chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasal congestion, Polymerase chain reaction
Clinical narrative: Tested Covid positive after being full vaccinated; Tested Covid positive after being full vaccinated; Had Fever; I do now have my taste, smell back; I do now have my taste, smell back; Have slight bit of congestion; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), dose 2 intramuscular, administered in Deltoid Right (On right shoulder) on 28Apr2021 10:00 AM morning (at the age of 33-years-old) as dose 2, single and dose 1 received on an unspecified date for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported and no other products. The patient had no other Prior Vaccination. The patient got Covid positive result this morning on 10Jul2021 after being fully vaccinated. He did two different type of tests, he got a rapid test and PCR test. He does know there was possibility that he can still get Covid. He was not calling to complaint or being rude or whatever he just didn't know he guess who to reach out regarding that just because he does know that this was all new, he didn't know if you guys are collecting data on this type of test or anything, but he also wanted to let you know that he personally feel that your vaccine did helped a lot regarding the symptoms. He was like in and out the fever and all of that within a day and he do now have his taste and smell back. He would clarify if he needs to report that or what. He was not taking any right now, at first onset of symptoms he did take Allegra 24 to help with the decongestion and it did help and once he developed a slight fever (on 28Apr2021) he did take Tylenol and that also helped the symptoms and then he was symptom free other than slight bit of congestion (in 2021), just normal. He also had taste and smell loss (on 28Apr2021) and stated his taste and smell came back today (on 10Jul2021) and he don't have any other symptoms. He just wants to figure out that do you know the difference between the ongoing things, he just wanted to make sure that he would be followed up with you guys. The outcome of vaccination failure and Covid 19 was unknown. The outcome of the events smell loss, taste loss was recovered on 10Jul2021 and fever in 2021. The outcome of congestion nasal was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Covid positive after being full vaccinated; Tested Covid positive after being full vaccinated; Had Fever; I do now have my taste, smell back; I do now have my taste, smell back; Have slight bit of congestion; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), dose 2 intramuscular, administered in Deltoid Right (On right shoulder) on 28Apr2021 10:00 AM morning (at the age of 33-years-old) as dose 2, single and dose 1 received on an unspecified date for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported and no other products. The patient had no other Prior Vaccination. The patient got Covid positive result this morning on 10Jul2021 after being fully vaccinated. He did two different type of tests, he got a rapid test and PCR test. He does know there was possibility that he can still get Covid. He was not calling to complaint or being rude or whatever he just didn't know he guess who to reach out regarding that just because he does know that this was all new, he didn't know if you guys are collecting data on this type of test or anything, but he also wanted to let you know that he personally feel that your vaccine did helped a lot regarding the symptoms. He was like in and out the fever and all of that within a day and he do now have his taste and smell back. He would clarify if he needs to report that or what. He was not taking any right now, at first onset of symptoms he did take Allegra 24 to help with the decongestion and it did help and once he developed a slight fever (on 28Apr2021) he did take Tylenol and that also helped the symptoms and then he was symptom free other than slight bit of congestion (in 2021), just normal. He also had taste and smell loss (on 28Apr2021) and stated his taste and smell came back today (on 10Jul2021) and he don't have any other symptoms. He just wants to figure out that do you know the difference between the ongoing things, he just wanted to make sure that he would be followed up with you guys. The outcome of vaccination failure and Covid 19 was unknown. The outcome of the events smell loss, taste loss was recovered on 10Jul2021 and fever in 2021. The outcome of congestion nasal was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID 19 test/body aches, runny nose, loss of smell; Positive COVID 19 test/body aches, runny nose, loss of smell; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that:   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Positive Covid 19 test, Body aches, Runny nose, Loss of smell on an unspecified date. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on an unspecified date. Query was raised to confirm the Adverse Event. And response was received that reporter is the one who experienced the AE. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Investigation
Clinical narrative: Stroke; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (reporters friend's mom) that an unspecified age elder female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route on an unspecified date as single dose for COVID-19 immunization. On an unspecified date patient died she had a stroke, and they were trying to say that because she was older, she just passed her organ test, and she was perfectly fine and 2 days later after her second shot she had a stroke (Not clarified hence split not made) and it was like they keep on and understood that there were multiple reasons that someone could have a stroke specially if patient was older. The outcome of evet was fatal  Information on the lot/batch number has been requested. Additional information is requested.; Reported Cause(s) of Death: stroke
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Ovarian cyst, SARS-CoV-2 test
Clinical narrative: Ovarian cyst; heavier period at 22 day cycle/10 day shed/ 27day cycle with liquid like menstruation with clumps 9 day duration; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Left arm, on 27Apr2021 09:00 (at the age of 43-year-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included type 1 diabetes mellitus and Ferritin deplete anemia. The patient's concomitant medications were not reported. The patient previously received fluorescein and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Left arm, on 06Apr2021 (at the age of 43-year-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has been tested for COVID-19. The patient experienced heavier period at 22 day cycle on 18May2021, ovarian cyst in Jun2021, 10 day shed on 09Jun2021,  27day cycle with liquid like menstruation with clumps 9 day duration on Jul2021. It was reported that events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Pct (nasal swab) in 2021 (unknown result). The events were assessed as non-serious. The patient didn't receive any treatment for the events. The outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received BNT162B2 (Lot Number: emu199) via an unspecified route of administration, administered in Left arm, on 13Mar2021 at 13:00 as dose 1, single (age at vaccination: 47 years) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ew0150), via an unspecified route of administration, administered in Left arm on 04Apr2021 at 14:00 as dose 2, single (age at vaccination: 47 years) for COVID-19 immunization. Medical history included known allergies to sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX); bupropion hydrochloride (WELLBUTRIN); berberine; magnesium; menaquinone-7 (K2) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that, on 07Jul2021, she contracted COVID and COVID-19 confirmed by positive COVID-19 test on 10Jul2021. Reportedly, the patient was not diagnosed with COVID-19, prior to vaccination and since the vaccination, had been tested for COVID-19 via Nasal Swab on 19Jun2021 and 01Jul2021, both with negative results. There was no corrective treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender reported that the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: the number was 19289, it was EW0196 (as reported), Expiry Date: Unknown), via an unspecified route of administration on 12Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Jul2021, after the patient took the shot, the patient had diarrhea. The outcome of event was unknown.   Information about lot and batch number was requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Getting like dizziness spells; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 22-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0181, Expiry date was unknown) via unspecified route of administration in Arm Left (at the age of 22-years-old) on 07Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, levonorgestrel (CHATEAL) taken for an unspecified indication, start and stop date were not reported. On 09Jul2021, the patient experienced getting like dizziness spells. Patient got the vaccine, the Pfizer vaccine dose number 2 on Wednesday, this Wednesday and she didn't feel bad the day after but the following Friday, Friday after, patient started getting like dizziness spells and she had read that something she should call someone about. Patient don't have a primary provider at this time, so she did not know where else to call. Therapeutic measures were taken with Advil painkiller today but that was it, it was Advil Liqui-Gels. The outcome of the event was unknown.  Follow-Up (13Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cytokine storm, Deep vein thrombosis, Haemophagocytic lymphohistiocytosis, Nervous system disorder
Clinical narrative: Neurologic damage (Shaking/memory/speech/motorskills); DVT; Afib; Secondary hlh; Cytokine Storm; This is a spontaneous report from a Pfizer-sponsored program.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient experienced neurologic damage (Shaking/memory/speech/motorskills), DVT, Afib, secondary hlh, cytokine storm on 2021. The patient was hospitalized for neurologic damage (Shaking/memory/speech/motorskills), dvt, Afib, Secondary hlh and cytokine storm from 12Apr2021 to an unknown date. The patient underwent lab tests and procedures which included platelet count: 15,000. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The outcome of all the events was Fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021879892 same source, different reporter/ patient; Reported Cause(s) of Death: The Pfizer shots killed my beautiful mother
Sex: F
Vaccine: COVID19
Symptoms: Platelet count
Clinical narrative: Neurologic damage (Shaking/memory/speech/motorskills); DVT; Afib; Secondary hlh; Cytokine Storm; This is a spontaneous report from a Pfizer-sponsored program.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient experienced neurologic damage (Shaking/memory/speech/motorskills), DVT, Afib, secondary hlh, cytokine storm on 2021. The patient was hospitalized for neurologic damage (Shaking/memory/speech/motorskills), dvt, Afib, Secondary hlh and cytokine storm from 12Apr2021 to an unknown date. The patient underwent lab tests and procedures which included platelet count: 15,000. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The outcome of all the events was Fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021879892 same source, different reporter/ patient; Reported Cause(s) of Death: The Pfizer shots killed my beautiful mother
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Limb discomfort, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Second dose: very hard to lift her left arm up; Second dose: challenging to shower or even put a shirt on; Second dose: can barely do anything with her left arm; Second dose: her mother had to help put her underwear on this morning; Second dose: muscle pain; Second dose: excruciating pain in her left shoulder where she received the vaccine injection; Second dose: excruciating pain in her left shoulder where she received the vaccine injection; This is a spontaneous report from a contactable consumer. A 32-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0198), via an unspecified route of administration in left deltoid on 10Jul2021 at 13:45 (age at the time of vaccination was 32-year-old) as single dose for COVID-19 immunization. The patient's medical history included ovarian cyst, soreness in her arm. In Dec2019, the patient received a yellow fever, hepatitis a, and typhoid vaccine. The patient did not receive any other vaccine within four weeks prior to the first administration of COVID-19 vaccine. The patient's concomitant medication included unspecified birth control medication, multivitamin. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0180) via an unspecified route of administration on 19Jun2021 as single dose for COVID-19 immunization. On 10Jul2021 at around 13:45, the patient received second dose of vaccine drug and at evening on Saturday, the patient experienced excruciating pain in her left shoulder where the patient received the vaccine injection. The patient would not too worried about it because that was listed as a side effect but now it was Monday, 12Jul2021 and she was still having pain. It was very hard to lift her left arm up. It was challenging to shower or even put a shirt on. The patient can barely do anything with her left arm. The patient's mother had to help put her underwear on this morning. The patient was wanting additional information regarding this side effect. From her understanding the patient should have expected side effects for 24 to 48 hours and they did mention muscle pain. But she could not lift her arm without excruciating pain. The patient not needed emergency room or physician office visit. The outcome of the events was activities of daily living impaired, and myalgia was unknown and rest all other events not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Second dose: very hard to lift her left arm up; Second dose: challenging to shower or even put a shirt on; Second dose: can barely do anything with her left arm; Second dose: her mother had to help put her underwear on this morning; Second dose: muscle pain; Second dose: excruciating pain in her left shoulder where she received the vaccine injection; Second dose: excruciating pain in her left shoulder where she received the vaccine injection; This is a spontaneous report from a contactable consumer. A 32-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0198), via an unspecified route of administration in left deltoid on 10Jul2021 at 13:45 (age at the time of vaccination was 32-year-old) as single dose for COVID-19 immunization. The patient's medical history included ovarian cyst, soreness in her arm. In Dec2019, the patient received a yellow fever, hepatitis a, and typhoid vaccine. The patient did not receive any other vaccine within four weeks prior to the first administration of COVID-19 vaccine. The patient's concomitant medication included unspecified birth control medication, multivitamin. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0180) via an unspecified route of administration on 19Jun2021 as single dose for COVID-19 immunization. On 10Jul2021 at around 13:45, the patient received second dose of vaccine drug and at evening on Saturday, the patient experienced excruciating pain in her left shoulder where the patient received the vaccine injection. The patient would not too worried about it because that was listed as a side effect but now it was Monday, 12Jul2021 and she was still having pain. It was very hard to lift her left arm up. It was challenging to shower or even put a shirt on. The patient can barely do anything with her left arm. The patient's mother had to help put her underwear on this morning. The patient was wanting additional information regarding this side effect. From her understanding the patient should have expected side effects for 24 to 48 hours and they did mention muscle pain. But she could not lift her arm without excruciating pain. The patient not needed emergency room or physician office visit. The outcome of the events was activities of daily living impaired, and myalgia was unknown and rest all other events not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Menstruation irregular
Clinical narrative: started menstruating; This is a spontaneous report from a contactable consumer or other non-health care professional. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/ Batch Number: Not reported), dose 2 via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient received first dose of BNT162B2 (Lot/ Batch Number: Not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient experienced started menstruating on an unspecified date. The patient was 18 months post menopause and menstruating started exactly three weeks after her first dose. Patient underwent lab tests and procedures which included tests was biopsy of uterus were negative on an unspecified date. Upon follow-up general company information was reported. Patient stated Does the vaccine have anything to do regarding this. Thanking you advance for looking into this matter. The outcome of the event was unknown. Information regarding lot/batch number has been requested
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Dyspnoea, Fatigue
Clinical narrative: Sars-cov-2 test positive: positive on 07Jul2021; sars-cov-2 test positive: positive on 07Jul2021; Cough; Fever; Congestion; Headache; SOB; Fatigue / tired; Dose 1 08Apr2021 / Dose 2 08Apr2021; This is a spontaneous report from a contactable other Health Care Professional. A 44-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown) via an unspecified route of administration on 08Apr2021 (age at the time of vaccination was 50-year-old) as single, first dose via an unspecified route of administration on 08Apr2021, (Lot Number: GN6204 and Expiry date: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed COVID prior to the vaccination. On 06Jul2021, the patient experienced cough, fever, congestion, headache, fatigue, tired and SOB (shortness of breath). On 07Jul2021, the patient underwent COVID-19 test and resulted positive. The adverse events resulted in doctor or other healthcare professional office/clinic and Emergency room/department or urgent care visit. The patient received unspecified antibiotics and steroids as treatment medication for the events.; Sender's Comments: Based on Plausible association, there is a casual relationship between the suspected drug BNT162b2 and the reported events COVID-19 along with Drug Ineffective.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sars-cov-2 test positive: positive on 07Jul2021; sars-cov-2 test positive: positive on 07Jul2021; Cough; Fever; Congestion; Headache; SOB; Fatigue / tired; Dose 1 08Apr2021 / Dose 2 08Apr2021; This is a spontaneous report from a contactable other Health Care Professional. A 44-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown) via an unspecified route of administration on 08Apr2021 (age at the time of vaccination was 50-year-old) as single, first dose via an unspecified route of administration on 08Apr2021, (Lot Number: GN6204 and Expiry date: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed COVID prior to the vaccination. On 06Jul2021, the patient experienced cough, fever, congestion, headache, fatigue, tired and SOB (shortness of breath). On 07Jul2021, the patient underwent COVID-19 test and resulted positive. The adverse events resulted in doctor or other healthcare professional office/clinic and Emergency room/department or urgent care visit. The patient received unspecified antibiotics and steroids as treatment medication for the events.; Sender's Comments: Based on Plausible association, there is a casual relationship between the suspected drug BNT162b2 and the reported events COVID-19 along with Drug Ineffective.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Malaise, Pneumonia, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; thought she had pneumonia or bronchitis; Caller states she would have reported within 24 hours, but she just did not feel well enough.; thought she had pneumonia or bronchitis; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736), via an unspecified route in the right arm on 29Apr2021 at 08:00 (at the age of 44-years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: GN6204), via an unspecified route in the left arm on 08Apr2021 at 08:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021, the patient experienced and went to urgent care, she thought she had pneumonia or bronchitis, they did a rapid test and the rapid test came back positive and that day, she went to the store drive-thru to get a molecular test and on 10Jul2021, the molecular test came back positive but they didn't specify if it was the variant or not. Patient stated that she would have reported within 24 hours, but she just did not feel well enough and she is perfectly healthy, she's not on any medications. The patient visited to physician office and not went to emergency room. The outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; thought she had pneumonia or bronchitis; Caller states she would have reported within 24 hours, but she just did not feel well enough.; thought she had pneumonia or bronchitis; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736), via an unspecified route in the right arm on 29Apr2021 at 08:00 (at the age of 44-years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: GN6204), via an unspecified route in the left arm on 08Apr2021 at 08:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021, the patient experienced and went to urgent care, she thought she had pneumonia or bronchitis, they did a rapid test and the rapid test came back positive and that day, she went to the store drive-thru to get a molecular test and on 10Jul2021, the molecular test came back positive but they didn't specify if it was the variant or not. Patient stated that she would have reported within 24 hours, but she just did not feel well enough and she is perfectly healthy, she's not on any medications. The patient visited to physician office and not went to emergency room. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received both doses of the Pfizer Covid-19 vaccine in Apr2021 and tested positive for Covid-19 on 09Jul2021; received both doses of the Pfizer Covid-19 vaccine in Apr2021 and tested positive for Covid-19 on 09Jul2021; This is a spontaneous report from a contactable consumer.   A 78-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Apr2021 as dose 1, single for COVID-19 immunization. The caller reported that the patient (husband) received both doses of the Pfizer COVID-19 vaccine on an unspecified date in Apr2021 and tested positive for Covid-19 on 09Jul2021. Caller was asking how the variant type of the COVID-19 was tested for after being vaccinated against Covid-19 and testing positive. Caller asked if her husband could have given COVID-19 to their grandkids who stayed with them that weekend. Caller asked if you would get less sick and be less contagious if you were vaccinated. Caller was asking if she should isolate from her husband who was COVID-19 positive. Caller asked if there was any proof that mild cases of COVID-19 were not transmissible or transmissible. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 09Jul2021. Outcome of the events was reported as unknown.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On an unknown date after the first injection of the pfizer covid-19 vaccine, the patient got COVID-19 infection.; On an unknown date after the first injection of the pfizer covid-19 vaccine, the patient got COVID-19 infection.; This is a spontaneous report received from a contactable pharmacist via Pfizer Sponsored Program. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number and Expiration date was not reported), via an unspecified route of administration on 25May2021 as a single dose for covid-19 immunization. On an unspecified date in 2021, after the first injection of the Pfizer covid-19 vaccine, the patient got COVID-19 infection. On 16Jun2021, the patient was treated with monoclonal antibodies for the COVID-19 infection. It was reported that, patient is scheduled to get their second dose of the product today (as per report 12Jul2021). However, the patient took a medication for COVID on 16Jun2021, and reporter wanted to confirm if the patient could safely get the second dose of the vaccine today (12Jul2021). The reporter assessed the event as non serious. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known safety profile and plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Oropharyngeal pain
Clinical narrative: Bell's palsy; Sore throat; This is a spontaneous report from a contactable Physician. A 13-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: LSW0196) via an unspecified route of administration on 05Jul2020 (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient's medical history, concomitant medications or past drug history were not reported. On 10Jul2020 (Saturday), the patient experienced sore throat and on 11Jul2020, patient experienced numbness of face on Sunday and was diagnosed with Bell's palsy. The patient was started on unspecified steroids as treatment medication after Bell's palsy diagnosis. The parent still wants child to receive second dose of vaccine and asked if this was okay. The outcome of the events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Bell's Palsy cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient developed COVID-19 infection after being vaccinated; patient developed COVID-19 infection after being vaccinated; This is a spontaneous report from a contactable physician. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unknown date in 2021, as unknown dose number, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jul2021, patient developed COVID-19 infection after being vaccinated. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment in response to the event. Outcome of the event was not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Covid 19 and suspect drug BNT162B2 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Arterial catheterisation, Arterial occlusive disease, Dyspnoea, Echocardiogram, Inappropriate schedule of product administration
Clinical narrative: Caller states she and her husband received their 2nd Pfizer vaccine dose in June, 90 days after first dose; dying septic; I had an echocardiogram and one of my cardiac arteries is 90% blocked and could this be the vaccine; had trouble with breathing worse after 2nddose of vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6200, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation and experienced Covid and trouble breathing. The patient stated, she and her husband received their 2nd Pfizer vaccine dose in Jun, 90 days after first dose. She had trouble with breathing worse after 2nd dose of vaccine (In 2021). She had an echocardiogram and one of her cardiac arteries was 90% blocked (in 2021) and could this be the vaccine. She stated this was not blocked 1.5 yrs. ago. Her cardiologist said it was highly unusual to get blockage this soon. Could the vaccine cause blockage in her arteries. The patient wrote a letter to Pfizer asking if this could cause the blockage and no one wrote back. She wants answers. She would send another letter and if no one answers me this time, she would go to the Television (TV) and media and report Pfizer. She has been bounced between offices 2-3 times today. This was taking hours and is ridiculous. She said after her second COVID Vaccination she was dying septic (in 2021) of the (voice not clear) she doesn't know what that was. She says that one of her arteries was 90 percent blocked now in her heart and she was wanting to know if this vaccine could've had anything to do with it. She wanted to speak to someone. Her question when she first roll back way back then, could the shot cause COVID. They still haven't answered that question but now happened was she had been on wound healers (voice not clear) and have been having problems' (not clarified further hence not captured as event) and she went in for a catheterization the other day and they found that one of her arteries was 90 percent blocked and it was not blocked at all a year and a half ago. So, the doctors wondering why (incomplete sentence). The outcome of event had trouble with breathing worse after 2nddose of vaccine was not recovered and outcome of all other events was unknown.   Follow-up attempts are needed. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Caller states she and her husband received their 2nd Pfizer vaccine dose in June, 90 days after first dose; dying septic; I had an echocardiogram and one of my cardiac arteries is 90% blocked and could this be the vaccine; had trouble with breathing worse after 2nddose of vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6200, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation and experienced Covid and trouble breathing. The patient stated, she and her husband received their 2nd Pfizer vaccine dose in Jun, 90 days after first dose. She had trouble with breathing worse after 2nd dose of vaccine (In 2021). She had an echocardiogram and one of her cardiac arteries was 90% blocked (in 2021) and could this be the vaccine. She stated this was not blocked 1.5 yrs. ago. Her cardiologist said it was highly unusual to get blockage this soon. Could the vaccine cause blockage in her arteries. The patient wrote a letter to Pfizer asking if this could cause the blockage and no one wrote back. She wants answers. She would send another letter and if no one answers me this time, she would go to the Television (TV) and media and report Pfizer. She has been bounced between offices 2-3 times today. This was taking hours and is ridiculous. She said after her second COVID Vaccination she was dying septic (in 2021) of the (voice not clear) she doesn't know what that was. She says that one of her arteries was 90 percent blocked now in her heart and she was wanting to know if this vaccine could've had anything to do with it. She wanted to speak to someone. Her question when she first roll back way back then, could the shot cause COVID. They still haven't answered that question but now happened was she had been on wound healers (voice not clear) and have been having problems' (not clarified further hence not captured as event) and she went in for a catheterization the other day and they found that one of her arteries was 90 percent blocked and it was not blocked at all a year and a half ago. So, the doctors wondering why (incomplete sentence). The outcome of event had trouble with breathing worse after 2nddose of vaccine was not recovered and outcome of all other events was unknown.   Follow-up attempts are needed. Further information is requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: after the first dose had broken out into hives from head to toe; This is a spontaneous report from a Pfizer sponsored program. A contactable Other Health Professional reported for a 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left deltoid on 04Jun2021 (at age of 12-year-old) (Batch/Lot Number: EW0186) as single dose for covid-19 immunisation. There was no medical history. The concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine and after the first dose had broken out into hives from head to toe. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. The outcome of the event was not recovered.; Sender's Comments: The causal association of the event urticaria in relation to suspected drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be totally excluded based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and then via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, all for covid-19 immunization. Medical history and concomitant medications were not reported. The patient was fully vaccinated and had been for just about six months. The patient recently tested positive for COVID. Whom should the patient send this information to, to better support the need for a third vaccine. Also, if there somewhere the patient can get his/her blood drawn to distinguish which variant he/she was exposed to, further support scientific study and research. Please keep him/her informed. The patient was a withheld and did not mind contributing to this research. The patient underwent lab tests and procedures which included tested positive for COVID on an unknown date. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the temporal relationship the causal role between the events  Drug ineffective and COVID-19 cannot be fully excluded. However the possibility of Covid being an intercurrent condition cannot be ruled out.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: The patient received Menactra that was exposed to negative 51 Fahrenheit for about 14 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00672249) and transmitted to Sanofi on 07-Jul-2021.  This case involves a 16 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], which was exposed to negative 51 F (Fahrenheit) for about 14 hours (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6919AA, expiry date: 13-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "The physician mentioned that the temperature excursion was discovered after 3 people had already received the Menactra and she called to confirm if revaccination was needed"  At time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.