chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Burning sensation, Cerebrovascular accident, Chest pain, Pain
Clinical narrative: stroke after vaccine; burning feet; pin needles; zapping pains, also the pain move towards tummy and chest area; zapping pains, also the pain move towards tummy and chest area; zapping pains, also the pain move towards tummy and chest area; itching skin; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150, Expiry date: Unknown), via an unspecified route of administration, administered in the left arm on 07Apr2021 at 13:15 (at the age of 43-years-old) as dose 1, single for covid-19 immunization. Medical history included heart surgery before vaccine on an unknown date and cerebrovascular accident from unknown date. It was reported that no covid prior to vaccination and no covid tested post vaccination. No known allergies. There were no concomitant medications, no other vaccines in four weeks and no other medications in two weeks. On an unspecified date in 2021, after vaccination, the patient experienced stroke after vaccine, burning feet, pin needles and zapping pains, also the pain move towards tummy and chest area, itching skin. Adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment received for events. The clinical outcome of events was not recovered at the time of report.    Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: stroke after vaccine; burning feet; pin needles; zapping pains, also the pain move towards tummy and chest area; zapping pains, also the pain move towards tummy and chest area; zapping pains, also the pain move towards tummy and chest area; itching skin; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150, Expiry date: Unknown), via an unspecified route of administration, administered in the left arm on 07Apr2021 at 13:15 (at the age of 43-years-old) as dose 1, single for covid-19 immunization. Medical history included heart surgery before vaccine on an unknown date and cerebrovascular accident from unknown date. It was reported that no covid prior to vaccination and no covid tested post vaccination. No known allergies. There were no concomitant medications, no other vaccines in four weeks and no other medications in two weeks. On an unspecified date in 2021, after vaccination, the patient experienced stroke after vaccine, burning feet, pin needles and zapping pains, also the pain move towards tummy and chest area, itching skin. Adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment received for events. The clinical outcome of events was not recovered at the time of report.    Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Hyperacusis, Hypoaesthesia, Pain
Clinical narrative: 6 hours after shot temporarily lost hearing (muffled sound).; When it came back, pressure and ringing in ears.; Ears still have tinnitus and pressure issues.; Sensitivity to sound, which still causes pain.; When it came back, pressure and ringing in ears.; numbness in hands, face and feet; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 31-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 06May2021 (at the age of 31-year-old) as single dose for COVID-19 immunization at Facility type vaccine: other. The patient medical history included lyme disease (healed). No other vaccine received by patient in four weeks and no other medications in two weeks. The patient had no known allergies. The patient's concomitant medications were not reported. It was reported as yes for covid prior to vaccination and no to covid tested post vaccination. The patient experienced 6 hours after shot temporarily lost hearing (muffled sound), when it came back, pressure and ringing in ears, ears still have tinnitus and pressure issues, sensitivity to sound, which still caused pain, numbness in hands, face and feet (occasional) on 06May2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient was treated for adverse events. Therapeutic measures were taken as a result of 6 hours after shot temporarily lost hearing (muffled sound), when it came back, pressure and ringing in ears, ears still have tinnitus and pressure issues, sensitivity to sound, which still causes pain, when it came back, pressure and ringing in ears, numbness in hands, face and feet. The clinical outcome of all events was not resolved.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 6 hours after shot temporarily lost hearing (muffled sound).; When it came back, pressure and ringing in ears.; Ears still have tinnitus and pressure issues.; Sensitivity to sound, which still causes pain.; When it came back, pressure and ringing in ears.; numbness in hands, face and feet; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 31-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 06May2021 (at the age of 31-year-old) as single dose for COVID-19 immunization at Facility type vaccine: other. The patient medical history included lyme disease (healed). No other vaccine received by patient in four weeks and no other medications in two weeks. The patient had no known allergies. The patient's concomitant medications were not reported. It was reported as yes for covid prior to vaccination and no to covid tested post vaccination. The patient experienced 6 hours after shot temporarily lost hearing (muffled sound), when it came back, pressure and ringing in ears, ears still have tinnitus and pressure issues, sensitivity to sound, which still caused pain, numbness in hands, face and feet (occasional) on 06May2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient was treated for adverse events. Therapeutic measures were taken as a result of 6 hours after shot temporarily lost hearing (muffled sound), when it came back, pressure and ringing in ears, ears still have tinnitus and pressure issues, sensitivity to sound, which still causes pain, when it came back, pressure and ringing in ears, numbness in hands, face and feet. The clinical outcome of all events was not resolved.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue pruritus
Clinical narrative: tingling on her lips; Top of tongue itching; This is a spontaneous report from a contactable consumer (patient).  A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 20Aug2021 at 09:30 Am (at the age of 25-years-old) as dose 1, single for covid-19 immunisation. Medical history included obesity, Chronic asthma from an unknown date and unknown if ongoing. The concomitant medications were none. On 20Aug2021 10:15, 45 minutes after vaccination, the patient experienced tingling on her lips, top of tongue itching. Patient stated 45 minutes post vaccination she felt itchiness on the top of her tongue and tingling on her lips. It was reported that she took Benadryl and that she is on the way to her physician. She took Benadryl and went to sleep for an hour and 30 minutes. When she woke up her lips were sill tinging, but not swollen. She can still feel her lips tingling after the COVID vaccine, but it got better because of Benadryl. Therapeutic measures taken for the events. The outcome of the event tingling on her lips was recovering while for Top of tongue itching was Recovered on Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Pain
Clinical narrative: Patient covid positive; Patient covid positive; feel body pains; fatigue; fever (37.8C); Cough; This is a spontaneous report from a contactable consumer (reported for himself). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 40-years-old) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EW0158/Batch number was not reported) as dose 2, single for covid-19 immunisation at other. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced feel body pains, fatigue, fever (37.8 Centigrade), cough on 16Aug2021 and patient covid positive on 18Aug2021. The event patient covid positive assessed as serious (medically significant). The patient underwent lab tests and procedures which included body temperature: 37.8 Centigrade on 16Aug2021 and sars-cov-2 test: positive on 18Aug2021 (nasal swab). The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient covid positive; Patient covid positive; feel body pains; fatigue; fever (37.8C); Cough; This is a spontaneous report from a contactable consumer (reported for himself). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6205/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 40-years-old) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EW0158/Batch number was not reported) as dose 2, single for covid-19 immunisation at other. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced feel body pains, fatigue, fever (37.8 Centigrade), cough on 16Aug2021 and patient covid positive on 18Aug2021. The event patient covid positive assessed as serious (medically significant). The patient underwent lab tests and procedures which included body temperature: 37.8 Centigrade on 16Aug2021 and sars-cov-2 test: positive on 18Aug2021 (nasal swab). The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Lethargy, Unresponsive to stimuli
Clinical narrative: unresponsiveness; lethargy; This is a spontaneous report from a contactable physician via a Pfizer-sponsored program. A 2-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), first dose (at age of 2 months old) and second dose (at age of 4 month old) both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation. The patient medical history and concomitant medications were not reported. The physician had a patient that was 10 years old (at this time) and was being cared for by another pediatrician before the reporter. After his 2 month and 4 month vaccines which included PREVNAR 13 he was hospitalized after each dose of the vaccine for lethargy and unresponsiveness. The patient had a medical exemption for vaccines that were administered at this time. When it comes to all those ingredients in those vaccines, was there anything in common with the ones he received back in 2011 and the ones he has not yet received. The reporter pulled all the package inserts from all the vaccines in his/her office and reporter had gone through them. The patient was looking at the other ingredient section which was the descriptions section. The reporter figure patient's never going to get PREVNAR 13 again. His hospitalization with lethargy and unresponsiveness sounds like a typical reaction to the pertussis component of the DTP vaccine and usually when the child comes in you don't give them a pertussis containing vaccine. You give them the diphtheria tetanus without pertussis. The reporter didn't think his doctor did that so he didn't know which component he reacted to. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product, events most likely due to patient underlying contributory factors
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron increased, Muscle spasms, Pain in extremity, Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN0179), via an unspecified route of administration (at the age of 57-years), administered in arm right on 11Aug2021 at 16:30 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus from 2020 to an unknown date additional Information for other conditions: found out last year. There were no concomitant medications. The vaccination was administered at hospital. On an unspecified date in Aug2021, the patient experienced burnt mark on her right arm/dark patch on her right arm, her iron level is high, soreness and muscle spasms. Caller was calling about receiving the first dose of the Pfizer Covid-19 vaccine; her iron level is high per DSU agent. Caller is a 57 year old female who received the first dose of the Pfizer Covid-19 vaccine on 11Aug2021 and states that she is not calling because of her iron level is high. Caller states that after the first dose of the Pfizer Covid-19 vaccine that she had complaints of soreness, muscle spasms, and a burnt mark on her right arm. Caller describes the burnt mark as a dark square that was at her injection site on the right shoulder. Stated that it looks like a suntan; one part is darker than the other. Caller was asking if a burnt mark at the injection site is a side effect that has been re-ported for the Pfizer Covid-19 vaccine? She got her shot, she got something on her arm, a patch, or dark mark on her arm, like it was burnt. Is that normal? Caller mentions she was driving. Adds her next dose on 01Sep2021. Caller reported that she noticed the dark patch on her right arm; she thought it was where the band aid came off; but it looked burnt; a couple of days later after the vaccination she noticed it. It is staying the same. Caller asked can she call back because she has somewhere to go? She does not have time to finish the report right now. Received follow up call from consumer regarding the Pfizer COVID 19 Vaccine. She just spoke with someone at Pfizer Drug Safety and had to run into the store, so she was calling back. She would like to know what was wrong with her iron. It is high after taking the first dose of the Pfizer COVID 19 Vaccine. She did not wish to provide an email or date of birth. There was no product complaint to report. Medical information request: She would like to know what is wrong with her iron. It is high after taking the first dose of the Pfizer COVID 19 Vaccine. The patient underwent lab tests and procedures which included blood iron: high on and unspecified date and her iron level is high. The clinical outcome of the event burnt mark on her right arm/dark patch on her right arm was reported as not recovered while for other events was reported as unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Diarrhoea, Dry mouth, Dyspnoea
Clinical narrative: chest pain (feeling of heavy gas build up in chest and needle feeling); Arm sensitivity (feeling of arm on clothes felt off); hand tingling within 15 min; Nausea; headache; Tiredness; fog brain; arm pain within 3 hours; intense night sweats; diarrhea; heavy breathing during movement; dry mouth; dry mouth/ tongue; This is a spontaneous report from a non-contactable consumer. A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Fa7485) via an unspecified route of administration, administered in Arm Right on 30Jul2021 at 12:15 as DOSE 1, SINGLE (at the age of 23-year-old) for covid-19 immunisation. The patient's medical history included drug hypersensitivity (Sulfer based medicine), gastrooesophageal reflux disease, contraception. The patient's concomitant medication(s) included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for gastrooesophageal reflux disease, contraception. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 12:30, patient experienced arm sensitivity (feeling of arm on clothes felt off) and hand tingling within 15 min (tingling was for 2 minutes), nausea and headache within 1 hour, tiredness, fog brain, and arm pain within 3 hours (arm pain only lasted 8 hours) nausea, intense night sweats, chest pain (feeling of heavy gas build up in chest and needle feeling), diarrhea, heavy breathing during movement, 99 temp, dry mouth/ tongue for 3-4 days (chest pains up to 2 weeks-has never happened before). The patient received the treatment for the events. The outcome of the events was recovered in unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Limb discomfort
Clinical narrative: chest pain (feeling of heavy gas build up in chest and needle feeling); Arm sensitivity (feeling of arm on clothes felt off); hand tingling within 15 min; Nausea; headache; Tiredness; fog brain; arm pain within 3 hours; intense night sweats; diarrhea; heavy breathing during movement; dry mouth; dry mouth/ tongue; This is a spontaneous report from a non-contactable consumer. A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Fa7485) via an unspecified route of administration, administered in Arm Right on 30Jul2021 at 12:15 as DOSE 1, SINGLE (at the age of 23-year-old) for covid-19 immunisation. The patient's medical history included drug hypersensitivity (Sulfer based medicine), gastrooesophageal reflux disease, contraception. The patient's concomitant medication(s) included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for gastrooesophageal reflux disease, contraception. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 12:30, patient experienced arm sensitivity (feeling of arm on clothes felt off) and hand tingling within 15 min (tingling was for 2 minutes), nausea and headache within 1 hour, tiredness, fog brain, and arm pain within 3 hours (arm pain only lasted 8 hours) nausea, intense night sweats, chest pain (feeling of heavy gas build up in chest and needle feeling), diarrhea, heavy breathing during movement, 99 temp, dry mouth/ tongue for 3-4 days (chest pains up to 2 weeks-has never happened before). The patient received the treatment for the events. The outcome of the events was recovered in unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Tongue dry
Clinical narrative: chest pain (feeling of heavy gas build up in chest and needle feeling); Arm sensitivity (feeling of arm on clothes felt off); hand tingling within 15 min; Nausea; headache; Tiredness; fog brain; arm pain within 3 hours; intense night sweats; diarrhea; heavy breathing during movement; dry mouth; dry mouth/ tongue; This is a spontaneous report from a non-contactable consumer. A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Fa7485) via an unspecified route of administration, administered in Arm Right on 30Jul2021 at 12:15 as DOSE 1, SINGLE (at the age of 23-year-old) for covid-19 immunisation. The patient's medical history included drug hypersensitivity (Sulfer based medicine), gastrooesophageal reflux disease, contraception. The patient's concomitant medication(s) included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for gastrooesophageal reflux disease, contraception. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 12:30, patient experienced arm sensitivity (feeling of arm on clothes felt off) and hand tingling within 15 min (tingling was for 2 minutes), nausea and headache within 1 hour, tiredness, fog brain, and arm pain within 3 hours (arm pain only lasted 8 hours) nausea, intense night sweats, chest pain (feeling of heavy gas build up in chest and needle feeling), diarrhea, heavy breathing during movement, 99 temp, dry mouth/ tongue for 3-4 days (chest pains up to 2 weeks-has never happened before). The patient received the treatment for the events. The outcome of the events was recovered in unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antinuclear antibody, Blood cholesterol, Blood test, Blood thyroid stimulating hormone
Clinical narrative: I did not respond to the vaccine. When they took blood from me after the vaccine to see if I have developed antibody to the Covid the vaccine has not worked for me at all; My weight it is I am losing a bit of weight; I just had the booster before I get the antibodies test again; I just had the booster before I get the antibodies test again; This is a spontaneous report from a contactable consumer (patient herself) or other non hcp. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: FD8448), via intramuscular route of administration, administered in Arm Left on 15Aug2021 (at the age of 70-Years-old) as dose 3, single for COVID-19 immunisation. Medical history included crohn's disease, ankylosing spondylitis, fibromyalgia, blood iron, addison's disease, ehlers-danlos syndrome, osteoporosis from unknown start and stop dates and ongoing atrial tachycardia (am having atrial tachycardia, that's brand new). Concomitant medication(s) included abatacept (ORENCIA), prednisone, indometacin (INDOCIN), temazepam and etanercept taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, via unspecified route of administration, administered on 02-Feb-2021 as dose 1, single (Lot Number: EL3248) and dose 2 on 23-Feb-2021 (Lot number: EM9810) for COVID-19 immunisation and no events were experienced by the patient (at the age of 70-Years-old). The patient did not respond to the vaccine. when they took blood from patient after the vaccine to see if developed antibody to the covid the vaccine has not worked for me at all, losing a bit of weight, patient just had the booster before and get the antibodies test again on 15Aug2021 on 15Aug2021. The patient underwent lab tests and procedures which included antibody test: has less than 1% protection, antinuclear antibody: normal, blood cholesterol: cholesterol was high, blood test: normal, blood thyroid stimulating hormone: normal, blood triglycerides: normal, blood uric acid: normal, creatinine renal clearance: normal, high density lipoprotein: normal, laboratory test: normal, low density lipoprotein: high and vitamin d: normal on an unspecified date. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides, Blood uric acid, Creatinine renal clearance, Drug ineffective, Extra dose administered
Clinical narrative: I did not respond to the vaccine. When they took blood from me after the vaccine to see if I have developed antibody to the Covid the vaccine has not worked for me at all; My weight it is I am losing a bit of weight; I just had the booster before I get the antibodies test again; I just had the booster before I get the antibodies test again; This is a spontaneous report from a contactable consumer (patient herself) or other non hcp. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: FD8448), via intramuscular route of administration, administered in Arm Left on 15Aug2021 (at the age of 70-Years-old) as dose 3, single for COVID-19 immunisation. Medical history included crohn's disease, ankylosing spondylitis, fibromyalgia, blood iron, addison's disease, ehlers-danlos syndrome, osteoporosis from unknown start and stop dates and ongoing atrial tachycardia (am having atrial tachycardia, that's brand new). Concomitant medication(s) included abatacept (ORENCIA), prednisone, indometacin (INDOCIN), temazepam and etanercept taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, via unspecified route of administration, administered on 02-Feb-2021 as dose 1, single (Lot Number: EL3248) and dose 2 on 23-Feb-2021 (Lot number: EM9810) for COVID-19 immunisation and no events were experienced by the patient (at the age of 70-Years-old). The patient did not respond to the vaccine. when they took blood from patient after the vaccine to see if developed antibody to the covid the vaccine has not worked for me at all, losing a bit of weight, patient just had the booster before and get the antibodies test again on 15Aug2021 on 15Aug2021. The patient underwent lab tests and procedures which included antibody test: has less than 1% protection, antinuclear antibody: normal, blood cholesterol: cholesterol was high, blood test: normal, blood thyroid stimulating hormone: normal, blood triglycerides: normal, blood uric acid: normal, creatinine renal clearance: normal, high density lipoprotein: normal, laboratory test: normal, low density lipoprotein: high and vitamin d: normal on an unspecified date. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: High density lipoprotein, Laboratory test, Low density lipoprotein, Off label use, Vitamin D
Clinical narrative: I did not respond to the vaccine. When they took blood from me after the vaccine to see if I have developed antibody to the Covid the vaccine has not worked for me at all; My weight it is I am losing a bit of weight; I just had the booster before I get the antibodies test again; I just had the booster before I get the antibodies test again; This is a spontaneous report from a contactable consumer (patient herself) or other non hcp. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: FD8448), via intramuscular route of administration, administered in Arm Left on 15Aug2021 (at the age of 70-Years-old) as dose 3, single for COVID-19 immunisation. Medical history included crohn's disease, ankylosing spondylitis, fibromyalgia, blood iron, addison's disease, ehlers-danlos syndrome, osteoporosis from unknown start and stop dates and ongoing atrial tachycardia (am having atrial tachycardia, that's brand new). Concomitant medication(s) included abatacept (ORENCIA), prednisone, indometacin (INDOCIN), temazepam and etanercept taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, via unspecified route of administration, administered on 02-Feb-2021 as dose 1, single (Lot Number: EL3248) and dose 2 on 23-Feb-2021 (Lot number: EM9810) for COVID-19 immunisation and no events were experienced by the patient (at the age of 70-Years-old). The patient did not respond to the vaccine. when they took blood from patient after the vaccine to see if developed antibody to the covid the vaccine has not worked for me at all, losing a bit of weight, patient just had the booster before and get the antibodies test again on 15Aug2021 on 15Aug2021. The patient underwent lab tests and procedures which included antibody test: has less than 1% protection, antinuclear antibody: normal, blood cholesterol: cholesterol was high, blood test: normal, blood thyroid stimulating hormone: normal, blood triglycerides: normal, blood uric acid: normal, creatinine renal clearance: normal, high density lipoprotein: normal, laboratory test: normal, low density lipoprotein: high and vitamin d: normal on an unspecified date. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: I did not respond to the vaccine. When they took blood from me after the vaccine to see if I have developed antibody to the Covid the vaccine has not worked for me at all; My weight it is I am losing a bit of weight; I just had the booster before I get the antibodies test again; I just had the booster before I get the antibodies test again; This is a spontaneous report from a contactable consumer (patient herself) or other non hcp. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: FD8448), via intramuscular route of administration, administered in Arm Left on 15Aug2021 (at the age of 70-Years-old) as dose 3, single for COVID-19 immunisation. Medical history included crohn's disease, ankylosing spondylitis, fibromyalgia, blood iron, addison's disease, ehlers-danlos syndrome, osteoporosis from unknown start and stop dates and ongoing atrial tachycardia (am having atrial tachycardia, that's brand new). Concomitant medication(s) included abatacept (ORENCIA), prednisone, indometacin (INDOCIN), temazepam and etanercept taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, via unspecified route of administration, administered on 02-Feb-2021 as dose 1, single (Lot Number: EL3248) and dose 2 on 23-Feb-2021 (Lot number: EM9810) for COVID-19 immunisation and no events were experienced by the patient (at the age of 70-Years-old). The patient did not respond to the vaccine. when they took blood from patient after the vaccine to see if developed antibody to the covid the vaccine has not worked for me at all, losing a bit of weight, patient just had the booster before and get the antibodies test again on 15Aug2021 on 15Aug2021. The patient underwent lab tests and procedures which included antibody test: has less than 1% protection, antinuclear antibody: normal, blood cholesterol: cholesterol was high, blood test: normal, blood thyroid stimulating hormone: normal, blood triglycerides: normal, blood uric acid: normal, creatinine renal clearance: normal, high density lipoprotein: normal, laboratory test: normal, low density lipoprotein: high and vitamin d: normal on an unspecified date. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate
Clinical narrative: heart rate would drop to as low as 30 then bounce up in the 90's; This is a spontaneous report from contactable nurse (Patient). A 56-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: ER 8729), via an unspecified route of administration on 06Apr2021 at 16:00(at the age of 56-years-old) into Arm Left as a single dose for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Scarlet fever age 18, spondylolisthesis s/p fusion (all from an unknown date and unknown if ongoing). The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Apr2021 at 08:15, the patient experienced heart rate would drop to as low as 30 then bounce up in the 90's. It was reported that: "My entire life my heart rate has always been in the 80 s. I did not experience any of the common side effects following either vaccine but about a week after 1st dose, I noticed my heart rate would drop to as low as 30 then bounce up in the 90 s. My galaxy watch has captured multiple events like this daily every day since. This never occurred prior to receiving your vaccine". No treatment given for the event. Seriousness criteria assessed as Disability. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events  arrhythmia and the suspect drug.   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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Lethargy, Muscle fatigue
Clinical narrative: Heart racing often; shortness of breath; lethargic; extreme brain fog; weight gain; muscle fatigue; headaches; body aches; This is a spontaneous report from a contactable consumer(patient) reported that. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 11:00 (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 34 years). The patient past Medical history included known allergies: Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. on 29Apr2021 18:00, the patient experienced Heart racing often, shortness of breath, lethargic, extreme brain fog to the point where I couldn't do my work, weight gain, muscle fatigue, headaches and body aches. The seriousness criteria are disability. The events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received. The event outcome was recovered with sequelae on an unspecified date in 2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Weight increased
Clinical narrative: Heart racing often; shortness of breath; lethargic; extreme brain fog; weight gain; muscle fatigue; headaches; body aches; This is a spontaneous report from a contactable consumer(patient) reported that. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 11:00 (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 34 years). The patient past Medical history included known allergies: Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. on 29Apr2021 18:00, the patient experienced Heart racing often, shortness of breath, lethargic, extreme brain fog to the point where I couldn't do my work, weight gain, muscle fatigue, headaches and body aches. The seriousness criteria are disability. The events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received. The event outcome was recovered with sequelae on an unspecified date in 2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Blood test, COVID-19, Chest pain
Clinical narrative: Heart pain and palpitations; Tachycardia; blurred vision; confusion; dizziness; vomiting; nausea; weakness; loss of appetite; couldn't form a sentence; Heart pain and palpitations; severe headaches; severe head pressure; severe ear pressure; internal tremors; chest pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep 2533, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 43-year-old) as dose 2, single for covid-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: er 2613, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 43-year-old) as dose 1, single for covid-19 immunization. On 12May2021 the patient experienced heart pain and palpitations, tachycardia, blurred vision, confusion, dizziness, vomiting, nausea, weakness, loss of appetite, couldn't form a sentence, heart pain and palpitations, severe headaches, severe head pressure, severe ear pressure, internal tremors, chest pain. The patient was hospitalized for 2 days. On an unspecified date the patient underwent lab tests and procedures which included blood test: unknown result, computerized tomogram: unknown result, covid-19: unknown result. The patient was received treatment for the resulted events. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The clinical outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Confusional state, Decreased appetite, Dizziness, Ear discomfort
Clinical narrative: Heart pain and palpitations; Tachycardia; blurred vision; confusion; dizziness; vomiting; nausea; weakness; loss of appetite; couldn't form a sentence; Heart pain and palpitations; severe headaches; severe head pressure; severe ear pressure; internal tremors; chest pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep 2533, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 43-year-old) as dose 2, single for covid-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: er 2613, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 43-year-old) as dose 1, single for covid-19 immunization. On 12May2021 the patient experienced heart pain and palpitations, tachycardia, blurred vision, confusion, dizziness, vomiting, nausea, weakness, loss of appetite, couldn't form a sentence, heart pain and palpitations, severe headaches, severe head pressure, severe ear pressure, internal tremors, chest pain. The patient was hospitalized for 2 days. On an unspecified date the patient underwent lab tests and procedures which included blood test: unknown result, computerized tomogram: unknown result, covid-19: unknown result. The patient was received treatment for the resulted events. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The clinical outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Nausea, Palpitations, Speech disorder
Clinical narrative: Heart pain and palpitations; Tachycardia; blurred vision; confusion; dizziness; vomiting; nausea; weakness; loss of appetite; couldn't form a sentence; Heart pain and palpitations; severe headaches; severe head pressure; severe ear pressure; internal tremors; chest pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep 2533, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 43-year-old) as dose 2, single for covid-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: er 2613, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 43-year-old) as dose 1, single for covid-19 immunization. On 12May2021 the patient experienced heart pain and palpitations, tachycardia, blurred vision, confusion, dizziness, vomiting, nausea, weakness, loss of appetite, couldn't form a sentence, heart pain and palpitations, severe headaches, severe head pressure, severe ear pressure, internal tremors, chest pain. The patient was hospitalized for 2 days. On an unspecified date the patient underwent lab tests and procedures which included blood test: unknown result, computerized tomogram: unknown result, covid-19: unknown result. The patient was received treatment for the resulted events. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The clinical outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor, Vision blurred, Vomiting
Clinical narrative: Heart pain and palpitations; Tachycardia; blurred vision; confusion; dizziness; vomiting; nausea; weakness; loss of appetite; couldn't form a sentence; Heart pain and palpitations; severe headaches; severe head pressure; severe ear pressure; internal tremors; chest pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep 2533, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 43-year-old) as dose 2, single for covid-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: er 2613, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 43-year-old) as dose 1, single for covid-19 immunization. On 12May2021 the patient experienced heart pain and palpitations, tachycardia, blurred vision, confusion, dizziness, vomiting, nausea, weakness, loss of appetite, couldn't form a sentence, heart pain and palpitations, severe headaches, severe head pressure, severe ear pressure, internal tremors, chest pain. The patient was hospitalized for 2 days. On an unspecified date the patient underwent lab tests and procedures which included blood test: unknown result, computerized tomogram: unknown result, covid-19: unknown result. The patient was received treatment for the resulted events. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The clinical outcome of events was not recovered.  Information on the Lot/batch number has been requested.