chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore right arm; Headache; This is a spontaneous report from a contactable Consumer or other non-HCP, the patient. A 57-Year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the right arm on 09Mar2021 at 03:15 PM (at the age of 57-years-old) as a single dose for COVID-19 vaccination. The patient's medical history include histoplasmosis in teenage years. It is unknown if patient took any medications for histoplasmosis. Patient has not tested positive for COVID-19 before receiving vaccine. Concomitant medications include Estradiol testosterone 2mg 5 mg (MANUFACTURER UNKNOWN) and Progesterone 200 (MANUFACTURER UNKNOWN) which patient has taken within 2 weeks of vaccination for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not allergic to medications, food, or other products. Patient has not tested positive for COVID-19 since receiving the vaccine. On 10Mar2021 patient experienced very sore right arm which resolved after applying ice pack on right arm. Patient also experienced bad headache off and on for a week. It was painful and it hurt to touch on both sides of forehead which then extended to sinus area above forehead. Therapeutic measures taken included Tylenol (MANUFACTURER UNKNOWN) and Extra strength Excedrin (MANUFACTURER UNKNOWN). The clinical outcome of sore right arm was recovered and for headache was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chills, Diarrhoea, Heart rate irregular
Clinical narrative: Heart Rate fluctuations (64-110 bpm); Chills; abdominal cramping; Extreme diarrhea; Weakness; Nausea; This is a spontaneous report from a contactable Heath care professional, the Nurse. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN6208), via an unspecified route of administration on Right Arm on 16Mar2021 at 17:15 hours (at the age of 51-years-old and the patient was not pregnant at the time of vaccination) as a single dose for COVID-19 immunization. Medical history included Seasonal Allergies and No other biomedical health issues were reported. Weight 119 lbs, small body frame. Past drug history have not been provided. Concomitant medications included Xzal, Vit B complex, Vit D, Vit C taken within two weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 21:15 hours, patient experienced Sudden Nausea, Abdominal cramps and Extreme Diarrhea with complete emptying (similar to a colonoscopy preparation) and also Chills, without fever, Weakness, and Heart Rate fluctuations with 64-110 beats per minute. The patient did not receive any treatment for adverse events. The clinical outcome of the all events were recovering. No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Heart Rate fluctuations (64-110 bpm); Chills; abdominal cramping; Extreme diarrhea; Weakness; Nausea; This is a spontaneous report from a contactable Heath care professional, the Nurse. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN6208), via an unspecified route of administration on Right Arm on 16Mar2021 at 17:15 hours (at the age of 51-years-old and the patient was not pregnant at the time of vaccination) as a single dose for COVID-19 immunization. Medical history included Seasonal Allergies and No other biomedical health issues were reported. Weight 119 lbs, small body frame. Past drug history have not been provided. Concomitant medications included Xzal, Vit B complex, Vit D, Vit C taken within two weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 21:15 hours, patient experienced Sudden Nausea, Abdominal cramps and Extreme Diarrhea with complete emptying (similar to a colonoscopy preparation) and also Chills, without fever, Weakness, and Heart Rate fluctuations with 64-110 beats per minute. The patient did not receive any treatment for adverse events. The clinical outcome of the all events were recovering. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nausea, Vertigo
Clinical narrative: Intermittently nauseated; vertigo; Head started feeling heavy; This is a spontaneous report from a contactable non health care professional, the patient. A 48 year old female patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot/batch no: EN6207) solution for injection via unspecified route of administration at left arm on 10Mar2021 as single dose for COVID-19 Immunisation. Medical history included allergy to sulfa, PCN (Penicillin) and shellfish. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included Wellbutrin for unknown indication. Past medication was not reported. On 14Mar2021 the patient complained of her head started feeling heavy and she became intermittently nauseated with vertigo. The patient was not tested positive for covid-19 since vaccination. The clinical outcome for the events Head started feeling heavy, intermittently nauseated, vertigo was recovering at the time of reporting. Consent was given to contact the reporter. Consent was not given to contact Health care professional. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: calf muscle pain; calf muscles have become extremely tight; This is a spontaneous report from a contactable Consumer, the patient. A 68 Year(s) old Male patient received BNT162B2 {PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch number: Unknown} via an unspecified route of administration in left arm on 14Feb2021 at 12:00PM, as a second single dose (age at vaccination was 68-year-old) for COVID-19 immunization at  Clinic. The patient's medical history and concomitant medications was unknown. Patient not had any allergies to medications, food or other products. The patient previously took first single dose of BNT162B2 {PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch number: Unknown} via an unspecified route of administration in left arm on 24Jan2021 at 12:00PM for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 And not had been tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks and any other medications within 2 weeks prior of covid19 vaccination. On 17Feb2021, the patient felt that calf muscles had become extremely tight which resulted in extreme pain when getting out of a bed or getting up from sitting for more than 30 minutes. Noproxin was taken as a Therapeutic measure for muscle relaxation and physical therapy. The patient had not recovered from the event at the time of reporting. No follow up attempts are possible,  information about batch number cannot be  obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears will not stop; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), as a single dose via unspecified route of administration on 12Mar2021 at 14:45 (at the age of 59-year-old at vaccination) for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient did not had any allergies to medications, food or other products. 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 vaccines within four weeks prior to the vaccination. The patient experienced ringing in ears, which would not stop on an unspecified date. No Therapeutic measures taken for the adverse event ringing in ears. At the time of report, the outcome of the event ringing in ears was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives on wrist, arms, back, stomach, breast, and thighs; Rash; This is a spontaneous report from a contactable other health care professional. A 27-year-old non pregnant female received first dose of BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Batch No: EN6199) via an unspecified route of administration, in left arm on 04Mar2021 (at the age of 27-year-old)  for COVID-19 immunisation. The patient medical history included hypertension, left ventricular hypertrophy and hypermobility. The patient was allergic to Ciprofloxacin, Sulfa, Ace Inhibitors, Minocycline, Nabumetone and Cefaclor. The patient had not received any other vaccine within 4 weeks of COVID-19 Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Concomitant medications included Bystolic (MANUFACTURER UNKNOWN) and Xyzal (MANUFACTURER UNKNOWN) for an unknown indication. On 11Mar2021, the patient experienced rash and hives on wrist, arms, back, stomach, breast, and thighs. Therapeutic measures included Dexamethasone injection and oral Prednisone which included Doctor visit and emergency room visit. The clinical outcome of the events was not resolved at the time of report. No follow-up attempts are needed. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Dizziness; Hypertension; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6198) via an unspecified route in the left arm on 22Feb2021 at 12:00 PM (at the age of 62-years-old), as a second single dose for COVID-19 immunization. The patient's medical history included hypertension, depression and anxiety. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril HCTZ (hydrochlorothiazide) and fluoxetine (PROZAC) for unknown indications received on unknown dates. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN5318), via an unspecified route in the left arm on 30Jan2021 at 12:00 PM, as a first single dose for COVID-19 immunization. The patient got the COVID-19 vaccine administered at the hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced dizziness and hypertension. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with meclizine and increased dose of lisinopril for the adverse events. The clinical outcome of dizziness and hypertension was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This s a spontaneous report received from a contactable physician (physician reported for himself). A 65 year old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6203; Expiration Date: unknown), via an unspecified route of administration in arm left on 11Mar2021 14:00 (at the age of 65-year-old) as 2nd DOSE, SINGLE for covid-19 immunization at workplace clinic. Patient had received first dose of vaccine Pfizer BNT162B2 (formulation: solution for injection, lot number: EL3247, Expiration Date: unknown) on 19Feb2021 11:00 via an unspecified route of administration in right arm as 1st dose, single for covid-19 immunization. The patient medical history included increased cholesterol and past history of reactive arthritis. The patient's concomitant medications were Atorvastatin, ASA received within 2 weeks. Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 15:00, patient experienced Sore arm for 3 to 4 days. No treatment was given for the event. Patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination. Outcome of the event was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Rash, Urticaria
Clinical narrative: Rash and hives on neck from ear to ear; Redness; Rash and hives on neck from ear to ear; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA) (Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 10:30AM as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient reported she was allergic to Bee sting and beeswax. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Concomitant medications were not reported. On 16Mar2021 at 3:45 PM, the patient experienced Rash and hives on neck from ear to ear, redness, and continuous Nausea. The patient contacted Doctor via telephone for treatment advice and he was advised to take Benadryl every 4 hourly for the event. The clinical outcomes of the events Rash and hives on neck from ear to ear, redness and Nausea were recovering. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: Nausea come and go.; Running 100+ fever; Bad head ache; This is a spontaneous report received from a non-contactable consumer, the patient. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6208, dose number: 2) via an unspecified route of administration in the right arm on 16Mar2021 at 15:30 as single dose for COVID-19 immunisation (at the age of 65). The past drug included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no; EN6198; dose number:1) via an unspecified route of administration in the right arm on 22Feb2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included allergic to statins. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. On 16Mar2021 at 16:00, the patient experienced nausea which was come and go, running 100+ (units unspecified) fever and bad headache. No therapeutic measures were taken for the event. The clinical outcome of the events fever, headache and nausea were not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable patient. A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on the left arm on 14Mar2021 at 11:15 AM (at the age of 68-years-old), as a single dose for COVID-19 immunization. Medical history included urinary tract infection. Patient had known allergies which have not been specified. Concomitant medications included Doxycycline and Uribel. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to vaccination, the patient had not tested positive for COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. On Mar2021 at 07:30 PM, the patient experienced diarrhoea. No therapeutic measure were taken for the event experienced. The clinical outcome of the event diarrhoea was recovered. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheaded; This is a spontaneous report received from a contactable consumer, the patient.   A 38-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EL3302) via an unspecified route of administration in the left arm on 15Mar2021 at 01:00 PM (at the age of 38-years) as a single dose for COVID-19 immunization. Medical history included ovarian cyst. The patient was allergic to amoxicillin, ceclor and flagyl. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient received other medications within 2 weeks of vaccination however, medicines were unspecified. Concomitant medications were not reported. The patient felt lightheaded on 15Mar2021. The patient did not receive any treatment for the event lightheaded. The clinical outcome of the event lightheaded was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Rash papular
Clinical narrative: Raised rash; Itchy; Red spotty rash; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on 09Mar2021 at 08:45 (at the age of 53-years-old), on the left arm as a first single dose for COVID-19 immunisation. The patient's medical history included Chronic obstructive pulmonary disease, Asthma, and Thyroid disorder. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. Patient had no allergies of food, medicines and other medicinal products. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. It is unknown whether the patient had undergone any lab test or procedures. On eight day post the immunisation, the patient experienced red spotty rash size of a silver dollar, raised and itchy. The patient did not receive any treatment for the event. The clinical outcome for the event red spotty rash, raised rash and itchy was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Intermenstrual bleeding, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Early period; swollen lymph nodes; Very tender breasts; This is a spontaneous report received from a contactable consumer, the patient. A 43-years old Caucasian non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/lot number: Unknown) via an unspecified route and site of administration for COVID-19 immunization on 08 March2021. Medical history included covid-19 and the patient was not allergic to the medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. The patient did not receive any Concomitant medication within 2 weeks of vaccination. On 14March2021 the patient experienced Very tender breasts, swollen lymph nodes and early period. No therapeutic measures were taken as a result of these events. The clinical outcome of very tender breasts, swollen lymph nodes and early period was unknown. No follow-up possible. Batch/lot number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: left side of lower lip swelled up.; 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: unknown), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 and 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 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Prior to 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 have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient's left side of lower lip swelled up, about 18 hours after the second dose. The patient had no trouble in breathing. The patient did not receive any treatment for the event. The clinical outcome of the event left side of lower lip swelled up was recovered on an unspecified date. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle ache; Chest pain; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old pregnant female patient received BNT162B2 (Pfizer BioNTech Covid 19mRNA vaccine, Batch/lot number: 6206), via unknown route of administrated on her left arm on 16Mar2021 at 11:45AM (at the age of 28-years-old) as a single dose for Covid-19 immunisation. The patient's medical history included Penicillin allergy. Concomitant medications included Yasmin. Patient had no symptoms associated with COVID-19. Patient was not enrolled in the clinical trial. Patient had not been tested positive for COVID-19 since having the vaccine. The patient experienced Chest pain, Fever, Fatigue and muscle ache on 16Mar2021 at 16 hours. It was unknown if patient received treatment for the events. The clinical outcome of these events chest pain, fever, fatigue and muscle ache was reported as not recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Dehydration, Headache
Clinical narrative: cold chills; sweating; joint pain; dehydration; headache; vomiting; tight chest; light sensitivity; shaking; muscle pain; This is a spontaneous report from a non-contactable consumer. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)(Batch/ Lot Number: Unknown), 2nd dose, via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 AM for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drug history included BNT162B2 (Lot/batch no: Unknown), 1st dose, via an unspecified route of administration on an unknown date for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. 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 4 weeks prior to vaccination. On an unknown date in Mar2021, the patient experienced shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity. The patient did not received any therapeutic measures for the adverse events. The clinical outcome of the events shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity were recovering at the time of reporting. No follow up attempts are possible,  information about batch number cannot be  obtained. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Photophobia, Tremor, Vomiting
Clinical narrative: cold chills; sweating; joint pain; dehydration; headache; vomiting; tight chest; light sensitivity; shaking; muscle pain; This is a spontaneous report from a non-contactable consumer. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)(Batch/ Lot Number: Unknown), 2nd dose, via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 AM for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drug history included BNT162B2 (Lot/batch no: Unknown), 1st dose, via an unspecified route of administration on an unknown date for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. 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 4 weeks prior to vaccination. On an unknown date in Mar2021, the patient experienced shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity. The patient did not received any therapeutic measures for the adverse events. The clinical outcome of the events shaking, sweating, cold chills, vomiting, headache, muscle pain, joint pain, dehydration, tight chest and light sensitivity were recovering at the time of reporting. No follow up attempts are possible,  information about batch number cannot be  obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-1 test
Clinical narrative: Got my period a week early after receiving vaccine.; This is a spontaneous report from a contactable other hcp. A 38-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported.     The patient's concomitant medications were not reported.  On 10Mar2021 13:15, the patient got her period a week early after receiving vaccine. The patient underwent lab tests and procedures on 15Mar2021 which included COVID test (sars-cov-2 test) via nasal swab with pending result. The outcome of event was unknown. Patient did not receive treatment for the event.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema of eyelid, Eyelid pain, Pain in extremity, Pain in jaw
Clinical narrative: Left arm sore; swollen at the edges of the lid with secretions; red at the edges of the lid; Left eyelid began to get sore; shoulder were very sore; Pain in jaw near my earlobe when chewing; This is a spontaneous report from a non-contactable Non-Health Care Professional (Consumer or other HCP). A 53-years-old non-pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6208) as a single dose on an unspecified route administered in left arm on 12Mar2021 at 8:00am (at the age of 53-year-old) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Patient past drug includes penicillin allergy. The patient lab test was not reported. On 12Mar2021, patient experienced left arm sore, shoulder very sore and on the same day patient experienced left eyelid began to get sore, red and swollen at the edges of the lid with secretions for four days and also had pain in jaw near earlobe while chewing. Therapeutic measures were not taken for any events. The clinical outcome of the events was reported as recovering. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Also, the patient was not tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Left arm sore; swollen at the edges of the lid with secretions; red at the edges of the lid; Left eyelid began to get sore; shoulder were very sore; Pain in jaw near my earlobe when chewing; This is a spontaneous report from a non-contactable Non-Health Care Professional (Consumer or other HCP). A 53-years-old non-pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6208) as a single dose on an unspecified route administered in left arm on 12Mar2021 at 8:00am (at the age of 53-year-old) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Patient past drug includes penicillin allergy. The patient lab test was not reported. On 12Mar2021, patient experienced left arm sore, shoulder very sore and on the same day patient experienced left eyelid began to get sore, red and swollen at the edges of the lid with secretions for four days and also had pain in jaw near earlobe while chewing. Therapeutic measures were not taken for any events. The clinical outcome of the events was reported as recovering. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Also, the patient was not tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: vomiting; Nausea; This is a spontaneous report from a contactable consumer, the patient.   A 38-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 15Mar2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation.  Medical history included Hashimoto's disease and psoriasis. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took gentamicin (MANUFACTURER UNKNOWN) for an unknown indication on unknown dates and experienced drug allergy.  On 15Mar2021 at 23:30, the patient experienced vomiting and nausea. The patient did not receive any treatment for the event. The clinical outcomes of the vomiting and nausea were recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Left arm itching  with rash; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), dose number 1, via an unspecified route of administration in the left arm on 13Mar2021 at 12:30 PM (at the age of 68-years-old), as a single dose for COVID-19 vaccination. The patient's medical history included diabetes, arthritis and high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Abd Novolin insulin injections (MANUFACTURER UNKNOWN) and Ozempic (MANUFACTURER UNKNOWN), all for unknown indications on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to vaccination. On 14Mar2021 (day after vaccination), the patient experienced left arm itching with rash; as a corrective treatment for the adverse event patient used anti itch cream (unspecified). The clinical outcome of left arm itching with rash was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity, Rhinorrhoea
Clinical narrative: Pain in left arm; Runny nose; Continuous cough; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown], via an unspecified route of administration, in left arm on 11Mar2021 at 10:00 AM (at the age of 67-year-old) as single dose for COVID-19 immunisation. Concomitant medications and past drug/medical history were unknown at the time of reporting. 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 COVID-19 vaccine. On 12Mar2021, the patient experienced Continuous cough, Pain in left arm, Runny nose. The patient did not receive any treatment for the events. The clinical outcomes of the events continuous cough, Pain in left arm, Runny nose were not recovered/ not resolved at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She was tested positive for Covid on the next day after first dose of vaccine; This is a spontaneous report from a contactable consumer (patient's son) via Pfizer sponsored Program. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number and expiration date was unknown) via an unspecified route of administration on 22Feb2021 (at the age of 72-years-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Feb2021, the next day of vaccination, patient tested positive to Covid-19 virus. Patient was fully recovered to Covid-19 virus, 4-5 days now without a fever she just back up and running around. Reporter inquired if patient could go ahead and take the 2nd dose to the assigned schedule appointment to her at 15Mar2021. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Food craving, Headache, Lacrimation increased
Clinical narrative: MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SIDED FRONTAL HEADACHE; POST NASAL DRIP; I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS.; This is a spontaneous report from a non-contactable non-health care professional. A 42-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine) (Lot/batch no: EN6199) dose number 1 via unspecified route of administration on left arm as a single dose for COVID-19 immunisation on 04Mar2021 at 06:30 PM (at the age of 42-year-old). Medical history included allergy to gold. Concomitant medication was not provided. Reported patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness within the first 15 minutes. Within the first hour her eye brows swelled and she had a right sided frontal headache. 2 hours later she felt like she was at high altitude which lasted for 36-48 hours. The swelling broke during the night with massive eye tearing and post nasal drip. She craved for black licorice like mad on 04Mar2021. The action taken was not applicable. Therapeutic measures were taken as a result of events and included self-treatment with ice pack, tylenol, and clairitin from an unknown date. The patients recovered from the events dizziness, eye brows swelled, frontal headache, massive eye tearing and post nasal drip was recovered. No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Upper-airway cough syndrome
Clinical narrative: MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SIDED FRONTAL HEADACHE; POST NASAL DRIP; I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS.; This is a spontaneous report from a non-contactable non-health care professional. A 42-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine) (Lot/batch no: EN6199) dose number 1 via unspecified route of administration on left arm as a single dose for COVID-19 immunisation on 04Mar2021 at 06:30 PM (at the age of 42-year-old). Medical history included allergy to gold. Concomitant medication was not provided. Reported patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness within the first 15 minutes. Within the first hour her eye brows swelled and she had a right sided frontal headache. 2 hours later she felt like she was at high altitude which lasted for 36-48 hours. The swelling broke during the night with massive eye tearing and post nasal drip. She craved for black licorice like mad on 04Mar2021. The action taken was not applicable. Therapeutic measures were taken as a result of events and included self-treatment with ice pack, tylenol, and clairitin from an unknown date. The patients recovered from the events dizziness, eye brows swelled, frontal headache, massive eye tearing and post nasal drip was recovered. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: sweating; Fever; This is a spontaneous report from contactable consumer. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot/Batch Number: EL3247), via an unspecified route of administration in the right arm on 22Feb2021 at 9:45 (at the age of 49-years-old) as first dose, single for COVID-19 vaccination. Medical history of the patient was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. It was not known whether the patient was enrolled in clinical trial. The patient neither received any other vaccines within 4 weeks prior to the COVID vaccine nor other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient experienced fever and sweating on15March2021 at 02:00. No therapeutic measures were taken for the events. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot/Batch Number: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 at 9:45 (at the age of 49-years-old) as second dose, single for COVID-19 vaccination. The clinical outcome of the adverse events fever and sweating patient was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: upper left thigh muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a first dose in the left arm on 12Feb2021 and (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3302) as a second dose on 07Mar2021 via an unspecified route of administration for COVID-19 vaccination (Age at vaccination: 75 years). Medical history included HBP (High Blood Pressure) and cholesterol. Concomitant medications included blood pressure (unspecified) and cholesterol medication(unspecified) from unknown dates to unknown dates for High blood pressure and Cholesterol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy. On an unknown date, the patient experienced upper left thigh muscle ache (back of thigh) badly for a couple of weeks. (No accidents, falls, etc. that might have caused this). The patient did not receive treatment for the event of upper left thigh muscle ache. The outcome of the event of upper left thigh muscle ache was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Product dose omission issue, SARS-CoV-2 antibody test
Clinical narrative: she has been hospitalized (due to having Covid infection) from 12Feb2021 to 19Feb2021; she has been hospitalized (due to having Covid infection) from 12Feb2021 to 19Feb2021; Scheduled 5-6 weeks for second shot and missed appointment; Scheduled 5-6 weeks for second shot and missed appointment; This is a spontaneous report from a contactable consumer (patient) received via . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date patient was tested positive for the Sars-cov-2 antibody test and diagnosed to have COVID-19 infection. Patient was admitted to hospital from 12Feb2021 to 19Feb2021 due to having Covid infection. Technically, she also missed her second shot because it had already been more than 21 days since the first vaccine shot. The patient reported that she received the COVID shot first dose on 26Jan2021 and the paperwork that she got said second dose should be received 3 weeks apart. She was scheduled instead for 5-6 weeks and she missed her scheduled appointment for second shot. If the minimum was three weeks, patient wanted to know what the maximum was, or did she have to start over again. Patient enquired if she missed her window for the second vaccine. Patient declined to proceed with report at this time. Patient stated she had called the number the agent gave and selected option 3 and now has been waiting again. She also clarified that she spoke with a Pfizer representative already and got all the information. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [15Mar2021], this case now contains serious adverse reaction(s). Information processed together.The outcome of the events were unknown.  Information on lot/ batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: FEEL QUEASY; AWFUL HEADACHE; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received 1st dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number/Batch Number: UNKNOWN), solution for injection via an unspecified route of administration in the left arm on 14March2021 at 10.30 am as a single dose for COVID-19 immunisation. The patient was allergic to gluten (celiac), Zithromax and Augmentin. The patient concomitant medications include Zoloft (Manufacturer unknown) , Junel birth control (Manufacturer unknown) and Claritin (Manufacturer unknown). On 14March2021, the patient experienced awful headache and queasy. The patient has recovering from the event headache and queasy at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lymphadenopathy, Urticaria
Clinical narrative: Mild muscle soreness around injection site; Swollen lymph nodes in left armpit; Hives at major joints.; Severe fatigue day of, for about 24 hrs.; This is a spontaneous report from a contactable patient. A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Batch number: EN6208) via an unspecified route of administration in left arm on 10Mar2021 (at the age of 45-years-old), as an unspecified single dose for COVID-19 Immunisation. The patient's medical history included G6pd enzyme deficient, diabetes mellitus. The concomitant medication included Lisinopril, Pioglitazone. The patient was allergic to Sulpha drugs, NSAIDs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced Mild muscle soreness around injection site, severe fatigue day of, for about 24 hours on an unspecified date. On 15Mar2021, five days later broke out in hives at major joints/lymph node areas that went away after about 8-10 hours. The patient also experienced swollen lymph nodes in left armpit on an unspecified date. The clinical outcome of the event muscle soreness around injection site, swollen lymph nodes in left armpit was unknown, fatigue, hives at major joints/lymph node was recovered. No follow-up attempts are possible; No further information is expected.