chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sciatica
Clinical narrative: Sharp pain in her left arm where the injection/immense pain where shot was given; sciatica in the entire left side; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 27Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated that from 28Apr2021 she had a sharp pain in her left arm where the injection was given and sciatica in the entire left side. The caller went to her chiropractor but needed something stronger, so she went and saw her primary care provider. The caller's primary care provider put the caller on steroids- methylprednisolone, the generic for Mediprol. The caller finished the steroid on 17May2021 and was scheduled for her second dose on 18May2021. The patient was on steroid so she knew it decreases the inflammation and wanted to know how long she should wait for the second dose of vaccine. The caller's pharmacist said nothing was going to happen to the caller after the second dose. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pyrexia
Clinical narrative: chest pain similar to heart burn.; high fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 32-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 left arm on 15May2021 at 12:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the 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 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 17May2021 at 00:00, about 36 hours after second vaccination shot the patient started to have chest pain similar to heart burn, high fever and headache for the last 30 hours as well. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chest pain similar to heart burn, high fever and headache were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Inflammation, Loss of personal independence in daily activities, Pain
Clinical narrative: Vaccine caused old dance injury to become inflamed; was in able to walk for two weeks; Pain still resides; causes inability to reform task; This is a spontaneous report from a contactable healthcare professional, the patient. This 22-year-old non-pregnant female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COBVID-19 mRNA vaccine, lot number: EL9267) via unspecified route in the left arm on 18Feb2021 at 07:30 as a single dose for COVID-19 immunization. Medical history included old dance injury. There were no concomitant medications. Past drug history included allergy to cephalexin (CEPHEX). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have COVID-19 prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COBVID-19 mRNA vaccine, lot number: EL9264) via unspecified route on 30Jan2021 at 11:00 (at the age of 22-years-old) as a single dose in the left arm for COVID-19 immunization. On 20Feb2021, vaccine caused old dance injury to become inflamed and patient was unable to walk for two weeks. Pain still resides and causes inability to perform task. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received included Cortisone shot. The clinical outcome of the events 'old dance injury to become inflamed and patient was unable to walk for two weeks' was recovered with sequel (reported as recovered with lasting effects), while for 'Pain still resides and causes inability to perform task' was not recovered. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: based on the temporal relationship the causality between the events inflammation , pain ,unable to walk and the suspect vaccine comirnaty cannot be completely ruled out  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Tiredness; Headache; Chills; Nausea; Feeling a general malaise; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration  in the left arm on 12May2021 at 11:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient medical history included service connected veteran. The patient did not have allergies to medications, food, or other products. Concomitant medication included MULTIVITAMIN from an unknown date, for unknown indication. 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.  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 12May2021 at 12:00, the patient experienced tiredness, headache, chills, nausea, felt a general malaise. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events  tiredness, headache, chills, nausea, felt a general malaise was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Alopecia
Clinical narrative: It started with the pneumonia vaccine and then the 2 covid vaccines and I lost all my hair; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced it started with the pneumonia vaccine and then the 2 covid vaccines and i lost all my hair (alopecia) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 46-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 46, via an unspecified route of administration, left arm, on May 5, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food or other products. Concomitant medications included Drospirenone/ethinyl-estradiol and trazodone 25mg; both from unknown dates for unspecified indications. Prior to the vaccination, patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 8, 2021, at 01:30, patient experienced vomiting. No therapeutic measures taken as a result of the event. The event did not result in doctor/other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of vomiting recovered on an unknown date in May 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune hepatitis (AIH), mixed connective tissue disease, arthritis, hypertension (HTN), gastroesophageal reflux disease (GERD), obstructive sleep apnea syndrome (OSA), overactive bladder (OAB) and prediabetes (Pre-DM). The patient had allergy to penicillin and allergy to quinolones. The patient received unspecified medications for autoimmune AIH, HTN... within twoweeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. 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 01May2021, the patient experienced shingles. The event shingles resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event shingles and included treatment with VALTREX, gabapentin and FLEXIRIL. The clinical outcome of the event shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menses onset 2 days after, 21 day cycle; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was 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 16May2021, the patient had menses onset 2 days after, 21-day cycle. The event did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of this event. The clinical outcome of the event menses onset 2 days after, 21-day cycle was recovered on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Fatigue; Fever; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0107) via an unspecified route of administration in the arm left on 14May2021 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021, the patient experienced headache, fatigue, fever, injection site pain. The clinical outcome of the events headache, fatigue, fever, injection site pain was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Taste disorder, Vomiting
Clinical narrative: Throwing up; Diarrhea; chills; low energy; Bad taste on mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo168) via an unspecified route of administration in the left arm on 15May2021 at 14:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified birth control pill from an unknown date. 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. The patient had no known allergies to medications, food or other products. On an unknown date in May2021 at 15:30, the patient experienced throwing up, diarrhea, chills, low energy and bad taste on mouth. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of throwing up, diarrhea, chills, low energy and bad taste on mouth were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Extreme headache; Chills; Fever; Body aches; Nauseous; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ew0167) via an unspecified route of administration in the left arm on 14May2021 at 15:45 as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 16:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. 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 15May2021 at 12:00, the patient experienced extreme headache, chills, fever, body aches and nauseous. 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 events. The clinical outcome of the events extreme headache, chills, fever, body aches and nauseous were recovered with sequelae.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Extreme headache; chills; just had a sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER3736) via an unspecified route of administration in the left arm on 16May2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. It was unknown if the patient had any known allergies. Concomitant medications were not reported. 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 16May2021 at 14:00 the patient experienced extreme headache, chills two hours after the shot. The patient was better by the next day and just had a sore arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with tylenol started from unspecified date. The clinical outcome of the events extreme headache and chills was recovered on the next day on 17May2021, while that of the event sore arm was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. it was unknown if the patient was allergic to any food, medications or other products. Concomitant medications included apremilast (OTEZLA), fish oil, tocopherol (OMEGA 3), B12, Probiotic; started on unknown date for unknown indication and unknown if ongoing. 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 27Apr2021, the patient experienced hives. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Irritability, Pain
Clinical narrative: felt like a pill is stuck in chest between trachea and lower wind pipe but haven't taken any pills.; It's very annoying; slightly pain; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 at 15:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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 12May2021, from the day after the vaccine, and now a week later the patient felt like a pill was stuck in the patient's chest between her trachea and lower windpipe but had not taken any pills and it happens more in the later part of the day or after exercising. At the time of the report happened in the morning which was very annoying and slightly painful. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of events felt like a pill was stuck in the chest between the trachea and lower windpipe, annoying and slightly painful were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Diarrhoea, Malaise
Clinical narrative: stomach ache; Diarrhea; shoulder pain; lower back pain; feeling unwell; body pain; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 13:45 as a single dose for COVID-19 immunisation. Medical history included leukemia from 2013 to 2018. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medication within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the 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. On 16May2021, the patient experienced stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: stomach ache; Diarrhea; shoulder pain; lower back pain; feeling unwell; body pain; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 13:45 as a single dose for COVID-19 immunisation. Medical history included leukemia from 2013 to 2018. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medication within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the 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. On 16May2021, the patient experienced stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives; Itching all over; Entire body was red; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewoln6) via an unspecified route of administration in the right arm on 14May2021 at 12:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT) for unspecified indication from unknown date. The patient had no known allergies to medications, food or other products. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021 at 14:00, 2 hours after vaccine, the patient experienced hives, itching all over and entire body was red. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, itching all over and entire body was red were recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Pain to the left stomach area when using the restroom; Extremely nauseous; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 15May2021 at 10:45 (at the age of 14-years-old), as a single dose for COVID-19 immunisation. The patient did not have any other medical history. The patient had no known allergies. Concomitant medications were not reported. 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 16May2021 at 18:45, the patient experienced extremely nauseous and pain to the left stomach area when using the restroom. It was unknown whether any therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events extremely nauseous and pain to the left stomach area when using the restroom were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: headache; fever 102.2 F; chills; joint pain; muscle pain; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable physician, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiac dysrhythmia (extra systoles), seasonal allergies, and known allergies to birch pollen trees and nut-bearing trees. The patient did not receive any medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the 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. On 14May2021, after receiving the second dose of the vaccine, the patient experienced headache, fever of 102.2 Degrees Fahrenheit, chills, joint pain, muscle pain, fatigue, and swollen lymph nodes. On 14May2021 body temperature was checked and it was 102.2 degrees Fahrenheit. 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 which included treatment with acetaminophen 325 mg (MANUFACTURER UNKNOWN) and diphenhydramine HCl 25 mg (MANUFACTURER UNKNOWN). The clinical outcome of the events headache, fever of 102.2 Degrees Fahrenheit, chills, joint pain, muscle pain, fatigue, and swollen lymph nodes were 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: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: headache; fever 102.2 F; chills; joint pain; muscle pain; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable physician, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiac dysrhythmia (extra systoles), seasonal allergies, and known allergies to birch pollen trees and nut-bearing trees. The patient did not receive any medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the 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. On 14May2021, after receiving the second dose of the vaccine, the patient experienced headache, fever of 102.2 Degrees Fahrenheit, chills, joint pain, muscle pain, fatigue, and swollen lymph nodes. On 14May2021 body temperature was checked and it was 102.2 degrees Fahrenheit. 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 which included treatment with acetaminophen 325 mg (MANUFACTURER UNKNOWN) and diphenhydramine HCl 25 mg (MANUFACTURER UNKNOWN). The clinical outcome of the events headache, fever of 102.2 Degrees Fahrenheit, chills, joint pain, muscle pain, fatigue, and swollen lymph nodes were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Muscular weakness, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Tingling and weakness in right arm; Tingling and weakness in right arm; Extremely heavy period; Headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10May2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as no. The patient had no known allergies to medications, food, or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 14:00, the patient experienced tingling and weakness in right arm, headaches, extremely heavy period. 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 events. On an unknown date in 2021, post vaccination, the patient underwent COVID- 19 test via nasal swab and the result was not reported. The clinical outcome of the events tingling and weakness in right arm, headaches, extremely heavy period was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Migraine, Neck pain
Clinical narrative: Headache at migraine level; Pain from elbow into neck; Pain from elbow into neck and behind shoulder blade; Headache; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 03May2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and migraines and allergy to some chemical sensitivity. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and tizanidine hydrochloride (ZANAFLEX); from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 00:00, the patient experienced pain from elbow into neck and behind shoulder blade for 2 full days before subsiding and fully stopped after 5 days. Also experienced headache for a full week. First 2 days were at migraine level. Extreme fatigue has reduced, but still experiencing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of pain from elbow into neck and behind shoulder blade was resolved on 09May2021 after the duration of 5 days. The clinical outcome of the was resolved with sequelae on 11May2021 after a full week. The clinical outcome of the event headache at migraine level was resolved with sequelae on 06May2021. The clinical outcome of the event extreme fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Swelling face, Swelling of eyelid
Clinical narrative: right upper eyelid and forehead area swelling with one papule; right upper eyelid and forehead area swelling with one papule; papule; This is a spontaneous report from a contactable other hcp.   A 60-years-old female (non- pregnant) patient received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:00 (Batch/Lot Number: EL3246) as DOSE 2, SINGLE for covid-19 immunisation (60yeras at the age of vaccination). Medical history included hyperthyroidism from an unknown date and unknown if ongoing , alopecia areata from an unknown date and unknown if ongoing , gastrooesophageal reflux disease from an unknown date and unknown if ongoing , irritable bowel syndrome from an unknown date and unknown if ongoing , osteoarthritis from an unknown date and unknown if ongoing , osteoporosis from an unknown date and unknown if ongoing , hyperlipidaemia from an unknown date and unknown if ongoing , raynaud's phenomenon from an unknown date and unknown if ongoing , herpes zoster from 15Dec2020 to an unknown date involving right upper eyelid, temple area and hairline. Concomitant medication(s) included pravastatin sodium (PRAVASTATIN NA) 20 mg taken for an unspecified indication, start and stop date were not reported; esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) 20 mg taken for an unspecified indication, start and stop date were not reported; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took cleocin s and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. The historical vaccine include BNT162B2 (Product: Covid 19, Brand Pfizer, lot Number:  EL1284, Administration Time : 10:00 AM, vaccination Location: Left arm, Dose : 01) for COVID-19 immunisation (At 60 years) on 06Jan2021. The patient experienced right upper eyelid and forehead area swelling with one papule, right upper eyelid and forehead area swelling with one papule and papule on 07Feb2021 07:00.  No treatment received for the events. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 18Apr2021 (at the age of 40-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on 09May2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Other medication within two weeks of vaccination was not reported. 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 19Apr2021, the patient experienced fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness in face and mouth; Numbness in face and mouth area; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 14May2021, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 14May2021, 1 hour after the administration of second dose, the patient experienced numbness in face and mouth area. The clinical outcome of both the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise, Pain in extremity
Clinical narrative: Left facial numbness lasted for the remainder of the day and the day after; Left arm soreness; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (at the age of 33-years-old) as a single dose for covid-19 immunization. Medical history included in vitro fertilisation from an unknown date and unknown if ongoing (undergoing egg retrieval 2 weeks prior). Concomitant medication(s) and received within 2 weeks of vaccination included vitamin d; minerals nos, vitamins nos (PRENATAL PLUS); fish oil; dexamethasone; doxycycline hydrochloride (DOXY-1). The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 15:30, the patient experienced left facial numbness lasted for the remainder of the day and the day after. Left arm soreness and general malaise lasted for 36 hours after the initial vaccination. The patient did not receive any treatment. The events were reported as non-serious. Outcome of the event was recovered on an unspecified date in 2021, at the time of this report. Device Date was 17May2021. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise, Pain, Pain in extremity
Clinical narrative: Numbness on the left side of the face; body ache; general malaise; Soreness in the left arm; This is a spontaneous report from a contactable consumer or other non health care professional. A 33-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05May2021 17:00 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included oocyte harvest and was undergoing egg retrieval 4 weeks prior. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), ascorbic acid, ferrous fumarate, folic acid, retinol (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]), fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness on the left side of the face, body ache, general malaise, soreness in the left arm (non-serious) on 05May2021 17:30. This events lasted for 24 hours. On an unknown date in May2021 the events recovered.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Pain, Pyrexia
Clinical narrative: Fever (101); chills; aches; a mild cough; started to get itchy red spots in a few places on my body; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in Left arm on 03May2021 12:30 pm (46-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history was reported as none. The concomitant medications were reported as none. The patient received ibuprofen (IBUPROFEN) and experienced allergy. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Left arm on 05Apr2021 at 12:30 pm (46-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient does not have COVID prior to vaccination. The patient was tested positive since vaccination. On 04May2021 (reported as 12:00 am), the day after vaccination, the patient experienced Fever (101), chills, aches and a mild cough. The patient also started to get itchy red spots in a few places on body. Had mild symptoms the day after the second shot and then again on Sunday 09May. The. Starting the night of 14May I started to experience more severe symptoms. Fever (101), chills, aches and a mild cough. Also, started to get itchy red spots in a few places on my body. The symptoms seem to come and go in severity, but usually worst at night. They persist as of today 17May. No treatment was received for the events. The patient underwent lab tests which included Body temperature  101 (fever) on 04May2021 and PCR Abott ID NOW (nasal swab) negative on 17May2021. The outcome of the events were Not recovered as of 17May.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test
Clinical narrative: Fever (101); chills; aches; a mild cough; started to get itchy red spots in a few places on my body; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in Left arm on 03May2021 12:30 pm (46-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history was reported as none. The concomitant medications were reported as none. The patient received ibuprofen (IBUPROFEN) and experienced allergy. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Left arm on 05Apr2021 at 12:30 pm (46-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient does not have COVID prior to vaccination. The patient was tested positive since vaccination. On 04May2021 (reported as 12:00 am), the day after vaccination, the patient experienced Fever (101), chills, aches and a mild cough. The patient also started to get itchy red spots in a few places on body. Had mild symptoms the day after the second shot and then again on Sunday 09May. The. Starting the night of 14May I started to experience more severe symptoms. Fever (101), chills, aches and a mild cough. Also, started to get itchy red spots in a few places on my body. The symptoms seem to come and go in severity, but usually worst at night. They persist as of today 17May. No treatment was received for the events. The patient underwent lab tests which included Body temperature  101 (fever) on 04May2021 and PCR Abott ID NOW (nasal swab) negative on 17May2021. The outcome of the events were Not recovered as of 17May.  Follow-up attempts completed. No further information expected.