chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: throat felt very dry; her throat had swollen up; she could barely talk or catch her breath; hives on her chest; This is a spontaneous report from a contactable nurse reported for herself.  A 30-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular in left arm on 22Dec2020 09:15 at single dose for COVID-19 immunization.  Medical history included known allergies was Yellow jacket/ bee venom, cholecystectomy, tonsillectomy, cholestasis during pregnancy.  The patient's concomitant medications included methylphenidate hydrochloride (RITALIN) and ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 5 mins after receiving the injection, the patient throat felt very dry. The patient took paracetamol (TYLENOL) and sipped on some water and realized that she could not swallow. Several minutes later her throat had swollen up and she could barely talk or catch her breath. The doctor assessing her told her she had hives on her chest and gave her a epipen injection in her right thigh. She shortly felt relief and could breath better after. She was taken to the emergency room and given solumedeol, benadryl and famotidine (PEPCID). She seemed to be doing ok 10 hours after the event. The event onset date was reported as 22Dec2020 09:15. The events were reported as serious as resulted in: emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The outcome of all the events was recovering.; Sender's Comments: Severe allergic reaction including anaphylaxis is the known risk factor;  a possible causal association between administration of BNT162B2 and the onset of dry throat, swelling throat unable to swallow/breath and hives 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.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry throat, Dysphagia, Dyspnoea, Pharyngeal swelling, Speech disorder
Clinical narrative: throat felt very dry; her throat had swollen up; she could barely talk or catch her breath; hives on her chest; This is a spontaneous report from a contactable nurse reported for herself.  A 30-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular in left arm on 22Dec2020 09:15 at single dose for COVID-19 immunization.  Medical history included known allergies was Yellow jacket/ bee venom, cholecystectomy, tonsillectomy, cholestasis during pregnancy.  The patient's concomitant medications included methylphenidate hydrochloride (RITALIN) and ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 5 mins after receiving the injection, the patient throat felt very dry. The patient took paracetamol (TYLENOL) and sipped on some water and realized that she could not swallow. Several minutes later her throat had swollen up and she could barely talk or catch her breath. The doctor assessing her told her she had hives on her chest and gave her a epipen injection in her right thigh. She shortly felt relief and could breath better after. She was taken to the emergency room and given solumedeol, benadryl and famotidine (PEPCID). She seemed to be doing ok 10 hours after the event. The event onset date was reported as 22Dec2020 09:15. The events were reported as serious as resulted in: emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The outcome of all the events was recovering.; Sender's Comments: Severe allergic reaction including anaphylaxis is the known risk factor;  a possible causal association between administration of BNT162B2 and the onset of dry throat, swelling throat unable to swallow/breath and hives 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.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Bilevel positive airway pressure, Lip swelling, Nausea, Status asthmaticus
Clinical narrative: anaphylactic reaction; Approximately 7 minutes after pt received vaccine - she started exhibiting sign of allergic reaction.; audible wheeze; resp 40/ minute lips noted to be swollen; nausea; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 22Dec2020 15:00 at single dose at left arm for immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not diagnosed as covid-19 prior vaccination, and no covid tested post vaccination. Patient previously took sulfamethoxazole and had adult reaction anaphylaxis and exacerbation of asthma. There's no other vaccine in four weeks prior to the COVID vaccine. Approximately 7 minutes after patient received vaccine - she started exhibiting sign of allergic reaction. RN assessed and noted audible wheeze, resp 40/ minute, lips noted to be swollen and patient complained of nausea. It was determined patient needed emergency care and was wheeled to the ER (2-minute walk) in a wheelchair accompanied by two RN's. Upon arrival to ED it was determined patient was having an anaphylactic reaction and was immediately treated. In emergency care, patient received SoluMedrol-125, benadryl 50mg, famotidine 20mg, EPI 0.3mg IM X1, EPI 0.3mg IV X1 as treatment. Patient was progressed and was ultimately intubated and admitted to ICU where she currently was. Outcome of all events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events anaphylactic reaction and the associated symptoms due to temporal association. However patient past history of allergy to other drugs and asthma could have played a contributory role
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: anaphylactic reaction; Approximately 7 minutes after pt received vaccine - she started exhibiting sign of allergic reaction.; audible wheeze; resp 40/ minute lips noted to be swollen; nausea; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 22Dec2020 15:00 at single dose at left arm for immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not diagnosed as covid-19 prior vaccination, and no covid tested post vaccination. Patient previously took sulfamethoxazole and had adult reaction anaphylaxis and exacerbation of asthma. There's no other vaccine in four weeks prior to the COVID vaccine. Approximately 7 minutes after patient received vaccine - she started exhibiting sign of allergic reaction. RN assessed and noted audible wheeze, resp 40/ minute, lips noted to be swollen and patient complained of nausea. It was determined patient needed emergency care and was wheeled to the ER (2-minute walk) in a wheelchair accompanied by two RN's. Upon arrival to ED it was determined patient was having an anaphylactic reaction and was immediately treated. In emergency care, patient received SoluMedrol-125, benadryl 50mg, famotidine 20mg, EPI 0.3mg IM X1, EPI 0.3mg IV X1 as treatment. Patient was progressed and was ultimately intubated and admitted to ICU where she currently was. Outcome of all events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events anaphylactic reaction and the associated symptoms due to temporal association. However patient past history of allergy to other drugs and asthma could have played a contributory role
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Endotracheal intubation, Hypersensitivity, Intensive care, Lip swelling
Clinical narrative: anaphylactic reaction; Approximately 7 minutes after pt received vaccine - she started exhibiting sign of allergic reaction.; audible wheeze; resp 40/ minute lips noted to be swollen; nausea; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 22Dec2020 15:00 at single dose at left arm for immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not diagnosed as covid-19 prior vaccination, and no covid tested post vaccination. Patient previously took sulfamethoxazole and had adult reaction anaphylaxis and exacerbation of asthma. There's no other vaccine in four weeks prior to the COVID vaccine. Approximately 7 minutes after patient received vaccine - she started exhibiting sign of allergic reaction. RN assessed and noted audible wheeze, resp 40/ minute, lips noted to be swollen and patient complained of nausea. It was determined patient needed emergency care and was wheeled to the ER (2-minute walk) in a wheelchair accompanied by two RN's. Upon arrival to ED it was determined patient was having an anaphylactic reaction and was immediately treated. In emergency care, patient received SoluMedrol-125, benadryl 50mg, famotidine 20mg, EPI 0.3mg IM X1, EPI 0.3mg IV X1 as treatment. Patient was progressed and was ultimately intubated and admitted to ICU where she currently was. Outcome of all events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events anaphylactic reaction and the associated symptoms due to temporal association. However patient past history of allergy to other drugs and asthma could have played a contributory role
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Wheezing
Clinical narrative: anaphylactic reaction; Approximately 7 minutes after pt received vaccine - she started exhibiting sign of allergic reaction.; audible wheeze; resp 40/ minute lips noted to be swollen; nausea; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 22Dec2020 15:00 at single dose at left arm for immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not diagnosed as covid-19 prior vaccination, and no covid tested post vaccination. Patient previously took sulfamethoxazole and had adult reaction anaphylaxis and exacerbation of asthma. There's no other vaccine in four weeks prior to the COVID vaccine. Approximately 7 minutes after patient received vaccine - she started exhibiting sign of allergic reaction. RN assessed and noted audible wheeze, resp 40/ minute, lips noted to be swollen and patient complained of nausea. It was determined patient needed emergency care and was wheeled to the ER (2-minute walk) in a wheelchair accompanied by two RN's. Upon arrival to ED it was determined patient was having an anaphylactic reaction and was immediately treated. In emergency care, patient received SoluMedrol-125, benadryl 50mg, famotidine 20mg, EPI 0.3mg IM X1, EPI 0.3mg IV X1 as treatment. Patient was progressed and was ultimately intubated and admitted to ICU where she currently was. Outcome of all events was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events anaphylactic reaction and the associated symptoms due to temporal association. However patient past history of allergy to other drugs and asthma could have played a contributory role
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Grip strength decreased, Headache
Clinical narrative: pain in the arm of injection site; numbness and pins and needle tingling in the lower arm and hand; numbness and pins and needle tingling in the lower arm and hand; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects/weakness; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; dizziness; severe joint pain; throbbing headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ 1685, expiry date unknown) via unspecified route of administration at left arm on 19Dec2020 07:30 at single dose for COVID-19 immunization. The reporter informed that the covid-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included asthma, allergies to penicillin, allergies to milk, seasonal allergy, allergies to bees, allergies to latex. Concomitant medications included montelukast, fluticasone, budesonide, formoterol fumarate (SYMBICORT) and cetirizine; all from unspecified date for unspecified indication. The patient previously took Bactrim and experienced allergies. On 19Dec2020 15:00, the patient experienced pain in the arm of injection site including numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness and weakness, severe joint pain and throbbing headache. The patient underwent lab test and procedures post vaccination which included nasal swab/Covid-19 RNA rapid: negative on 22Dec2020. No treatment was received due to the events. The outcome of the events pain in the arm of injection site, numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness, weakness, severe joint pain, throbbing headache was not recovered. The events were assessed as non-serious which did not results in death, not Life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and not a congenital anomaly/birth defect.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, SARS-CoV-2 test negative, Sensory loss
Clinical narrative: pain in the arm of injection site; numbness and pins and needle tingling in the lower arm and hand; numbness and pins and needle tingling in the lower arm and hand; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects/weakness; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; dizziness; severe joint pain; throbbing headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ 1685, expiry date unknown) via unspecified route of administration at left arm on 19Dec2020 07:30 at single dose for COVID-19 immunization. The reporter informed that the covid-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included asthma, allergies to penicillin, allergies to milk, seasonal allergy, allergies to bees, allergies to latex. Concomitant medications included montelukast, fluticasone, budesonide, formoterol fumarate (SYMBICORT) and cetirizine; all from unspecified date for unspecified indication. The patient previously took Bactrim and experienced allergies. On 19Dec2020 15:00, the patient experienced pain in the arm of injection site including numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness and weakness, severe joint pain and throbbing headache. The patient underwent lab test and procedures post vaccination which included nasal swab/Covid-19 RNA rapid: negative on 22Dec2020. No treatment was received due to the events. The outcome of the events pain in the arm of injection site, numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness, weakness, severe joint pain, throbbing headache was not recovered. The events were assessed as non-serious which did not results in death, not Life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and not a congenital anomaly/birth defect.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Hypoaesthesia
Clinical narrative: pain in the arm of injection site; numbness and pins and needle tingling in the lower arm and hand; numbness and pins and needle tingling in the lower arm and hand; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects/weakness; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; dizziness; severe joint pain; throbbing headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ 1685, expiry date unknown) via unspecified route of administration at left arm on 19Dec2020 07:30 at single dose for COVID-19 immunization. The reporter informed that the covid-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included asthma, allergies to penicillin, allergies to milk, seasonal allergy, allergies to bees, allergies to latex. Concomitant medications included montelukast, fluticasone, budesonide, formoterol fumarate (SYMBICORT) and cetirizine; all from unspecified date for unspecified indication. The patient previously took Bactrim and experienced allergies. On 19Dec2020 15:00, the patient experienced pain in the arm of injection site including numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness and weakness, severe joint pain and throbbing headache. The patient underwent lab test and procedures post vaccination which included nasal swab/Covid-19 RNA rapid: negative on 22Dec2020. No treatment was received due to the events. The outcome of the events pain in the arm of injection site, numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness, weakness, severe joint pain, throbbing headache was not recovered. The events were assessed as non-serious which did not results in death, not Life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and not a congenital anomaly/birth defect.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Motor dysfunction, Paraesthesia, SARS-CoV-2 test negative, Sensory loss
Clinical narrative: pain in the arm of injection site; numbness and pins and needle tingling in the lower arm and hand; numbness and pins and needle tingling in the lower arm and hand; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects/weakness; loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects; dizziness; severe joint pain; throbbing headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ 1685, expiry date unknown) via unspecified route of administration at left arm on 19Dec2020 07:30 at single dose for COVID-19 immunization. The reporter informed that the covid-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included asthma, allergies to penicillin, allergies to milk, seasonal allergy, allergies to bees, allergies to latex. Concomitant medications included montelukast, fluticasone, budesonide, formoterol fumarate (SYMBICORT) and cetirizine; all from unspecified date for unspecified indication. The patient previously took Bactrim and experienced allergies. On 19Dec2020 15:00, the patient experienced pain in the arm of injection site including numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness and weakness, severe joint pain and throbbing headache. The patient underwent lab test and procedures post vaccination which included nasal swab/Covid-19 RNA rapid: negative on 22Dec2020. No treatment was received due to the events. The outcome of the events pain in the arm of injection site, numbness and pins and needle tingling in the lower arm and hand, loss of feeling in hand and loss of sensation and strength; difficulty holding onto objects, dizziness, weakness, severe joint pain, throbbing headache was not recovered. The events were assessed as non-serious which did not results in death, not Life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and not a congenital anomaly/birth defect.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pruritus, Rash pruritic, Urticaria
Clinical narrative: Hives all over his body, on his tummy, his legs, his wrist; did a cold compress, it seemed to work but it came back again; This is a spontaneous report from a contactable consumer (patient's wife). A 47-year-old male patient received BNT162B2 (Lot# EK5730), via an unspecified route of administration on an unspecified date at single dose for COVID -19 immunization. Medical history included type 1 diabetic, blood pressure high and cholesterol. Concomitant medication included insulin. The patient got the vaccine on Friday. On 21Dec2020, the patient had hives all over his body, on his tummy, his legs, his wrist. He started getting it at midnight and the reporter wondering do she need to take him in or can she just give him Benadryl. she was looking at the documents trying to find a number to call. He got the COVID Vaccine on Friday and no trouble till this morning, now at midnight. The treatment included he did a cold compress on it, it seemed to work but it came back again. It's still the same. Cold compress last night or this morning, it seemed to help. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over his body, on his tummy, his legs, his wrist; did a cold compress, it seemed to work but it came back again; This is a spontaneous report from a contactable consumer (patient's wife). A 47-year-old male patient received BNT162B2 (Lot# EK5730), via an unspecified route of administration on an unspecified date at single dose for COVID -19 immunization. Medical history included type 1 diabetic, blood pressure high and cholesterol. Concomitant medication included insulin. The patient got the vaccine on Friday. On 21Dec2020, the patient had hives all over his body, on his tummy, his legs, his wrist. He started getting it at midnight and the reporter wondering do she need to take him in or can she just give him Benadryl. she was looking at the documents trying to find a number to call. He got the COVID Vaccine on Friday and no trouble till this morning, now at midnight. The treatment included he did a cold compress on it, it seemed to work but it came back again. It's still the same. Cold compress last night or this morning, it seemed to help. The outcome of the event was not recovered.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Blood pressure increased, Dry mouth, Flushing, Sensory disturbance
Clinical narrative: dry mouth; peculiar sensations running through extremities/trunk/abdomen (akin to IV contrast administration); elevated BP; tachycardia; lower abdominal cramping; This is a spontaneous report from a contactable physician (patient). A 46-year-old male patient received the first single dose of BNT162B2 (Lot number: EH9899, exp date not reported), intramuscular (vaccine location: left arm) on 21Dec2020 15:00 for Covid-19 immunisation. Medical history included hyperlipidaemia. The patient had no known allergies. Concomitant medication included atorvastatin (LIPITOR), and omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered at a Hospital. On 21Dec2020 at 3:00 pm (also reported as within minutes of receiving vaccine),  the patient developed dry mouth, peculiar sensations running through extremities/trunk/abdomen (akin to IV contrast administration), elevated BP, tachycardia, and lower abdominal cramping. The patient considered the events as non-serious. AEs resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The patient had no prior COVID vaccination and did not undergo COVID testing post vaccination. The patient recovered from the events on an unspecified date Dec2020.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: dry mouth; peculiar sensations running through extremities/trunk/abdomen (akin to IV contrast administration); elevated BP; tachycardia; lower abdominal cramping; This is a spontaneous report from a contactable physician (patient). A 46-year-old male patient received the first single dose of BNT162B2 (Lot number: EH9899, exp date not reported), intramuscular (vaccine location: left arm) on 21Dec2020 15:00 for Covid-19 immunisation. Medical history included hyperlipidaemia. The patient had no known allergies. Concomitant medication included atorvastatin (LIPITOR), and omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered at a Hospital. On 21Dec2020 at 3:00 pm (also reported as within minutes of receiving vaccine),  the patient developed dry mouth, peculiar sensations running through extremities/trunk/abdomen (akin to IV contrast administration), elevated BP, tachycardia, and lower abdominal cramping. The patient considered the events as non-serious. AEs resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The patient had no prior COVID vaccination and did not undergo COVID testing post vaccination. The patient recovered from the events on an unspecified date Dec2020.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Blood pressure increased, Dry mouth, Sensory disturbance, Tachycardia
Clinical narrative: dry mouth; peculiar sensations running through extremities/trunk/abdomen (akin to IV contrast administration); elevated BP; tachycardia; lower abdominal cramping; This is a spontaneous report from a contactable physician (patient). A 46-year-old male patient received the first single dose of BNT162B2 (Lot number: EH9899, exp date not reported), intramuscular (vaccine location: left arm) on 21Dec2020 15:00 for Covid-19 immunisation. Medical history included hyperlipidaemia. The patient had no known allergies. Concomitant medication included atorvastatin (LIPITOR), and omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered at a Hospital. On 21Dec2020 at 3:00 pm (also reported as within minutes of receiving vaccine),  the patient developed dry mouth, peculiar sensations running through extremities/trunk/abdomen (akin to IV contrast administration), elevated BP, tachycardia, and lower abdominal cramping. The patient considered the events as non-serious. AEs resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The patient had no prior COVID vaccination and did not undergo COVID testing post vaccination. The patient recovered from the events on an unspecified date Dec2020.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Urticaria
Clinical narrative: headache; soreness on injection site; hives; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 20Dec2020 10:30 at a single dose for covid-19 immunization. The patient's medical history included chronic cough, post nasal drip, asthma, sinusitis, and allergies to sulfa. The patient was not pregnant. Concomitant medications included levocetirizine dihydrochloride (XYZAL), amoxicillin, clavulanic acid (AUGMENTIN), omeprazole (PROTONIX), fluticasone propionate, salmeterol xinafoate (ADVAIR), budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), and guaifenesin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Dec2020 16:00, the patient experienced headache, soreness on injection site, hives started on the day of injection in the afternoon until current day. The patient underwent lab tests and procedures which included COVID-19 Nasal Swab was negative on 13Nov2020. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 on Dec2020 since the vaccination. No treatment was received for the adverse events. Outcome of the events was recovering. The events was considered non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, SARS-CoV-2 test, Urticaria
Clinical narrative: headache; soreness on injection site; hives; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 20Dec2020 10:30 at a single dose for covid-19 immunization. The patient's medical history included chronic cough, post nasal drip, asthma, sinusitis, and allergies to sulfa. The patient was not pregnant. Concomitant medications included levocetirizine dihydrochloride (XYZAL), amoxicillin, clavulanic acid (AUGMENTIN), omeprazole (PROTONIX), fluticasone propionate, salmeterol xinafoate (ADVAIR), budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), and guaifenesin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Dec2020 16:00, the patient experienced headache, soreness on injection site, hives started on the day of injection in the afternoon until current day. The patient underwent lab tests and procedures which included COVID-19 Nasal Swab was negative on 13Nov2020. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 on Dec2020 since the vaccination. No treatment was received for the adverse events. Outcome of the events was recovering. The events was considered non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: tingling in injection arm, left arm, left neck, around the lips/tingling through arms, hands, fingers, and legs/worsened by sitting on legs/dense tingling in anterior shins upon standing; tingling in injection arm, left arm, left neck, around the lips/tingling through arms, hands, fingers, and legs/worsened by sitting on legs/dense tingling in anterior shins upon standing; tingling in injection arm, left arm, left neck, around the lips/tingling through arms, hands, fingers, and legs/worsened by sitting on legs/dense tingling in anterior shins upon standing; This is a spontaneous report from a contactable physician (who is also the patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration in left arm, on 19Dec2020 09:30, at single dose, for COVID-19 immunization. There were no medical history and no known allergies. The patient's concomitant medications were not reported. The patient reported that about 30 minutes after vaccination on 19Dec2020 at 10:00, while driving home, tingling was noted in injection arm, traveling up the left arm into the left neck and around the lips. Tingling resolved but the next day, tingling was noted to be diffuse, light and scattered through arms, hands, fingers, and legs equally and bilaterally. No dermatomal or distinct nerve distribution. Tingling worsened by sitting on legs, became dense tingling in the anterior shins upon standing, but then resolved a few minutes later to the more diffuse light tingling. No notable difference in strength (able to hike and cook) and no notable numbness. No rashes, no shortness of breath, no changes in heart rate. The events resulted in "doctor or other healthcare professional office/clinic visit". No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The reporter assessed the case as non-serious. The outcome of the events was recovered (as reported).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site paraesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling in injection arm, left arm, left neck, around the lips/tingling through arms, hands, fingers, and legs/worsened by sitting on legs/dense tingling in anterior shins upon standing; tingling in injection arm, left arm, left neck, around the lips/tingling through arms, hands, fingers, and legs/worsened by sitting on legs/dense tingling in anterior shins upon standing; tingling in injection arm, left arm, left neck, around the lips/tingling through arms, hands, fingers, and legs/worsened by sitting on legs/dense tingling in anterior shins upon standing; This is a spontaneous report from a contactable physician (who is also the patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration in left arm, on 19Dec2020 09:30, at single dose, for COVID-19 immunization. There were no medical history and no known allergies. The patient's concomitant medications were not reported. The patient reported that about 30 minutes after vaccination on 19Dec2020 at 10:00, while driving home, tingling was noted in injection arm, traveling up the left arm into the left neck and around the lips. Tingling resolved but the next day, tingling was noted to be diffuse, light and scattered through arms, hands, fingers, and legs equally and bilaterally. No dermatomal or distinct nerve distribution. Tingling worsened by sitting on legs, became dense tingling in the anterior shins upon standing, but then resolved a few minutes later to the more diffuse light tingling. No notable difference in strength (able to hike and cook) and no notable numbness. No rashes, no shortness of breath, no changes in heart rate. The events resulted in "doctor or other healthcare professional office/clinic visit". No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The reporter assessed the case as non-serious. The outcome of the events was recovered (as reported).
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Electrocardiogram, Headache, Pain, SARS-CoV-2 test
Clinical narrative: headache; Tachycardia; chills; body aches; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscularly on right arm at 07:30 AM on 18Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced tachycardia, chills, body aches, headache at 12:00 AM on 19Dec2020, events resulted in: Emergency room/department or urgent care], events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested COVID post vaccination on 19Dec2020; COVID test type: Nasal Swab, COVID test name : Covid PCR, Covid test result: Negative. The patient did not receive any treatment for events. The outcome of events was recovered in Dec2020.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: headache; Tachycardia; chills; body aches; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscularly on right arm at 07:30 AM on 18Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced tachycardia, chills, body aches, headache at 12:00 AM on 19Dec2020, events resulted in: Emergency room/department or urgent care], events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested COVID post vaccination on 19Dec2020; COVID test type: Nasal Swab, COVID test name : Covid PCR, Covid test result: Negative. The patient did not receive any treatment for events. The outcome of events was recovered in Dec2020.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: headache; Tachycardia; chills; body aches; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), intramuscularly on right arm at 07:30 AM on 18Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced tachycardia, chills, body aches, headache at 12:00 AM on 19Dec2020, events resulted in: Emergency room/department or urgent care], events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested COVID post vaccination on 19Dec2020; COVID test type: Nasal Swab, COVID test name : Covid PCR, Covid test result: Negative. The patient did not receive any treatment for events. The outcome of events was recovered in Dec2020.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Feeling hot, Paraesthesia
Clinical narrative: Facial Tingling 25 minutes after injection. Still with mild tingling.; Face and ears felt very warm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 21Dec2020 13:30 at single dose on her left arm for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD) and known allergies included Latex, epinephrine ("epi"), shell fish. Concomitant medication in two weeks included fexofenadine hydrochloride (ALLEGRA), lansoprazole (PREVACID), plantago ovata (METAMUCIL), dextran sulfate sodium (DSS). The patient previously took epinephrine and experienced drug hypersensitivity. The patient experienced face and ears felt very warm. Facial Tingling 25 minutes after injection on 21Dec2020 14:00. No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Facial Tingling 25 minutes after injection. Still with mild tingling.; Face and ears felt very warm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 21Dec2020 13:30 at single dose on her left arm for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD) and known allergies included Latex, epinephrine ("epi"), shell fish. Concomitant medication in two weeks included fexofenadine hydrochloride (ALLEGRA), lansoprazole (PREVACID), plantago ovata (METAMUCIL), dextran sulfate sodium (DSS). The patient previously took epinephrine and experienced drug hypersensitivity. The patient experienced face and ears felt very warm. Facial Tingling 25 minutes after injection on 21Dec2020 14:00. No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: Immediately injection site was itchy, but no distress. within 10 minutes, throat became very dry; back of tongue started to tingle and feel as if it were swelling. No shortness of breath noted.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Immediate post-injection reaction, Injection site pruritus, Paraesthesia oral, Swollen tongue
Clinical narrative: Immediately injection site was itchy, but no distress. within 10 minutes, throat became very dry; back of tongue started to tingle and feel as if it were swelling. No shortness of breath noted.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Urgency, repeated episodes of diarrhea; GI symptoms; Cramping; This is a spontaneous report from a contactable physician (patient).  A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration at right arm on 19Dec2020 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypertension (HTN), obesity, had hx of stroke 2007 and COVID-19 (diagnosed prior to vaccination). No allergies to medications, food, or other products. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASA 81) and multivitamin. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 20Dec2020 09:00, the patient experienced gastrointestinal (GI) symptoms, cramping, and "urgency, repeated episodes of diarrhea". No fever. No treatment was taken as a result of the events. The outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Defaecation urgency, Diarrhoea, Gastrointestinal disorder, Muscle spasms
Clinical narrative: Urgency, repeated episodes of diarrhea; GI symptoms; Cramping; This is a spontaneous report from a contactable physician (patient).  A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration at right arm on 19Dec2020 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypertension (HTN), obesity, had hx of stroke 2007 and COVID-19 (diagnosed prior to vaccination). No allergies to medications, food, or other products. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASA 81) and multivitamin. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 20Dec2020 09:00, the patient experienced gastrointestinal (GI) symptoms, cramping, and "urgency, repeated episodes of diarrhea". No fever. No treatment was taken as a result of the events. The outcome of the events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: injection site pain, redness around injection site, Fatigue
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: injection site pain, redness around injection site, Fatigue
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient (no pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 22Dec2020 10:00 AM on left arm at single dose for COVID-19 immunization. The patient's medical history included allergy to cefdiner and augmentin and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The concomitant drug was not reported. The patient experienced headache on 23Dec2020 05:00 AM. No treatment for adverse event. The outcome of the events was recovered in Dec2020.