chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Dizziness, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: abnormal ECG/EKG; Feverish; severe tachycardia (160bpm, resting); heart palpitations; lightheadedness; severe headache; confusion; nausea; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 Intramuscular administered in Arm Right on 31Aug2021 16:00 (Lot Number: FC3184) as dose 3 (booster), single (at age of 35-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included Behcet's, CVID (a primary immune deficiency), RA (seronegative), osteoporosis, known allergies. No covid prior vaccination. Historical Vaccine included the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) on 19Mar2021 13:15 (at age of 35-years-old) administrated in Right arm Covid-19 immunization; the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 26Feb2021 15:45 (at age of 34-years-old) administrated in Right arm Covid-19 immunization. Concomitant medications were unspecified drugs. On 08Sep2021 00:30, the patient experienced abnormal ECG/EKG (hospitalization), feverish, severe tachycardia (160 bpm, resting), heart palpitations, lightheadedness, severe headache, confusion, nausea. The event clinical course was as follows: Feverish for about a week after booster; the Wed after the booster, 6 days prior, she began experiencing severe tachycardia (160bpm, resting) and heart palpitations along with lightheadedness, severe headache, confusion, nausea, and an increase in fever. She went to urgent care and had an abnormal ECG/EKG and was sent via ambulance to hospital. She has a primary immune deficiency so after her hospital EKGs came back, and her labs came back normal. She was discharged conditionally (no doctor wanted to hospitalize her unnecessarily BC of her high risk of contracting nosocomial infection). It had taken about a month for all symptoms to subside, without medical intervention. The patient underwent lab tests and procedures which included body temperature: increase on 08Sep2021, ECG: abnormal on 08Sep2021, EKG: abnormal on 08Sep2021, heart rate: 160 bpm on 08Sep2021, labs: normal on 08Sep2021, Nasal Swab: negative on 16Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. Outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Investigation, Nausea, Palpitations
Clinical narrative: abnormal ECG/EKG; Feverish; severe tachycardia (160bpm, resting); heart palpitations; lightheadedness; severe headache; confusion; nausea; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 Intramuscular administered in Arm Right on 31Aug2021 16:00 (Lot Number: FC3184) as dose 3 (booster), single (at age of 35-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included Behcet's, CVID (a primary immune deficiency), RA (seronegative), osteoporosis, known allergies. No covid prior vaccination. Historical Vaccine included the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) on 19Mar2021 13:15 (at age of 35-years-old) administrated in Right arm Covid-19 immunization; the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 26Feb2021 15:45 (at age of 34-years-old) administrated in Right arm Covid-19 immunization. Concomitant medications were unspecified drugs. On 08Sep2021 00:30, the patient experienced abnormal ECG/EKG (hospitalization), feverish, severe tachycardia (160 bpm, resting), heart palpitations, lightheadedness, severe headache, confusion, nausea. The event clinical course was as follows: Feverish for about a week after booster; the Wed after the booster, 6 days prior, she began experiencing severe tachycardia (160bpm, resting) and heart palpitations along with lightheadedness, severe headache, confusion, nausea, and an increase in fever. She went to urgent care and had an abnormal ECG/EKG and was sent via ambulance to hospital. She has a primary immune deficiency so after her hospital EKGs came back, and her labs came back normal. She was discharged conditionally (no doctor wanted to hospitalize her unnecessarily BC of her high risk of contracting nosocomial infection). It had taken about a month for all symptoms to subside, without medical intervention. The patient underwent lab tests and procedures which included body temperature: increase on 08Sep2021, ECG: abnormal on 08Sep2021, EKG: abnormal on 08Sep2021, heart rate: 160 bpm on 08Sep2021, labs: normal on 08Sep2021, Nasal Swab: negative on 16Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. Outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tachycardia
Clinical narrative: abnormal ECG/EKG; Feverish; severe tachycardia (160bpm, resting); heart palpitations; lightheadedness; severe headache; confusion; nausea; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 Intramuscular administered in Arm Right on 31Aug2021 16:00 (Lot Number: FC3184) as dose 3 (booster), single (at age of 35-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included Behcet's, CVID (a primary immune deficiency), RA (seronegative), osteoporosis, known allergies. No covid prior vaccination. Historical Vaccine included the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534) on 19Mar2021 13:15 (at age of 35-years-old) administrated in Right arm Covid-19 immunization; the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 26Feb2021 15:45 (at age of 34-years-old) administrated in Right arm Covid-19 immunization. Concomitant medications were unspecified drugs. On 08Sep2021 00:30, the patient experienced abnormal ECG/EKG (hospitalization), feverish, severe tachycardia (160 bpm, resting), heart palpitations, lightheadedness, severe headache, confusion, nausea. The event clinical course was as follows: Feverish for about a week after booster; the Wed after the booster, 6 days prior, she began experiencing severe tachycardia (160bpm, resting) and heart palpitations along with lightheadedness, severe headache, confusion, nausea, and an increase in fever. She went to urgent care and had an abnormal ECG/EKG and was sent via ambulance to hospital. She has a primary immune deficiency so after her hospital EKGs came back, and her labs came back normal. She was discharged conditionally (no doctor wanted to hospitalize her unnecessarily BC of her high risk of contracting nosocomial infection). It had taken about a month for all symptoms to subside, without medical intervention. The patient underwent lab tests and procedures which included body temperature: increase on 08Sep2021, ECG: abnormal on 08Sep2021, EKG: abnormal on 08Sep2021, heart rate: 160 bpm on 08Sep2021, labs: normal on 08Sep2021, Nasal Swab: negative on 16Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Headache, Pyrexia, Stomach scan
Clinical narrative: High temperatures; Head pain; The initial case was missing the following minimum criteria: the reporter cannot be identified for direct/private contact (internet source). Upon receipt of follow-up information on (08Oct2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's father) of an unspecified age that received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced high temperatures on an unspecified date with outcome of unknown, head pain on an unspecified date with outcome of unknown. Seriousness criteria of the events was hospitalization. The patient underwent lab tests and procedures which included blood test: unknown results, body temperature: high (really high temperatures), stomach scan: unknown results, x-ray: unknown results. Therapeutic measures were taken as a result of high temperatures, head pain. The clinical course was reported as follows: "Hi, my name is withheld and I have a question about the vaccine. Over the last few months, my father is receiving really high temperatures and head pain after taking your Covid-19 vaccine. The GP doctor couldn't help him, except give him antibiotics which have not helped. He has been admitted to hospital last week and had several tests done(lung x-ray, stomach x-ray, blood tests etc.) but they cannot find the cause. Do you know of any medicine or cure that could help him? Could you send this message to who can help?"  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: High temperatures; Head pain; The initial case was missing the following minimum criteria: the reporter cannot be identified for direct/private contact (internet source). Upon receipt of follow-up information on (08Oct2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's father) of an unspecified age that received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced high temperatures on an unspecified date with outcome of unknown, head pain on an unspecified date with outcome of unknown. Seriousness criteria of the events was hospitalization. The patient underwent lab tests and procedures which included blood test: unknown results, body temperature: high (really high temperatures), stomach scan: unknown results, x-ray: unknown results. Therapeutic measures were taken as a result of high temperatures, head pain. The clinical course was reported as follows: "Hi, my name is withheld and I have a question about the vaccine. Over the last few months, my father is receiving really high temperatures and head pain after taking your Covid-19 vaccine. The GP doctor couldn't help him, except give him antibiotics which have not helped. He has been admitted to hospital last week and had several tests done(lung x-ray, stomach x-ray, blood tests etc.) but they cannot find the cause. Do you know of any medicine or cure that could help him? Could you send this message to who can help?"  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program Support. This consumer reported similar events for six patients. This is the second of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-202101332906 same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program  Support. This consumer reported similar events for six patients. This is the third of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101332906 same reporter/drug/event, different patients
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Energy increased, Insomnia
Clinical narrative: Complete sleeplessness Didn?t sleep a wink the night of shot Feel very energetic Heart rate is normal:66bpm Treatment: stayed in bed and read all night Please note that I had similar sleeplessness with both Pfizer shots Also please note that I have not experienced this sleeplessness in the past with any other vaccinations such as boosters for traveling
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Body aches Chills Sore throat Ear ache Headache Nausea
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches Chills Sore throat Ear ache Headache Nausea
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain
Clinical narrative: Extreme back pain
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Error: Wrong Patient (documentation in EMR)-
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Confusional state, Dizziness, Dyspnoea, Flushing
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient was given COVID 19 vaccine and passed out. Patient appeared to be having difficulty breathing and passed out after vaccine. Epi-pen was adminmisted IM in Left Upper thigh and she was able to respond within a few seconds to commands. Patient was advised not to get a 2nd dose of vaccine. EMS was called and they checked patient and monitored her. Patient refused transport to ER.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Syncope, Tremor
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient was given COVID 19 vaccine and passed out. Patient appeared to be having difficulty breathing and passed out after vaccine. Epi-pen was adminmisted IM in Left Upper thigh and she was able to respond within a few seconds to commands. Patient was advised not to get a 2nd dose of vaccine. EMS was called and they checked patient and monitored her. Patient refused transport to ER.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient was given COVID 19 vaccine and passed out. Patient appeared to be having difficulty breathing and passed out after vaccine. Epi-pen was adminmisted IM in Left Upper thigh and she was able to respond within a few seconds to commands. Patient was advised not to get a 2nd dose of vaccine. EMS was called and they checked patient and monitored her. Patient refused transport to ER.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This is a spontaneous report from a non-contactable consumer via a Regulatory authority. This consumer reported similar events for six patients. This is the fourth of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101332906 same reporter/drug/event, different patients
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: numbness in arm-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient received vaccine in 5/2021. Still complains of pain and numbness in arm, or other exermities. She is not quiet sure, but will see precriber.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program Support. This consumer reported similar events for six patients. This is the fifth of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101332906 same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program Support. This consumer reported similar events for six patients. This is the sixth of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101332906 same reporter/drug/event, different patients
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RA; This is a spontaneous report from a contactable Other HCP (patient). A 71-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL 9261) via an unspecified route of administration, administered in Arm Left on 11Feb2021 10:00 (at 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hypertension (HTN), hyperlipidaemia, seasonal allergies. No Covid prior vaccination. Concomitant medications included enalapril; atorvastatin calcium (LIPITOR); and amlodipine. No other vaccine in four weeks. The patient previously received the first single dose of bnt162b2 on 14Jan2021 10:00 AM (Lot No: EL 3246) at Left arm for covid-19 immunisation. The patient reported that she had no reaction to either shot. However 3 weeks post 2nd shot she developed a severe inflammatory condition, mainly left sided which was diagnosed as RA. Prior to vaccination, she had never had even an achy joint. Adverse event start date reported as Mar2021. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The outcome of the event was not recovered. Treatment received for the event included Plaquenil, prednisone, methotrexate.; Sender's Comments: As there is limited information in the case provided, the causal association between the event rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Myocarditis, Syncope
Clinical narrative: myocarditis-heart muscle inflammation; syncopal episode; This is a spontaneous report from a contactable nurse. A male patient in his 40's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number was not reported), via an unspecified route of administration on 20Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. HCP reported that the patient received the Pfizer Covid-19 vaccine on 20Aug2021, had a syncopal episode on 21Aug2021, and on 23Aug2021 his cardiac enzymes were elevated and was diagnosed with myocarditis-heart muscle inflammation. HCP is asking if there were any incidences with stroke after a delay of time after the administration of the Pfizer Covid-19 vaccine? The outcome of the events was unknown.   The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: Foetal death
Clinical narrative: patients has received both the regular and the booster Pfizer Covid vaccines but subsequently had a baby demise; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single, and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 2, single, and then third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 3 (booster), single, all for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received both the regular and the booster Pfizer covid vaccines but subsequently had a baby demise on an unspecified date. It was reported that the patient wants to donate the fetus to Pfizer for eventual studies. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of fetal demise due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed upon receipt of follow-up information.   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: M
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: her husband is having ankle replacement in 10 days; This is a spontaneous report from a Pfizer-sponsored program from a consumer (wife) reported for husband.   An elderly male patient over the age of 65 years received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE  (at unspecified age) for covid-19 immunisation.  The patient received dose one of BNT162B2 for Covid-19 immunization on unspecified date, route and lot number.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The reporter stated her husband is having ankle replacement in 10 days on an unspecified date with outcome of unknown.    The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Off label use
Clinical narrative: Shingles; Dose received: 3; Dose received: 3; This is a spontaneous report from a non-contactable consumer (reporting for herself).  A 58-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in the right arm on 28Sep2021 at 14:00 (Batch/Lot Number: FE3592) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (INFLUENZA) taken for immunisation from 27Sep2021 to 27Sep2021 in the left arm; venlafaxine hcl (VENLAFAXINE HCL) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; and curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took demerol and amoxicillin and experienced drug allergy. Historical vaccination included first dose of BNT162B2 administered on 05Mar2021 at 15:30 in the right arm, Lot number: EN6205 for covid 19 immunization, and second dose of BNT162B2 administered on 26Mar2021 at 15:30 in the right arm, Lot number: ER8732 for covid-19 immunization. The patient did not have Covid prior to vaccination. The patient did not take a covid test post vaccination. The patient experienced shingles on 28Sep2021 at 17:00. The event of shingles resulted in emergency room/department or urgent care visit. The patient was given Valacyclovir HCL 1 Gram as treatment for shingles. The outcome of event shingles was recovering and for the at risk events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from regulatory authority, manufacturer control number: 21K-163-4106907-00.    A contactable consumer (patient) reported that a 67-year-old male patient received bnt162b2 (manufactured by Pfizer, Batch/Lot number was not reported), first dose intramuscular on 08Jan2021 at the age of 66-year-old as single dose, second dose intramuscular on 13Feb2021 at the age of 66-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at citrate free for psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 in 2021. Solicited report by a consumer of a 67-year-old male with events of non-serious first COVID injection like had been hit with a baseball bat on arm, second COVID injection shot had pain, knee pain/started hurting as stands on concrete a lot with job and causes stiffness, COVID and some days pain, some days less and some extra pain with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced some days pain, some days less and some extra pain. In 2021, the patient experienced COVID. On 08Jan2021, the patient experienced first COVID injection like had been hit with a baseball bat on arm. On 13Feb2021, the patient experienced second COVID injection shot had pain. On 13Feb2021, the second COVID injection shot had pain resolved. In September 2021, the patient experienced knee pain/started hurting as stands on concrete a lot with job causes stiffness. In 2021, the first COVID Injection hurt like had been hit with a baseball bat on and COVID resolved. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown results in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of events was resolved.   The reporter's causality for the event of COVID with adalimumab was not provided. Causality as per reporter (Drug/Vaccine) for COVID-19 with bnt162b2 was Possible.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and suspected COVID-19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Seizure
Clinical narrative: Seizure/couldn't have Harbor without having seizures she entered darkened room; had a blood clot on brain; had 2 strokes; This is a spontaneous report from a non-contactable consumer. A female patient (Age 42: Unit Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient had a blood clot on brain and had whole head drilled in her brain and had seizure and dying in hospital. It was declared vaccine injury from Pfizer, Is anything going to make stop these and make more safe before they get in to children. The patient was serious now. She had 2 strokes. She was 42 and an average runner and she had 2 strokes and she was coded blue twice. She couldn't have Harbor without having seizures she entered darkened room. She can't have visitors, television, light or telephone (Duration was not clarify, hence Hospitalization was not checked). She got a clot on her brain because of that and it was declared as Pfizer vaccine injury. The patient was hospitalized, but she was sent home she thought that important to the hospital but she was as of today, she was home and send with Palliative care. Outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101335055 different  patient, same drug, different event;US-PFIZER INC-202101335052 different  patient, same drug, different event
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance
Clinical narrative: Stroke; still couldn't walk; This is a spontaneous report from a non-contactable consumer reported for the other uncle. A male patient of unspecified age received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The reporter's family, personally had 3 people experience the stroke within 1st 24 hours after 2nd dose. The patient (reporter's other uncle) was 59 or 60 (not clarified). The patient had a stroke and he still couldn't walk. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101335048 different  patient, same drug, different event;US-PFIZER INC-202101335052 different  patient, same drug, different event
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills; Myalgia; Fatigue; Headache; This is a spontaneous report from a non-contactable pharmacist. An adult male patient of unsoecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. The patient has no relevant medication history and no concomitant medications. He has no known allergies and did not have history of previous COVID-19 infection. The patient previous received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) on an unspecified date (lot number was not reported) as dose 2, single for COVID-19 immunization, and experienced chills, myalgia, fatigue, headache. The patient, who is an emergency room physician, experienced chills, myalgia, fatigue, and headache on 04Oct2021, after receiving a booster shot of the Pfizer COVID vaccine on an unspecified date. The symptoms lasted for two days. The patient stated that he had similar symptoms after the second dose of the Pfizer COVID vaccine. Therapeutic measures were not taken as result of the events. The outcome of the events was recovered on 06Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Double vaccinated and post Covid 19 (between 1st & 2nd  doses).; Double vaccinated and post Covid 19 (between 1st & 2nd  doses).; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient was double vaccinated and post Covid 19 (between 1st & 2nd doses). He was interested in a clinical trial. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Peripheral swelling
Clinical narrative: his leg filled with fluid and stayed swollen for 3 weeks; his leg filled with fluid and stayed swollen for 3 weeks; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 dose 1 in Mar2021 for Covid-19 immunization and experienced INR was elevated at age 76 years old. On unspecified date the patient experienced his leg filled with fluid and stayed swollen for 3 weeks. Outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: I had my first TIA 9 days after 2nd Pfizer vaccine shot, otherwise no prior strokes of any kind.; First dose: 6-MAY-2021; Second dose: 18-JUN-2021; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient, not pregnant, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jun2021 (Lot Number: EW0181) at vaccination age of 54 years, as dose 2, single for covid-19 immunisation.  Previously the patient received the first dose of bnt162b2, administered in Arm Right on 06May2021 at 09:00 AM (Lot Number: EW0173) for covid-19 immunisation. No other vaccine in four weeks. The patient previously took Compazine and experienced allergy. Medical history included Borderline Blood pressure high and PreDiabetic. No covid prior vaccination. Concomitant medications included metformin, hctz, losartan, colecalciferol (VIT D), ascorbic acid (VIT C), zinc, all taken for an unspecified indication, start and stop date were not reported.   On 27Jun2021 05:30 the patient experienced her first TIA 9 days after 2nd Pfizer vaccine shot, otherwise no prior strokes of any kind. The patient was hospitalized for 2 days and the outcome of the event was recovered with sequelae. Therapeutic measures were taken as a result of the event.  Event treatment included: Mri, Ct, Echo, Swalliw Test, PT. The patient received bnt162b2 first dose: 6May2021 and second dose: 18Jun2021, resulting in inappropriate schedule of product administration. The patient underwent lab tests and procedures which included sars-cov-2 test (Rapid and Reg): negative on 03Oct2021 Nasal Swab.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a non-contactable consumer. This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. Other medical conditions, not even cold, no diabetes, no cancer. The patient had a stroke. He was 63-64 (not further clarify). He had 2 strokes. The reporter didn't know, what kind of thing' but had not had any symptoms experienced as immediately, lost in a week. The reporter meant within 48 hours this thing happened. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness
Clinical narrative: Stroke; She has went Dizzy and cozy; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age (Age 57; it: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced stroke. The patient had gone dizzy and cozy went to urgent care she wasn't hospitalized. She was in urgent care, that was in July2021. The outcomes of events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccine breakthrough infection, mild/moderate symptoms; Vaccine breakthrough infection, mild/moderate symptoms; mild chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was Er8739, and expiration date was not reported), via an unspecified route of administration, administered in left arm on 02May2021 (Age at vaccination was 30 years) as dose 2, single for covid-19 immunisation at School or Student Health Clinic and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was Ep7533, and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 11Apr2021 (Age at vaccination was 30 years) as dose 1, single for COVID-19 immunization at School or Student Health Clinic. The patient medical history was none. The patient did not have covid prior to vaccination. The patient's concomitant medications were not reported. The patient did not take other vaccine in four weeks and other medications in two weeks. On 04Oct2021 the patient experienced vaccine breakthrough infection, mild/moderate symptoms including fever, muscle aches, cough, congestion. On same date patient also experienced mild chest pain. On 06Oct2021 the patient underwent lab tests and procedures which included body temperature with result unknown and sars-cov-2 test having result positive with nasal Swab. Supportive care was taken as therapeutic measures. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fully CV19 vaccinated individual had a COVID-19 PCR test on 07Oct2021 with a positive result given on 08Oct2021; Fully CV19 vaccinated individual had a COVID-19 PCR test on 07Oct2021 with a positive result given on 08Oct2021; This is a spontaneous report from a contactable nurse. A 23-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0170; Expiration date: Unknown), via an unspecified route of administration on 27Apr2021 as dose 2, single, and received first dose of BNT162B2 (Lot Number: EW0150; Expiration date: Unknown), via an unspecified route of administration on 06Apr2021 as dose 1, single; both (at the age of 22-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient after being fully COVID-19 vaccinated individual had a COVID-19 PCR test on 07Oct2021, nurse notified a positive result given on 08Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive (Nasal Swab) on 07Oct2021, reported as COVID test post vaccination. It was unknown if patient received treatment as result of events. The outcome of the events was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.