chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gastrointestinal pain, Pain, Pelvic mass, Pelvic pain
Clinical narrative: lower pelvic pain that progressed into severe pain over the next day; pain with bowel movements; difficulty to sit; weight loss; 4 hours after injection developed again the severe pain; pelvic mass; This is a spontaneous report from a contactable Physician (for herself).   A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 43-years-old , as single dose for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing (known allergy Latex - contact) and COVID-19 infection (prior to vaccination, the patient was diagnosed with COVID-19). The patient was not pregnant and was not pregnant at the time of vaccination. The patient received first dose of BNT162B2 (lot number EL1284), on 07Jan2021 12:00 PM, vaccine location Arm Left and experienced lower pelvic pain that progressed into severe pain over the next day, pain with bowel movements, difficulty to sit, weight loss, resulted in hospitalisation for one day for suspected pelvic mass. Facility where the most recent COVID-19 vaccine was administered: Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included daily multivitamin. The patient received 2nd on 28Jan2021 and 4 hours after injection, she developed again the severe pain experienced after the first injection require pain management. Underwent laparoscopic surgery for removal of pelvic mass and lysis of adhesions of intestines. Prior to the 1st vaccine on 07Jan2021 I had no pelvic pain or intestinal issues, no prior surgery and had maintained a very active lifestyle. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based from known drug safety profile and temporal occurrence, the causal association of the reported events in relation to suspected drug  BNT162B2 cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: lower pelvic pain that progressed into severe pain over the next day; pain with bowel movements; difficulty to sit; weight loss; 4 hours after injection developed again the severe pain; pelvic mass; This is a spontaneous report from a contactable Physician (for herself).   A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 43-years-old , as single dose for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing (known allergy Latex - contact) and COVID-19 infection (prior to vaccination, the patient was diagnosed with COVID-19). The patient was not pregnant and was not pregnant at the time of vaccination. The patient received first dose of BNT162B2 (lot number EL1284), on 07Jan2021 12:00 PM, vaccine location Arm Left and experienced lower pelvic pain that progressed into severe pain over the next day, pain with bowel movements, difficulty to sit, weight loss, resulted in hospitalisation for one day for suspected pelvic mass. Facility where the most recent COVID-19 vaccine was administered: Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included daily multivitamin. The patient received 2nd on 28Jan2021 and 4 hours after injection, she developed again the severe pain experienced after the first injection require pain management. Underwent laparoscopic surgery for removal of pelvic mass and lysis of adhesions of intestines. Prior to the 1st vaccine on 07Jan2021 I had no pelvic pain or intestinal issues, no prior surgery and had maintained a very active lifestyle. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based from known drug safety profile and temporal occurrence, the causal association of the reported events in relation to suspected drug  BNT162B2 cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Unknown), via an unspecified route of administration on 09Mar2021, as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported that she would receive her second dose of Covid-19 vaccine on 30Mar2021. On an unspecified date in Mar2021, after receiving first vaccine, she was tested positive for covid and she asked if she can still get the second dose. Seriousness of events was medically significant. The outcome of events was unknown.  Upon follow-up on 29Mar2021 and Follow-up on 01Apr2021: This is a follow-up spontaneous report received from a contactable consumer via a Medical information team. No new information received.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID diagnosed with positive test, symptoms (lost taste and smell); This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored pro-gram . A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on 12Mar2021 the patient got his first Pfizer shot and on 25Mar2021 he was diagnosed with Covid. Stated he is now symptom free and scheduled to go back to work tomorrow. The patient stated that he was tested positive after he got the 1st dose last 12Mar2021 and on the 25th he was tested positive, he lost his taste and smell but now it returned as per caller. He will be having the 2nd dose appointment on 01Apr2021, and he want to know if he can continue to get that since he is totally fine right now. Caller was asking if he is okay to get his next shot on 01Apr2021. Caller stated he had been on hold for 45 minutes and the 1st person he talked to knew what he was calling about and he was doing the right thing and now he can't get an answer. Stated this was straight forward. Caller stated if he was transferred again he will probably be on hold for another hour and he can' do that. States if he doesn't get it, what trouble will he have rescheduling it in a few weeks and can the call handler help him with that. Caller asking if he doesn't get the 2nd shot in 21 days how long he can wait until. Caller states this is very frustrating why the first person transferred him here. Caller states he will call his doctor and abruptly disconnected. Referred caller to his healthcare provider for medical advice. Referred caller to contact his local health department, doctors office or place that he had his dose scheduled for scheduling and availability questions. Investigation Assessment was Not Provided. Outcome of the event was recovered in Mar2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Hypersensitivity, Nasal congestion, Oropharyngeal pain
Clinical narrative: She says her work made her get a COVID test on Sunday March 21st that was positive; Headache; stuffy nose; wet sore throat; she realized her symptoms were more like allergies; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown,), via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient got her first dose of the Pfizer COVID-19 vaccine on March 11th, then on Saturday March 20th she started having some symptoms that were not necessarily COVID, like a headache, stuffy nose, and a wet sore throat. Her work made her get a COVID test on Sunday March 21st that was positive. She was tested again on Thursday March 25th and she tested negative, and she realized her symptoms were more like allergies. She knows when she got a PCR test that there was a small trace of genetic material and the vaccine was a spike protein which was defined as genetic material. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: She says her work made her get a COVID test on Sunday March 21st that was positive; Headache; stuffy nose; wet sore throat; she realized her symptoms were more like allergies; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown,), via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient got her first dose of the Pfizer COVID-19 vaccine on March 11th, then on Saturday March 20th she started having some symptoms that were not necessarily COVID, like a headache, stuffy nose, and a wet sore throat. Her work made her get a COVID test on Sunday March 21st that was positive. She was tested again on Thursday March 25th and she tested negative, and she realized her symptoms were more like allergies. She knows when she got a PCR test that there was a small trace of genetic material and the vaccine was a spike protein which was defined as genetic material. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: unknowingly were all exposed to the covid virus and tested positive; This is a spontaneous report from a contactable consumer reporting same the same event under the same suspect product for 3 patients (this is for the reporter's husband). This is one of 3 reports. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination was unknown at a pharmacy. The patient medical history included unknowingly exposed to the covid virus and tested positive on an unspecified date. The patient's concomitant medications were not reported. The patient was unknowingly exposed to the COVID virus on an unspecified date and tested positive with symptom of fever on 09Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Mar2021 Positive. Reporter asked if they should receive the second vaccine or start again. They were told after 90 days, they had to start over again. The patient received the antibody infusion for the virus from reporter's mother in law on the 24th. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021354303 same reporter, suspect drug, same adverse event; different patient.;PFIZER INC-2021357177 same reporter, suspect drug, same adverse event; different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: exposed to the covid virus and tested positive/started having symptoms; This is a spontaneous report from a contactable consumer reporting same the same event under the same suspect product for 3 patients (this is for the reporter's son). This is one of 3 reports. A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 27Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown at a pharmacy. Medical history included autistic and patient was unknowingly exposed to the COVID virus  from an unknown date. The patient's concomitant medications were not reported. The patient was unknowingly exposed to the COVID virus and tested positive on 01Mar2021 and started having symptoms that day which includes sweating from his head, fever, and cough. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Mar2021 Positive. Reporter asked if they should receive the second vaccine or start again. They were told after 90 days, they had to start over again. The patient received the antibody infusion for the virus from reporter's mother in law on the 24th. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021354303 same reporter, suspect drug, same adverse event; different patient.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Abnormal bleeding / Menstrual cycle began 4 days early; heavy blood clots / Menstrual cycle began 4 days early; This is a spontaneous report received from a contactable consumer. A 35-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #ER8730) via an unspecified routed of administration in arm left on 26Mar2021 05:00 PM at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Mar2021 the patient experienced abnormal bleeding with heavy blood clots and menstrual cycle began 4 days earlier (less than 72hours after second vaccine). Adverse event start time was 10:00 AM. The events were resolving at the time of report. No treatment was received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccinated in January and ended up with Covid; vaccinated in January and ended up with Covid; This is a spontaneous report from a contactable other HCP. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller mentioned that her daughter in law's mother is a critical care nurse who was vaccinated in January and ended up with Covid. It was not specified which vaccine the nurse received. The reporter states that she thinks this person picked up a variant since the vaccine that she got did not cover her. This person was symptomatic but had not been hospitalized. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, and on the plausible temporal association, there is a reasonable possibility that the event Drug ineffective (vaccinated in January and ended up with Covid) is related to the suspect product (BNT162B2).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Shortness of Breath/Hard to breathe; some heart palpitations; This is a spontaneous case received from a contactable consumer (patient). This 64-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6202) via an unspecified route of administration in the right arm on 17Mar2021 12:00 PM at single dose for covid-19 immunisation. Medical history included cancer survivor, herniated disc, knee surgery. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included vitamins nos, calcium, chondroitin sulfate sodium/glucosamine (GLUCOSAMINE AND CHONDROITIN), ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9264) via an unspecified route of administration in the right arm on 24Feb2021 12:00 PM at 64 years old at single dose for covid-19 immunisation. The patient experienced shortness of breath, some heart palpitations, hard to breathe on 28Mar2021 at 12:00 AM. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event with prescribed (Albuterol Sulfate). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.   No Follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Got covid after first dose of the covid-19 vaccine; Got covid after first dose of the covid-19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: CN6200), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2016 and ongoing. The patient's concomitant medications were not reported. On 11Mar2021, the patient experienced got covid after first dose of the COVID-19 vaccine. The patient states she was due for her second dose of Pfizer COVID-19 vaccine on 24Mar2021 and wants to know if she should get the second dose even though she has antibodies now, has not gotten second dose scheduled for 24Mar2021. The patient states symptoms started on 11Mar2021 and she tested positive on 15Mar2021. She clarified that she only had one test, then she stated she had a rapid test and the 3 day test and the rapid was negative and the 3 day test was positive. She states only cough medicine but that was it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got covid after first dose of the covid-19 vaccine; Got covid after first dose of the covid-19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: CN6200), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2016 and ongoing. The patient's concomitant medications were not reported. On 11Mar2021, the patient experienced got covid after first dose of the COVID-19 vaccine. The patient states she was due for her second dose of Pfizer COVID-19 vaccine on 24Mar2021 and wants to know if she should get the second dose even though she has antibodies now, has not gotten second dose scheduled for 24Mar2021. The patient states symptoms started on 11Mar2021 and she tested positive on 15Mar2021. She clarified that she only had one test, then she stated she had a rapid test and the 3 day test and the rapid was negative and the 3 day test was positive. She states only cough medicine but that was it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Respiratory rate
Clinical narrative: hypertension; This is a spontaneous report from a non-contactable other healthcare professional. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 31Mar2021 (Lot Number: en5318) as single dose for COVID-19 immunisation.  The patient had no relevant medical history. It was unknown if the patient was pregnant. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 31Mar2021 at 17:00 the patient experienced hypertension. The patient respirations were normal at 18, pulse normal in the range of 80s, trending blood pressure started at 152/100 and went up to 176 within 20 min. The adverse event resulted in emergency room visit. No treatment was received for the hypertension. The clinical outcome of the hypertension was unknown.  No follow-up attempts are possible. No further information is expected.; 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 event Hypertension cannot be 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
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Dizziness; blurred vision; joint aches; extreme pain; difficulty breathing; fever; chills; sweats; large rash; This is a spontaneous report from a contactable consumer. A non-pregnant 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 21Mar2021 at 15:30 (Batch/Lot Number: EN 62v3) at 37-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient's medical history included gluten allergy from an unknown date and unknown if ongoing, COVID-19 prior to vaccination from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Feb2021 (Lot Number: EN6201, administration time 15:30, location: Left arm, dose number: 1). On 22Mar2021 02:00, the patient experienced: dizziness, blurred vision, joint aches, extreme pain, difficulty breathing, fever, chills, sweats, large rash; all of which required a visit to a doctor or other healthcare professional office/clinic, emergency room/department or urgent care and hospitalization.  The patient was hospitalized for all of the events for 1 day.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Mar2021.  Therapeutic measures were taken as a result of the events, which included intravenous (IV) fluids and pain medications. The clinical outcome of the events was recovered with sequelae on an unspecified date.   Follow-up attempts have been completed and no further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, SARS-CoV-2 test, Vision blurred
Clinical narrative: Dizziness; blurred vision; joint aches; extreme pain; difficulty breathing; fever; chills; sweats; large rash; This is a spontaneous report from a contactable consumer. A non-pregnant 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 21Mar2021 at 15:30 (Batch/Lot Number: EN 62v3) at 37-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  The patient's medical history included gluten allergy from an unknown date and unknown if ongoing, COVID-19 prior to vaccination from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Feb2021 (Lot Number: EN6201, administration time 15:30, location: Left arm, dose number: 1). On 22Mar2021 02:00, the patient experienced: dizziness, blurred vision, joint aches, extreme pain, difficulty breathing, fever, chills, sweats, large rash; all of which required a visit to a doctor or other healthcare professional office/clinic, emergency room/department or urgent care and hospitalization.  The patient was hospitalized for all of the events for 1 day.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Mar2021.  Therapeutic measures were taken as a result of the events, which included intravenous (IV) fluids and pain medications. The clinical outcome of the events was recovered with sequelae on an unspecified date.   Follow-up attempts have been completed and no further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Aphonia, Asthenia, COVID-19
Clinical narrative: there is clear liquid or mucus when she blows her nose and her nose is constantly running and she feels it in the back of her throat; her nose is constantly running and she feels it in the back of her throat; Tested positive for covid; Coughs up little specs of blood with dry cough; Fever; Feels a little weak at night sometimes; Light to mild cough; Losing her voice; Dry throat; Having problems breathing because of nose and throat; Loss of sense of taste and smell; Loss of sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm left on 16Mar2021 12:30 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced Dry throat, light to mild cough, Having problems breathing because of nose and throat, loss of sense of taste and smell, Losing her voice on 26Mar2021. The patient experienced fever, feels a little weak at night sometimes on 27Mar2021. The patient was tested positive for covid on 28Mar2021. She coughs up little specs of blood with dry cough on 28Mar2021. There was clear liquid or mucus when she blows her nose and her nose was constantly running and she felt it in the back of her throat. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Therapeutic measures included Nyquil were taken as a result of fever, feels a little weak at night sometimes, dry throat, light to mild cough. The outcome of events tested positive for COVID-19 was unknown, fever was recovered with sequelae, feels a little weak at night sometimes, light to mild cough, coughs up little specs of blood with dry cough, loss of sense of taste and smell, losing her voice was recovering while dry throat, having problems breathing because of nose and throat was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Dyspnoea, Haemoptysis, Pyrexia
Clinical narrative: there is clear liquid or mucus when she blows her nose and her nose is constantly running and she feels it in the back of her throat; her nose is constantly running and she feels it in the back of her throat; Tested positive for covid; Coughs up little specs of blood with dry cough; Fever; Feels a little weak at night sometimes; Light to mild cough; Losing her voice; Dry throat; Having problems breathing because of nose and throat; Loss of sense of taste and smell; Loss of sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm left on 16Mar2021 12:30 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced Dry throat, light to mild cough, Having problems breathing because of nose and throat, loss of sense of taste and smell, Losing her voice on 26Mar2021. The patient experienced fever, feels a little weak at night sometimes on 27Mar2021. The patient was tested positive for covid on 28Mar2021. She coughs up little specs of blood with dry cough on 28Mar2021. There was clear liquid or mucus when she blows her nose and her nose was constantly running and she felt it in the back of her throat. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Therapeutic measures included Nyquil were taken as a result of fever, feels a little weak at night sometimes, dry throat, light to mild cough. The outcome of events tested positive for COVID-19 was unknown, fever was recovered with sequelae, feels a little weak at night sometimes, light to mild cough, coughs up little specs of blood with dry cough, loss of sense of taste and smell, losing her voice was recovering while dry throat, having problems breathing because of nose and throat was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Upper-airway cough syndrome
Clinical narrative: there is clear liquid or mucus when she blows her nose and her nose is constantly running and she feels it in the back of her throat; her nose is constantly running and she feels it in the back of her throat; Tested positive for covid; Coughs up little specs of blood with dry cough; Fever; Feels a little weak at night sometimes; Light to mild cough; Losing her voice; Dry throat; Having problems breathing because of nose and throat; Loss of sense of taste and smell; Loss of sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm left on 16Mar2021 12:30 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced Dry throat, light to mild cough, Having problems breathing because of nose and throat, loss of sense of taste and smell, Losing her voice on 26Mar2021. The patient experienced fever, feels a little weak at night sometimes on 27Mar2021. The patient was tested positive for covid on 28Mar2021. She coughs up little specs of blood with dry cough on 28Mar2021. There was clear liquid or mucus when she blows her nose and her nose was constantly running and she felt it in the back of her throat. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Therapeutic measures included Nyquil were taken as a result of fever, feels a little weak at night sometimes, dry throat, light to mild cough. The outcome of events tested positive for COVID-19 was unknown, fever was recovered with sequelae, feels a little weak at night sometimes, light to mild cough, coughs up little specs of blood with dry cough, loss of sense of taste and smell, losing her voice was recovering while dry throat, having problems breathing because of nose and throat was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenopia, Confusional state, Dizziness, Head discomfort
Clinical narrative: Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep talking, Syncope, Tremor, Vertigo
Clinical narrative: Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Vasovagal syncope; Blood pressure drop - fainting; This is a spontaneous report received from a contactable consumer, the patient.  A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955), via an unspecified route of administration on arm left on 31Mar2021 08:00 AM at single dose for COVID-19 immunization. The patient medical history included methylenetetrahydrofolate reductase gene mutation from an unknown date and unknown if ongoing , wolff-parkinson-white syndrome from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient concomitant medications included omeprazole (ZEGERID [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10 [UBIDECARENONE]) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported, fish oil, quatrefloic within 2 weeks of vaccination. The patient previously took ampicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 08:30 AM, the patient experienced Blood pressure drop,  fainting, vasovagal syncope.The seriousness criteria of the events has not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The event was assessed as serious based on seriousness criteria. The patient did not receive any treatment for the events. The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac stress test, Chest pain, Electrocardiogram, Headache
Clinical narrative: chest pain; heart attack; headache; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 09:15 at single dose in left arm for COVID-19 immunization. Medical history included Irregular heart beat. The patient had no Allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN), and metoprolol. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On Monday morning (29Mar2021 06:45), when the patient got out of bed she started having chest pain, took a shower and the pain got worse like she was having a heart attack, she was admitted to the hospital and treated for the pain and had EKG, stress test done, blood pressure was high, and she had a very bad headache; The events resulted Emergency room/department or urgent care. Tuesday morning (30Mar2021) the pain started to decreased and after another EKG and her blood pressure went down she was released and advised to follow up with her primary doctor as well as the cardiologist. Lab test included Nasal swab negative on 29Mar2021. Treatment was received for all events. The outcome of all events was resolved.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: chest pain; heart attack; headache; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 09:15 at single dose in left arm for COVID-19 immunization. Medical history included Irregular heart beat. The patient had no Allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN), and metoprolol. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On Monday morning (29Mar2021 06:45), when the patient got out of bed she started having chest pain, took a shower and the pain got worse like she was having a heart attack, she was admitted to the hospital and treated for the pain and had EKG, stress test done, blood pressure was high, and she had a very bad headache; The events resulted Emergency room/department or urgent care. Tuesday morning (30Mar2021) the pain started to decreased and after another EKG and her blood pressure went down she was released and advised to follow up with her primary doctor as well as the cardiologist. Lab test included Nasal swab negative on 29Mar2021. Treatment was received for all events. The outcome of all events was resolved.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ischaemic, Laboratory test, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: passed out; ischemic colitis; This is a spontaneous report received from a contactable consumer (patient). This 51-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8727) at single dose via an unknown route in left arm on 22Mar2021 09:45 for Covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), levothyroxine, colecalciferol (VITAMIN D 3), cetirizine hydrochloride (ZYRTEC), and fish oil.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient passed out on Weds evening 24Mar2021 at 09:00 PM, followed by nausea, vomiting, passing of blood, and stomach cramping and was admitted to the hospital on 25Mar2021. Duration of hospitalization was 5 days. Patient was diagnosed with ischemic colitis. This was a condition she had never had before and considered herself completely fine before this incident. A battery of tests uncovered no reason for the passing out to have happened. Lab data included nasal swab on 26Mar2021: negative. The adverse event result in Emergency room/department or urgent care. It was unknown if treatment received for the adverse event. Outcome of the events was resolving.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Magnetic resonance imaging
Clinical narrative: Became deaf in her right ear after receiving the 1st vaccine; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: En 6205), via an unspecified route of administration, administered in arm left on 03Mar2021 19:30 at single dose for COVID-19 immunisation. Medical history and concomitant medications were both reported as none. No known allergies. No other vaccine in four weeks, and no other medications in two weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient became deaf in her right ear after receiving the 1st vaccine on 15Mar2021 12:00 with outcome of not recovered. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event that included steroid injections. The patient underwent lab tests and procedures in 2021 which included hearing tests: unknown results, magnetic resonance imaging (MRI): unknown results. The patient received the second dose of BNT162B2 (Lot number: Ep 7534) in the right arm on 24Mar2021.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness
Clinical narrative: Became deaf in her right ear after receiving the 1st vaccine; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: En 6205), via an unspecified route of administration, administered in arm left on 03Mar2021 19:30 at single dose for COVID-19 immunisation. Medical history and concomitant medications were both reported as none. No known allergies. No other vaccine in four weeks, and no other medications in two weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient became deaf in her right ear after receiving the 1st vaccine on 15Mar2021 12:00 with outcome of not recovered. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event that included steroid injections. The patient underwent lab tests and procedures in 2021 which included hearing tests: unknown results, magnetic resonance imaging (MRI): unknown results. The patient received the second dose of BNT162B2 (Lot number: Ep 7534) in the right arm on 24Mar2021.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unknown date in Jan2021 as single dose for covid-19 immunization. The patient experienced sore arm on an unknown date. The report received as, the patient receiving both doses of the COVID-19 vaccine manufactured by Pfizer. Caller experienced a sore arm after receiving the vaccine. Caller reports the first dose was administered on an unspecified date in Jan2021 and the second dose on an unspecified date in Feb2021. It is unknown if the consumer experienced as sore arm after both doses or just one dose. No clarifying details were provided. No PQC. No additional information provided. Outcome of the event was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.