chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: noticed a metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 33-years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in left arm on 24Mar2021 at 11:45 (at the age of 33-years old) as a single dose for COVID-19 immunisation and took amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 30Apr2021 at 19:00, 2 weeks after second dose, the patient experienced metallic taste in her mouth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW5169) via an unspecified route of administration in the left arm on 02May2021 at 10:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and attention deficit hyperactivity disorder (Adhd). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL) 300 mg and methylphenidate hydrochloride (RITALINE) 20 mg; both from unknown date and for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 11Apr2021 at 10:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 00:00, after second day of vaccination, the patient had fever (100). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of event fever and included treatment with unspecified over the counter (OTC) fever reducer. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; Body aches; Headache; Chills; Quick jabbing (needle pricking) pain that lasted for just a second on right side of back skull and repeated every 5 minutes or 10 minutes mostly for about 5-6 hours until I fell asleep.; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 30Apr2021 at 08:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine (due to hormone). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included sumatriptan (MANUFACTURER UNKNOWN), 100 mg for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 08:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  It was reported that patient experienced after 36 hours of second vaccine, on 01May2021 at 22:00, the patient experienced quick jabbing (needle pricking) pain that lasted for just a second on right side of back skull, and repeated every 5 minutes or 10 minutes mostly for about 5-6 hours until I fell asleep. After waking up next morning (48hours after the shot), had only one jabbing pain. On 02May2021 the patient experienced sore arm, body aches, headache and chills after about 18 hours. By 28 hours after, she was feeling almost normal except some arm soreness until this back head needle pain started. she had taken one Tylenol after 27 hours due to minor forehead headache, and headache was gone soon. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the headache which included treatment with tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches and chills, quick jabbing (needle pricking) pain that lasted for just a second on right side of back skull, and repeated every 5 minutes or 10 minutes, jabbing pain and body aches was recovered in Apr2021. The clinical outcome of the event sore arm was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Insomnia, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Discharge once from right breast; Could not sleep on right side due to arm pain; Pain in right arm; Pain throughout deltoid - not just at injection site; Pain throughout deltoid - not just at injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via an unspecified route of administration in the right arm on 12Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, asthma, vasodepressor syncope, thryoid nodules, degenerative "disk" disease, mild scoliosis, osteopenia and low blood pressure. The patient had no known allergies to medications, food, or other products. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), timolol maleate, brimonidine tartrate (COMBIGAN), latanoprostene bunod (VYZULTA) and ergocalciferol (VITAMIN D2); all taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route of administration on 22Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Feb2021 at 20:00, after second dose, the patient experienced discharge once from right breast, pain in right arm that the patient had still eleven weeks later. At first, pain worse when pulling up, pushing down pants. The patient could not sleep on right side due to arm pain. The patient had pain throughout deltoid - not just at injection site. Her husband massaged it nightly -said felt ropey, but that improved over time and the patient had been doing physical training (PT) exercises for old frozen shoulder issue in left arm to see if that helped (based on suggestion of physical therapist who was treating a hip issue). It makes it hurt. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events could not sleep on right side due to arm pain, discharge once from right breast, pain in right arm and pain throughout deltoid - not just at injection site were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: face was warm; face was warm, red; face was warm, red,swollen; face was warm, red,swollen, and itching; rash on face expanded/ A big rash appeared on left legbehind knee/Also a big rash on lower and upper back; The rash behind knee spread, and it was itching; The rash behind knee spread, and it was itching and red.; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 30Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included rash on face. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of COVID-19 vaccine. On 01May2021 at 00:30 the patient experienced, the rash on face expanded, a big rash appeared on left leg behind knee. On the same day at 08:00, the patient experienced face was warm, red, swollen, and itching. Also, a big rash on her lower and upper back. On the same day, the patient experienced the rash behind her knee spread, and it was itching and red. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL 25 mg every 6 hrs, prednisone 20 mg x3 daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on face expanded, a big rash appeared on left leg behind knee, face was warm, red, swollen, and itching. Also, a big rash on her lower and upper back, rash behind her knee spread, and it was itching and red was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling face
Clinical narrative: face was warm; face was warm, red; face was warm, red,swollen; face was warm, red,swollen, and itching; rash on face expanded/ A big rash appeared on left legbehind knee/Also a big rash on lower and upper back; The rash behind knee spread, and it was itching; The rash behind knee spread, and it was itching and red.; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 30Apr2021 at 09:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included rash on face. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of COVID-19 vaccine. On 01May2021 at 00:30 the patient experienced, the rash on face expanded, a big rash appeared on left leg behind knee. On the same day at 08:00, the patient experienced face was warm, red, swollen, and itching. Also, a big rash on her lower and upper back. On the same day, the patient experienced the rash behind her knee spread, and it was itching and red. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL 25 mg every 6 hrs, prednisone 20 mg x3 daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on face expanded, a big rash appeared on left leg behind knee, face was warm, red, swollen, and itching. Also, a big rash on her lower and upper back, rash behind her knee spread, and it was itching and red was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Swelling under left arm; fever of 100.5; chills; fatigue; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration in the left arm on 01May2021 at 10:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and borderline high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in the left arm on 03Apr2021 at 16:15 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. On 02May2021, the patient experienced swelling under left arm, fever of 100.5 (unspecified units), chills and fatigue. On 02May2021, the patient underwent lab tests and procedures which included body temperature and the fever was 100.5. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events swelling under left arm, fever of 100.5 (unspecified units), chills and fatigue was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; headache; muscle pain; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ascorbic acid (VITAMIN C), zinc (MANUFACTURER UNKNOWN) and virgin coconut oil (COCONUT OIL), all from unknown dates and for  unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced fatigue, headache, muscle pain and chills. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, muscle pain and chills was not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Shortness of breath; high fever; chest pains; dizziness; pains shooting up left leg; swollen face; hives on stomach; headache; vomiting; extremely high heart rate; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 27Apr2021 at 13:30 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included asthma from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took oxycodone, codeine and experienced allergy. Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, the patient was tested with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced shortness of breath, high fever, chest pains, dizziness, pains shooting up left leg, swollen face, hives on stomach, headache, vomiting, extremely high heart rate. The adverse events were resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (SARS-CoV-2 antibody test) was negative on 28Apr2021. The patient received the treatment for all the events. The outcome of the events reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 antibody test, Swelling face, Urticaria
Clinical narrative: Shortness of breath; high fever; chest pains; dizziness; pains shooting up left leg; swollen face; hives on stomach; headache; vomiting; extremely high heart rate; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 27Apr2021 at 13:30 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included asthma from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took oxycodone, codeine and experienced allergy. Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, the patient was tested with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced shortness of breath, high fever, chest pains, dizziness, pains shooting up left leg, swollen face, hives on stomach, headache, vomiting, extremely high heart rate. The adverse events were resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (SARS-CoV-2 antibody test) was negative on 28Apr2021. The patient received the treatment for all the events. The outcome of the events reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Shortness of breath; high fever; chest pains; dizziness; pains shooting up left leg; swollen face; hives on stomach; headache; vomiting; extremely high heart rate; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 27Apr2021 at 13:30 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included asthma from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took oxycodone, codeine and experienced allergy. Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, the patient was tested with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced shortness of breath, high fever, chest pains, dizziness, pains shooting up left leg, swollen face, hives on stomach, headache, vomiting, extremely high heart rate. The adverse events were resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (SARS-CoV-2 antibody test) was negative on 28Apr2021. The patient received the treatment for all the events. The outcome of the events reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: fever; slight cough; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 18May2021 (at the age of 51-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that she received the first dose of the Pfizer COVID-19 vaccine on 18May2021 and on an unspecified date in May2021, had a fever and was experienced slight cough. She was just wondering if having a cough or slight cough one of side effect. She was asking if this was a side effect from the vaccine and was there "Sulfur" in the vaccine. Product details and pharmacy details could not be probed as the consumer hung up abruptly. Hence limited information available over the call. The outcome of the events was unknown.  Response: No information found  Revised: 19May2021  Information about lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a Pfizer sponsor programme Pfizer COVAX Support. A Contactable consumer (patient's husband) reported for female patient (wife). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 on an unspecified date vas single dose for COVID-19 immunisation. The patient experienced fever and chills on an unspecified date. The reporter asked if after two months like they would like to ask if that was still related to the Covid 19 vaccine. The outcome of the events was reported as unknown.  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 completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Malaise, Pyrexia
Clinical narrative: has a temperature over 100; Headache; Feels horrible; She doesn't feel well; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 20May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Historical vaccine included BNT162B2 for COVID-10 immunisation on an unspecified date as dose 1, single and experienced sore arm. No PQC was present. On 21May2021 the patient experienced has a temperature over 100, headache, feels horrible, she doesn't feel well. The patient underwent lab tests and procedures which included body temperature resulted over 100 Fahrenheit on 21May2021. Caller reported that she didn't feel like this after her first dose. She stated that she only had a sore arm for two days. Caller would like to know how long her side effects may last. Caller did not want to transfer to Pfizer. She stated that she doesn't feel well and just wants to get off the phone. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electric shock sensation, Headache, Laboratory test, Magnetic resonance imaging, Pain in extremity
Clinical narrative: Leg pain; headache; Felt like out of body sounds send shock like sensations; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's wife).  A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6204), intramuscular on 03Mar2021 16:40 (at the age of 64-year old ) as dose 1, single for COVID-19 immunisation.  Medical history was not reported. Concomitant medication included olmesartan from 02Nov2020; zolpidem tartrate from 17Mar2021, diclofenac sodium from 06May2020 , Vitamin B-complex from 25Feb2020; aspirin [ACETYLSALICYLIC ACID ] from 11Jan2020, and a dietary supplement from 06May2020, all for an unknown indication. No prior vaccinations. On 03Mar2021 11:30, the patient experienced headache and went to a neurologist. His headache never went away, it felt like out of body sounds that send shock-like sensations. He went to an ENT and confirmed it was not sinuses nor migraines. He had no relief from headache, and it got so severe he felt like he was going to explode. The patient received Tramadol from 19Apr2021 for leg pain and headache and was then started on gabapentin. The patient underwent lab tests and procedures on an unspecified date, which included, MRI and other tests, all seemed okay. At the time of report, it's been over 4 months, and the events have not gone away, gets worse as day progresses. The events were reported serious due to important medical events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal X-ray, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head, Feeling abnormal
Clinical narrative: Leg pain; headache; Felt like out of body sounds send shock like sensations; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's wife).  A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6204), intramuscular on 03Mar2021 16:40 (at the age of 64-year old ) as dose 1, single for COVID-19 immunisation.  Medical history was not reported. Concomitant medication included olmesartan from 02Nov2020; zolpidem tartrate from 17Mar2021, diclofenac sodium from 06May2020 , Vitamin B-complex from 25Feb2020; aspirin [ACETYLSALICYLIC ACID ] from 11Jan2020, and a dietary supplement from 06May2020, all for an unknown indication. No prior vaccinations. On 03Mar2021 11:30, the patient experienced headache and went to a neurologist. His headache never went away, it felt like out of body sounds that send shock-like sensations. He went to an ENT and confirmed it was not sinuses nor migraines. He had no relief from headache, and it got so severe he felt like he was going to explode. The patient received Tramadol from 19Apr2021 for leg pain and headache and was then started on gabapentin. The patient underwent lab tests and procedures on an unspecified date, which included, MRI and other tests, all seemed okay. At the time of report, it's been over 4 months, and the events have not gone away, gets worse as day progresses. The events were reported serious due to important medical events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging head, Muscle spasms, Urinary system X-ray
Clinical narrative: Leg pain; headache; Felt like out of body sounds send shock like sensations; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's wife).  A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6204), intramuscular on 03Mar2021 16:40 (at the age of 64-year old ) as dose 1, single for COVID-19 immunisation.  Medical history was not reported. Concomitant medication included olmesartan from 02Nov2020; zolpidem tartrate from 17Mar2021, diclofenac sodium from 06May2020 , Vitamin B-complex from 25Feb2020; aspirin [ACETYLSALICYLIC ACID ] from 11Jan2020, and a dietary supplement from 06May2020, all for an unknown indication. No prior vaccinations. On 03Mar2021 11:30, the patient experienced headache and went to a neurologist. His headache never went away, it felt like out of body sounds that send shock-like sensations. He went to an ENT and confirmed it was not sinuses nor migraines. He had no relief from headache, and it got so severe he felt like he was going to explode. The patient received Tramadol from 19Apr2021 for leg pain and headache and was then started on gabapentin. The patient underwent lab tests and procedures on an unspecified date, which included, MRI and other tests, all seemed okay. At the time of report, it's been over 4 months, and the events have not gone away, gets worse as day progresses. The events were reported serious due to important medical events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Antibody test, Rash, Rash erythematous, Reaction to excipient
Clinical narrative: could be allergic reaction to polyethylene glycol (PEG) can cause anaphylactic reaction; anaphylactic reaction; large red rash left arm; presistent rash all over; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 20Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 76-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 04Mar2021 09:30 (Lot Number: EM 9810) as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to AE. The patient's concomitant medications were none.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm left at 11Feb2021, 09:30 (Lot number: EL9269) for covid-19 immunisation. The patient experienced presistent rash all over on 14Apr2021, seriousness Criteria was Life-threatening; Hospitalization.; Persistent / Significant disability / Incapacity; Important medical event, hospitalized from 14Apr2021 to 15Apr2021 required visit to emergency room and physician office, received treatment with Solumedrol: (resulted in) SOB (short of breath), Prednisone: (resulted in) Rash, Pepcid: (resulted in) anaphylaxis shock; large, red rash left arm on 09May2021, seriousness criteria was hospitalized from 09May2021, required visit to emergency room and physician office, received treatment with Solumedrol: (resulted in) SOB, Prednisone: (resulted in) Rash, Pepcid: IV, pertinent details indicated could be allergic reaction to polyethylene glycol (PEG) can cause anaphylactic reaction saw allergist, primary dermatalogist, ER physicians, immunologist, cause unknown, could be viral or allergy- do not know. The patient also experienced unspecified ongoing adverse event since 04Aug2021 and required visit to Emergency Room, Physician Office, received treatment with Solumedrol: (resulted in) SOB, Prednisone: (resulted in) Rash, Pepcid: IV. The patient underwent lab tests and procedures which included Antibody test to platelet factor IV: unknown results on unknown date, Covid Test: negative on 14Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: could be allergic reaction to polyethylene glycol (PEG) can cause anaphylactic reaction; anaphylactic reaction; large red rash left arm; presistent rash all over; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 20Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 76-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 04Mar2021 09:30 (Lot Number: EM 9810) as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to AE. The patient's concomitant medications were none.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm left at 11Feb2021, 09:30 (Lot number: EL9269) for covid-19 immunisation. The patient experienced presistent rash all over on 14Apr2021, seriousness Criteria was Life-threatening; Hospitalization.; Persistent / Significant disability / Incapacity; Important medical event, hospitalized from 14Apr2021 to 15Apr2021 required visit to emergency room and physician office, received treatment with Solumedrol: (resulted in) SOB (short of breath), Prednisone: (resulted in) Rash, Pepcid: (resulted in) anaphylaxis shock; large, red rash left arm on 09May2021, seriousness criteria was hospitalized from 09May2021, required visit to emergency room and physician office, received treatment with Solumedrol: (resulted in) SOB, Prednisone: (resulted in) Rash, Pepcid: IV, pertinent details indicated could be allergic reaction to polyethylene glycol (PEG) can cause anaphylactic reaction saw allergist, primary dermatalogist, ER physicians, immunologist, cause unknown, could be viral or allergy- do not know. The patient also experienced unspecified ongoing adverse event since 04Aug2021 and required visit to Emergency Room, Physician Office, received treatment with Solumedrol: (resulted in) SOB, Prednisone: (resulted in) Rash, Pepcid: IV. The patient underwent lab tests and procedures which included Antibody test to platelet factor IV: unknown results on unknown date, Covid Test: negative on 14Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chest pain
Clinical narrative: I have heart hurts; I have heart hurts; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: GW0167), via an unspecified route of administration, administered in left arm on 20May2021 at 14:15 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history and concomitant medications were not reported. The patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 06:00, the patient experienced heart hurts. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Rash
Clinical narrative: Heart pains; A rash started; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jun2021 15:30 (at age of 14 -year-old) as DOSE 2, SINGLE for covid-19 immunisation. No other medical history. No known allergies. No COVID prior vaccination. The patient did not take concomitant medications (No other medications in two weeks). No other vaccine in four weeks. Patient previously had first dose of BNT162B2 (lot number: EW0178) on 27May2021 at 03:30 PM (at age of 14 -year-old) for COVID-19 immunisation. On 21Jun2021 08:30, the patient experienced heart pains and a rash started. Adverse event treatment was Ibuprophen, Benadryl. Outcome of event was recovering.   Follow up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever; Felt sick; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient stated that he recently received his covid vaccine and afterwards, he developed a fever and felt sick. The outcome of events was unknown.  The 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
Symptoms: Blood pressure measurement, Diarrhoea, Hypertension, Nausea
Clinical narrative: has a high blood pressure/ her blood pressure was 153 over 81; diarrhea; feels like about to vomit but unable to vomit anything because she has not eaten any.; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient received the 1st dose of our COVID-19 vaccine last 05Jun2021 and 2nd dose last 26Jun2021 (exactly 21 days apart). The patient was now sick and had a high blood pressure. Last time she checked, her blood pressure was 153 over 81. She was also suffering from diarrhea and felt like about to vomit but unable to vomit anything because she had not eaten. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy
Clinical narrative: 8-9 broken blood vessels in my hands/had broken blood vessels in her hands and other parts of her body; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history included she was born with hole in her heart from an unknown date and unknown if ongoing and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced 8-9 broken blood vessels in her hands and other parts of her body. This lasted a couple of weeks. When the caller went for her 2nd dose, she was turned away and told to follow up with her HCP, because of the broken blood vessels after the 1st dose. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vomiting
Clinical narrative: Vomiting; It was awful after the first vaccine too; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 54-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Jun2021 (at the age of 54-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation.  Medical history included covid-19 prior to vaccination from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that It was awful after the first vaccine too, including a day of vomiting and being in bed on 23Jun2021. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Since the vaccination, patient not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; body aches; laid in bed; This is a spontaneous report from a contactable consumer or other non hcp.    A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on an unspecified date (Lot Number and Expire Date was not reported) as single dose for COVID-19 immunisation. Medical history included none. There were no concomitant medications reported. The patient experienced first dose: flu like symptoms, first dose: body aches and laid in bed on an unspecified date. With the first Covid 19 vaccine he was told to stay for 15 minutes after he received the vaccine. The staff member at the facility told him that he needed to stay longer so he ended up staying for 30 minutes and he received water while waiting. After he received the first Covid 19 vaccine he had flu like symptoms for a couple of days then that went away. When asked to describe flu like symptoms he stated that he could not describe it. He stated he laid in bed. He stated there was body aches. He did not recall the anatomical location of where he received the first dose of the Covid 19 vaccine. Time the vaccination was given for first dose was afternoon. No relevant tests performed. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He did not require a visit to emergency room or physician office. He received both doses but could not locate vaccine card with his dates. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Limb discomfort, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: knees and elbows were sore and stiff/ I had joint pain all the joints; Pain in arm; can't even drive and pickup anything because of his arm; every so often my right leg is still having some issues; it just slowly got worse; knees and elbows were sore and stiff; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of vaccine three weeks ago and he mentioned about the side effects that he experienced. On an unspecified date in 2021, the patient experienced his knees and elbows were sore and stiff and he was also experiencing lot of pain in his arm, he believed it was in the injection site. The patient stated that this would be close to almost 5 weeks, when he got the shot very next day it was when he had joint pain, and all the joints felt better now expect for one he got shot in, it never got any better it just slowly got worse and every so often his right leg was still having some issues, it was mainly his right arm. He said that he couldn't even drive and pickup anything because of his arm until today. He also mentioned that he was not able to get the second dose yet. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.