chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Oxygen saturation decreased, Pharyngeal swelling, Tachycardia
Clinical narrative: immediate swelling at injection site, anaphylactic reaction with oxygen desaturation, throat swelling and tachycardia.    supplemenmental oxygen, IV fluids, epinepherine IM, benadryl given at vaccine site, transported to Emergency Room via ambulance.  I was stable at the time of transport.  IV solumedrol and pepcid given at hospital. EKG and bloodwork done.  I had low potassium and was provided supplement. discharged and prescribed Prednasone, Pepcid, Zyrtic and potassium
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature increased, Fatigue, Food aversion, Hypersomnia
Clinical narrative: Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient).  A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization.  Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Peripheral swelling
Clinical narrative: Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient).  A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization.  Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Restlessness
Clinical narrative: Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient).  A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization.  Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Food aversion, Inappropriate schedule of product administration, Lymph node pain
Clinical narrative: Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient).  A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization.  Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Nausea, Pain
Clinical narrative: Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient).  A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization.  Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Cheilitis, Erythema, Lip exfoliation, Pain
Clinical narrative: Fever, Chills, Extreme Fatigue, Lymph node pain, Headache, Blisters on palms of hands and fingers, Sloughing off of skin inside mouth
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, Extreme Fatigue, Lymph node pain, Headache, Blisters on palms of hands and fingers, Sloughing off of skin inside mouth
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Chills, Fatigue, Headache, Lymph node pain
Clinical narrative: Fever, Chills, Extreme Fatigue, Lymph node pain, Headache, Blisters on palms of hands and fingers, Sloughing off of skin inside mouth
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral mucosal exfoliation, Pyrexia
Clinical narrative: Fever, Chills, Extreme Fatigue, Lymph node pain, Headache, Blisters on palms of hands and fingers, Sloughing off of skin inside mouth
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness,  face turned red elevated BP
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Erythema, Hypoaesthesia
Clinical narrative: Facial numbness,  face turned red elevated BP
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hot flush, Hypertension
Clinical narrative: severe hypertension (190/100); flushing tachycardia; flushing tachycardia; blurred vision in the left eye; This is a spontaneous report from a contactable healthcare professional reporting for self. This 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing underlying HTN (hypertension). Concomitant medications were not reported. The patient experienced AE following administration of first dose of vaccine of including: severe hypertension (190/100), flushing tachycardia, and blurred vision in the left eye.  These symptoms started 20minutes after administration. The patient stated her PCP thought that she had underlying hypertension and had since started her on medications. She was looking for guidance with regard to receiving the second dose.  The outcome of events was unknown.    Information about Batch/Lot number has been requested.; Sender's Comments: The administration of BNT162B2 might have played a contributory role in triggering the onset of serious event hypertension worsened, considering the plausible temporal relationship.  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, COVID19
Symptoms: Flushing, Hypertension, Tachycardia, Vision blurred
Clinical narrative: severe hypertension (190/100); flushing tachycardia; flushing tachycardia; blurred vision in the left eye; This is a spontaneous report from a contactable healthcare professional reporting for self. This 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history included ongoing underlying HTN (hypertension). Concomitant medications were not reported. The patient experienced AE following administration of first dose of vaccine of including: severe hypertension (190/100), flushing tachycardia, and blurred vision in the left eye.  These symptoms started 20minutes after administration. The patient stated her PCP thought that she had underlying hypertension and had since started her on medications. She was looking for guidance with regard to receiving the second dose.  The outcome of events was unknown.    Information about Batch/Lot number has been requested.; Sender's Comments: The administration of BNT162B2 might have played a contributory role in triggering the onset of serious event hypertension worsened, considering the plausible temporal relationship.  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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: Patient reported severe pain in injection site waking her at 4 am morning after vaccination.  She c/o "frozen shoulder" requiring her to see her PCP who has prescribed 8 day course of steroids and physical therapy.   This information was provided to the institution who provided the injection 9 days after vaccine was administered.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Periarthritis
Clinical narrative: Patient reported severe pain in injection site waking her at 4 am morning after vaccination.  She c/o "frozen shoulder" requiring her to see her PCP who has prescribed 8 day course of steroids and physical therapy.   This information was provided to the institution who provided the injection 9 days after vaccine was administered.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Cough, Fatigue, Headache
Clinical narrative: 23 yo female presented to the observation room at ~1132 after receiving COVID vaccine. This RN was flagged by staff @ 1140 that pt reported not feeling well; she reports feeling dizzy and having palpitations. Provided cold pack behind her neck and vital signs taken 126/85 with HR 84 O2 SAT 100% RA. Pt then reported having tongue feel swollen and an increase in dizziness. Pt was then transferred to gurney. Pt reported not having anything to eat as of yet and reports being on medication for anxiety. Pt denies any other use of medications, and denies any allergies. Vitals signs continued to be taken as seen below. Pt's spouse contacted @ 1230pm and notified to come to receive pt. Spouse arrived @ 1238pm, reviewed pt status and reviewed with pt and spouse to continue to monitor for the rest of the day, if symptoms return go to ER. Reminded pt to eat and keep hydrated prior to next injection. Pt and spouse verbalized understanding of instructions. Staff present in waiting area.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 23 yo female presented to the observation room at ~1132 after receiving COVID vaccine. This RN was flagged by staff @ 1140 that pt reported not feeling well; she reports feeling dizzy and having palpitations. Provided cold pack behind her neck and vital signs taken 126/85 with HR 84 O2 SAT 100% RA. Pt then reported having tongue feel swollen and an increase in dizziness. Pt was then transferred to gurney. Pt reported not having anything to eat as of yet and reports being on medication for anxiety. Pt denies any other use of medications, and denies any allergies. Vitals signs continued to be taken as seen below. Pt's spouse contacted @ 1230pm and notified to come to receive pt. Spouse arrived @ 1238pm, reviewed pt status and reviewed with pt and spouse to continue to monitor for the rest of the day, if symptoms return go to ER. Reminded pt to eat and keep hydrated prior to next injection. Pt and spouse verbalized understanding of instructions. Staff present in waiting area.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dizziness postural, Dyspnoea, Malaise, Palpitations
Clinical narrative: 23 yo female presented to the observation room at ~1132 after receiving COVID vaccine. This RN was flagged by staff @ 1140 that pt reported not feeling well; she reports feeling dizzy and having palpitations. Provided cold pack behind her neck and vital signs taken 126/85 with HR 84 O2 SAT 100% RA. Pt then reported having tongue feel swollen and an increase in dizziness. Pt was then transferred to gurney. Pt reported not having anything to eat as of yet and reports being on medication for anxiety. Pt denies any other use of medications, and denies any allergies. Vitals signs continued to be taken as seen below. Pt's spouse contacted @ 1230pm and notified to come to receive pt. Spouse arrived @ 1238pm, reviewed pt status and reviewed with pt and spouse to continue to monitor for the rest of the day, if symptoms return go to ER. Reminded pt to eat and keep hydrated prior to next injection. Pt and spouse verbalized understanding of instructions. Staff present in waiting area.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: 23 yo female presented to the observation room at ~1132 after receiving COVID vaccine. This RN was flagged by staff @ 1140 that pt reported not feeling well; she reports feeling dizzy and having palpitations. Provided cold pack behind her neck and vital signs taken 126/85 with HR 84 O2 SAT 100% RA. Pt then reported having tongue feel swollen and an increase in dizziness. Pt was then transferred to gurney. Pt reported not having anything to eat as of yet and reports being on medication for anxiety. Pt denies any other use of medications, and denies any allergies. Vitals signs continued to be taken as seen below. Pt's spouse contacted @ 1230pm and notified to come to receive pt. Spouse arrived @ 1238pm, reviewed pt status and reviewed with pt and spouse to continue to monitor for the rest of the day, if symptoms return go to ER. Reminded pt to eat and keep hydrated prior to next injection. Pt and spouse verbalized understanding of instructions. Staff present in waiting area.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Areflexia, Guillain-Barre syndrome, Laboratory test, Magnetic resonance imaging, Sensory loss
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Areflexia, Balance disorder, CSF culture negative, CSF glucose normal, CSF protein increased
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: CSF white blood cell count, Diarrhoea, Electrocardiogram normal, Full blood count normal, Guillain-Barre syndrome
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Magnetic resonance imaging brain normal, Metabolic function test normal, Muscular weakness
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Sensory loss, Vital capacity decreased
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Areflexia, Balance disorder, CSF glucose normal, CSF protein increased, CSF white blood cell count negative
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dyskinesia, Glycosylated haemoglobin normal, Guillain-Barre syndrome, Hypertension
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Magnetic resonance imaging spinal normal, Muscular weakness, Neuralgia
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neurological examination abnormal, Pain in extremity, Paraesthesia, Peripheral sensory neuropathy, Scan with contrast normal
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sensory loss, Sleep disorder, Tachycardia, Vitamin B12 increased
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: diagnosed w a prominently sensory Guillain barre syndrome; paresthesia in arms/also involved the legs; This is a spontaneous report from a contactable physician (patient). A 36-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 08:30 at single dose at left arm for covid-19 immunization. Medical history was none. No known allergies to medications, food, or other products. Concomitant medication in two weeks included drospirenone, ethinylestradiol betadex clathrate (YAZ) oral contraceptive. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient developed paresthesia in arms at 6: 00 am 01Jan2021, 9 days after receiving the vaccine which have worsened over the past 7 days and also involved the legs, patient was seen in the ER on 08Jan2021 and diagnosed as a prominently sensory Guillain barre syndrome. Patient had test for covid-19 of nasal swab with negative result on 08Jan2021. Patient didn't receive treatment for events. Outcome of events was not recovered. The report is considered as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.; Sender's Comments: Except for time association, there is not enough evidence such as a biological plausibility to establish a causal relationship between the occurrence of the event paresthesia diagnosed as a prominently sensory Guillain barre syndrome and the administration of the suspect vaccine in the individual 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: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself).  A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization.  Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies.  Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening.  The patient went to the Emergency room due to the events.  Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg.   The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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.