chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Electric shock sensation, Hypoaesthesia oral, Paraesthesia, Tongue discomfort
Clinical narrative: burning on bottom of feet, bottom of hands; pins and needles; numbness on tongue; electric impulses on the top of her toes; tongue she has had burning; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- EWO176, expiration date was unknown) via an unspecified route of administration, in left arm upper shoulder, on 06May2021, (at the age of 61-year-old), dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had her first shot on 06May2021 and ended up not getting the second because she had weird reactions that have not went away. On 08May2021, patient had burning on bottom of feet, bottom of hands; hands have gotten better and her feet no, pins and needles; it's still there every day, it's persisting; numbness on tongue, also got electric impulses on the top of her toes. Patient clarified that, she has had numbness, pins, and needles, burning on both her hands and feet. On her tongue she has had burning, pins and needles. Her tongue was consistent. Patient called to her internist and he said maybe she shouldn't get the second dose because it sounded like an allergic reaction. No additional vaccines administered on same date of the Pfizer suspect. No other vaccine prior vaccinations within 4 weeks. Patient did not require a visit to emergency room and physician office. Patient did not receive any treatment to the events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Has a terrible itchy red rash after getting the second dose; This is a spontaneous report from a Pfizer Sponsored Program via non-contactable consumer or other non hcp (Patient's daughter). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date the patient experienced a terrible itchy red rash after getting the second dose of the covid vaccine and was still experiencing these side effects. Event was non-serious, and the outcome was not recovered.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Illness, Nausea
Clinical narrative: The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; Caller states his wife is in the hospital she is that bad; Sick; Nauseous; This is a spontaneous report from a contactable consumer (spouse). A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported stated, his wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized. Reporter wanted to know what he should do about receiving the second Pfizer Covid 19 Vaccine. Again stated, his wife was in the hospital she was that bad. Stated he does not think that answering questions for a report would be helpful. Stated he got it because an unfortunate person had it and gave it to him and his wife. Reporter stated what he was concerned with now, she was in the hospital and he was at home and feels better and it has been at least 10-14 days, he figures he can he get the shot, but he wants to see what he should do about the second dose. Reporter stated the same thing happened with his wife and it hit. Stated it was not the next day but they felt nauseous and sick, not the day after but a few days after, probably a week or so before someone gave them a push. Stated he does not wish to complete any reports at this time, he does not feel that it would help anything. The events were assessed as serious and caused/prolonged hospitalization. The patient underwent lab tests and procedures which included diagnosed with Covid: positive on an unspecified date. The outcome of events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021881074 same reporter/drug/AE , different patient.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; Caller states his wife is in the hospital she is that bad; Sick; Nauseous; This is a spontaneous report from a contactable consumer (spouse). A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported stated, his wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized. Reporter wanted to know what he should do about receiving the second Pfizer Covid 19 Vaccine. Again stated, his wife was in the hospital she was that bad. Stated he does not think that answering questions for a report would be helpful. Stated he got it because an unfortunate person had it and gave it to him and his wife. Reporter stated what he was concerned with now, she was in the hospital and he was at home and feels better and it has been at least 10-14 days, he figures he can he get the shot, but he wants to see what he should do about the second dose. Reporter stated the same thing happened with his wife and it hit. Stated it was not the next day but they felt nauseous and sick, not the day after but a few days after, probably a week or so before someone gave them a push. Stated he does not wish to complete any reports at this time, he does not feel that it would help anything. The events were assessed as serious and caused/prolonged hospitalization. The patient underwent lab tests and procedures which included diagnosed with Covid: positive on an unspecified date. The outcome of events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021881074 same reporter/drug/AE , different patient.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: her husband got sick from the vaccine; This is a spontaneous report from a contactable consumer (patient wife) via Medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller states her husband got sick from the vaccine on an unspecified date, but she had nothing besides the side effect on her arm. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Fatigue, Heart rate increased, Hypertension
Clinical narrative: her blood pressure, it was a little bit high; little bit shortness of breath; she felt not well; a little bit tired; a fast pulse; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jun2021 as single dose (at age of 80-years old) for COVID-19 immunization. The patient medical history include she still did not see doctor but the last time she saw a doctor was years ago when her husband was in critical condition, for anxiety, and he passed away she still has anxiety off and on. The patient concomitant medications were not reported. The patient had the Pfizer vaccine three weeks ago (Jun2021) and tomorrow (13Jul2021) will be the second shot that she supposed to take, but today (12Jul2021) and during the first week it was fine. she states before she took the first one, and her blood pressure was perfect, she did it twice, but after that, a week later (Jun2021), she felt a little bit tired and fast pulse and it was going on for about a week and she felt not well. She states now she feels better, and she goes to have another shot tomorrow. States on 12Jul2021 (today), she took her blood pressure, and it was a little bit high. It was 144/72 and 71 and sometimes, it came down to 142 so she wondered if it was okay if she comes tomorrow for another shot. She states her doctor was not available, so she wonders if its because of the blood pressure machine, but she did it three times. it was 144/77, 63 and then it came down to 143/71, 72 so was it okay for her to come tomorrow. She did have a little bit shortness of breath for the second week (Jun2021). She wants to know that it was okay if she comes back tomorrow with a little high blood pressure like that she states but tomorrow, it will be her appointment for her second shot and the question was if she could come tomorrow for another shot with a little bit high blood pressure like that because she afraid that the side effect of the second time will be worse than the first one. Caller states she's short and this was not that serious of a reaction because she still keeps on doing her daily tasks, she walks, and jogging around, but with a little bit shortness of breath for the 2nd week in the beginning and a couple days later, and now its coming down, and today she feels good. The outcome of events a little bit tired, a fast pulse, her blood pressure, it was a little bit high and little bit shortness of breath was unknown and the outcome of event she felt not well was resolved on unknown Jul2021.  Information regarding the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: her blood pressure, it was a little bit high; little bit shortness of breath; she felt not well; a little bit tired; a fast pulse; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jun2021 as single dose (at age of 80-years old) for COVID-19 immunization. The patient medical history include she still did not see doctor but the last time she saw a doctor was years ago when her husband was in critical condition, for anxiety, and he passed away she still has anxiety off and on. The patient concomitant medications were not reported. The patient had the Pfizer vaccine three weeks ago (Jun2021) and tomorrow (13Jul2021) will be the second shot that she supposed to take, but today (12Jul2021) and during the first week it was fine. she states before she took the first one, and her blood pressure was perfect, she did it twice, but after that, a week later (Jun2021), she felt a little bit tired and fast pulse and it was going on for about a week and she felt not well. She states now she feels better, and she goes to have another shot tomorrow. States on 12Jul2021 (today), she took her blood pressure, and it was a little bit high. It was 144/72 and 71 and sometimes, it came down to 142 so she wondered if it was okay if she comes tomorrow for another shot. She states her doctor was not available, so she wonders if its because of the blood pressure machine, but she did it three times. it was 144/77, 63 and then it came down to 143/71, 72 so was it okay for her to come tomorrow. She did have a little bit shortness of breath for the second week (Jun2021). She wants to know that it was okay if she comes back tomorrow with a little high blood pressure like that she states but tomorrow, it will be her appointment for her second shot and the question was if she could come tomorrow for another shot with a little bit high blood pressure like that because she afraid that the side effect of the second time will be worse than the first one. Caller states she's short and this was not that serious of a reaction because she still keeps on doing her daily tasks, she walks, and jogging around, but with a little bit shortness of breath for the 2nd week in the beginning and a couple days later, and now its coming down, and today she feels good. The outcome of events a little bit tired, a fast pulse, her blood pressure, it was a little bit high and little bit shortness of breath was unknown and the outcome of event she felt not well was resolved on unknown Jul2021.  Information regarding the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Inappropriate schedule of product administration, Ophthalmological examination, Vision blurred
Clinical narrative: Blurry and double vision in left eye; Blurry and double vision in left eye; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0169, Expiration date not reported), via an unspecified route of administration, administered in arm Left on 25Mar2021 (at the age of 44-year-old) as a single dose, and  first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730, Expiration date not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation at Doctor's office/urgent care. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Mar2021, the patient had inappropriate schedule of vaccine administered. On 02May2021 19:00, the patient experienced blurry and double vision in left eye. It was reported that the patient saw an ophthalmologist but could not correct. Ophthalmologist cannot get my vision to 20/20 with any lens at all. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. On an unspecified date in 2021, the patient underwent lab tests and procedures which included eye test: cannot get my vision (Ophthalmologist cannot get my vision to 20/20 with any lens at all). The seriousness of the events was reported as non-serious. Therapeutic measures were taken as a result of blurry and double vision in left eye. The outcome of event blurry and double vision in left eye was not resolved and the outcome of inappropriate schedule of vaccine administered was unknown. Device Date was reported as 12Jul2021.  Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Palpitations
Clinical narrative: Myocardium/pounding heart episodes started 3 days after second dose; Reaction and illness lasted one week; This is a spontaneous report from a contactable consumer (patient, self-reported). A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 10Jun2021 at 14:30 PM (age at vaccination: 70 years), as a single dose for COVID-19 immunization at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient did not have known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on an unspecified date in 2021 at 02:30 PM (age at vaccination: 70 years), as a single dose for COVID-19 immunization at pharmacy or drug store. The patient reported that on 13Jun2021 at 03:30 PM, he experienced myocardium/pounding heart episodes started 3 days after second dose and reaction and illness lasted one week. The patient did not receive treatment for the adverse event. Outcome of the events was recovering.  Information regarding the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Got sore on her arm; This is a spontaneous report from contactable consumer (patient's spouse) received from a Pfizer sponsored program. A female patient of an unspecified age received dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that "About the medication Celebrex being removed from the Patient assistance program. During the call caller stated the following about their experience with The Pfizer-BioNTech COVID-19 vaccine. The caller stated that My wife and I both we took the COVID shot both of them it was through Pfizer. We did not had no side effects my wife it kind of got sore on her arm on unknown date, but it was just like nothing on me I did not feel nothing". The outcome of the event was reported as unknown.   Note: The patient's first and last name and date of birth was not provided during the call.  The following information was not confirmed during the call, but retrieved from the system: Patient DOB.  Information about lot/Batch number has been requested
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Deafness unilateral, Fatigue, Hypothyroidism
Clinical narrative: Hypothyroidism; Loss of hearing in my left ear; autoimmune flair up; Injection site pain; muscle ache; Fever; Fatigue; Dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734) dose 1 via an unspecified route of administration, administered in arm right on 2021 12:00 PM and dose 2 via an unspecified route of administration, administered in arm left on 2021 (Batch/Lot Number: Er8736) both as single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID) 100 mcg. Patient had no allergies. Patient was not pregnant at the time of vaccination. Patent did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. In 2021, dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021 also. On 21Apr2021 22:00, the patient experienced hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. These events resulted in doctor or other healthcare professional office/clinic visit. SYNTHROID dose was increased, and blood work (date and result: not reported) was performed to treat the adverse events of hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. The outcome of events hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue were recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Hypothyroidism, condition aggravated, Unilateral deafness and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Hypothyroidism; Loss of hearing in my left ear; autoimmune flair up; Injection site pain; muscle ache; Fever; Fatigue; Dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734) dose 1 via an unspecified route of administration, administered in arm right on 2021 12:00 PM and dose 2 via an unspecified route of administration, administered in arm left on 2021 (Batch/Lot Number: Er8736) both as single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID) 100 mcg. Patient had no allergies. Patient was not pregnant at the time of vaccination. Patent did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. In 2021, dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021 also. On 21Apr2021 22:00, the patient experienced hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. These events resulted in doctor or other healthcare professional office/clinic visit. SYNTHROID dose was increased, and blood work (date and result: not reported) was performed to treat the adverse events of hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. The outcome of events hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue were recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Hypothyroidism, condition aggravated, Unilateral deafness and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable pharmacist. A 40-years-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El3249) via an intramuscular route of administration in Arm Right on 20Jan2021 03:15 (age at vaccination 40years old) as Dose 2,Single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, HTN, hyperlipidaemia from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine was administered in Workplace clinic. Concomitant medication(s) included semaglutide (OZEMPIC); metformin (METFORMIN); hydrochlorothiazide, losartan potassium (HYZAAR); rosuvastatin calcium (CRESTOR). All taken for an unspecified indication, start and stop date were not reported. The patient was allergic to the drug Amoxil.Since the vaccination, the patient had not been tested positive for COVID-19. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El0142) via an intramuscular route of administration in Arm Right on 30Dec2020 03:15 as Dose 1,Single for COVID-19 immunization. The patient experienced transverse myelitis in Jun2021. The patient was hospitalized for transverse myelitis for 3 days. The patient received any treatment for the adverse events. Therapeutic measures were taken as a result of transverse myelitis. The clinical outcome of the event recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate increased
Clinical narrative: Rapid heartbeat; Blood pressure dropped; It was even in the 80 over 50; This is a spontaneous report from a contactable Nurse (patient). An 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Left upper arm on 23Jun2021 (at the age of 81-years-old) (Batch/Lot Number: EW0180) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient did not receive any prior vaccination (within 4 weeks). The patient reported that she had it on the 23rd and that evening, she started experiencing very rapid heartbeat and then her blood pressure dropped, it took almost two weeks to bring her blood pressure, where it was even in the 80 over 50. When asked about treatment received, patient stated that no, she had to do it herself, her son is quadriplegic (further clarification unknown) and she couldn't leave him by himself. Patient stated causality, "Yes." (not clarified further by appropriately paraphrasing events, hence causality tab left unchecked). Outcome of the event rapid heartbeat was unknown, blood pressure dropped was recovered in Jul2021.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and  got diagnosed with Covid 19 on 26Jun2021; Got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and got diagnosed with Covid 19 on 26Jun2021; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) via an unspecified route of administration on Feb2021, dose number unknown, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and she got diagnosed with Covid 19 on 26Jun2021. The reporter further mentioned that her whole family was vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and her parents were also diagnosed with Covid 19 on the same day. MD said them that they had the virus breakthrough and she mentioned that it seems to be happening to many people. On 26Jun2021, the patient underwent lab tests and procedures which included being diagnosed with Covid 19 (sars-cov-2 test was positive). The outcome of the event was unknown.  Follow up needed, further information about Lot/Batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021884586 Same reporter/drug/AE, different patient.;US-PFIZER INC-2021884585 Same reporter/drug/AE, different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got diagnosed with Covid 19 on June 26,2021. My parents were diagnosed with Covid 19 on the same day.; I got diagnosed with Covid 19 on June 26,2021. My parents were diagnosed with Covid 19 on the same day.; This is a spontaneous report from a Pfizer sponsored program Pfizer. This consumer reported for a male patient (reporter's father) that, A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter said that, my whole family is vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and I got diagnosed with Covid 19 on 26Jun2021. My parents were diagnosed with Covid 19 on the same day. MD said we had the virus breakthrough. It seems to be happening to many people. Outcome of unknown The patient underwent lab tests and procedures which included sars-cov-2 test which was, positive on 26Jun2021 (got diagnosed with Covid 19 on 26Jun2021).  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021884456 Same reporter/drug/AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got diagnosed with Covid 19 on 26Jun2021. My parents were diagnosed with Covid 19 on the same day.; I got diagnosed with Covid 19 on 26Jun2021. My parents were diagnosed with Covid 19 on the same day.; This is a spontaneous report from a Pfizer sponsored program. This consumer for a female patient (reporters mother) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced i got diagnosed with covid 19 on 26jun2021, my parents were diagnosed with covid 19 on the same day. It was reported that his whole family was vaccinated with the Covid 19 vaccine by Pfizer since Feb2021. MD says we had the virus breakthrough. It seemed to be happened to many people in the (with held) and just wanted you to be aware. The patient underwent lab tests and procedures which included COVID-19: positive, got diagnosed with Covid 19 on 26Jun2021. Events were considered serious (medically significant). The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021884456 Same reporter/drug/AE, different patient.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Discharge
Clinical narrative: Yellow fluid leaking out of her hands; This is a spontaneous report from a contactable consumer or other non hcp.   A 25-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0202; Expiration Date: Sep2021) via an unspecified route of administration, administered in Deltoid Left on 30May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia from an unknown date and unknown if ongoing Verbatim: Anaemia. The patient's concomitant medications were not reported. Reporter stated, "She is not taking any with us and I am assuming she is probably just getting some Iron supplements. (Further not clarified. Hence, not captured in tab). The patient experienced yellow fluid leaking out of her hands on an unspecified date.It was reported that patient who took the first dose and she was about to get the second dose today. But she said that during the first dose when she received this, she had an adverse event which was there is a yellow fluid leaking out of her hands. The outcome of the event discharge was recovering.  No follow-up attempts are needed. No further information was expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was fully vaccinated with Pfizer vaccine back in April and I got positive with covid 2 weeks ago.; I was fully vaccinated with Pfizer vaccine back in April and I got positive with covid 2 weeks ago.; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EP7534) via an intramuscular route of administration in left arm on 16Mar2021 (age at vaccination 25-year-old) as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0153; Expiration Date: 31Jul2021) via an intramuscular route of administration in left arm on 08Apr2021 (age at vaccination 25-year-old) as dose 2, single for Covid -19 immunization. Patient medical history was not provided. Patient concomitant medications were none. Patient was fully vaccinated with Pfizer vaccine back in April and on 11Apr2021 patient got positive with covid. Patient did not receive any treatment for covid because he had pretty minor symptoms, so he did not take any medicines. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021. Product quality group provided investigation results: Description of complaint: tested positive for COVID-19 on 11Apr2021 after receiving both doses of Pfizer COVID-19 vaccine on 16Mar2021 and 08Apr2021. Additional lot numbers: EP7534 and EW0153. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0153 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging, Muscle spasms
Clinical narrative: small CVA to the right side of my brain; spasms to my left leg; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). This consumer (patient) reported via follow-up letter which included that:   A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unspecified route of administration on 12Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 18Feb2021 for covid-19 immunization and on 02Mar2021 was admitted to hospital after suffering from several falls. The patient was discharged on 11Mar2021 with no definitive diagnosis but had spasms in left lower leg and foot. In order to obtain a second opinion, went to withheld in withheld, withheld again, no specific reason for the spasms and option for treatment. Patient purpose for reaching out to you was patient awareness that there are reported instances of Covina 19 vaccines causing neurological problems possibility, because of unintended auto immune responses. The patient appreciate looked into this possibility as any information available may helped me in finding a procedure my doctors can used to correct these spasms that were causing so much difficulty. On 12Mar2021, patient received second dose of injection and went to emergency room. On 02Apr2021 with spasms to left leg and to rule out TIA vs CVA. On this admission patient underwent MRI which indicated that had a small CVA to the right side of brain. Patient was transferred to hospital on 09Apr2021, for surgical evaluation. Patient has been admitted into 2 hospitals for a total of 15 days with no explication of why the patient was suffering from spasms. These spasms have limited patient's ability to ambulate, thus patient spent most of patient's time in a wheelchair. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: Experienced spotting and bleeding and it was not supposed to be my normal cycle; Experienced spotting and bleeding and it was not supposed to be my normal cycle; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0198) via Intramuscular in right arm on 01Jul2021 (in the afternoon probably a little closer to 2 O'clock) as single dose (at the age of 45-year-old) for COVID-19 immunisation at pharmacy. Medical history and concomitant medications were none. Patient was healthy, and don't take any other prescriptions. No other vaccination received 4 weeks prior to COVID 19 Vaccine. Patient received vaccine on 01Jul2021 on Thursday and a week after that she experienced spotting and bleeding and it was not supposed to be her normal cycle, so she found that a little odd on 08Jul2021. She was still experiencing, it's been, let's see Thursday Friday Saturday Sunday and yeah, it's almost been five days now. She stated it looks like it was starting to Improve. The second one is coming up on Thursday it's going to be 22Jul2021. Patient not had physical yet so it's been a year. No treatment was received. The outcome of events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Chills, Cough, Diarrhoea
Clinical narrative: Contracted COVID 19; Contracted COVID 19; Extremely tired and fatigued; Cough; Congestion; Headache; Fever; Chills; Body aches; Diarrhea; Loss of taste; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0158) via intramuscular route of administration in Arm Left on 09Apr2021 17:00 as DOSE 2, SINGLE, patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534) via intramuscular route of administration in Arm Left on 19Mar2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination the patient received other medications within 2 weeks of vaccination was Lipitor. Medical history included lymphoma from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported patient was not diagnosed with COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. On 07Jul2021 the patient experienced contracted covid 19, contracted covid 19, extremely tired and fatigued, cough, congestion, headache, fever, chills, body aches, diarrhoea, loss of taste patient had physician office visit for the events. The patient received treatment for rest all events was unknown and for vaccination failure, covid-19 did not received any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jul2021. The outcome of the events vaccination failure, covid-19, fatigue, cough, nasal congestion, headache, pyrexia, chills, pain, diarrhoea, ageusia was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Contracted COVID 19; Contracted COVID 19; Extremely tired and fatigued; Cough; Congestion; Headache; Fever; Chills; Body aches; Diarrhea; Loss of taste; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0158) via intramuscular route of administration in Arm Left on 09Apr2021 17:00 as DOSE 2, SINGLE, patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534) via intramuscular route of administration in Arm Left on 19Mar2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination the patient received other medications within 2 weeks of vaccination was Lipitor. Medical history included lymphoma from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported patient was not diagnosed with COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. On 07Jul2021 the patient experienced contracted covid 19, contracted covid 19, extremely tired and fatigued, cough, congestion, headache, fever, chills, body aches, diarrhoea, loss of taste patient had physician office visit for the events. The patient received treatment for rest all events was unknown and for vaccination failure, covid-19 did not received any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jul2021. The outcome of the events vaccination failure, covid-19, fatigue, cough, nasal congestion, headache, pyrexia, chills, pain, diarrhoea, ageusia was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID 19; Contracted COVID 19; Extremely tired and fatigued; Cough; Congestion; Headache; Fever; Chills; Body aches; Diarrhea; Loss of taste; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0158) via intramuscular route of administration in Arm Left on 09Apr2021 17:00 as DOSE 2, SINGLE, patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534) via intramuscular route of administration in Arm Left on 19Mar2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination the patient received other medications within 2 weeks of vaccination was Lipitor. Medical history included lymphoma from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported patient was not diagnosed with COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. On 07Jul2021 the patient experienced contracted covid 19, contracted covid 19, extremely tired and fatigued, cough, congestion, headache, fever, chills, body aches, diarrhoea, loss of taste patient had physician office visit for the events. The patient received treatment for rest all events was unknown and for vaccination failure, covid-19 did not received any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jul2021. The outcome of the events vaccination failure, covid-19, fatigue, cough, nasal congestion, headache, pyrexia, chills, pain, diarrhoea, ageusia was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin malformation
Clinical narrative: skin growth under and on my left armpit and arm; Rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced skin growth under and on my left armpit and arm and rash. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: huge inflammation, comparable to a golf ball on her collarbone; This is a spontaneous report from a non-contactable consumer (patient friend) reporting for a female patient.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient also mentioned that one of her friends who took the Pfizer Covid vaccine had left her with side effects. On an unspecified date patient experienced a huge inflammation, comparable to a golf ball on her collarbone She even had pictures. However, her friend's doctor did not give her any indication for treatment and said to let the body assume the effects and the natural antibody production after receiving the vaccine. The adverse event did not result in Life Threatening, Disabling Incapacitating, Intervention Medically Important, Congenital Anomaly Birth Defect, Death, Hospitalization Required and Hospitalization Prolonged. Product Complaint: There was no product complaint associated with this case. The outcome of event was unknown.   No follow up attempts are needed, No further information is expected.