chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Experienced skin rash/Some of the rash showed up in new places like her trunk; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that: A 77-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E13236), via an unspecified route of administration, administered in left arm on 21Jan2021 between 10:15-10:30 (at the age of 77 years old) as a single dose for COVID-19 immunisation. The patient medical history included Allergic to Sulfa drugs. The patient is generally a veru healthy person, does not have diabetes, not overweight and exercises. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine of Flu vaccines, Hepatitis A and Hepatitis B, shingles shot (sore arm), pneumonia shots. On 22Jan2021 at 20:00 the patient experienced Rash: began night of 22Jan2021. Rash is migrating. Started around right armpit all around the edges. At the same time it was on the edges of her left armpit. Rash is still there, but faint because she has been taking this medicine. There are larger blotches now on her right shoulder, both breasts, upper thighs, and small places. Might be one starting on her stomach. The patient visited dermatology doctor's office. The patient received treatment for the events with steroid creams: Fluocinonide Gel 0.5%, Clobetasol Propionate cream 0.05%, and Triamcinolone Acetonide cream 0.1% and Benadryl to lessen the rash. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Injection site pain
Clinical narrative: injection site pain; CHILLS; tired; dizzy; elev BP and pulse; elev BP and pulse; This is a spontaneous case from a contactable consumer. A 66-Years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm on 18-FEB-2021 10:30 at the age of 66 years old as single dose for COVID-19 immunisation. Historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered at Left arm on 28Jan2021 01:45 PM. The patient medical history included multiple sclerosis and chronic lymphocytic leukaemia. The patient past drug events included oxybutynin, trospium chloride and myrbetriq. The patient was allergies to sulfa, nickel on skin and bandage adhesive. Concomitant medications were not reported. On 18Feb2021at 18:00, the patient had experienced vaccination site pain, chills, tired, dizzy, elevated BP and pulse. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.  Information on lot number/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Dizziness, Fatigue
Clinical narrative: injection site pain; CHILLS; tired; dizzy; elev BP and pulse; elev BP and pulse; This is a spontaneous case from a contactable consumer. A 66-Years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm on 18-FEB-2021 10:30 at the age of 66 years old as single dose for COVID-19 immunisation. Historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered at Left arm on 28Jan2021 01:45 PM. The patient medical history included multiple sclerosis and chronic lymphocytic leukaemia. The patient past drug events included oxybutynin, trospium chloride and myrbetriq. The patient was allergies to sulfa, nickel on skin and bandage adhesive. Concomitant medications were not reported. On 18Feb2021at 18:00, the patient had experienced vaccination site pain, chills, tired, dizzy, elevated BP and pulse. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.  Information on lot number/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pulse abnormal, Vaccination site pain
Clinical narrative: injection site pain; CHILLS; tired; dizzy; elev BP and pulse; elev BP and pulse; This is a spontaneous case from a contactable consumer. A 66-Years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered on left arm on 18-FEB-2021 10:30 at the age of 66 years old as single dose for COVID-19 immunisation. Historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered at Left arm on 28Jan2021 01:45 PM. The patient medical history included multiple sclerosis and chronic lymphocytic leukaemia. The patient past drug events included oxybutynin, trospium chloride and myrbetriq. The patient was allergies to sulfa, nickel on skin and bandage adhesive. Concomitant medications were not reported. On 18Feb2021at 18:00, the patient had experienced vaccination site pain, chills, tired, dizzy, elevated BP and pulse. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.  Information on lot number/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphagia, Neck pain, Pain in extremity, Pruritus
Clinical narrative: throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of water; unable to eat (beans and rice); generalized swelling at left arm; pain in left arm referring into back and neck; pain in left arm referring into back and neck; pain in left arm referring into back and neck; limited ROM; unable to lift arm; itchy ears; This is a spontaneous report from a contactable Other HCP (reported herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry dates were not provided) via unspecified route of administration on 18Feb2021 17:45 as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history was not reported. The patient was allergic to amoxicillin, azithromycin, doxycycline, sensitive to caines and walnut. Concomitant medications included ergocalciferol (VIT D) daily, vitamin b complex daily, melatonin as needed. Patient did not receive other vaccines within 4 weeks or prior vaccination. The patient did not have COVID 19 prior to vaccination and no COVID-19 test post vaccination. On 18Feb2021 17:45, the patient throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears. Therapeutic measures were taken with 50 mg Benadryl for throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), after 15-30 minutes later able to eat and no treatment received for rest of the events. The outcome of the events throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice) was recovered on an unspecified date on 2021 and generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Throat irritation
Clinical narrative: throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of water; unable to eat (beans and rice); generalized swelling at left arm; pain in left arm referring into back and neck; pain in left arm referring into back and neck; pain in left arm referring into back and neck; limited ROM; unable to lift arm; itchy ears; This is a spontaneous report from a contactable Other HCP (reported herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry dates were not provided) via unspecified route of administration on 18Feb2021 17:45 as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history was not reported. The patient was allergic to amoxicillin, azithromycin, doxycycline, sensitive to caines and walnut. Concomitant medications included ergocalciferol (VIT D) daily, vitamin b complex daily, melatonin as needed. Patient did not receive other vaccines within 4 weeks or prior vaccination. The patient did not have COVID 19 prior to vaccination and no COVID-19 test post vaccination. On 18Feb2021 17:45, the patient throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears. Therapeutic measures were taken with 50 mg Benadryl for throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), after 15-30 minutes later able to eat and no treatment received for rest of the events. The outcome of the events throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice) was recovered on an unspecified date on 2021 and generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Cough, Dysphagia, Ear pruritus, Feeding disorder
Clinical narrative: throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of water; unable to eat (beans and rice); generalized swelling at left arm; pain in left arm referring into back and neck; pain in left arm referring into back and neck; pain in left arm referring into back and neck; limited ROM; unable to lift arm; itchy ears; This is a spontaneous report from a contactable Other HCP (reported herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry dates were not provided) via unspecified route of administration on 18Feb2021 17:45 as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history was not reported. The patient was allergic to amoxicillin, azithromycin, doxycycline, sensitive to caines and walnut. Concomitant medications included ergocalciferol (VIT D) daily, vitamin b complex daily, melatonin as needed. Patient did not receive other vaccines within 4 weeks or prior vaccination. The patient did not have COVID 19 prior to vaccination and no COVID-19 test post vaccination. On 18Feb2021 17:45, the patient throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears. Therapeutic measures were taken with 50 mg Benadryl for throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), after 15-30 minutes later able to eat and no treatment received for rest of the events. The outcome of the events throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice) was recovered on an unspecified date on 2021 and generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Neck pain, Pain in extremity, Throat clearing, Throat tightness
Clinical narrative: throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of water; unable to eat (beans and rice); generalized swelling at left arm; pain in left arm referring into back and neck; pain in left arm referring into back and neck; pain in left arm referring into back and neck; limited ROM; unable to lift arm; itchy ears; This is a spontaneous report from a contactable Other HCP (reported herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry dates were not provided) via unspecified route of administration on 18Feb2021 17:45 as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history was not reported. The patient was allergic to amoxicillin, azithromycin, doxycycline, sensitive to caines and walnut. Concomitant medications included ergocalciferol (VIT D) daily, vitamin b complex daily, melatonin as needed. Patient did not receive other vaccines within 4 weeks or prior vaccination. The patient did not have COVID 19 prior to vaccination and no COVID-19 test post vaccination. On 18Feb2021 17:45, the patient throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears. Therapeutic measures were taken with 50 mg Benadryl for throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), after 15-30 minutes later able to eat and no treatment received for rest of the events. The outcome of the events throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice) was recovered on an unspecified date on 2021 and generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: throat tightness; throat clearing; throat clearing difficulty swallowing; coughing with drink of water; unable to eat (beans and rice); generalized swelling at left arm; pain in left arm referring into back and neck; pain in left arm referring into back and neck; pain in left arm referring into back and neck; limited ROM; unable to lift arm; itchy ears; This is a spontaneous report from a contactable Other HCP (reported herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201 and expiry dates were not provided) via unspecified route of administration on 18Feb2021 17:45 as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient's medical history was not reported. The patient was allergic to amoxicillin, azithromycin, doxycycline, sensitive to caines and walnut. Concomitant medications included ergocalciferol (VIT D) daily, vitamin b complex daily, melatonin as needed. Patient did not receive other vaccines within 4 weeks or prior vaccination. The patient did not have COVID 19 prior to vaccination and no COVID-19 test post vaccination. On 18Feb2021 17:45, the patient throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears. Therapeutic measures were taken with 50 mg Benadryl for throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice), after 15-30 minutes later able to eat and no treatment received for rest of the events. The outcome of the events throat tightness, throat clearing difficulty swallowing, coughing with drink of water, unable to eat (beans and rice) was recovered on an unspecified date on 2021 and generalized swelling at left arm, pain in left arm referring into back and neck, limited ROM, unable to lift arm and itchy ears was not recovered.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Decreased appetite, Echocardiogram, Electrocardiogram, Emotional distress
Clinical narrative: liver inflamed and enlarged; liver inflamed and enlarged; Night sweats; Liver enzymes elevated; dizziness; weakness; fever highest 101.9; headache; nausea; body aches; chills; Abdominal tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at 12:30 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. Medical history included cystic fibrosis. Concomitant medications included elexacaftor, ivacaftor, tezacaftor (TRIKAFTA); bupropion hydrochloride (WELLBUTRIN); piroxicam (PAXIL [PIROXICAM]); omeprazole (PROTONIX [OMEPRAZOLE]); montelukast sodium (SINGULAIR); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); pancreatin (CREON); betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES). On 04Feb2021 at 13:00, the patient experienced headache, nausea, body aches, and chills. On 05Feb2021, the patient had a fever highest 101.9. On 06Feb2021, patient experienced dizziness, and weakness. On 08Feb2021, night sweats and liver enzymes elevated were noted, the patient kept getting worse. On 11Feb2021, the patient had liver inflamed and enlarged. It was also reported that abdominal tenderness was noted on an unspecified date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was also referred to a GI specialist. No treatment was given. The patient underwent lab tests and procedures which included body temperature: 101.9 on 05Feb2021; flu (influenza virus test) and nasal swab: both negative on 08Feb2021; blood work: unknown results and liver enzymes test: elevated both on 10Feb2021; chest x-ray: unknown results, CT scan: liver inflamed and enlarged, and liver enzymes test: unknown results on 11Feb2021; and nasal swab: negative on 18Feb2021. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fluid retention, Hepatomegaly, Insomnia, Liver function test
Clinical narrative: liver inflamed and enlarged; liver inflamed and enlarged; Night sweats; Liver enzymes elevated; dizziness; weakness; fever highest 101.9; headache; nausea; body aches; chills; Abdominal tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at 12:30 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. Medical history included cystic fibrosis. Concomitant medications included elexacaftor, ivacaftor, tezacaftor (TRIKAFTA); bupropion hydrochloride (WELLBUTRIN); piroxicam (PAXIL [PIROXICAM]); omeprazole (PROTONIX [OMEPRAZOLE]); montelukast sodium (SINGULAIR); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); pancreatin (CREON); betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES). On 04Feb2021 at 13:00, the patient experienced headache, nausea, body aches, and chills. On 05Feb2021, the patient had a fever highest 101.9. On 06Feb2021, patient experienced dizziness, and weakness. On 08Feb2021, night sweats and liver enzymes elevated were noted, the patient kept getting worse. On 11Feb2021, the patient had liver inflamed and enlarged. It was also reported that abdominal tenderness was noted on an unspecified date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was also referred to a GI specialist. No treatment was given. The patient underwent lab tests and procedures which included body temperature: 101.9 on 05Feb2021; flu (influenza virus test) and nasal swab: both negative on 08Feb2021; blood work: unknown results and liver enzymes test: elevated both on 10Feb2021; chest x-ray: unknown results, CT scan: liver inflamed and enlarged, and liver enzymes test: unknown results on 11Feb2021; and nasal swab: negative on 18Feb2021. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: liver inflamed and enlarged; liver inflamed and enlarged; Night sweats; Liver enzymes elevated; dizziness; weakness; fever highest 101.9; headache; nausea; body aches; chills; Abdominal tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at 12:30 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. Medical history included cystic fibrosis. Concomitant medications included elexacaftor, ivacaftor, tezacaftor (TRIKAFTA); bupropion hydrochloride (WELLBUTRIN); piroxicam (PAXIL [PIROXICAM]); omeprazole (PROTONIX [OMEPRAZOLE]); montelukast sodium (SINGULAIR); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); pancreatin (CREON); betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES). On 04Feb2021 at 13:00, the patient experienced headache, nausea, body aches, and chills. On 05Feb2021, the patient had a fever highest 101.9. On 06Feb2021, patient experienced dizziness, and weakness. On 08Feb2021, night sweats and liver enzymes elevated were noted, the patient kept getting worse. On 11Feb2021, the patient had liver inflamed and enlarged. It was also reported that abdominal tenderness was noted on an unspecified date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was also referred to a GI specialist. No treatment was given. The patient underwent lab tests and procedures which included body temperature: 101.9 on 05Feb2021; flu (influenza virus test) and nasal swab: both negative on 08Feb2021; blood work: unknown results and liver enzymes test: elevated both on 10Feb2021; chest x-ray: unknown results, CT scan: liver inflamed and enlarged, and liver enzymes test: unknown results on 11Feb2021; and nasal swab: negative on 18Feb2021. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal tenderness, Asthenia, Blood count, Body temperature, Chest X-ray
Clinical narrative: liver inflamed and enlarged; liver inflamed and enlarged; Night sweats; Liver enzymes elevated; dizziness; weakness; fever highest 101.9; headache; nausea; body aches; chills; Abdominal tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at 12:30 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. Medical history included cystic fibrosis. Concomitant medications included elexacaftor, ivacaftor, tezacaftor (TRIKAFTA); bupropion hydrochloride (WELLBUTRIN); piroxicam (PAXIL [PIROXICAM]); omeprazole (PROTONIX [OMEPRAZOLE]); montelukast sodium (SINGULAIR); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); pancreatin (CREON); betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES). On 04Feb2021 at 13:00, the patient experienced headache, nausea, body aches, and chills. On 05Feb2021, the patient had a fever highest 101.9. On 06Feb2021, patient experienced dizziness, and weakness. On 08Feb2021, night sweats and liver enzymes elevated were noted, the patient kept getting worse. On 11Feb2021, the patient had liver inflamed and enlarged. It was also reported that abdominal tenderness was noted on an unspecified date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was also referred to a GI specialist. No treatment was given. The patient underwent lab tests and procedures which included body temperature: 101.9 on 05Feb2021; flu (influenza virus test) and nasal swab: both negative on 08Feb2021; blood work: unknown results and liver enzymes test: elevated both on 10Feb2021; chest x-ray: unknown results, CT scan: liver inflamed and enlarged, and liver enzymes test: unknown results on 11Feb2021; and nasal swab: negative on 18Feb2021. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Computerised tomogram, Dizziness, Headache, Hepatic enzyme increased
Clinical narrative: liver inflamed and enlarged; liver inflamed and enlarged; Night sweats; Liver enzymes elevated; dizziness; weakness; fever highest 101.9; headache; nausea; body aches; chills; Abdominal tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at 12:30 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. Medical history included cystic fibrosis. Concomitant medications included elexacaftor, ivacaftor, tezacaftor (TRIKAFTA); bupropion hydrochloride (WELLBUTRIN); piroxicam (PAXIL [PIROXICAM]); omeprazole (PROTONIX [OMEPRAZOLE]); montelukast sodium (SINGULAIR); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); pancreatin (CREON); betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES). On 04Feb2021 at 13:00, the patient experienced headache, nausea, body aches, and chills. On 05Feb2021, the patient had a fever highest 101.9. On 06Feb2021, patient experienced dizziness, and weakness. On 08Feb2021, night sweats and liver enzymes elevated were noted, the patient kept getting worse. On 11Feb2021, the patient had liver inflamed and enlarged. It was also reported that abdominal tenderness was noted on an unspecified date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was also referred to a GI specialist. No treatment was given. The patient underwent lab tests and procedures which included body temperature: 101.9 on 05Feb2021; flu (influenza virus test) and nasal swab: both negative on 08Feb2021; blood work: unknown results and liver enzymes test: elevated both on 10Feb2021; chest x-ray: unknown results, CT scan: liver inflamed and enlarged, and liver enzymes test: unknown results on 11Feb2021; and nasal swab: negative on 18Feb2021. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatitis, Hepatomegaly, Influenza virus test, Liver function test, Nausea
Clinical narrative: liver inflamed and enlarged; liver inflamed and enlarged; Night sweats; Liver enzymes elevated; dizziness; weakness; fever highest 101.9; headache; nausea; body aches; chills; Abdominal tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at 12:30 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. Medical history included cystic fibrosis. Concomitant medications included elexacaftor, ivacaftor, tezacaftor (TRIKAFTA); bupropion hydrochloride (WELLBUTRIN); piroxicam (PAXIL [PIROXICAM]); omeprazole (PROTONIX [OMEPRAZOLE]); montelukast sodium (SINGULAIR); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); pancreatin (CREON); betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES). On 04Feb2021 at 13:00, the patient experienced headache, nausea, body aches, and chills. On 05Feb2021, the patient had a fever highest 101.9. On 06Feb2021, patient experienced dizziness, and weakness. On 08Feb2021, night sweats and liver enzymes elevated were noted, the patient kept getting worse. On 11Feb2021, the patient had liver inflamed and enlarged. It was also reported that abdominal tenderness was noted on an unspecified date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was also referred to a GI specialist. No treatment was given. The patient underwent lab tests and procedures which included body temperature: 101.9 on 05Feb2021; flu (influenza virus test) and nasal swab: both negative on 08Feb2021; blood work: unknown results and liver enzymes test: elevated both on 10Feb2021; chest x-ray: unknown results, CT scan: liver inflamed and enlarged, and liver enzymes test: unknown results on 11Feb2021; and nasal swab: negative on 18Feb2021. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: liver inflamed and enlarged; liver inflamed and enlarged; Night sweats; Liver enzymes elevated; dizziness; weakness; fever highest 101.9; headache; nausea; body aches; chills; Abdominal tenderness; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 at 12:30 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. Medical history included cystic fibrosis. Concomitant medications included elexacaftor, ivacaftor, tezacaftor (TRIKAFTA); bupropion hydrochloride (WELLBUTRIN); piroxicam (PAXIL [PIROXICAM]); omeprazole (PROTONIX [OMEPRAZOLE]); montelukast sodium (SINGULAIR); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); pancreatin (CREON); betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES). On 04Feb2021 at 13:00, the patient experienced headache, nausea, body aches, and chills. On 05Feb2021, the patient had a fever highest 101.9. On 06Feb2021, patient experienced dizziness, and weakness. On 08Feb2021, night sweats and liver enzymes elevated were noted, the patient kept getting worse. On 11Feb2021, the patient had liver inflamed and enlarged. It was also reported that abdominal tenderness was noted on an unspecified date in Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was also referred to a GI specialist. No treatment was given. The patient underwent lab tests and procedures which included body temperature: 101.9 on 05Feb2021; flu (influenza virus test) and nasal swab: both negative on 08Feb2021; blood work: unknown results and liver enzymes test: elevated both on 10Feb2021; chest x-ray: unknown results, CT scan: liver inflamed and enlarged, and liver enzymes test: unknown results on 11Feb2021; and nasal swab: negative on 18Feb2021. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Started feeling nauseous about 45 mins after injection; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN198) via an unspecified route of administration in left arm on 19Feb2021 at 09:45 as single dose for COVID-19 immunization. The patient medical history and concomitant medications included meloxicam, progesterone and losartan. On 19Feb2021 at 10:45, patient started feeling nauseous about 45 mins after injection. Outcome of the event was recovered.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: felt light-headed; right hand began to tingle; my hand also had tremors.; This is a spontaneous report from a contactable nurse (Patient). A 26-year-old female patient (Non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration in left arm on 19Feb2021 09:30 AM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. On 19Feb2021 10:15 AM, the patient waited 15 minutes after the vaccine to leave, patient experienced when she stood, she felt lightheaded, but event went away after a few deep breaths. About 20-25 minutes after getting the vaccine, patient right hand began to tingle and lasted for 3 hours from 10:15 AM to 1:20 pm. For the first 30 minutes of tingling her hand also had tremors. The patient did not receive any treatment for the events. The outcome of the events was reported as recovered on 19Feb2021.  Information on Lot/Batch number has been requested
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia, Tremor
Clinical narrative: felt light-headed; right hand began to tingle; my hand also had tremors.; This is a spontaneous report from a contactable nurse (Patient). A 26-year-old female patient (Non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration in left arm on 19Feb2021 09:30 AM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. On 19Feb2021 10:15 AM, the patient waited 15 minutes after the vaccine to leave, patient experienced when she stood, she felt lightheaded, but event went away after a few deep breaths. About 20-25 minutes after getting the vaccine, patient right hand began to tingle and lasted for 3 hours from 10:15 AM to 1:20 pm. For the first 30 minutes of tingling her hand also had tremors. The patient did not receive any treatment for the events. The outcome of the events was reported as recovered on 19Feb2021.  Information on Lot/Batch number has been requested
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Neck pain, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Left arm sore. Left arm painful to lift up.pain runs from left arm to left tendon in neck; Left arm sore. Left arm painful to lift up.pain runs from left arm to left tendon in neck; Entire body is cold especially both feet even with two layers of clothes; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6198, Expiration date: Unknown) via an unspecified route of administration in arm Left on 20Feb2021 10:00 as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included thyroid Hasimotos disease and Known allergies included Morphine. The patient previously took morphine and experienced drug hypersensitivity. The patient had no other vaccine in four weeks. The patient not had COVID prior vaccination. Concomitant medication in two weeks included pravastatin (PRAVASTATIN) 20 mg, levothyroxine sodium (LEVOTHYROXIN) 50 mcg and lisinopril (LISINOPRIL) for unknown indication. On 21Feb2021 07:00, the patient experienced left arm sore, left arm painful to lift up. Pain runs from left arm to left tendon in neck and entire body is cold especially both feet even with two layers of clothes. The patient not tested COVID post vaccination. The patient did not receive any treatment for the event. The outcome of events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Peripheral coldness
Clinical narrative: Left arm sore. Left arm painful to lift up.pain runs from left arm to left tendon in neck; Left arm sore. Left arm painful to lift up.pain runs from left arm to left tendon in neck; Entire body is cold especially both feet even with two layers of clothes; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6198, Expiration date: Unknown) via an unspecified route of administration in arm Left on 20Feb2021 10:00 as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included thyroid Hasimotos disease and Known allergies included Morphine. The patient previously took morphine and experienced drug hypersensitivity. The patient had no other vaccine in four weeks. The patient not had COVID prior vaccination. Concomitant medication in two weeks included pravastatin (PRAVASTATIN) 20 mg, levothyroxine sodium (LEVOTHYROXIN) 50 mcg and lisinopril (LISINOPRIL) for unknown indication. On 21Feb2021 07:00, the patient experienced left arm sore, left arm painful to lift up. Pain runs from left arm to left tendon in neck and entire body is cold especially both feet even with two layers of clothes. The patient not tested COVID post vaccination. The patient did not receive any treatment for the event. The outcome of events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocardial infarction, Pulmonary thrombosis
Clinical narrative: Chest pain/stabbing pain on her chest wall at the right side; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EL9269; Expiration Date: unknown), via an unspecified route of administration, administered in arm Left on 30Jan2021 at 11:00 (at the age of 76-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included Lupus from 1976 to an unknown date. There were no concomitant medications. Prior Vaccinations (within 4 weeks) reported as none. History of all previous immunization and additional vaccines administered on same date with the Pfizer vaccine reported as none. Consumer reported that she had a side effect that she had never seen listed. She had no pain or redness at the vaccine site; but about 18:00 on Sunday night she had stabbing pain on her chest wall at the right side with no other symptoms. She took an aspirin and laid down because she couldn't move with the pain. The next morning she took another aspirin and laid in bed that day. It was bad for three days. The last time she noticed that the pain was on Monday. She was thinking that she had dodged a bullet because she was not having any pain at the site. Patient stated that she had friends, (name provided) and (name provided), in their 80s, who had pain from the elbow to shoulder, she spoke with them the day after they received their shots and they got there shot at the same time and place as the patient. Patient was scheduled to receive the second dose of the vaccine on 20Feb2021. She wanted to know that the chest pain a side effect and mentioned that she was concerned about getting the next dose. On 31Jan2021, the patient experienced Chest pain/stabbing pain on her chest wall at the right side. Therapeutic measures were taken as a result of chest pain and included treatment with aspirin. Patient did not required a visit to physician or Emergency room. Relevant test reported as none. The outcome of the event was recovered on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain/stabbing pain on her chest wall at the right side; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EL9269; Expiration Date: unknown), via an unspecified route of administration, administered in arm Left on 30Jan2021 at 11:00 (at the age of 76-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included Lupus from 1976 to an unknown date. There were no concomitant medications. Prior Vaccinations (within 4 weeks) reported as none. History of all previous immunization and additional vaccines administered on same date with the Pfizer vaccine reported as none. Consumer reported that she had a side effect that she had never seen listed. She had no pain or redness at the vaccine site; but about 18:00 on Sunday night she had stabbing pain on her chest wall at the right side with no other symptoms. She took an aspirin and laid down because she couldn't move with the pain. The next morning she took another aspirin and laid in bed that day. It was bad for three days. The last time she noticed that the pain was on Monday. She was thinking that she had dodged a bullet because she was not having any pain at the site. Patient stated that she had friends, (name provided) and (name provided), in their 80s, who had pain from the elbow to shoulder, she spoke with them the day after they received their shots and they got there shot at the same time and place as the patient. Patient was scheduled to receive the second dose of the vaccine on 20Feb2021. She wanted to know that the chest pain a side effect and mentioned that she was concerned about getting the next dose. On 31Jan2021, the patient experienced Chest pain/stabbing pain on her chest wall at the right side. Therapeutic measures were taken as a result of chest pain and included treatment with aspirin. Patient did not required a visit to physician or Emergency room. Relevant test reported as none. The outcome of the event was recovered on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Wheezing; cough; Feverish feeling in her chest; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 16:15 (at the age of 75-year-old) as a single dose for COVID-19 immunization in Pharmacy/drug store. Medical history included fibromyalgia, arthritis, sinus problems, acid reflux, high blood pressure and seasonal allergies. Concomitant medications included Omeprazole treated for acid reflux, Pregabalin and Tramadol for fibromyalgia and arthritis, lisinopril for high blood pressure, colecalciferol (VITAMIN D), Fish oil, loratadine (CLARITINE) for seasonal allergies and Hair Skin & Nails.The patient did not receive any other vaccines within four weeks prior to the vaccination and did not experienced any adverse reactions prior vaccination. Patient felt fine until 11Feb2021 and had been experiencing a lot of coughing and wheezing but had no fever. Patient was taking over the counter cough medicine to treat the reaction. Patient enquired if this reaction can happen 4-5 days after receiving the vaccine. On an unspecified date in Feb2021, the patient experienced feverish feeling in her chest. The outcome for the events coughing and wheezing was recovering and feverish feeling in her chest was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Wheezing
Clinical narrative: Wheezing; cough; Feverish feeling in her chest; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 16:15 (at the age of 75-year-old) as a single dose for COVID-19 immunization in Pharmacy/drug store. Medical history included fibromyalgia, arthritis, sinus problems, acid reflux, high blood pressure and seasonal allergies. Concomitant medications included Omeprazole treated for acid reflux, Pregabalin and Tramadol for fibromyalgia and arthritis, lisinopril for high blood pressure, colecalciferol (VITAMIN D), Fish oil, loratadine (CLARITINE) for seasonal allergies and Hair Skin & Nails.The patient did not receive any other vaccines within four weeks prior to the vaccination and did not experienced any adverse reactions prior vaccination. Patient felt fine until 11Feb2021 and had been experiencing a lot of coughing and wheezing but had no fever. Patient was taking over the counter cough medicine to treat the reaction. Patient enquired if this reaction can happen 4-5 days after receiving the vaccine. On an unspecified date in Feb2021, the patient experienced feverish feeling in her chest. The outcome for the events coughing and wheezing was recovering and feverish feeling in her chest was not recovered.