chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Full blood count, Pyrexia, Rash, Vomiting
Clinical narrative: low grade fever (99.7°F); His wife had a rash on the right side of her abdomen and inner thigh/rash on the right side of hrash on inner thigh of one leger belly/rash on inner thigh of one leg; diarrhea; vomiting/Throwing up; This is spontaneous report from a contactable consumer (patient husband). This report is regarding his wife. A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: PHFEEL9263, Expiration date: Unknown), via an intramuscular route in the left arm on 28Jan2021 Thursday at 12:00 PM, as 1 ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history included cancer; however, she is cancer-free right now. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 30Jan2021 until 23:00 or midnight patient was fine, and the patient had experienced heavy 20 minutes being in the bathroom throwing up and having diarrhoea and in the morning rash on the right side of her abdomen about the size of a saucer and inner thigh and on 02Feb2021, a low grade fever (99.7 degree Fahrenheit). Her temperature never went higher than 99.7 degrees. Patient wanted to know if can expect these side effects from the second dose and could they be worse. The patient underwent lab test and procedure which included regular CBC (like whole bloodwork) on 01Feb2021, Monday. She doesn't have any test results to include. The clinical outcome of fever has subsided and outcome for the event rash on the right side of her abdomen and inner thigh of one leg was recovering, outcome for diarrhoea and throwing up was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Pruritus, Swelling face
Clinical narrative: face became entirely swollen - no breathing problems; eyes itching; itching spread to body - no rash; eyes itching; itching spread to body - no rash; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264, expiration date was not reported) via an unspecified route of administration administered in Arm Right on 28Jan2021 at 15:00 pm, as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies and had not received COVID prior vaccination and had not tested positive for COVID post vaccination. Patient had not received any other vaccine in four weeks. Caller stated that after receiving the first dose of vaccine on 28Jan2021 at 15:45 pm the patient experienced eyes itching; itching spread to body - no rash; face became entirely swollen - no breathing problems. Benadryl was given as therapeutic measures to treat the events. Outcome of all events was recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: infection in the lower eye lid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient was taking eye drops, tobramycin, dexamethasone, ophthalmic suspension for a underlying medical condition. On an unspecified date, it was reported that patient was in the middle of a ten day prescription of Tobramycin, Dexamethasone (lot number: 342311, expiry: Feb2022) ophthalmic suspension to treat an infection in the lower eye lid. One of the drugs in the suspension was an antibiotic. Patient further wanted to know that theses drugs would have any effect on the efficacy of the second COVID19 vaccination and patient was scheduled to receive the second dose towards end of the week. Patient also heard on the news its not recommended to take the NSAIDS or Aleve before getting vaccine.  Information about the Lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm they put it on, it is itchy and red; Arm they put it on, it is itchy and red; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration in arm on 02Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. On an unspecified date the patient stated that, the arm they put it on, it was itchy and red. The patient further stated that with the first dose patient didn't have any problem but second dose they gave caused itching around it and kind of redness just a little bit, not big deal. The clinical outcome for the event was unknown.  Information on lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Mild soreness of injection site, only lasted a day.; This is a spontaneous report from a non-contactable other HCP (patient herself). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration, administered in Arm Left on 29Jan2021 18:30 (at the age of 40-years-old) as 1st dose, single dose for covid-19 immunisation. The patient's had no medical history and no known allergies. The patient's concomitant medication included bupropion in two weeks 75 mg two times a day (BID) for an unspecified indication. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. On 30Jan2021, the patient experienced mild soreness of injection site, that only lasted a day. The patient tested for covid post vaccination, covid test type post vaccination nasal swab, a polymerase chain reaction (PCR) test done on 31Jan2021 which showed negative result. The patient did not receive treatment for the adverse event. The outcome of the event was recovered on 30Jan2021.  No follow up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gastrooesophageal reflux disease, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: The next day I have severe acid reflux and I don't have that normally; Severe runny nose; achey; chills; really bad sore arm; This is a spontaneous report from a contactable other health care professional. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: El9265, Expiration date: Unknown) via an intramuscular route of administration in right arm on 02Feb2021 (at the age of 50-year-old) as UNKNOWN, SINGLE DOSE for Covid-19 immunisation. The patient medical history was not reported. No known allergies were reported. No known allergies were reported. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 02Feb2021 at 14:45, the patient had experienced severe runny nose, achey, and chills, really bad sore arm and on 03Feb2021, next day patient had severe acid reflux and don't have that normally. Patient did not receive any treatment for the events. The outcome of events was recovering at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose administered in Right arm on 12Jan2021 for covid-19 immunisation. On 03Feb2021, the patient experienced Dizziness, sore arm, and low grade fever. No treatment was given. The outcome of the events was recovering.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient, reported for self).   A 59-years-old (non pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 21Jan2021 09:15 (At the age of 59-years-old) as single dose, for COVID-19 immunisation. Medical history included diabetes mellitus from an unspecified date and unknown if ongoing. The patient did not have known allergies. The patient did not have other vaccine in four weeks. The patient did not have COVID prior vaccination. Other medications in two weeks, yes.  On 22Jan2021 22:00, the patient experienced sore arm. The patient was not tested for COVID post vaccination. No treatment was given for the event. The outcome of the event was recovered.  The information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on Jan2021 06:45 PM (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient previously took clarithromycin (MACROBID), T-DAP vaccine and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination and other medications in two weeks as Statin. Prior or post to the vaccination, the patient was not diagnosed with COVID-19. On 29Jan2021, patient experienced, extreme soreness on scalp. Reported as "two days after vaccine on the left and six days after vaccine on the right. Each lasted about 24 hours" Patient did not receive any treatment for the events. The clinical outcome of the event was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Dizziness/lightheaded-comes and goes throughout the day; "brain fog" can't think clearly; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Feb2021 13:45 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. There was no medical history. The patient was not pregnant at time of vaccination. Age at vaccination was 35-year-old. The patient's concomitant medications were not reported. On 03Feb2021 13:00, the patient experienced Dizziness/lightheaded-comes and goes throughout the day, "brain fog" can't think clearly. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Pyrexia, Ultrasound scan
Clinical narrative: Low Fever 100 degree F; hot flasher/ cold chills; hot flasher/ cold chills; This is a spontaneous report from a contactable Consumer. This 36-year-old- (Pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1284) via an unspecified route of administration, administered in arm left on 10Jan2021 (Batch/Lot Number: EL1284) as second dose, single dose for COVID-19 immunization. Medical history included polycystic ovaries, hypothyroidism from 2016 treated with Levothyroxine. The patient was allergic to Flagyl (historic not active) and experienced drug hypersensitivity. The patient previously receive first dose of bnt162b2 (Lot/Batch number: #1-EK5730) and experienced off label use. Concomitant medications included progesterone (PROGESTERONE) from 13Dec2020; escitalopram oxalate (LEXAPRO) from 2015; buspirone hydrochloride (BUSPAR) from 2015; levothyroxine (LEVOTHYROXINE) from 2016. The 41-year-old father had a heart disease and had exposure to products Crestor (Oral, 10mg/day) from 2016, Cialis (oral, 5mg/day) from 2020. Both were neither smoking, nor drinking alcohol nor using illicit drugs during the pregnancy. On 11Jan2021 3:30, the patient experienced hot flasher/ cold chills. On 11Jan2021 6:30 the patient experienced low fever 100degree fever. The mother reported she became pregnant while taking bnt162b2.The mother was 1 Months pregnant at the onset of the event. The mother was due to deliver on 30Aug2021. The patient reported that she was five weeks pregnant and received first COVID-19 vaccination at 3 weeks 4 days (25-days/gestational period at time of initial exposure reported as 1 month/ 1st trimester as reported) on 20Dec2020. The patient underwent lab tests and procedures which included Ultrasound scan: Normal (Ante-natal check-up) on 18Jan2021.The outcome of the event cold chills/hot flashes was recovered on unspecified date and the event fever outcome was unknown.  No Follow-up attempts are needed. No Further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Nausea, Pain
Clinical narrative: patient was scheduled before 21 days for the second vaccine; 102 fever; body aches; fatigue; chills/body tremors; sore arm; nausea; chills/body tremors; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL8982) via an unspecified route of administration, administered in left arm on 11Feb2021 at 09:45 (at the age of 39-years) as 2nd single dose for COVID-19 immunisation at Hospital. The patient had known allergies to sulfa drugs, gluten. The patient received no other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number EL3246) via an unspecified route of administration in left arm on 25Jan2021 at 09:30 for COVID-19 immunisation. On 12Feb2021 at 12:00, patient experienced 102 fever, body aches, fatigue, chills, body tremors, sore arm, nausea. The fatigue and body aches lasted 48 hours. Patient was wondering if the reaction was more severe because patient was scheduled before 21 days for the second vaccine. It was reported that no therapeutic measures were taken for the events experienced. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: patient was scheduled before 21 days for the second vaccine; 102 fever; body aches; fatigue; chills/body tremors; sore arm; nausea; chills/body tremors; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL8982) via an unspecified route of administration, administered in left arm on 11Feb2021 at 09:45 (at the age of 39-years) as 2nd single dose for COVID-19 immunisation at Hospital. The patient had known allergies to sulfa drugs, gluten. The patient received no other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number EL3246) via an unspecified route of administration in left arm on 25Jan2021 at 09:30 for COVID-19 immunisation. On 12Feb2021 at 12:00, patient experienced 102 fever, body aches, fatigue, chills, body tremors, sore arm, nausea. The fatigue and body aches lasted 48 hours. Patient was wondering if the reaction was more severe because patient was scheduled before 21 days for the second vaccine. It was reported that no therapeutic measures were taken for the events experienced. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: The doctor has ruled out the fungal infection since it has not cleared up after being on the medication for seven days; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation.The patient experienced doctor has ruled out the fungal infection since it has not cleared up after being on the medication for seven days on an unspecified date. Therapeutic measures were taken because of possible fungal infection. It was reported that patient just had the second dose of the COVID-19 vaccine the day before this report. Patient had been treated by her doctor for a possible fungal infection with fluconazole, states it was the generic for Diflucan. The fluconazole had not been working. The doctor ruled out the fungal infection since it did not clear up after being on the medication for seven days. The doctors next step of action would be to put her on prednisone, patient was assuming it would-be short-term period she would be on the steroid prednisone. Patient asked if it would be ok or safe to take prednisone. Patient called the pharmacist and was told it was safe to take fluconazole between the first and second dose. It was reported that patient declined to complete a report. In response patient was told that she would get her question answered. Outcome of the event was unknown.    Follow-Up (31Mar2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye irritation, Pruritus, Rash, Swollen tongue
Clinical narrative: severe rash/worsened considerably; severe itching; dizziness; swollen tongue; tight throat; even bothering my eyes; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, neuropathy, heart disease, starts and stop date was not reported for all and patient was allergic with sulfa. The patient's concomitant medication(s) included prednisone; gabapentine and unspecified blood pressure medicine, all are taken within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 78-year-old at the time of vaccination), via an unspecified route of administration in left arm on 25Jan2021 at 03:00 pm as a single dose for COVID-19 immunisation. Patient previously took simvastatin and had allergies. On 24Feb2021 at 12:00, the patient experienced severe rash and worsened considerably, severe itching, dizziness, swollen tongue, tight throat, even bothering my eyes. Patient received treatment with benadryl then Zyrtec for all events. Patient not received other vaccine in four weeks of vaccination. Patient visited doctor office/clinic visit for the events. Patient had not covid prior vaccination and not tested covid post vaccination. The final outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: severe rash/worsened considerably; severe itching; dizziness; swollen tongue; tight throat; even bothering my eyes; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, neuropathy, heart disease, starts and stop date was not reported for all and patient was allergic with sulfa. The patient's concomitant medication(s) included prednisone; gabapentine and unspecified blood pressure medicine, all are taken within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 78-year-old at the time of vaccination), via an unspecified route of administration in left arm on 25Jan2021 at 03:00 pm as a single dose for COVID-19 immunisation. Patient previously took simvastatin and had allergies. On 24Feb2021 at 12:00, the patient experienced severe rash and worsened considerably, severe itching, dizziness, swollen tongue, tight throat, even bothering my eyes. Patient received treatment with benadryl then Zyrtec for all events. Patient not received other vaccine in four weeks of vaccination. Patient visited doctor office/clinic visit for the events. Patient had not covid prior vaccination and not tested covid post vaccination. The final outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Inappropriate schedule of product administration
Clinical narrative: recurring yeast infections since receiving the vaccine; dose 1 administration date 15Jan2021; dose 2 administration date 15Jan2021; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported for herself.  A 44-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 15Jan2021 at 12:00 AM as 1st dose, single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration in left arm on 15Jan2021 at 11:30 AM as 2nd dose, single dose for covid-19 immunisation. Medical history included high blood pressure, Covid-19 from an unknown date and unknown if ongoing. The patient had known allergies to Sulfa. Concomitant medication included guaifenesin (MUCINEX), paracetamol (TYLENOL), ibuprofen (IBUPROFEN), losartan (LOSARTAN) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in four weeks. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 25Jan2021, the patient experienced recurring yeast infections since receiving the vaccine. This has never been an issue with me before. The events resulted Doctor or other healthcare professional office/clinic visit. The patient received treatment with Diflucan the first time, Monistat x 2 since then. The outcome of recurring yeast infections since receiving the vaccine was not resolved, while with other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Suspected COVID-19
Clinical narrative: Running a temperature; My temperature is still 99.9; I have been feeling like I got Covid all over again; This is a spontaneous report from a contactable consumer(patient). A 76-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot/batch no: EN6206) via unspecified route, as a 1st dose, single dose on 08Mar2021 for COVID-19 immunization (at the age of 76-years). Medical history included blood pressure measurement, Type 2 Diabetic and covid-19 infection from an unknown date. Concomitant medication included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported. Patient stated that she received her first dose of vaccine on Monday (08Mar2021) at noon and she felt fine. But by Tuesday morning, she was running a temperature and she had been feeling like she got Covid all over again, the whole time because she had it in November. That morning, her temperature was still 99.9. Patient wanted to know if she was contagious to somebody, she meant, she was trying to get the shot to take care of that but here felt like she got it again. The patient underwent lab tests and procedures which included body temperature: still 99.9 on an unspecified date. The clinical outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Severe headache; severe neck pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 13Mar2021 at 08:00 AM, as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis, asthma, high blood pressure, heart attack. The patient received other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 00:00 AM, the patient experienced severe headache and severe neck pain. Therapeutic measures were unknown for the reported events severe headache and severe neck pain. The clinical outcome of severe headache and severe neck pain was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Aches; Chills; Headache; Injection site pain; This is a spontaneous report received from a contactable health care professional, the patient. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration on the left arm on 17Mar2021 at 01:30PM (at the age of 49-year-old) as single dose for COVID-19 immunisation. The past drug included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration on the left arm on 25Feb2021 at 01:30PM as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. 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 not had any allergies to medications, food or other products. Concomitant medications were not reported. On 18Mar2021 at 12:00AM, the patient experienced fever, aches, chills, fever, headache, injection site pain (vaccination site pain). The events were treated with tylenol (MANUFACTURER UNKNOWN). The clinical outcome of the events aches, chills, fever, headache, injection site pain (vaccination site pain) was recovering at the time of this report.    No follow up attempts are possible, information about lot number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Influenza, Myalgia
Clinical narrative: Achy muscles all over; flu; Headache; Chills; No appetite; This is a spontaneous report from a contactable consumer.  A 67 years old non-pregnant female patient received her first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; lot number: UNKNOWN) via unspecified route of administration at left arm on 24Feb2021 at 11.15am as single dose for COVID 19 immunization. She also received her second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; lot number: UNKNOWN) via unspecified route of administration at right arm on 17Mar2021 at 11.15am as single dose for COVID 19 immunization. The patient was not diagnosed with COVID-19 prior or after the vaccination. Medical history included approximal Atrial fibrillation, GERD hypothyroidism since an unknown date. Concomitant medication included Levothyroxine (MANUFACTURER UNKNOWN),, Eliquis (MANUFACTURER UNKNOWN), Pantoprazole (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) for an unknown indication since an unspecified date. The patient did not undergo any lab tests or procedure. On 18Mar2021, the patient experienced achy muscles all over like flu, headache chills and no appetite. The did not received any treatment for the events.  The events achy muscles all over like flu, headache chills and no appetite were not resolved at the time of the report. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Ear infection, Fatigue, Malaise
Clinical narrative: Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ear infection; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EN6208, Expiration date: Jun2021), via an unspecified route on an 10Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9266, Expiration date: 31May2021) via an unspecified route on an 17Feb2021, both as a single dose for covid-19 immunization. Medical history included thyroid and blood pressure. Concomitant medication included lisinopril taking for about 4-5 years and levothyroxine taking may be for 15 years for thyroid. On an unknown date after receiving the first dose, patient experienced stomach upset, nausea, sinuses, tiredness, muscle pain and dizziness. She feels so unwell that she went to the emergency room after the first Pfizer Covid vaccine administered on 17Feb2021 for feeling so unwell. They could not find anything wrong, hence not admitted her. She had improved some but was not really good when she went for the second dose on 10Mar2021. Therapeutic measures taken as a result of the events included antibiotics after the first dose for sinuses and possible ear infection and treated with amoxicillin Clav 875/125mg tablet, dosage two times a day for 21 days, came in an orange colour. The clinical outcome of the events was still experiencing the same side effects after the second dose.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Sinus disorder
Clinical narrative: Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ear infection; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EN6208, Expiration date: Jun2021), via an unspecified route on an 10Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9266, Expiration date: 31May2021) via an unspecified route on an 17Feb2021, both as a single dose for covid-19 immunization. Medical history included thyroid and blood pressure. Concomitant medication included lisinopril taking for about 4-5 years and levothyroxine taking may be for 15 years for thyroid. On an unknown date after receiving the first dose, patient experienced stomach upset, nausea, sinuses, tiredness, muscle pain and dizziness. She feels so unwell that she went to the emergency room after the first Pfizer Covid vaccine administered on 17Feb2021 for feeling so unwell. They could not find anything wrong, hence not admitted her. She had improved some but was not really good when she went for the second dose on 10Mar2021. Therapeutic measures taken as a result of the events included antibiotics after the first dose for sinuses and possible ear infection and treated with amoxicillin Clav 875/125mg tablet, dosage two times a day for 21 days, came in an orange colour. The clinical outcome of the events was still experiencing the same side effects after the second dose.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling sensation on the left side of my body from face to feet, then it traveled toward my right side.; numbing sensation on the left side of my body from face to feet, then it traveled toward my right side.; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 08:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included tourette syndrome from unknown duration. The patient had a known allergy to chamomile and penicillin. Concomitant medications included MENOPUR, GONAL F and CLOMID taking as fertility medication and were received within 2 weeks of 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 has not been tested for COVID-19. On 18Mar2021, at 17:45, the patient experienced tingling and slight numbing sensation starting 10 hours after the first dose, on the left side of her body from face to feet, then it traveled toward the right side of her body. The patient did not receive any treatment for the events. The clinical outcome of the events tingling sensation and numbing sensation was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: swelling at injection site; Itchiness; Hard lump at injection site; Headache; Swollen lymph nodes; injection site along with itchiness and soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-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 left arm on 13Mar2021 at 17:30 (at the age of 32 years old) as a single dose for COVID-19 immunisation. Medical history of the patient included migraines. 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 tested for COVID-19. Concomitant medication of the patient included verapamil HCL ER (MANUFACTURE UNKNOWN) for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The past drug history of the patient included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration and unspecified anatomical site on unknown date as a single dose for COVID-19 immunisation. On 13Mar2021 at 19:00, patient experienced swelling at the vaccination site along with itchiness and soreness, hard lump at the vaccination site, swollen lymph node/ hard lump in the armpit of the arm that did not receive the injection and headaches for two days. No therapeutic measures were taken as the result of these events. The clinical outcomes of the events swelling at the vaccination site along with itchiness and soreness, hard lump at the vaccination site, swollen lymph node/ hard lump and headache was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling at injection site; Itchiness; Hard lump at injection site; Headache; Swollen lymph nodes; injection site along with itchiness and soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-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 left arm on 13Mar2021 at 17:30 (at the age of 32 years old) as a single dose for COVID-19 immunisation. Medical history of the patient included migraines. 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 tested for COVID-19. Concomitant medication of the patient included verapamil HCL ER (MANUFACTURE UNKNOWN) for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The past drug history of the patient included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration and unspecified anatomical site on unknown date as a single dose for COVID-19 immunisation. On 13Mar2021 at 19:00, patient experienced swelling at the vaccination site along with itchiness and soreness, hard lump at the vaccination site, swollen lymph node/ hard lump in the armpit of the arm that did not receive the injection and headaches for two days. No therapeutic measures were taken as the result of these events. The clinical outcomes of the events swelling at the vaccination site along with itchiness and soreness, hard lump at the vaccination site, swollen lymph node/ hard lump and headache was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus
Clinical narrative: Racing heart, itchy (no rash); Racing heart, itchy (no rash); This is a spontaneous report received from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in left arm on 18Mar2021 at 11:00 (at the age of 37-year-old) for COVID-19 immunisation. Medical history of the patient was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medication was not reported. The patient did not have allergies to medication, food or other products. The patient experienced racing heart, itchy (no rash) on 18Mar2021 at 12:00PM. No therapeutic measures were taken as a result of the events. The clinical outcome of racing heart, itchy (no rash) was not recovered at the time of this report.   No follow-up attempts are needed. Information about lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: I had an infected tooth; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN6199) as unknown, single dose for COVID-19 immunization. Medical history included tooth ache. The patient's concomitant medications were not reported. The patient reported that he/she woke up with a tooth ache but decided to get the vaccine first then go to the dentist. The patient went to the dentist the next day and had an infected tooth. The patient was put on a drug called Clindamycin. The patient almost taken all of the medication and then realized in the precautions it says do not have any immunization vaccinations while using this medication because it can affect the effectiveness of the vaccine. The patient asked information regarding the matter. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pain, Rash
Clinical narrative: Severe aches and pain; chills; Fatigue; Full body rash; first dose on 04Mar2021 at 08:00 AM/second dose on 17Mar2021 at 08:30 AM; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not known) as a single dose via unspecified route in right arm on 17Mar2021 at 08:30 AM (at the age of 60-year-old) for COVID-19 immunisation. The patient medical history included known allergies to penicillin and non-steroidal anti-Inflammatory drugs (NSAIDS). Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not known) as a single dose via unspecified route on 04Mar2021 at 08:00 AM (at the age of 60-year-old) for COVID-19 immunisation of event rash, swollen lips, tingle lips. Concomitant medications included biotin and multi vitamin (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 17:00, the patient experienced severe aches and pain, chills, fatigue and full body rash. The treatment was taking Benadryl and Tylenol received for the events. The clinical outcome of severe aches and pain, chills, fatigue and full body rash was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: ITCHY; painful rash. Moves to different areas of body about every 24-36 hrs. A couple of the rashes have stayed in one spot. Wrist and groin area. Some of the rash is barely visible; This is a spontaneous report from a contactable Consumer, the patient. A 54-year-old female non pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Lot number:unknown) via an unspecified route of administration on Left arm on 16Feb2021 at 02:30pm as a single dose for Covid-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number:unknown) via an unspecified route of administration on Left arm on 09Mar2021 at 03:15pm as a single dose for Covid-19 immunisation. The patients medical history includes lung cancer, end date was 2016, chronic lyme disease and Allergie to Doxycycline. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received nexuim, supplements and crestor within 2 weeks of vaccination: On 28Feb2021 at 12:00 the patient experienced events of Itchy and painful rashes which Moves to different areas of body in about every 24-36 hrs a couple of the rashes have stayed in one spot in Wrist and groin area. Some of the rashes were barely visible but extremely itch. some was pink circle patches sized from nickel to quarter..not as painful, just as itchy. Had very slight reaction after first dose, after second dose, same evening it became much greater in numbers of rashes. The patient had not received any treatment for the reported events. The clinical outcome of the Itchy and painful rashe was not recovered at time of reporting. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Herpes zoster, Pain in extremity, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in right arm for COVID-19 immunisation at the age of 81-year-old. Medical history included hypertension, atrial fibrillation. Concomitant medications included losartan, amlodipine, metoprolol, apixaban (ELIQUIS). Historical vaccine included first administration of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunization. On unknown date, blood cholesterol resulted a little bit high. On unknown date, the patient experienced little spot on arm got bigger and started to swell, It got worse, patient had red splotches down my arm, down my wrist, underarm, and then even on side of body; on the other arm a few spots, he had soreness in that arm, the patient might have shingles, doctor gave the patient medication (Unspecified Medication); it did not do anything, the splotches actually got a little bit worse, right arm has 3 splotches on it, one in muscle area on upper arm, down elbow is another red spot, right down the elbow another one; other one has a lot of them; It was getting a little bit itchy. The outcome of the events was unknown.