chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pressure of speech
Clinical narrative: Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spasm; This is a spontaneous report from a contactable Other HCP (patient).  This 49-year-old male patient received his first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec202 at 17:30 in left arm at single dose for COVID-19 immunisation at the age of 49-year-old. Lot number was EK9231. Medical history included gout. Concomitant medications were unknown. On 10Jan2021, the patient experienced Pressured Speech, weakness and tremors to both limbs and muscle spasm. The events resulted in Emergency room/ department or urgent care and Hospitalization for one day. The patient was not treated for the events. COVID was tested post vaccination on 13Jan2021, Nasal Swab, polymerase chain reaction (PCR) and it resulted negative. The patient did not recover from the events.; Sender's Comments: The events pressured speech, weakness and tremors to both limbs ,muscle spasm are less likely related to suspect BNT162B2 administration given the weak time association. The available examination results would be helpful for further assessment. 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: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Muscle spasms, Pressure of speech, SARS-CoV-2 test negative, Tremor
Clinical narrative: Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spasm; This is a spontaneous report from a contactable Other HCP (patient).  This 49-year-old male patient received his first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec202 at 17:30 in left arm at single dose for COVID-19 immunisation at the age of 49-year-old. Lot number was EK9231. Medical history included gout. Concomitant medications were unknown. On 10Jan2021, the patient experienced Pressured Speech, weakness and tremors to both limbs and muscle spasm. The events resulted in Emergency room/ department or urgent care and Hospitalization for one day. The patient was not treated for the events. COVID was tested post vaccination on 13Jan2021, Nasal Swab, polymerase chain reaction (PCR) and it resulted negative. The patient did not recover from the events.; Sender's Comments: The events pressured speech, weakness and tremors to both limbs ,muscle spasm are less likely related to suspect BNT162B2 administration given the weak time association. The available examination results would be helpful for further assessment. 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Flushing, Hypoaesthesia oral, Pruritus
Clinical narrative: Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; This is a spontaneous report from a  contactable other hcp (patient) reported that a 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration on the left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included endometriosis, gastrooesophageal reflux disease (GERD) and liver lesion; all from an unknown date. Concomitant medications included fish oil (FISH OIL), omeprazole (PROTONIX [OMEPRAZOLE]) and sertraline hydrochloride (ZOLOFT); all were taken from an unspecified date for an unspecified indication. The patient previously took amantadine and experienced drug allergy. On 12Jan2021 03:00, the patient experienced facial swelling, and numbness and tingling of mouth, tongue and face. Therapeutic measures were taken as a result of facial swelling, numbness and tingling of mouth, tongue and face. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Swelling face
Clinical narrative: Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; This is a spontaneous report from a  contactable other hcp (patient) reported that a 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration on the left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included endometriosis, gastrooesophageal reflux disease (GERD) and liver lesion; all from an unknown date. Concomitant medications included fish oil (FISH OIL), omeprazole (PROTONIX [OMEPRAZOLE]) and sertraline hydrochloride (ZOLOFT); all were taken from an unspecified date for an unspecified indication. The patient previously took amantadine and experienced drug allergy. On 12Jan2021 03:00, the patient experienced facial swelling, and numbness and tingling of mouth, tongue and face. Therapeutic measures were taken as a result of facial swelling, numbness and tingling of mouth, tongue and face. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral infarction, Dysphagia, Facial paralysis, Magnetic resonance imaging brain abnormal, Transient ischaemic attack
Clinical narrative: throat swelling; face swelling; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eli283 and expiration date not provided), via an unspecified route of administration in right arm on 10Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included Type 1 diabetic with insulin pump, hypothyroid, heart disease, and sleep apnea. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took benzylpenicillin potassium (PENICILLIN G POTASSIUM) and experienced allergies. Concomitant medications included unspecified medications. On 11Jan2021 09:00, 24 hrs after injection, the patient experienced throat swelling and face swelling. The patient's wife gave him diphenhydramine hcl (BENADRYL) and called 911. The events resulted in emergency room/department or urgent care and hospitalization on an unspecified date in Jan2021 to Jan2021 for 1 day. The patient underwent COVID test post vaccination via nasal swab on 11Jan2021 and was negative. The outcome of the events was recovering.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, SARS-CoV-2 test negative, Swelling face
Clinical narrative: throat swelling; face swelling; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eli283 and expiration date not provided), via an unspecified route of administration in right arm on 10Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included Type 1 diabetic with insulin pump, hypothyroid, heart disease, and sleep apnea. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took benzylpenicillin potassium (PENICILLIN G POTASSIUM) and experienced allergies. Concomitant medications included unspecified medications. On 11Jan2021 09:00, 24 hrs after injection, the patient experienced throat swelling and face swelling. The patient's wife gave him diphenhydramine hcl (BENADRYL) and called 911. The events resulted in emergency room/department or urgent care and hospitalization on an unspecified date in Jan2021 to Jan2021 for 1 day. The patient underwent COVID test post vaccination via nasal swab on 11Jan2021 and was negative. The outcome of the events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Brain injury, Brain operation, Cerebral haemorrhage, Confusional state
Clinical narrative: thrombocytopenia; Stroke; bleed in the brain; This is a spontaneous report from a contactable physician (patient's sibling). A 39-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EJ1685), via an unspecified route of administration in the left arm deltoid on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The reporter is calling about the COVID Vaccine. She is calling on behalf of her sister (patient). The patient had her first dose on 18Dec2020, then she had thrombocytopenia (reported to be life threatening) causing her to bleed in the brain which led to a stroke (reported to be disabling). The reporter stated that she is a doctor herself, as well as her sister who experienced the stroke is a doctor also. The thrombocytopenia was diagnosed on 30Dec2020, which is the same day she had the stroke on 30Dec2020. They did the Tensilon Test when she was admitted to the emergency room on 30Dec2020. When admitted her platelets were Low, it was 36, that is dangerously low. They did a CT scan and found a large massive amount of blood clot. When queried if this is an infarct or hemorrhage, the reporter stated that this was an internal bleed for the stroke. She's in the hospital and had brain surgery. The thrombocytopenia at the moment was gone now. They gave her 6 units of blood and 4-5 units of platelets. The thrombocytopenia ended about 7 days after the diagnosis. Her sister is still in the hospital at this moment but in the Neuro Rehab unit. She is now confused after the stroke. Her sister has had no positive tests for Covid prior to the vaccine and no Antibody Test prior to the vaccine. Her sister has had no issues with vaccines in the past. Her sister had no vaccines on the same as the covid vaccine. At the end of the call, the reporter stated that because this was an injury caused by the vaccine, she is looking for compensation. The outcome of the event thrombocytopenia was recovered with sequel on 06Jan2021; for the event stroke was recovered with sequel on 30Dec2020; while for bleed in the brain was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events thrombocytopenia, bleed in the brain and stroke. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. 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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain operation, Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram head abnormal, Confusional state
Clinical narrative: thrombocytopenia; Stroke; bleed in the brain; This is a spontaneous report from a contactable physician (patient's sibling). A 39-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EJ1685), via an unspecified route of administration in the left arm deltoid on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The reporter is calling about the COVID Vaccine. She is calling on behalf of her sister (patient). The patient had her first dose on 18Dec2020, then she had thrombocytopenia (reported to be life threatening) causing her to bleed in the brain which led to a stroke (reported to be disabling). The reporter stated that she is a doctor herself, as well as her sister who experienced the stroke is a doctor also. The thrombocytopenia was diagnosed on 30Dec2020, which is the same day she had the stroke on 30Dec2020. They did the Tensilon Test when she was admitted to the emergency room on 30Dec2020. When admitted her platelets were Low, it was 36, that is dangerously low. They did a CT scan and found a large massive amount of blood clot. When queried if this is an infarct or hemorrhage, the reporter stated that this was an internal bleed for the stroke. She's in the hospital and had brain surgery. The thrombocytopenia at the moment was gone now. They gave her 6 units of blood and 4-5 units of platelets. The thrombocytopenia ended about 7 days after the diagnosis. Her sister is still in the hospital at this moment but in the Neuro Rehab unit. She is now confused after the stroke. Her sister has had no positive tests for Covid prior to the vaccine and no Antibody Test prior to the vaccine. Her sister has had no issues with vaccines in the past. Her sister had no vaccines on the same as the covid vaccine. At the end of the call, the reporter stated that because this was an injury caused by the vaccine, she is looking for compensation. The outcome of the event thrombocytopenia was recovered with sequel on 06Jan2021; for the event stroke was recovered with sequel on 30Dec2020; while for bleed in the brain was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events thrombocytopenia, bleed in the brain and stroke. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. 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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Tensilon test, Thrombocytopenia, Thrombosis
Clinical narrative: thrombocytopenia; Stroke; bleed in the brain; This is a spontaneous report from a contactable physician (patient's sibling). A 39-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EJ1685), via an unspecified route of administration in the left arm deltoid on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The reporter is calling about the COVID Vaccine. She is calling on behalf of her sister (patient). The patient had her first dose on 18Dec2020, then she had thrombocytopenia (reported to be life threatening) causing her to bleed in the brain which led to a stroke (reported to be disabling). The reporter stated that she is a doctor herself, as well as her sister who experienced the stroke is a doctor also. The thrombocytopenia was diagnosed on 30Dec2020, which is the same day she had the stroke on 30Dec2020. They did the Tensilon Test when she was admitted to the emergency room on 30Dec2020. When admitted her platelets were Low, it was 36, that is dangerously low. They did a CT scan and found a large massive amount of blood clot. When queried if this is an infarct or hemorrhage, the reporter stated that this was an internal bleed for the stroke. She's in the hospital and had brain surgery. The thrombocytopenia at the moment was gone now. They gave her 6 units of blood and 4-5 units of platelets. The thrombocytopenia ended about 7 days after the diagnosis. Her sister is still in the hospital at this moment but in the Neuro Rehab unit. She is now confused after the stroke. Her sister has had no positive tests for Covid prior to the vaccine and no Antibody Test prior to the vaccine. Her sister has had no issues with vaccines in the past. Her sister had no vaccines on the same as the covid vaccine. At the end of the call, the reporter stated that because this was an injury caused by the vaccine, she is looking for compensation. The outcome of the event thrombocytopenia was recovered with sequel on 06Jan2021; for the event stroke was recovered with sequel on 30Dec2020; while for bleed in the brain was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events thrombocytopenia, bleed in the brain and stroke. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. 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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transfusion
Clinical narrative: thrombocytopenia; Stroke; bleed in the brain; This is a spontaneous report from a contactable physician (patient's sibling). A 39-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EJ1685), via an unspecified route of administration in the left arm deltoid on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The reporter is calling about the COVID Vaccine. She is calling on behalf of her sister (patient). The patient had her first dose on 18Dec2020, then she had thrombocytopenia (reported to be life threatening) causing her to bleed in the brain which led to a stroke (reported to be disabling). The reporter stated that she is a doctor herself, as well as her sister who experienced the stroke is a doctor also. The thrombocytopenia was diagnosed on 30Dec2020, which is the same day she had the stroke on 30Dec2020. They did the Tensilon Test when she was admitted to the emergency room on 30Dec2020. When admitted her platelets were Low, it was 36, that is dangerously low. They did a CT scan and found a large massive amount of blood clot. When queried if this is an infarct or hemorrhage, the reporter stated that this was an internal bleed for the stroke. She's in the hospital and had brain surgery. The thrombocytopenia at the moment was gone now. They gave her 6 units of blood and 4-5 units of platelets. The thrombocytopenia ended about 7 days after the diagnosis. Her sister is still in the hospital at this moment but in the Neuro Rehab unit. She is now confused after the stroke. Her sister has had no positive tests for Covid prior to the vaccine and no Antibody Test prior to the vaccine. Her sister has had no issues with vaccines in the past. Her sister had no vaccines on the same as the covid vaccine. At the end of the call, the reporter stated that because this was an injury caused by the vaccine, she is looking for compensation. The outcome of the event thrombocytopenia was recovered with sequel on 06Jan2021; for the event stroke was recovered with sequel on 30Dec2020; while for bleed in the brain was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events thrombocytopenia, bleed in the brain and stroke. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Gait disturbance, Hypoaesthesia, Immune system disorder, Laboratory test
Clinical narrative: Diagnosis with acute inflammatory demyelinating polyneuropathy (AIDP) G61.0; This is a spontaneous report from a contactable healthcare professional, the patient.  A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the right arm on 21Dec2020 at 07:45 (at the age of 37-years-old) as a single dose for COVID-19 immunization.  There was no relevant medical history or concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 26Dec2020, the patient had leg weakness and numbness and was diagnosed with acute inflammatory demyelinating polyneuropathy. The patient was going to have a nerve conduction study done and spinal tab. The clinical outcome of acute inflammatory demyelinating polyneuropathy was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of acute inflammatory demyelinating polyneuropathy due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including spine MRI, results of nerve conduction tests, EMG and CSF analysis, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Diagnosis with acute inflammatory demyelinating polyneuropathy (AIDP) G61.0; This is a spontaneous report from a contactable healthcare professional, the patient.  A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the right arm on 21Dec2020 at 07:45 (at the age of 37-years-old) as a single dose for COVID-19 immunization.  There was no relevant medical history or concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 26Dec2020, the patient had leg weakness and numbness and was diagnosed with acute inflammatory demyelinating polyneuropathy. The patient was going to have a nerve conduction study done and spinal tab. The clinical outcome of acute inflammatory demyelinating polyneuropathy was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of acute inflammatory demyelinating polyneuropathy due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including spine MRI, results of nerve conduction tests, EMG and CSF analysis, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral coldness, Rash erythematous, Rash papular
Clinical narrative: Diagnosis with acute inflammatory demyelinating polyneuropathy (AIDP) G61.0; This is a spontaneous report from a contactable healthcare professional, the patient.  A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the right arm on 21Dec2020 at 07:45 (at the age of 37-years-old) as a single dose for COVID-19 immunization.  There was no relevant medical history or concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 26Dec2020, the patient had leg weakness and numbness and was diagnosed with acute inflammatory demyelinating polyneuropathy. The patient was going to have a nerve conduction study done and spinal tab. The clinical outcome of acute inflammatory demyelinating polyneuropathy was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of acute inflammatory demyelinating polyneuropathy due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including spine MRI, results of nerve conduction tests, EMG and CSF analysis, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Diagnosis with acute inflammatory demyelinating polyneuropathy (AIDP) G61.0; This is a spontaneous report from a contactable healthcare professional, the patient.  A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the right arm on 21Dec2020 at 07:45 (at the age of 37-years-old) as a single dose for COVID-19 immunization.  There was no relevant medical history or concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 26Dec2020, the patient had leg weakness and numbness and was diagnosed with acute inflammatory demyelinating polyneuropathy. The patient was going to have a nerve conduction study done and spinal tab. The clinical outcome of acute inflammatory demyelinating polyneuropathy was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of acute inflammatory demyelinating polyneuropathy due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including spine MRI, results of nerve conduction tests, EMG and CSF analysis, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cellulitis, Diarrhoea, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Erythema, Headache, Pain in extremity
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling, Skin warm, Swelling face, Vaccination site induration
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Eye swelling, Incorrect route of product administration, Injected limb mobility decreased, Limb mass
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Nodule, Pain, Pain in extremity, Swelling face
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Pt developed headache, diarrhea and redness, induration and warmth at vaccine site 1 day following administration. It resolved 8 days later- no swelling but the came back on day 9 post vaccine with redness, swelling and warmth in left arm. She also complains of arm pain, tingling in arm, mild swelling in face and arthralgias. Her vaccine was administered sub q instead of IM in the deltoid. Hers was placed more posterior by pharmacist who vaccinated her
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Initially in first hour- head spacey , lightheaded, left temple headache , scratchy throat dry mouth. Then nothing   Day 5 today I started feeling like I had a bruise in my armpit region on the chest wall side (where your armpit fat is but deep). It feels like a lymph node . Basically it feels like a bruise when I flex my bicep it hurts there or when my arm is relaxed at my side the pressure hurts in the armpit. It is not superficial .
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Dizziness, Dry mouth, Feeling abnormal, Headache
Clinical narrative: Initially in first hour- head spacey , lightheaded, left temple headache , scratchy throat dry mouth. Then nothing   Day 5 today I started feeling like I had a bruise in my armpit region on the chest wall side (where your armpit fat is but deep). It feels like a lymph node . Basically it feels like a bruise when I flex my bicep it hurts there or when my arm is relaxed at my side the pressure hurts in the armpit. It is not superficial .
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Rash
Clinical narrative: Redness and itching all over body. Treatment was Prednisone pill, still taking. Redness and itching decreased, but not gone.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching all over body. Treatment was Prednisone pill, still taking. Redness and itching decreased, but not gone.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Eye swelling, Feeling abnormal
Clinical narrative: Client complained of numbness & tingling of her face and lips.  Noted swelling on her face.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Swelling face
Clinical narrative: Client complained of numbness & tingling of her face and lips.  Noted swelling on her face.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Lymphadenopathy, Metabolic function test
Clinical narrative: Pt is a pleasant 61 year old female who received Moderna COVID19 prime vaccine dose on 1/15/2021 as part of employee immunization event.  Pt reported upper respiratory viral illness the week prior but determined with medical advice that she was well enough to be immunized on the 15th. Immediate post-vaccination period was unremarkable.  Later that evening pt experienced onset of HA and fatigue which progressed to severe HA, low grade fever (~99 F per patient), malaise, and sore shoulder the following day.  Symptoms gradually improved over the next 2-3 days with HA being the most troublesome and lingering symptom.  Pt used OTC analgesics to manage HA pain. On 1/19/2021, four days after prime dose administration, pt noted a visible lump mid-clavicle, determined to be a severely swollen lymph node.  Warm and tender to touch.  Pt sought medical attention for this the following day, 1/20/2021.  Physician's assessment: "Pt received the COVID moderna vaccine Friday, left arm.  She is a triage RN at Medical Clinic.  She states yesterday a lump appeared on her LT clavicle area.  Pt reports the lump is tender, "warm" but not red, and no surrounding erythema.  Yesterday had HA and a "weird sensation" radiating to LT ear from the lump.  The lump is now the size of a golf ball, did draw a line under it to see it.  She is able to swallow okay and has no other concerning Sx.  No changes in breathing.  Has had headaches, which have been reported possible side effect from COVD19 vaccination.  This vaccination was given quite high in her arm she thinks as well.  Fever Sunday night, 2 days after vaccination.  Has been taking Tylenol and IBU (not what she does usually) taking with food and has some GI upset.  Did try a cool compress on the lump yesterday which did not seem to help." // "Can clearly see her soft tissue mass above her left clavicle, with a line that she drove underneath it yesterday when it started to form. There is no redness but is certainly tender to touch. Can still see a little bit of bruise in her arm where her vaccine was given in her left arm which does seem quite high, not two finger widths from the acromion process. Discussed prednisone but she is terrified of this as she was given a Symbicort inhaler not that long ago and felt that the steroid really made her wired. Recommend warm compresses, alternate between Tylenol ibuprofen with food and even topical Voltaren gel which she has at home and Arnica gel to area. Can certainly get CBC CMP for further evaluation. Discussed soft tissue ultrasound if this does not improve, will order this today in case it is needed she can just get that scheduled. She is going to report her vaccine reaction to the link she was given on the paper which I think is appropriate. Hopefully symptoms will improve in the next few days and then can proceed with her second vaccination a month from the first."  I spoke with patient today, 1/27/2021, to submit VAERS report. She reports swollen lymph node is still visible though size and sensitivity continue to slowly diminish.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Contusion, Fatigue, Feeling abnormal
Clinical narrative: Pt is a pleasant 61 year old female who received Moderna COVID19 prime vaccine dose on 1/15/2021 as part of employee immunization event.  Pt reported upper respiratory viral illness the week prior but determined with medical advice that she was well enough to be immunized on the 15th. Immediate post-vaccination period was unremarkable.  Later that evening pt experienced onset of HA and fatigue which progressed to severe HA, low grade fever (~99 F per patient), malaise, and sore shoulder the following day.  Symptoms gradually improved over the next 2-3 days with HA being the most troublesome and lingering symptom.  Pt used OTC analgesics to manage HA pain. On 1/19/2021, four days after prime dose administration, pt noted a visible lump mid-clavicle, determined to be a severely swollen lymph node.  Warm and tender to touch.  Pt sought medical attention for this the following day, 1/20/2021.  Physician's assessment: "Pt received the COVID moderna vaccine Friday, left arm.  She is a triage RN at Medical Clinic.  She states yesterday a lump appeared on her LT clavicle area.  Pt reports the lump is tender, "warm" but not red, and no surrounding erythema.  Yesterday had HA and a "weird sensation" radiating to LT ear from the lump.  The lump is now the size of a golf ball, did draw a line under it to see it.  She is able to swallow okay and has no other concerning Sx.  No changes in breathing.  Has had headaches, which have been reported possible side effect from COVD19 vaccination.  This vaccination was given quite high in her arm she thinks as well.  Fever Sunday night, 2 days after vaccination.  Has been taking Tylenol and IBU (not what she does usually) taking with food and has some GI upset.  Did try a cool compress on the lump yesterday which did not seem to help." // "Can clearly see her soft tissue mass above her left clavicle, with a line that she drove underneath it yesterday when it started to form. There is no redness but is certainly tender to touch. Can still see a little bit of bruise in her arm where her vaccine was given in her left arm which does seem quite high, not two finger widths from the acromion process. Discussed prednisone but she is terrified of this as she was given a Symbicort inhaler not that long ago and felt that the steroid really made her wired. Recommend warm compresses, alternate between Tylenol ibuprofen with food and even topical Voltaren gel which she has at home and Arnica gel to area. Can certainly get CBC CMP for further evaluation. Discussed soft tissue ultrasound if this does not improve, will order this today in case it is needed she can just get that scheduled. She is going to report her vaccine reaction to the link she was given on the paper which I think is appropriate. Hopefully symptoms will improve in the next few days and then can proceed with her second vaccination a month from the first."  I spoke with patient today, 1/27/2021, to submit VAERS report. She reports swollen lymph node is still visible though size and sensitivity continue to slowly diminish.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Pt is a pleasant 61 year old female who received Moderna COVID19 prime vaccine dose on 1/15/2021 as part of employee immunization event.  Pt reported upper respiratory viral illness the week prior but determined with medical advice that she was well enough to be immunized on the 15th. Immediate post-vaccination period was unremarkable.  Later that evening pt experienced onset of HA and fatigue which progressed to severe HA, low grade fever (~99 F per patient), malaise, and sore shoulder the following day.  Symptoms gradually improved over the next 2-3 days with HA being the most troublesome and lingering symptom.  Pt used OTC analgesics to manage HA pain. On 1/19/2021, four days after prime dose administration, pt noted a visible lump mid-clavicle, determined to be a severely swollen lymph node.  Warm and tender to touch.  Pt sought medical attention for this the following day, 1/20/2021.  Physician's assessment: "Pt received the COVID moderna vaccine Friday, left arm.  She is a triage RN at Medical Clinic.  She states yesterday a lump appeared on her LT clavicle area.  Pt reports the lump is tender, "warm" but not red, and no surrounding erythema.  Yesterday had HA and a "weird sensation" radiating to LT ear from the lump.  The lump is now the size of a golf ball, did draw a line under it to see it.  She is able to swallow okay and has no other concerning Sx.  No changes in breathing.  Has had headaches, which have been reported possible side effect from COVD19 vaccination.  This vaccination was given quite high in her arm she thinks as well.  Fever Sunday night, 2 days after vaccination.  Has been taking Tylenol and IBU (not what she does usually) taking with food and has some GI upset.  Did try a cool compress on the lump yesterday which did not seem to help." // "Can clearly see her soft tissue mass above her left clavicle, with a line that she drove underneath it yesterday when it started to form. There is no redness but is certainly tender to touch. Can still see a little bit of bruise in her arm where her vaccine was given in her left arm which does seem quite high, not two finger widths from the acromion process. Discussed prednisone but she is terrified of this as she was given a Symbicort inhaler not that long ago and felt that the steroid really made her wired. Recommend warm compresses, alternate between Tylenol ibuprofen with food and even topical Voltaren gel which she has at home and Arnica gel to area. Can certainly get CBC CMP for further evaluation. Discussed soft tissue ultrasound if this does not improve, will order this today in case it is needed she can just get that scheduled. She is going to report her vaccine reaction to the link she was given on the paper which I think is appropriate. Hopefully symptoms will improve in the next few days and then can proceed with her second vaccination a month from the first."  I spoke with patient today, 1/27/2021, to submit VAERS report. She reports swollen lymph node is still visible though size and sensitivity continue to slowly diminish.