feel right, like he was in the twilight zone. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report from a contactable other hcp. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the second vaccine and then had breakthrough COVID-19 case and tested positive with a PCR 8 months after the second vaccine on an unspecified date. The adverse event was considered as serious with seriousness criteria of medically significant. The patient underwent lab tests and procedures which included sars-cov-2 antibody test, positive on an unspecified date. Reporter also wants to know if patient had a heart condition and considered immunocompromised. The outcome of the events was reported as unknown.  Information about lot/batch number has been requested. Sender's Comments: As there is limited information in the case provided, the causal association between the event Covid-19 and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA6780), intramuscular in left arm, on 06Jun2021 at 08:30 AM, as dose 2, single, for COVID-19 immunization. The patient's medical history included polymyalgia rheumatica from 20Sep2018 and ongoing. The patient's concomitant medication included prednisolone for polymyalgia rheumatica. The patient previously took the first dose of BNT162B2 (Lot Number: ER8733) on 19May2021 at 03:30 PM for COVID-19 immunization (intramuscular in left arm). The patient had no prior vaccinations within 4 weeks. The most recent vaccine was administered in a public health clinic or Veterans administration facility. On 10Jun2021, the patient experienced muscle and joint soreness that was considered serious per persistent or significant disability or incapacity. On or about 10Jun2021 (unspecified), the patient had been down to 5 mg prednisolone daily. Soreness (muscle and joint) returned in hands, arms, shoulders, knees, and ankles. Increased prednisolone to 7 mg helped a little for a few days, soreness returned and is increasing. Treatment included increased dosage of prednisolone. The events required visit and blood test (unknown results in 2021) with the physician. The patient had not recovered from the events.   Follow-up attempts are completed. No further information is expected.