chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Oropharyngeal pain, Pharyngeal swelling, Swollen tongue
Clinical narrative: About 20 minutes after shot it felt like my throat and tongue swelled up and my throat swelled up.   I had difficulty swallowing.About 8 hours later my throat was just really sore.    My thinking was also confused.  I should have went to the emergency room but I did not,  I felt very unwell right away.  I also had feeling of anxiety.  I stayed in bed for three days - unable to work etc.  I had chills exhaustion, dizziness.  On the fourth day I still was unwell but was able to get out of bed and shower etc.  My doctor has indicated I can?t get 2nd vaccine as I had allergic reaction.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis, Eye swelling
Clinical narrative: Conjunctivitis; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6208; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 27Mar2021 08:30 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included amlodipine (AMLODIPINE), fluticasone propionate, salmeterol xinafoate (ADVAIR), ketotifen fumarate (CLARITIN EYE) taken for an unspecified indication. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously took codine P and was allergic to codine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 08:00 the patient experienced conjunctivitis. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of conjunctivitis as patient had received treatment with TobraDex ST 1 drop 4Xdly, Moxifloxacin 1 drop 4X d. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test Nasal swab (Rapid test) which was negative on 16Apr2021. The outcome of event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis, SARS-CoV-2 test
Clinical narrative: Conjunctivitis; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6208; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 27Mar2021 08:30 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included amlodipine (AMLODIPINE), fluticasone propionate, salmeterol xinafoate (ADVAIR), ketotifen fumarate (CLARITIN EYE) taken for an unspecified indication. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously took codine P and was allergic to codine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 08:00 the patient experienced conjunctivitis. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of conjunctivitis as patient had received treatment with TobraDex ST 1 drop 4Xdly, Moxifloxacin 1 drop 4X d. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test Nasal swab (Rapid test) which was negative on 16Apr2021. The outcome of event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose normal, Dizziness, Fatigue, Heart rate increased, Hypoaesthesia
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA.  Symptoms immediately started after vaccination. Patient reports having chills, tremors, diaphoresis, numbness to his hands/stomach, palpitations, and light headedness. Nurse from the vaccine clinic reports giving the patient cetirizine prior to transferring to ED.  Continued having numbness to the hands and slight light headedness. No further intervention.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pain in extremity, Tremor
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA.  Symptoms immediately started after vaccination. Patient reports having chills, tremors, diaphoresis, numbness to his hands/stomach, palpitations, and light headedness. Nurse from the vaccine clinic reports giving the patient cetirizine prior to transferring to ED.  Continued having numbness to the hands and slight light headedness. No further intervention.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA.  Symptoms immediately started after vaccination. Patient reports having chills, tremors, diaphoresis, numbness to his hands/stomach, palpitations, and light headedness. Nurse from the vaccine clinic reports giving the patient cetirizine prior to transferring to ED.  Continued having numbness to the hands and slight light headedness. No further intervention.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Palpitations, Panic attack, Paranoia
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA.  Symptoms immediately started after vaccination. Patient reports having chills, tremors, diaphoresis, numbness to his hands/stomach, palpitations, and light headedness. Nurse from the vaccine clinic reports giving the patient cetirizine prior to transferring to ED.  Continued having numbness to the hands and slight light headedness. No further intervention.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA.  Symptoms immediately started after vaccination. Patient reports having chills, tremors, diaphoresis, numbness to his hands/stomach, palpitations, and light headedness. Nurse from the vaccine clinic reports giving the patient cetirizine prior to transferring to ED.  Continued having numbness to the hands and slight light headedness. No further intervention.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Palpitations, Tremor
Clinical narrative: Pfizer-BioNTech COVID-10 Vaccine EUA.  Symptoms immediately started after vaccination. Patient reports having chills, tremors, diaphoresis, numbness to his hands/stomach, palpitations, and light headedness. Nurse from the vaccine clinic reports giving the patient cetirizine prior to transferring to ED.  Continued having numbness to the hands and slight light headedness. No further intervention.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Flushing, Pruritus, Pyrexia, Rash
Clinical narrative: low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Flushing and redness in face; Flushing and redness in face; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included pollen allergies and no known allergies with medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included omeprazole 20 mg, atorvastatin 10 mg and tadalafil 5 (units not provided) (received within 2 weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:45 as a single dose for COVID-19 immunization. On 08Apr2021 at 13:15, the patient experienced rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees and had flushing and redness in face but no swelling/itching. As rash was subsided, low grade fever (100 degrees Fahrenheit) developed. Patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event rash was recovered on an unspecified date in 2021 and the rest of the events was recovering.  Information on Lot/Batch number was available.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Flushing and redness in face; Flushing and redness in face; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included pollen allergies and no known allergies with medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included omeprazole 20 mg, atorvastatin 10 mg and tadalafil 5 (units not provided) (received within 2 weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:45 as a single dose for COVID-19 immunization. On 08Apr2021 at 13:15, the patient experienced rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees and had flushing and redness in face but no swelling/itching. As rash was subsided, low grade fever (100 degrees Fahrenheit) developed. Patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event rash was recovered on an unspecified date in 2021 and the rest of the events was recovering.  Information on Lot/Batch number was available.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Erythema, Flushing, Pruritus, Pyrexia
Clinical narrative: low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Flushing and redness in face; Flushing and redness in face; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included pollen allergies and no known allergies with medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included omeprazole 20 mg, atorvastatin 10 mg and tadalafil 5 (units not provided) (received within 2 weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:45 as a single dose for COVID-19 immunization. On 08Apr2021 at 13:15, the patient experienced rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees and had flushing and redness in face but no swelling/itching. As rash was subsided, low grade fever (100 degrees Fahrenheit) developed. Patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event rash was recovered on an unspecified date in 2021 and the rest of the events was recovering.  Information on Lot/Batch number was available.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Flushing and redness in face; Flushing and redness in face; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included pollen allergies and no known allergies with medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included omeprazole 20 mg, atorvastatin 10 mg and tadalafil 5 (units not provided) (received within 2 weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:45 as a single dose for COVID-19 immunization. On 08Apr2021 at 13:15, the patient experienced rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees and had flushing and redness in face but no swelling/itching. As rash was subsided, low grade fever (100 degrees Fahrenheit) developed. Patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event rash was recovered on an unspecified date in 2021 and the rest of the events was recovering.  Information on Lot/Batch number was available.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: A rash broke out all over my body; This is a spontaneous report from a contactable consumer (patient). A patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number ER8733), via an unspecified route of administration, in arm left on 08Apr2021 at 14:45 as 1st dose single for COVID-19 immunisation. The patient had no medical history. The concomitant medications of the patient included bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL /HCTZ) and allopurinol both taken for an unspecified indication received within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. 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. Since the vaccination, the patient not been tested with COVID-19. On 08Apr2021 at 17:00, the patient experienced a rash broke out all over body. Therapeutic measures were taken as a result event that included over the counter Benadryl and Pepcid. The outcome of the event was not resolved.  Information on Lot/Batch number was available. Follow up letter has been generated for further information.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Cardiac arrest, Resuscitation
Clinical narrative: Headache evening of vaccination, woke up in morning with shortness of breath, difficulty walking from bedroom to living room, oxygen level via health app showed 74%,  called ambulance, cardiac arrest in ambulance on way to ER.   Due to my size, flown from ER to main hospital.     Woke up in ICU on ventilator.  Discharge diagnosis:  STEMI, hypotension, Morbid Obesity, Acute systolic heart failure, pulmonary edema, paroxysmal atrial fibrillation.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute left ventricular failure, Acute myocardial infarction, Atrial fibrillation, Cardiac arrest, Dyspnoea
Clinical narrative: Headache evening of vaccination, woke up in morning with shortness of breath, difficulty walking from bedroom to living room, oxygen level via health app showed 74%,  called ambulance, cardiac arrest in ambulance on way to ER.   Due to my size, flown from ER to main hospital.     Woke up in ICU on ventilator.  Discharge diagnosis:  STEMI, hypotension, Morbid Obesity, Acute systolic heart failure, pulmonary edema, paroxysmal atrial fibrillation.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Gait disturbance, Headache, Hypotension, Intensive care
Clinical narrative: Headache evening of vaccination, woke up in morning with shortness of breath, difficulty walking from bedroom to living room, oxygen level via health app showed 74%,  called ambulance, cardiac arrest in ambulance on way to ER.   Due to my size, flown from ER to main hospital.     Woke up in ICU on ventilator.  Discharge diagnosis:  STEMI, hypotension, Morbid Obesity, Acute systolic heart failure, pulmonary edema, paroxysmal atrial fibrillation.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Mechanical ventilation, Obesity, Pulmonary oedema
Clinical narrative: Headache evening of vaccination, woke up in morning with shortness of breath, difficulty walking from bedroom to living room, oxygen level via health app showed 74%,  called ambulance, cardiac arrest in ambulance on way to ER.   Due to my size, flown from ER to main hospital.     Woke up in ICU on ventilator.  Discharge diagnosis:  STEMI, hypotension, Morbid Obesity, Acute systolic heart failure, pulmonary edema, paroxysmal atrial fibrillation.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: He believes the nurse that injected him went too deep and hit the bone. He said it hurt more than usual; He believes the nurse that injected him went too deep and hit the bone. He said it hurt more than usual; This is a spontaneous report from a contactable physician (patient) via Pfizer sales representative. A 70-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, after the vaccination, the patient stated that he believes the nurse that injected him went too deep and hit the bone. He said it hurt more than usual. The patient was asking if the second dose of the vaccine would be effective if it did hit the bone. He wanted to know which antibody test he should get to see if he has immunity. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error, Vaccination site pain
Clinical narrative: He believes the nurse that injected him went too deep and hit the bone. He said it hurt more than usual; He believes the nurse that injected him went too deep and hit the bone. He said it hurt more than usual; This is a spontaneous report from a contactable physician (patient) via Pfizer sales representative. A 70-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, after the vaccination, the patient stated that he believes the nurse that injected him went too deep and hit the bone. He said it hurt more than usual. The patient was asking if the second dose of the vaccine would be effective if it did hit the bone. He wanted to know which antibody test he should get to see if he has immunity. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Peripheral swelling, Vaccination site bruising, Vaccination site mass
Clinical narrative: a large purple, hard area around the injection site; fingers on her right side were also swollen; a large purple, hard area around the injection site; stiffness in her fingers, legs, and neck; had scars on both arms where she received her covid vaccinations; tired; This is a spontaneous report from a contactable consumer (Patient, reported for self). This case is for the second dose of BNT162B2. A 40-years-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection,Batch/Lot Number: EP6555), via an unspecified route of administration, administered in arm right on 21Mar2021  as single dose for covid-19 immunisation. Medical history included von willebrand's disease. The patient concomitant medications were not reported. The patient had earlier received first dose of BNT16B2 and experienced adverse events. The patient experienced bleeding with acupuncture on 23Mar2021. The patient experienced that her fingers on her right side were also swollen and stiff along with her right leg and right side of her neck on 30Mar2021.  About a week later, she received regularly scheduled weekly allergy shots, one in each arm.  After the allergy shot, she noticed that her right arm developed a large purple, hard area around the injection site on 31Mar2021. She mentioned also feeling very tired after getting the second vaccination and she had scars on both arms where she received her COVID vaccinations in Mar2021.  She had called to see if these issues in her right side might be due to the fact that she had her second COVID vaccination in her right arm. She inquired if this reaction possibly due to receiving the allergy shot too close to the COVID injection site. She stated that she didn't re-ally bleed like a fountain but it was unexpected and surprising to the acupuncturist. She did bleed but it stopped. She has had acupuncture in the past and had a small amount of bleeding in the past. Pa-tient clarified that she received her first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the right arm; and the second dose on 21Mar2021 at an unknown time on the left arm. She added that she was tired after the first dose and after the second dose. She thinks the allergist inject-ed too close to the COVID 19 vaccination site and that caused the bruise. She stated that her arm was swollen and that has made it stiff. Her doctor didn't warn her about the von willebrand's disease possibly being activated by the vaccine. The scars she noticed from the COVID 19 vaccine are very tiny and one was close to the small pox scar. She mentioned that she got a B12 injection on the other arm and it was fine. The outcome of tired and had scars on both arms where she received her COVID vaccinations was unknown. The outcome of a large purple, hard area around the injection site was not recovered and stiffness in her fingers, legs, and neck was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site scar
Clinical narrative: a large purple, hard area around the injection site; fingers on her right side were also swollen; a large purple, hard area around the injection site; stiffness in her fingers, legs, and neck; had scars on both arms where she received her covid vaccinations; tired; This is a spontaneous report from a contactable consumer (Patient, reported for self). This case is for the second dose of BNT162B2. A 40-years-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection,Batch/Lot Number: EP6555), via an unspecified route of administration, administered in arm right on 21Mar2021  as single dose for covid-19 immunisation. Medical history included von willebrand's disease. The patient concomitant medications were not reported. The patient had earlier received first dose of BNT16B2 and experienced adverse events. The patient experienced bleeding with acupuncture on 23Mar2021. The patient experienced that her fingers on her right side were also swollen and stiff along with her right leg and right side of her neck on 30Mar2021.  About a week later, she received regularly scheduled weekly allergy shots, one in each arm.  After the allergy shot, she noticed that her right arm developed a large purple, hard area around the injection site on 31Mar2021. She mentioned also feeling very tired after getting the second vaccination and she had scars on both arms where she received her COVID vaccinations in Mar2021.  She had called to see if these issues in her right side might be due to the fact that she had her second COVID vaccination in her right arm. She inquired if this reaction possibly due to receiving the allergy shot too close to the COVID injection site. She stated that she didn't re-ally bleed like a fountain but it was unexpected and surprising to the acupuncturist. She did bleed but it stopped. She has had acupuncture in the past and had a small amount of bleeding in the past. Pa-tient clarified that she received her first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the right arm; and the second dose on 21Mar2021 at an unknown time on the left arm. She added that she was tired after the first dose and after the second dose. She thinks the allergist inject-ed too close to the COVID 19 vaccination site and that caused the bruise. She stated that her arm was swollen and that has made it stiff. Her doctor didn't warn her about the von willebrand's disease possibly being activated by the vaccine. The scars she noticed from the COVID 19 vaccine are very tiny and one was close to the small pox scar. She mentioned that she got a B12 injection on the other arm and it was fine. The outcome of tired and had scars on both arms where she received her COVID vaccinations was unknown. The outcome of a large purple, hard area around the injection site was not recovered and stiffness in her fingers, legs, and neck was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Vaccination site bruising, Vaccination site scar
Clinical narrative: a large purple, hard area around the injection site; fingers on her right side were also swollen; a large purple, hard area around the injection site; stiffness in her fingers, legs, and neck; had scars on both arms where she received her covid vaccinations; tired; This is a spontaneous report from a contactable consumer (Patient, reported for self). This case is for the second dose of BNT162B2. A 40-years-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection,Batch/Lot Number: EP6555), via an unspecified route of administration, administered in arm right on 21Mar2021  as single dose for covid-19 immunisation. Medical history included von willebrand's disease. The patient concomitant medications were not reported. The patient had earlier received first dose of BNT16B2 and experienced adverse events. The patient experienced bleeding with acupuncture on 23Mar2021. The patient experienced that her fingers on her right side were also swollen and stiff along with her right leg and right side of her neck on 30Mar2021.  About a week later, she received regularly scheduled weekly allergy shots, one in each arm.  After the allergy shot, she noticed that her right arm developed a large purple, hard area around the injection site on 31Mar2021. She mentioned also feeling very tired after getting the second vaccination and she had scars on both arms where she received her COVID vaccinations in Mar2021.  She had called to see if these issues in her right side might be due to the fact that she had her second COVID vaccination in her right arm. She inquired if this reaction possibly due to receiving the allergy shot too close to the COVID injection site. She stated that she didn't re-ally bleed like a fountain but it was unexpected and surprising to the acupuncturist. She did bleed but it stopped. She has had acupuncture in the past and had a small amount of bleeding in the past. Pa-tient clarified that she received her first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the right arm; and the second dose on 21Mar2021 at an unknown time on the left arm. She added that she was tired after the first dose and after the second dose. She thinks the allergist inject-ed too close to the COVID 19 vaccination site and that caused the bruise. She stated that her arm was swollen and that has made it stiff. Her doctor didn't warn her about the von willebrand's disease possibly being activated by the vaccine. The scars she noticed from the COVID 19 vaccine are very tiny and one was close to the small pox scar. She mentioned that she got a B12 injection on the other arm and it was fine. The outcome of tired and had scars on both arms where she received her COVID vaccinations was unknown. The outcome of a large purple, hard area around the injection site was not recovered and stiffness in her fingers, legs, and neck was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Hypoaesthesia oral, Laboratory test
Clinical narrative: severe reaction to the COVID-19 vaccine and she had anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a severe reaction to the COVID-19 vaccine and she had anaphylaxis. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Paraesthesia oral, Pruritus, Throat tightness, Tongue disorder
Clinical narrative: severe reaction to the COVID-19 vaccine and she had anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a severe reaction to the COVID-19 vaccine and she had anaphylaxis. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: severe reaction to the COVID-19 vaccine and she had anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a severe reaction to the COVID-19 vaccine and she had anaphylaxis. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe reaction to the COVID-19 vaccine and she had anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a severe reaction to the COVID-19 vaccine and she had anaphylaxis. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Pruritus
Clinical narrative: severe reaction to the COVID-19 vaccine and she had anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a severe reaction to the COVID-19 vaccine and she had anaphylaxis. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: I woke up at 1 am on April 19th with a sharp pain in my chest then a warm feeling came through my chest. The Pain continued it was hard to breath and my chest was tight it felt as if i was having a heart attack. I went to work but could not take it anymore and went to my local hospital.  They had found on CT angio chest confirmed Left-sided pulmonary embolism located small left-sided pulmonary embolism. They would not find where is had come from as the did a ultra sound of my legs. i had seen my doctor after i was release she refered me to a hematologist. they took 18 veils of blood  to test to see if there was any other reason as to why i had gotten blood clots. they called me with the results to say they could not
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood test normal, Chest discomfort, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: I woke up at 1 am on April 19th with a sharp pain in my chest then a warm feeling came through my chest. The Pain continued it was hard to breath and my chest was tight it felt as if i was having a heart attack. I went to work but could not take it anymore and went to my local hospital.  They had found on CT angio chest confirmed Left-sided pulmonary embolism located small left-sided pulmonary embolism. They would not find where is had come from as the did a ultra sound of my legs. i had seen my doctor after i was release she refered me to a hematologist. they took 18 veils of blood  to test to see if there was any other reason as to why i had gotten blood clots. they called me with the results to say they could not
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling hot, Impaired work ability, Pulmonary embolism, Ultrasound Doppler
Clinical narrative: I woke up at 1 am on April 19th with a sharp pain in my chest then a warm feeling came through my chest. The Pain continued it was hard to breath and my chest was tight it felt as if i was having a heart attack. I went to work but could not take it anymore and went to my local hospital.  They had found on CT angio chest confirmed Left-sided pulmonary embolism located small left-sided pulmonary embolism. They would not find where is had come from as the did a ultra sound of my legs. i had seen my doctor after i was release she refered me to a hematologist. they took 18 veils of blood  to test to see if there was any other reason as to why i had gotten blood clots. they called me with the results to say they could not
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Tinnitus
Clinical narrative: Rash on entire abdomen; oval shaped rash around the injection site; I had slightly increased tinnitus; This is a spontaneous report received from a contactable consumer (patient). A 56-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration in left arm on 09Mar2021 at 17:15 (age at vaccination 56years old) as 1st single dose for COVID-19 immunisation. Medical history included rashes on stomach previously when patient had viruses. Patient had no concomitant medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Mar2021 at 17:00, patient experienced rash on entire abdomen and oval shaped rash around the injection site, also had slightly increased tinnitus (along with a full abdominal rash 48 hours after vaccine). Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Tinnitus, Vaccination site rash
Clinical narrative: Rash on entire abdomen; oval shaped rash around the injection site; I had slightly increased tinnitus; This is a spontaneous report received from a contactable consumer (patient). A 56-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration in left arm on 09Mar2021 at 17:15 (age at vaccination 56years old) as 1st single dose for COVID-19 immunisation. Medical history included rashes on stomach previously when patient had viruses. Patient had no concomitant medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Mar2021 at 17:00, patient experienced rash on entire abdomen and oval shaped rash around the injection site, also had slightly increased tinnitus (along with a full abdominal rash 48 hours after vaccine). Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: To prevent soreness, the caller took Tylenol; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose yesterday. To prevent soreness, the patient took Tylenol 3 times yesterday. The patient stated that she read that you should not take any pain reliever afterward. The patient asked if it decrease the effectiveness of the vaccine. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: To prevent soreness, the caller took Tylenol; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose yesterday. To prevent soreness, the patient took Tylenol 3 times yesterday. The patient stated that she read that you should not take any pain reliever afterward. The patient asked if it decrease the effectiveness of the vaccine. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal erythema, Throat tightness
Clinical narrative: Tightening in throat (like the beginning of throat closing due to allergy); Redness inside throat.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm as a single dose on 22Apr2021 at 09:15 (at the age of 59-year-old) for COVID-19 immunisation. The medical history included seasonal allergies, allergic to horses, cats and hay. The patient previously took cherries, peaches, nectarines, plums, kiwi, melon, cantaloupe, raw nuts and raw carrots (as reported). Concomitant medication included famotidine(PEPCID) for an unknown indication ,fexofenadine(ALLEGRA)for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 01Apr2021 at 09:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient has not tested positive for COVID-19 since vaccination. The patient experienced tightening in throat (like the beginning of throat closing due to allergy) and redness inside throat on 23Apr2021 at 01:00. The patient took antihistamine ALLEGRA as treatment for reported events. The clinical outcome of the events tightening in throat and redness inside throat were recovered in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Pharyngeal swelling, Swelling face
Clinical narrative: Patient presented to the ED immediately after receiving dose 1 of vaccine with anaphylactic reaction. Patient had hives, difficulty swallowing. was given epinephrine, prednisone taper and benadryl.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Urticaria
Clinical narrative: Patient presented to the ED immediately after receiving dose 1 of vaccine with anaphylactic reaction. Patient had hives, difficulty swallowing. was given epinephrine, prednisone taper and benadryl.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: pain in my shoulder; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150; Expiration Date: 27Sep2021), via an unspecified route of administration on 14Apr2021 (at the age of 73-year-old) as 1st dose, single for covid-19 immunisation.The medical history included blood pressure medication. Concomitant medication included lisinopril taken for blood pressure medication and thyroid medication. On 16Apr2021 patient experienced pain in shoulder. Consumer stated that she took Lisinopril, and it said a blood pressure medication and the thyroid medication, the both low. She just wondering how long this condition is going to lasts and exactly why, she believe that the Nurse who gave me the shot, put the it high on the shoulder towards the back of her shoulder and so if I try to see the bandage and she looked back and can't see the bandage. The 3rd day after she received the shot, she started having pain in shoulder to the point when she had to use the medication in order to get rid of it. So, she wanted and she did, well She went to her family doctor last week. Doctor felt that it does not related to the vaccine and she gave her exercises to do. The Patient stated that her concern is, was this damage to a ligament or a nerve or something to the shoulder capsule and why she was having for this long a period of time. Reported No Seriousness. The patient received treatment Tylenol (500mg), using ice, a heating pad, using topical such as Bio-freeze and Salonpas. "Consumer stated, "Well, it's better over two weeks, since she got her shot. So, it's a matter of 2 weeks now. So, she guess yes. Persisting.". The outcome for the event was not recovered.   No follow-up attempts are needed. No further information is expected.