chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Menstruation irregular
Clinical narrative: miscarriage; irregular menstrual cycle; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 12Jan2021 (Batch/Lot Number: El0142) as dose 2, single (at the age of 37-years-old) for Covid-19 immunisation. Medical history included hypothyroidism and known allergies to latex and Hydrocodone. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included a compounded thyroid medication. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 22Dec2020 (Batch/Lot Number: Eh9899) as dose 1, single (at the age of 37-years-old) for Covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced irregular menstrual cycle and miscarriage on 27Jan2021. The patient underwent lab tests and procedures which included nasal swab with a negative result on an unknown date. No treatment was administered for the events. The outcome of the events was unknown. The events resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event abortion spontaneous cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: miscarriage; irregular menstrual cycle; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 12Jan2021 (Batch/Lot Number: El0142) as dose 2, single (at the age of 37-years-old) for Covid-19 immunisation. Medical history included hypothyroidism and known allergies to latex and Hydrocodone. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included a compounded thyroid medication. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 22Dec2020 (Batch/Lot Number: Eh9899) as dose 1, single (at the age of 37-years-old) for Covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced irregular menstrual cycle and miscarriage on 27Jan2021. The patient underwent lab tests and procedures which included nasal swab with a negative result on an unknown date. No treatment was administered for the events. The outcome of the events was unknown. The events resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event abortion spontaneous cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heart rate increased
Clinical narrative: heart dysrhythmia and tachycardia; heart dysrhythmia and tachycardia; initial heart rate was 175bpm/ her heart rate was 165bpm; This is a spontaneous report from a contactable consumer.     A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated received her first dose of the Pfizer Covid-19 dose and 8 days later experienced a heart dysrhythmia and tachycardia on an unspecified date, initial heart rate was 175bpm/ her heart rate was 165bpm on an unspecified date. She was transported by ambulance to the Emergency Department. Her initial heart rate was 175bpm, she was placed on a stretcher and loaded into the ambulance.  When she arrived at the hospital, her heart rate was 165bpm. Caller asking what does Pfizer recommend about me getting the second dose of the Pfizer Covid-19 Vaccine, was it safe. The patient underwent lab tests and procedures which included heart rate: 175 (initial heart rate was 175bpm), heart rate: 165 (bpm). The outcome of event was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Heart rate, Heart rate increased, Tachycardia
Clinical narrative: heart dysrhythmia and tachycardia; heart dysrhythmia and tachycardia; initial heart rate was 175bpm/ her heart rate was 165bpm; This is a spontaneous report from a contactable consumer.     A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated received her first dose of the Pfizer Covid-19 dose and 8 days later experienced a heart dysrhythmia and tachycardia on an unspecified date, initial heart rate was 175bpm/ her heart rate was 165bpm on an unspecified date. She was transported by ambulance to the Emergency Department. Her initial heart rate was 175bpm, she was placed on a stretcher and loaded into the ambulance.  When she arrived at the hospital, her heart rate was 165bpm. Caller asking what does Pfizer recommend about me getting the second dose of the Pfizer Covid-19 Vaccine, was it safe. The patient underwent lab tests and procedures which included heart rate: 175 (initial heart rate was 175bpm), heart rate: 165 (bpm). The outcome of event was unknown.  Information about lot/ batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Insomnia, Joint stiffness, Mental impairment, Sluggishness
Clinical narrative: Earache started 5 days later, worsened 6th day and now ringing and throbbing almost constantly.; Earache started 5 days later, worsened 6th day and now ringing and throbbing almost constantly.; Earache started 5 days later.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estrogen nos (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 15:00, 5 days after vaccination, the patient experienced earache which worsened on 6th day and on 30Apr2021, the patient experienced ringing and throbbing in the ear almost constantly. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events earache, ringing and throbbing in the ear almost constantly was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Pain, Tinnitus
Clinical narrative: Earache started 5 days later, worsened 6th day and now ringing and throbbing almost constantly.; Earache started 5 days later, worsened 6th day and now ringing and throbbing almost constantly.; Earache started 5 days later.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estrogen nos (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 15:00, 5 days after vaccination, the patient experienced earache which worsened on 6th day and on 30Apr2021, the patient experienced ringing and throbbing in the ear almost constantly. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events earache, ringing and throbbing in the ear almost constantly was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Arthralgia, Blood pressure increased, Joint dislocation, Pain in extremity
Clinical narrative: Right foot pain and swelling; Right foot pain and swelling; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 at 14:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received sulfur (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021 at 10:00, the patient experienced right foot pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right foot pain and swelling was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Prothrombin time
Clinical narrative: Right foot pain and swelling; Right foot pain and swelling; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 at 14:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received sulfur (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021 at 10:00, the patient experienced right foot pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right foot pain and swelling was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Right foot pain and swelling; Right foot pain and swelling; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 at 14:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient previously received sulfur (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021 at 10:00, the patient experienced right foot pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right foot pain and swelling was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast swelling, Fatigue, Headache, Pharyngeal swelling, Pruritus
Clinical narrative: itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 30Jul2021 09:00 (Batch/Lot Number: FA7484) (at the age of 61-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine.  Medical history included chronic fatigue syndrome from 1992 (chronic fatigue immune syndrome CFIDS diagnosed in 1992), latex dermabond allergy, and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]). The patient previously took erythromycin (Erythromycin is used for people that are allergic to penicillin). On 30Jul2021 09:15 AM, within minutes of 1st vaccine, the patient experienced itched all over, throat and ears swelled up, rash around ribs. The patient took Cetirizine 10 mg (for reactions) it calmed it down. Took another 3 hours later and then another six hours later. Next day itching stopped. Therapeutic measures were taken as a result of the events. On 31Jul2021, the patient recovered from itched all over while outcome of the other events was recovered on unspecified date in Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 30Jul2021 09:00 (Batch/Lot Number: FA7484) (at the age of 61-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine.  Medical history included chronic fatigue syndrome from 1992 (chronic fatigue immune syndrome CFIDS diagnosed in 1992), latex dermabond allergy, and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]). The patient previously took erythromycin (Erythromycin is used for people that are allergic to penicillin). On 30Jul2021 09:15 AM, within minutes of 1st vaccine, the patient experienced itched all over, throat and ears swelled up, rash around ribs. The patient took Cetirizine 10 mg (for reactions) it calmed it down. Took another 3 hours later and then another six hours later. Next day itching stopped. Therapeutic measures were taken as a result of the events. On 31Jul2021, the patient recovered from itched all over while outcome of the other events was recovered on unspecified date in Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear swelling, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 30Jul2021 09:00 (Batch/Lot Number: FA7484) (at the age of 61-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine.  Medical history included chronic fatigue syndrome from 1992 (chronic fatigue immune syndrome CFIDS diagnosed in 1992), latex dermabond allergy, and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]). The patient previously took erythromycin (Erythromycin is used for people that are allergic to penicillin). On 30Jul2021 09:15 AM, within minutes of 1st vaccine, the patient experienced itched all over, throat and ears swelled up, rash around ribs. The patient took Cetirizine 10 mg (for reactions) it calmed it down. Took another 3 hours later and then another six hours later. Next day itching stopped. Therapeutic measures were taken as a result of the events. On 31Jul2021, the patient recovered from itched all over while outcome of the other events was recovered on unspecified date in Jul2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site mass, Lymphadenopathy
Clinical narrative: a large lump (3-fingers big) on the shoulder; This is a spontaneous report from a contactable consumer or other non-HCP (patient).  A 50-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on 19May2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on unspecified date for covid-19 immunisation. On unspecified date in May2021, patient reported a large lump (3-fingers big) on the shoulder that he got since the second dose of the vaccine. At the time of this report, outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: a large lump (3-fingers big) on the shoulder; This is a spontaneous report from a contactable consumer or other non-HCP (patient).  A 50-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on 19May2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on unspecified date for covid-19 immunisation. On unspecified date in May2021, patient reported a large lump (3-fingers big) on the shoulder that he got since the second dose of the vaccine. At the time of this report, outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Limb mass
Clinical narrative: a large lump (3-fingers big) on the shoulder; This is a spontaneous report from a contactable consumer or other non-HCP (patient).  A 50-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on 19May2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on unspecified date for covid-19 immunisation. On unspecified date in May2021, patient reported a large lump (3-fingers big) on the shoulder that he got since the second dose of the vaccine. At the time of this report, outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Joint swelling, Menstruation irregular
Clinical narrative: shocks in different parts of her body; arm soreness; ankle swelling; muscle soreness; tiredness; headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jul2021 as Dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced shocks in different parts of her body, arm soreness, ankle swelling, muscle soreness, tiredness, and headache on 27Jul2021.The outcome of the events was unknown. The patient had query that whether the medical team can provide her with information on receiving the second dose if she continues to experience ongoing symptoms. The call centre team replied the patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as Pfizer cannot answer about the patient receiving the 2nd dose after experience of adverse events. The patient had not received any treatment for the events. Outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: shocks in different parts of her body; arm soreness; ankle swelling; muscle soreness; tiredness; headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jul2021 as Dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced shocks in different parts of her body, arm soreness, ankle swelling, muscle soreness, tiredness, and headache on 27Jul2021.The outcome of the events was unknown. The patient had query that whether the medical team can provide her with information on receiving the second dose if she continues to experience ongoing symptoms. The call centre team replied the patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as Pfizer cannot answer about the patient receiving the 2nd dose after experience of adverse events. The patient had not received any treatment for the events. Outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Joint swelling, Limb discomfort, Myalgia
Clinical narrative: shocks in different parts of her body; arm soreness; ankle swelling; muscle soreness; tiredness; headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jul2021 as Dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced shocks in different parts of her body, arm soreness, ankle swelling, muscle soreness, tiredness, and headache on 27Jul2021.The outcome of the events was unknown. The patient had query that whether the medical team can provide her with information on receiving the second dose if she continues to experience ongoing symptoms. The call centre team replied the patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as Pfizer cannot answer about the patient receiving the 2nd dose after experience of adverse events. The patient had not received any treatment for the events. Outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Shock symptom
Clinical narrative: shocks in different parts of her body; arm soreness; ankle swelling; muscle soreness; tiredness; headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jul2021 as Dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced shocks in different parts of her body, arm soreness, ankle swelling, muscle soreness, tiredness, and headache on 27Jul2021.The outcome of the events was unknown. The patient had query that whether the medical team can provide her with information on receiving the second dose if she continues to experience ongoing symptoms. The call centre team replied the patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as Pfizer cannot answer about the patient receiving the 2nd dose after experience of adverse events. The patient had not received any treatment for the events. Outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Blood magnesium increased, Blood potassium decreased, Cardiac arrest, Cardioversion
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Catheterisation cardiac normal, Chest pain, Electrocardiogram abnormal, Endotracheal intubation, Intensive care
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Nausea, Troponin I increased, Ventricular fibrillation, Ventricular tachycardia
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiomyopathy, Chest discomfort, Compartment syndrome, Death, Myocarditis
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid increased, C-reactive protein increased, Catheterisation cardiac, Chest pain, Coronary artery disease
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Electrocardiogram ST segment elevation, Fasciotomy, Fibrin D dimer increased, General physical health deterioration
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Liver function test increased, Lung assist device therapy, Nausea, Renal replacement therapy, Serum ferritin increased
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ventricular assist device insertion, Ventricular tachycardia, Vomiting
Clinical narrative: chest tightness, nausea, vomiting, developed cardiomyopathy, myocarditis, compartment syndrome, utimately death
Sex: U
Vaccine: COVID19
Symptoms: Bed rest, Medication error
Clinical narrative: LIE DOWN FOR 24 HOURS; MEDICATION ERROR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included covid-19 vaccine for prophylactic vaccination. On JUL-2021, the patient experienced medication error. On an unspecified date, the patient experienced lie down for 24 hours. The action taken with covid-19 vaccine was not applicable. The patient recovered from lie down for 24 hours, and the outcome of medication error was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Entire body feels like it's on fire; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Entire body feels like it's on fire) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to NSAIDS), Drug allergy (Methadone), Allergic reaction to analgesics (Tramadol), Allergic reaction to analgesics (Nucynta), Drug allergy (Buprenorphine) and Behcet's syndrome.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced FEELING HOT (Entire body feels like it's on fire). At the time of the report, FEELING HOT (Entire body feels like it's on fire) had not resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: When I awoke on Thursday morning (after receiving shot on Tues afternoon), my heart was racing. It continued to get worse as the day progressed. I eventually stopped working and laid down in bed around 4:30pm. I had not experienced this level of palpitations since my 2017 ablation. When I awoke Friday morning, it was a little better. On Saturday, my heartrate was normal again. I did not seek treatment as it never got worse than what I had experienced with bouts of SVT in the past.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Chills    24 hours Vomiting     an hour about 3 or 4 times Fever       7 hours Arm Pain  still hurts
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Heart rate increased, Hypertension
Clinical narrative: Five minutes after receiving shot, patient felt dizzy and anxious. Pharmacist checked blood pressure twice 20 minutes apart and was around 145-150/100 mmHg. Patient remained slightly dizzy and EMT was called. EMT verified blood pressure was still high was pulse was going down slowly (around 113 BPM). They discussed with patient and determined admission was not needed and patient may leave on her own when she desires as she was able to stand and walk on her own. Patient remained at pharmacy for another 15 minutes before leaving.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsey
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Heart rate increased, Palpitations
Clinical narrative: When sitting/hunched, bending, or laying down, I feel heart pounding - strong beats. When stand or straighten up, heart rate dramatically increases for about 5 seconds.  When heart rate increases, the rate goes from 60 to anywhere from 120 - 200. Went to visit primary doctor, who refered me to a cardiologist. I went to the ER a few days later. ER observed and noted the increase in heart rate(to 180) when bending. Prescribed VERAPAMIL. Heart rate issue improve (buffered) - still feel, but not pounding and less often. Visit Cardiologist who refered me to an Electrophysiologist. I wear a monitor for a week to document heart rate. EP recommends Ablation. Unsure of this fix.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling hot, Lymphadenopathy, Pain in extremity
Clinical narrative: Hot Ness in face,  swollen glands under arms, my arm is killing me like no strength still,  I honestly think it's causing me to feel like I'm heating up in my face
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Menstruation irregular, Pain
Clinical narrative: Period irregularity, sharp pains randomly in ovaries, Random sharp pains throughout my body (chest a lot)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Vaccine administration error.  mRNA vaccine mixed series error.  Patient was administered 1st dose of covid-19 vaccine, Pfizer.  Patient was then administered 2nd dose of covid-19 vaccine, Moderna, on 5-10-2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Feeling abnormal, Feeling cold, Hyperhidrosis
Clinical narrative: The night following the vaccine, I woke up with above a 104 degree fever, soaking wet with sweat, chills, shaking and literally crawled to my living room for an extra blanket, even though it was warm.  Each hour the temperature went down and by around 8pm was starting to feel normal again.  I worked the next day, though exhausted.  Long term side affects have been weird spot bruising on both legs, but especially my left (sometimes big and for no reason).  I still have brain fog and fatigue.  I don't feel the same after the vaccine.  I can't put my finger on it, but I'm off.  The bruising is starting to concern me.  As of right now, my left knew has a huge bruise on the knee cap and I don't know why.  I drink wine, but not to that excess.  The bruise covers my entire knee cap and it's the not first time.  It's just strange.  I sometimes feel off and can't pin point why.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: The night following the vaccine, I woke up with above a 104 degree fever, soaking wet with sweat, chills, shaking and literally crawled to my living room for an extra blanket, even though it was warm.  Each hour the temperature went down and by around 8pm was starting to feel normal again.  I worked the next day, though exhausted.  Long term side affects have been weird spot bruising on both legs, but especially my left (sometimes big and for no reason).  I still have brain fog and fatigue.  I don't feel the same after the vaccine.  I can't put my finger on it, but I'm off.  The bruising is starting to concern me.  As of right now, my left knew has a huge bruise on the knee cap and I don't know why.  I drink wine, but not to that excess.  The bruise covers my entire knee cap and it's the not first time.  It's just strange.  I sometimes feel off and can't pin point why.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Condition aggravated, Deafness bilateral, Extrasystoles, Heart rate irregular
Clinical narrative: SYMPTOMS: Increased tingling in lower legs, increased skipped or irregular heart beats; increased tinnitus in left ear; NEW distortion/crackling sounds in left ear. TREATMENT: June 15, 2021 - hearing test revealed hearing loss in both ears, but more loss in left ear. After reporting to Dr. all of the symptoms I was experiencing after the vaccine, he thought they could be the result of an inflammatory response. He recommended steroids (oral or injected) to reduce the inflammation in my left ear. I opted for injected steroids. Returned a few days later for another hearing test, which revealed some improvement in the left ear. He recommended another treatment. Returned a few days later for another hearing test, which revealed no further improvement. He did not recommend a third treatment. Recommended a 6-month follow-up hearing test. OUTCOME: Some hearing in left ear was restored, but not fully. Increased tinnitus in left ear remains the same. Increased tingling and skipped/irregular heart beats lessened after about a 4-5 weeks. Distortion/crackling sound has subsided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: SYMPTOMS: Increased tingling in lower legs, increased skipped or irregular heart beats; increased tinnitus in left ear; NEW distortion/crackling sounds in left ear. TREATMENT: June 15, 2021 - hearing test revealed hearing loss in both ears, but more loss in left ear. After reporting to Dr. all of the symptoms I was experiencing after the vaccine, he thought they could be the result of an inflammatory response. He recommended steroids (oral or injected) to reduce the inflammation in my left ear. I opted for injected steroids. Returned a few days later for another hearing test, which revealed some improvement in the left ear. He recommended another treatment. Returned a few days later for another hearing test, which revealed no further improvement. He did not recommend a third treatment. Recommended a 6-month follow-up hearing test. OUTCOME: Some hearing in left ear was restored, but not fully. Increased tinnitus in left ear remains the same. Increased tingling and skipped/irregular heart beats lessened after about a 4-5 weeks. Distortion/crackling sound has subsided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dehydration, Headache, Hepatic enzyme increased, Liver injury
Clinical narrative: Liver injury.   On 8/16 went to the ER due to dehydration from side effects of the vaccine. Liver enzymes were elevated.  Went back to the ER on 8/24 due to a headache with acute confusion, liver enzymes were even higher. Went to my PCP on 8/27 as a follow up and liver enzymes were even higher. Still waiting on other lab results to see if levels are due to illness.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive employee ; partially vaccinated ; first dose  only on 8/18/2021
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Impaired work ability, SARS-CoV-2 test positive
Clinical narrative: covid positive employee ; partially vaccinated ; first dose  only on 8/18/2021
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: reports possible community exposure 8/22/21. Onset of symptoms (pounding headache) 8/25. Called in sick for work 8/26. Covid test collected 8/26. 8/27 resulted positive.  confirms remains in quarantine and able to isolate from household/roommate(s) per CDC guidelines.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Impaired work ability, SARS-CoV-2 test positive
Clinical narrative: reports possible community exposure 8/22/21. Onset of symptoms (pounding headache) 8/25. Called in sick for work 8/26. Covid test collected 8/26. 8/27 resulted positive.  confirms remains in quarantine and able to isolate from household/roommate(s) per CDC guidelines.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Headache
Clinical narrative: Chest pains, trouble breathing symptoms such as mycocardia , 80BPM  no irregular heartbeats just chest feels heavy and headaches near the back bottom of head. These symptoms I?ve never experienced before in my life and have been persistent 12 days after the vaccine to present date.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure increased, Blood test, Chest X-ray, Dizziness
Clinical narrative: Can't walk for more than 10 steps without sever unbalance, blood pressure escalates to about 185/100, heart rate 125,  dizziness, falling down. hard to breath,  can;t make it far, can't go upstairs , has hard time functioning.   Legs extremley weak  Can only lay in the sofa.  Thank you .  I wish this  on them.  Sounds like Guillain Barre~
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fall, Muscular weakness
Clinical narrative: Can't walk for more than 10 steps without sever unbalance, blood pressure escalates to about 185/100, heart rate 125,  dizziness, falling down. hard to breath,  can;t make it far, can't go upstairs , has hard time functioning.   Legs extremley weak  Can only lay in the sofa.  Thank you .  I wish this  on them.  Sounds like Guillain Barre~
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy endometrium normal, Endometrial hyperplasia, Endometrial thickening, Menopause, Postmenopausal haemorrhage
Clinical narrative: 10 days after my 1st shot I started having a period and I'm Menopausal I haven't had a period in 18 years. Called my PCP he had me schedule a pap  with Dr for May 18, 2021 pap was normal, Dr scheduled me for a Vaginal Ultrasound  May 20, 2021 and it showed abnormal thickening of the endometrium with internal heterogeneous echogenic foci and cystic appearing components. The findings are nonspecific and my reflect endometrial hyperplasia. Dr scheduled me for an Endometrial Biopsy May 27, 2021 and it also was normal. I was referred to and OBGYN and I saw Dr on August 10, 2021 and I'm scheduled for surgery September 7, 2021, they go in vaginally with a camera and light and do a D&C an this is an outpatient procedure at Hospital.  I have since seeing Dr had ANOTHER Period lasting 6 days it started August 11, 2021 and I also came down with what they thought was Covid on August 11, 2021 but Covid test on August 13, 2021 was negative