chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient who received her first dose of Pfizer-Biontech Covid19 vaccine on 18Feb2021. Two days later, her boyfriend tested positive for Sars-Cov-2 infection, and she tested positive a week later. The patient experienced tested positive on 25Feb2021. The patient underwent lab tests and procedures which included covid-19: positive on 25Feb2021. The event assessed as medically significant. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Epistaxis, Eye pain, Neck pain
Clinical narrative: Tested positive for COVID; Nosebleed after the first dose; Severe pain in eyes, back, and neck; Severe pain in eyes, back, and neck; Severe pain in eyes, back, and neck; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no: EL8299, Expiration date: 31Aug2021 or 31May2021), via an unspecified route of administration in left arm, on 05Feb2021 at 12:05 as single dose for COVID-19 immunization. Medical history included Hypertension, Nosebleed, Cardiac failure, Diabetes mellitus, Obesity, Heart trouble, Asthma, Cholesterol, Diabetes, places under tongue for heart and Blood pressure. Historical Vaccine included flu shot either 1994 or 1999, she cannot remember. Concomitant medication included Metoprolol for blood pressure, Isosorbide, Nitroglycerin for places under tongue for heart, Aspirin for Cholesterol, Metformin for diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 05Feb201, the patient experienced nosebleed. On 15Feb2021, the patient tested positive for Covid-19. In Feb2021, the patient experienced severe pain in eyes, back, and neck. The events did not result in a visit to emergency room. The outcome of the events COVID-19 and nosebleed was unknown whereas of other events it was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Nosebleed after the first dose; Severe pain in eyes, back, and neck; Severe pain in eyes, back, and neck; Severe pain in eyes, back, and neck; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no: EL8299, Expiration date: 31Aug2021 or 31May2021), via an unspecified route of administration in left arm, on 05Feb2021 at 12:05 as single dose for COVID-19 immunization. Medical history included Hypertension, Nosebleed, Cardiac failure, Diabetes mellitus, Obesity, Heart trouble, Asthma, Cholesterol, Diabetes, places under tongue for heart and Blood pressure. Historical Vaccine included flu shot either 1994 or 1999, she cannot remember. Concomitant medication included Metoprolol for blood pressure, Isosorbide, Nitroglycerin for places under tongue for heart, Aspirin for Cholesterol, Metformin for diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 05Feb201, the patient experienced nosebleed. On 15Feb2021, the patient tested positive for Covid-19. In Feb2021, the patient experienced severe pain in eyes, back, and neck. The events did not result in a visit to emergency room. The outcome of the events COVID-19 and nosebleed was unknown whereas of other events it was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Epistaxis, Eye disorder, Eye pain, Neck pain
Clinical narrative: tested positive for COVID; Severe pain; Problems with her eyes; pain in back; Nosebleed; pain in eyes; pain in neck; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced tested positive for covid (sars-cov-2 test positive), severe pain, problems with her eyes, pain in back, nosebleed, pain in eyes, pain in neck. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. She stated she is having severe pain in her eyes. The pain is also in her neck and back. She is also having nose bleeds. She further mentioned after the first dose she had a few pains in her eye and nose bleeds. However, this time after the second dose the nose bleeding is more and severe in her eye and neck. She also tested positive for COVID after getting the first dose of the vaccine. While providing details about herself, at the end of the call, caller stated she is not the only one with these problems. Another lady had the same problems she had. She further explained after the COVID Vaccine she took the last one and she had problems with her eyes and severe pain. She also had pain in right shoulder up to her back and neck. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; Severe pain; Problems with her eyes; pain in back; Nosebleed; pain in eyes; pain in neck; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced tested positive for covid (sars-cov-2 test positive), severe pain, problems with her eyes, pain in back, nosebleed, pain in eyes, pain in neck. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. She stated she is having severe pain in her eyes. The pain is also in her neck and back. She is also having nose bleeds. She further mentioned after the first dose she had a few pains in her eye and nose bleeds. However, this time after the second dose the nose bleeding is more and severe in her eye and neck. She also tested positive for COVID after getting the first dose of the vaccine. While providing details about herself, at the end of the call, caller stated she is not the only one with these problems. Another lady had the same problems she had. She further explained after the COVID Vaccine she took the last one and she had problems with her eyes and severe pain. She also had pain in right shoulder up to her back and neck. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test result Positive; covid test result Positive; This is a spontaneous report received from a contactable nurse (patient). A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration in Right Arm on 13Jan2021 09:00 (33 years at the time of vaccination) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 via an unspecified route of administration on an unspecified date. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not have any adverse event. The patient did not receive any treatment. Prior to the vaccination, the patient had no covid infection. On 23Feb2021, post vaccination, the patient was tested positive through nasal swab PCR test. Seriousness of the events was medically significant. The outcome of events was unknown.  No follow-up attempts are possible. Information regarding lot/batch cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller received 1st dose of Covid vaccine 09Feb2021 and then tested positive for Covid on 14Feb2021; This is a spontaneous report. A contactable female consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that received 1st dose of Covid vaccine 09Feb2021 and then tested positive for Covid on 14Feb2021. Her next dose is 02Mar2021 and she is wondering if she can take the 2nd dose on time. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Feb2021. The outcome of the event was reported as reported as unknown.   Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Investigation
Clinical narrative: exposed to someone (her son) with covid symptoms; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 13Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 13Feb2021, the patient received the first dose and was scheduled to get the second dose on 06Mar2021 but on 28Feb2021 she was exposed to someone (her son) with covid symptoms. The patient took a test, but he doesn't know the results yet. He wanted to know how much protection he has from the first dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: She explained her husband has not been vaccinated, tested positive to COVID-19,  and thus they both have to quarantine; This is a spontaneous report from a consumer via a Pfizer-sponsored program.   A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 19Feb2021, as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Patient stated that her husband has not been vaccinated, tested positive to COVID-19, and thus they both have to quarantine until 08Mar2021. She asked if she should receive her second dose as planned. Patient stated that her second dose scheduled on 13Mar2021. At the time of this report event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient diagnosed with covid shortly after recieving first dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer  reported for a patient that a patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced patient diagnosed with covid shortly after receiving first dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Hyperhidrosis
Clinical narrative: Still positive for Covid antibodies after infection a year ago; Severe body aches; chills; sweats; cough; headache; elbow pain on site arm; This is a spontaneous report from a contactable consumer (her sellf). A 33-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, in right arm on 02Mar2021 09:30 (at the age of 33-years-old) as a single dose for covid-19 immunisation. Medical history included tachycardia and COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications were not reported. The patient received other medications in 2 weeks of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient had COVID prior vaccination. Post vaccination the patient tested for COVID on 03Mar2021, test type: Nasal Swab, test name: ID NOW RNA PCR and result was negative. The outcome of still positive for COVID antibodies after infection a year ago was not recovered and for the other events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Still positive for Covid antibodies after infection a year ago; Severe body aches; chills; sweats; cough; headache; elbow pain on site arm; This is a spontaneous report from a contactable consumer (her sellf). A 33-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, in right arm on 02Mar2021 09:30 (at the age of 33-years-old) as a single dose for covid-19 immunisation. Medical history included tachycardia and COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications were not reported. The patient received other medications in 2 weeks of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient had COVID prior vaccination. Post vaccination the patient tested for COVID on 03Mar2021, test type: Nasal Swab, test name: ID NOW RNA PCR and result was negative. The outcome of still positive for COVID antibodies after infection a year ago was not recovered and for the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diplopia, Neck pain
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's wife) via Medical Information Team. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 04Feb2021 13:15 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 14Jan2021 at 13:15 for COVID-19 immunization. The patient experienced soreness in his neck and shoulders on an unspecified date and after the 11th day after the vaccine, the patient experienced double vision in one eye on 15Feb2021. On 18Feb2021, the patient recovered from double vision in one eye while outcome of soreness in his neck and shoulders was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive today; COVID positive today; This is a spontaneous report from a contactable other health professional, the patient. A 25-year-old male patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm left on 28Dec2020 at 13:00 (Lot number: UNKNOWN) (at the age of 25 years-old) as a single dose and dose 2 intramuscular, administered in Arm left on 16Jan2021 (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history were not reported. Concomitant medications included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03Mar2021, at 08:00, the patent had COVID positive. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included COVID-19 nasal swab test on 03Mar2021 showed positive. The patient did not receive any treatment for the events. The outcome of the event Covid-19 was recovering and other event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive; This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date not reported) via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller (HCP) has a patient whose schedule for the 2nd dose of vaccine was today (24Feb2021) but the patient tested positive last 11Feb2021 (1 week after the patient's first dose). The caller is asking if they are going to proceed with the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: exposed to covid positive and tested positive after he got the first dose of the vaccine; exposed to covid positive and tested positive after he got the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable consumer (patient's wife) reported for a male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration in Feb2021 at single dose for COVID-19 Immunization. Patient medical history and concomitant medications were unknown. The caller reported that she and her husband got the first dose of the vaccine 2 weeks ago, and the patient (husband) exposed to covid positive and tested positive after patient got the first dose of the vaccine, also exposed to COVID positive but not tested positive however she is experiencing headache, cough, and sinus drainage, asked was it ok to get the second dose of the vaccine on the 03Mar2021. The patient underwent lab test included positive SARS-CoV-2 test. The outcome for the events were unknown at the time of report. Upon follow-up (24Feb2021): This is a follow-up spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable consumer (patient's wife) reported for a male patient (reporter's husband) included no new information.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: ended up testing positive for covid/had mild symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unknown route of administration on 10Feb2021 as a single dose for COVID-19 immunization. The relevant medical history and concomitant medication were not reported. The patient had mild symptoms after shot and decided to get tested for COVID on Thursday 18Feb2021 because the patient was still having mild symptoms. On Saturday 20Feb2021, the patient tested positive for COVID. The clinical outcome of the event was unknown.  Information of lot and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer . A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, developed Covid within a week after Frist Vaccine. How long do they have to wait to get second dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID by PCR; tested positive for COVID by PCR with cold/flu like symptoms; This is a spontaneous report from a contactable nurse (patient herself).   A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on unknown date for COVID-19 immunisation. Patient was vaccinated with the first dose of BNT162B2 on an unknown date. The patient started having cold/flu like symptoms on 22Feb2021 and tested positive for COVID by PCR on 23Feb2021. She did not become complacent. She was an RN and continued to wear 2 masks at a minimum. Have not seen her family since Aug2020. she literally works and come home. she did not take public transport.  She questioned if you are doing any studies on post vaccine, symptomatic, positive cases. She would be willing and interested in participating. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile and a strong temporal relationship, there is reasonable possibility of causal association between the events Covid 19 and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: tested positive after 1st dose; tested positive after 1st dose; This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number, expiration date: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient tested positive after 1st dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unknown date. The patient is scheduled to get 2nd dose on 27Feb2021. The outcome of the event was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She was positive to Covid-19 virus last week and this is her 10th day; She was positive to Covid-19 virus last week and this is her 10th day; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient, self -reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 26Jan2021, as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received COVID-19 vaccine first dose on 26Jan2021 and informed that her next dose will be tomorrow. She was positive to COVID-19 virus last week (on 15Feb2021) in SARS-CoV-2 test and this is her 10th day. Outcome of the event was unknown.   No Follow-up attempts are possible. Information on the lot/batch number can not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: She was exposed to a COVID positive, then a day after her 1st dose she was exposed again. Now the caller is COVID positive and experienced a cold; She was exposed to a COVID positive, then a day after her 1st dose she was exposed again. Now the caller is COVID positive and experienced a cold; She was exposed to a COVID positive, then a day after her 1st dose she was exposed again. Now the caller is COVID positive and experienced a cold; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program.  A female patient of an unspecified age received first BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), on an unspecified route of administration on 22Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her 1st dose on 22Feb2021, a day before she was exposed to a covid positive, then a day after her 1st dose she was exposed again. Now the patient is covid positive and experienced a cold. She wants to know will the vaccine help after all the exposure and what does she need to do not to expose others. At the time of this report event outcome was unknown.   Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date in Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In the first week of Jan2021, she got the first vaccination. She is a dialysis patient so they are constantly taking her temperature. She went and had dialysis. The patient tested covid positive on an Jan2021. Her temperature went up to 101, so they called the medic who took her to the hospital. was not admitted in the hospital, but they did a blood test and confirmed she had COVID. No one feels it was related to the vaccination because it was already in the facility. She is concerned about her second dose. She was asymptomatic. On an unspecified date COVID test was negative. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Second dose on 14Jan2021. Caller reports that her mother was just diagnosed with Covid; Second dose on 14Jan2021. Caller reports that her mother was just diagnosed with Covid; This is a spontaneous report from a contactable consumer (Daughter). Follow-up received on 05Mar2021 was processed together with initial information.  A 78-years-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . The patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 21Dec2020 as SINGLE DOSE for covid-19 immunisation. Medical history included , lung disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced second dose on 14Jan2021, caller reported that her mother was just diagnosed with covid on an unspecified date. It was  reported that her mother always had bad lung issues.  The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: fever; This is a spontaneous report from a Pfizer sponsored program from contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that in the morning of 25Feb2021 caller had a covid test done. The rapid test was negative. Later that day she had the first covid vaccine. She got the results for the PCR on 26Feb2021, and it was positive. she had a fever after the first dose in 2021. she wanted to know when she should get the second dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ) 5 mg tablets.  The patient experienced sore arm on an unspecified date. Patient stated that she just got her COVID shot and had to stop taking the tofacitinib citrate for one week, she had a sore arm but that's all. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection), dose 1 via an unspecified route of administration, on 21Jan2021 (lot Number: UNKNOWN) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 07Feb2021, patient tested positive for Covid 19. He was supposed to get the second dose of the vaccine on 11Feb2021, but he did not get it due to the infection. The patient wanted to know when he can get his second dose. The outcome for the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid 19; got covid 19; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) at SINGLE DOSE for covid-19 immunisation.   The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient was scheduled to receive the second dose of the vaccine on 18Mar2021, he had Covid-19 in the time between doses.   Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; tested positive; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient reported that she tested positive on 15Feb2021; wanted to know if it would be safe to have the second vaccine tomorrow after recovering for 10 days. No FAQ. Read ISI. Transferred to a facility due to being an AE/PCOM as well as to have clarification if the patient should receive the second covid vaccine. Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Breast pain, Fatigue, Headache, Myalgia
Clinical narrative: smelling bad smells/everything smelled bad 24 hrs; muscle/bone pain left forearm and right left thigh in back of leg.; breasts felt like on fire 24 hrs; muscle/bone pain left forearm and right left thigh in back of leg.; Headache 2 days; very tired 4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient (patient was not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208 and expiration date was not reported), via unspecified route of administration in left arm on unspecified date in Feb2021 at 12:00 PM as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date in Feb2021 at 12:00 PM patient experienced headache 2 days, very tired 4 days, smelling bad smells, everything smelled bad 24 hrs, breasts felt like on fire 24 hrs, muscle/bone pain left forearm and right left thigh in back of leg. The patient did not receive any other vaccine in four weeks. The patient did not receive any treatment for the adverse event. The patient did not test COVID prior and post vaccination. The outcome of the patient events was recovered on an unspecified date in 2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: smelling bad smells/everything smelled bad 24 hrs; muscle/bone pain left forearm and right left thigh in back of leg.; breasts felt like on fire 24 hrs; muscle/bone pain left forearm and right left thigh in back of leg.; Headache 2 days; very tired 4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient (patient was not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208 and expiration date was not reported), via unspecified route of administration in left arm on unspecified date in Feb2021 at 12:00 PM as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date in Feb2021 at 12:00 PM patient experienced headache 2 days, very tired 4 days, smelling bad smells, everything smelled bad 24 hrs, breasts felt like on fire 24 hrs, muscle/bone pain left forearm and right left thigh in back of leg. The patient did not receive any other vaccine in four weeks. The patient did not receive any treatment for the adverse event. The patient did not test COVID prior and post vaccination. The outcome of the patient events was recovered on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive after receiving the first shot; Tested positive after receiving the first shot; This is a spontaneous report from a Pfizer-sponsored program. A consumer reported that a female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reported stated, "They received the first dose of the COVID-19 Pfizer Vaccine and have a follow up for the second dose on the 15th which is this coming Monday and since my mother has got received the first dose she actually tested positive for COVID-19 and I am calling for her to see if I need to take her to get the second dose or how that would work like do we not need to take it or do we need to take this still. " The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Visual impairment
Clinical narrative: Loss of breath. Very hard to breathe; Vision degrade; Heart rate increase over 100 BPM; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 12:30 (at the age of 61-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. On 13Mar2021 00:45, the patient experienced heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath.  As a result of the events, a visit was made to the doctor or other healthcare professional office/clinic with the patient's heart rate, blood pressure and oxygen (level) were checked. As of 14Mar2021, the clinical outcomes of the heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath were resolved on an unspecified date in Mar2021.  The expiration date of the lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Defaecation urgency, Diarrhoea, SARS-CoV-2 test
Clinical narrative: diarrhea; Feeling the urge to go to the restroom; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient) reported a 61-year-old-male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an 28Feb2021 as a single dose for COVID-19 immunization. Medical history included a negative COVID-19 test in Jun2020. Three days later he showed symptoms of COVID-19 with no taste and a slight fever but never had a test to confirm he had COVID-19. Concomitant medications were not reported. On 28Feb2021 the patient experienced the urge to go to the restroom. The patient used the restroom before his appointment and did not have diarrhea but when he got home he had diarrhea real bad. The event was reported as non-serious. The patient also wanted to know if he should not receive the second dose of BNT162B2 because he had COVID-19 before. The outcome of diarrhea was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: runny nose a day or so later; little diarrhea; had a cough; post nasal drip; This is a spontaneous report from a contactable consumer (patient). This 79-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included allergies and diarrhea. Concomitant medications were not reported. On an unspecified date a day or so later after receiving BNT162B2 the patient experienced a runny nose and a little diarrhea. The patient was not sure if it was from the vaccine or not. The patient also had a cough and said it could be from post nasal drip. The outcomes of runny nose, diarrhea, cough, and post nasal drip were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache and body aches since Wednesday; Headache and body aches since Wednesday; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN608) via an unspecified route of administration on 10Mar2021 at 10:30 (at the age of 52-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder and seasonal hay fever. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included dextroamphetamine sulfate, trazodone, and spironolactone from unspecified dates for unspecified indications. The patient previously received penicillin, amoxicillin, sulfa, ciprofloxacine (CIPRO), and oxycodone hydrochloride, paracetamol (PERCOCET) from unknown dates for unknown indications and experienced allergy. The patient also had allergies to dust mites and hazelnuts. On 10Mar2021 at 12:00 the patient experienced headache and body aches since Wednesday (10Mar2021). The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with acetaminophen, ibuprofen (ADVIL), and naproxen. The outcomes of headache and body aches were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received both doses of vaccine and tested positive for Covid-19; received both doses of vaccine and tested positive for Covid-19; This is a spontaneous report received from a contactable male patient of an unspecified age received first dose and second of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), intramuscularly on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses of vaccine and tested positive for covid-19. On an unspecified date the patient underwent lab tests and procedures which included COVID-19 test positive. The outcome of the events were unknown.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she has been having a headache since Sunday; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on Saturday (13Mar2021) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a headache since Sunday (14Mar2021). The patient wanted to know if she could take acetaminophen (TYLENOL) or ibuprofen (ADVIL) to treat it. The outcome of headache since Sunday was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Started itching yesterday in his hands and back; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient started itching yesterday in his hands and back. The events were reported as non-serious. The outcome of itching in his hands and back was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: her arm was a little sore; redness and swelling at injection site.; redness and swelling at injection site.; This is a spontaneous report received from a contactable consumer (patient). This 73-year old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration om 02Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient's arm was a little sore just like the flu shot was gone within a couple of days. On 08Mar2021 or 09Mar2021 the patient developed redness and swelling at the injection site. The patient's arm did not hurt as much now but the redness went down her arm to above her elbow. The outcomes of arm was a little sore and swelling at the injection site were unknown. The outcome of redness at the injection site was not recovered.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Vaccination site pain
Clinical narrative: diarrhea; chills; fever; Arm was sore at the injection site; This is a spontaneous report received from a contactable consumer (patient). This 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. Medical history included allergies to sulfate, sulfite and penicillin, all from unknown dates and unknown if ongoing. Concomitant medications were not reported. The patient inquired about the approval status of BNT162B2 and whether diarrhea, chills, and fever were bad or severe side effects. The patient reported she experienced diarrhea, chills, fever and that her arm was sore at the injection site. She reported speaking with other people who also experienced pain at the injection site. She inquired if she should get the second dose since she had side effects after the first dose. The clinical outcomes of diarrhea, chills, fever and her arm was sore at the injection site were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.