chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm rupture, Herpes zoster, Investigation, Shock haemorrhagic
Clinical narrative: Passed away/Hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm; Passed away/Hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm; Shingles; This is a spontaneous report received from a contactable consumer or other non hcp (patient's child). A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8731) via an unspecified route of administration in arm (arm shoulder) on 18Apr2021 (age at vaccination 67years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the test (before vaccination) where they put dye in the bloodstream and where they check for any "insularism" (presented as reported until clarified) or anything he had that process done, may be in March (result: not reported). There was no other prior vaccination. On 20Apr2021, the patient had shingles. He broke out to shingles 2 days after receiving the Pfizer Covid-19 vaccine, reported the shingles broke out. The patient went to the Doctor and they gave him some medicine (unspecified medication) for his pain (onset date: 2021). Therapeutic measures were taken as a result of shingles. In May2021 (one month to the date he got his vaccine exactly), the patient went into the hospital (as per death record but the patient told reporter that 2 days after getting the vaccine, he broke out shingles and when he called, they gave him a confirmation). The patient had hemorrhagic shock acute blood loss ruptured abdominal aortic aneurysm on an unspecified date and patient passed away (as per death record). The reporter stated that patient had passed away and reporter believed it was due to the Pfizer BioNTech Covid-19 Vaccine. The clinical outcome of the events shingles was unknown. The patient died on 20May2021. Autopsy was performed with results not reported.   Follow-Up 07Jul2021: Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: hemorrhagic shock acute blood loss; Acute blood loss ruptured abdominal aortic aneurysm
Sex: F
Vaccine: COVID19
Symptoms: Illness, Joint range of motion decreased, Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: Her arm had swollen; Her lymph node underneath her arm are swollen; she can hardly move her arm; She is in lot of pain; sick at home; This is a spontaneous report from a non-contactable consumer or other non hcp (patient's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. Medical history patient had Covid back in January. The patient's concomitant medications were not reported. On an unspecified date after receiving the vaccination the patient experienced her arm had swollen, lymph node underneath her arm were swollen and she could hardly move her arm. She was in lot of pain, and sick at home. The patient mother enquired if they could get same reaction post second dose or not. The reported seriousness was unspecified. The outcome of the events was unknown.  Information on the lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: One week later he had a multiple sclerosis exacerbation/He had another MS exacerbation; This is a spontaneous report from a contactable consumer (Parent). This consumer reported for a male patient of unknown age (reporter's Son) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on Mar-2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. One week later after first dose, on an unspecified date, he had a multiple sclerosis exacerbation. He saw doctor who sent him for prednisone by IV for 5 days. He received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date a month later as dose 2, single for COVID-19 immunization and patient had another MS exacerbation and was treated again. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema nodosum, SARS-CoV-2 test
Clinical narrative: Erythema Nodosum on lower legs; This is a spontaneous report from a contactable other hcp (patient). A 16-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration in left arm on 27Mar2021 at 08:00 (age at vaccination 16-year-old) as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration in left arm on 17Apr2021 at 08:00 (age at vaccination 16-year-old) as dose 2, single for Covid-19 immunization at hospital. Patients relevant medical history was none. Patient did not have any known allergies. Patients concomitant medications included doxycycline and muslin birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Mar2021, patient took Varicella vaccine as dose 1 in left arm for immunization. On 12Apr2021, at 20:00 patient experienced Erythema Nodosum on lower legs. Adverse event resulted into doctor or other healthcare professional office/clinic visit. Patient received treatment of elevating legs for adverse event. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid Covid test (sars-cov-2 test, Nasal Swab): negative on 06May2021. The outcome of event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event erythema nodosum cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Breast cyst, Cyst, Fatigue, Joint swelling
Clinical narrative: Fatigue through out this time period which is going on 5 months; All lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks.; Then right shoulder pain began; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration in right arm on 16Feb2021 (Lot number: EM9810) (at the age of 67-year-old) as single dose for Covid-19 immunization. Facility type vaccine/Facility where the most recent COVID-19 vaccine was administered: Hospital. Other medical history was none. No known allergies reported. Covid was not tested prior or post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin (LIPITOR), paroxetine hydrochloride (PAXIL CR), zinc, colecalciferol (D3), cyanocobalamin (B12-VITAMIIN) and ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer, Lot number: EL9261) administered in right arm on 26Jan2021 11:00 AM (at the age of 67-year-old) for Covid-19 immunization and no reaction was reported. On 19Feb2021, all lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks. Then right shoulder pain began. Had clavicle swollen joints and "cists" develop in underarm, breast and shoulder. Fatigue throughout the time period which was going on 5 months. All occurred after the second vaccine on 16Feb2021. Privacy policy consent: Yes. Device timestamp/Device date: 05Jul2021. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received an unknown treatment in response to the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Fatigue through out this time period which is going on 5 months; All lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks.; Then right shoulder pain began; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration in right arm on 16Feb2021 (Lot number: EM9810) (at the age of 67-year-old) as single dose for Covid-19 immunization. Facility type vaccine/Facility where the most recent COVID-19 vaccine was administered: Hospital. Other medical history was none. No known allergies reported. Covid was not tested prior or post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin (LIPITOR), paroxetine hydrochloride (PAXIL CR), zinc, colecalciferol (D3), cyanocobalamin (B12-VITAMIIN) and ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer, Lot number: EL9261) administered in right arm on 26Jan2021 11:00 AM (at the age of 67-year-old) for Covid-19 immunization and no reaction was reported. On 19Feb2021, all lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks. Then right shoulder pain began. Had clavicle swollen joints and "cists" develop in underarm, breast and shoulder. Fatigue throughout the time period which was going on 5 months. All occurred after the second vaccine on 16Feb2021. Privacy policy consent: Yes. Device timestamp/Device date: 05Jul2021. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received an unknown treatment in response to the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Lymph node pain, Malaise, Pain, Tendon pain
Clinical narrative: Fatigue through out this time period which is going on 5 months; All lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks.; Then right shoulder pain began; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration in right arm on 16Feb2021 (Lot number: EM9810) (at the age of 67-year-old) as single dose for Covid-19 immunization. Facility type vaccine/Facility where the most recent COVID-19 vaccine was administered: Hospital. Other medical history was none. No known allergies reported. Covid was not tested prior or post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin (LIPITOR), paroxetine hydrochloride (PAXIL CR), zinc, colecalciferol (D3), cyanocobalamin (B12-VITAMIIN) and ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer, Lot number: EL9261) administered in right arm on 26Jan2021 11:00 AM (at the age of 67-year-old) for Covid-19 immunization and no reaction was reported. On 19Feb2021, all lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks. Then right shoulder pain began. Had clavicle swollen joints and "cists" develop in underarm, breast and shoulder. Fatigue throughout the time period which was going on 5 months. All occurred after the second vaccine on 16Feb2021. Privacy policy consent: Yes. Device timestamp/Device date: 05Jul2021. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received an unknown treatment in response to the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Fatigue through out this time period which is going on 5 months; All lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks.; Then right shoulder pain began; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; Have clavical swollen joints and "cists" develop in underarm, breast and shoulder.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (Solution for injection) via an unspecified route of administration in right arm on 16Feb2021 (Lot number: EM9810) (at the age of 67-year-old) as single dose for Covid-19 immunization. Facility type vaccine/Facility where the most recent COVID-19 vaccine was administered: Hospital. Other medical history was none. No known allergies reported. Covid was not tested prior or post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin (LIPITOR), paroxetine hydrochloride (PAXIL CR), zinc, colecalciferol (D3), cyanocobalamin (B12-VITAMIIN) and ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (COVID 19, Pfizer, Lot number: EL9261) administered in right arm on 26Jan2021 11:00 AM (at the age of 67-year-old) for Covid-19 immunization and no reaction was reported. On 19Feb2021, all lymph nodes hurt both sides in chest, chin, neck, underarms for 6-8 weeks. Then right shoulder pain began. Had clavicle swollen joints and "cists" develop in underarm, breast and shoulder. Fatigue throughout the time period which was going on 5 months. All occurred after the second vaccine on 16Feb2021. Privacy policy consent: Yes. Device timestamp/Device date: 05Jul2021. Events resulted in doctor or other healthcare professional office/clinic visit. The patient received an unknown treatment in response to the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Gland swelling next to her neck; Swelling close to she had the vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated, "My niece (patient) got Pfizer Covid vaccine after the first dose and she was complaining about her Gland swelling next to her neck and swelling close to she had the vaccine. She had already swollen and then after she had second dose vaccination she wondering if someone have report that as a side effect, she didn't have it before the vaccine." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Illness, Nausea, Vertigo
Clinical narrative: getting very ill. and vertigo; I started getting very ill. and vertigo; I started feeling a little odd; throwing up; very dizzy and nauseous; very dizzy and nauseous; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0217 and Expiration date: Sep2021) via an unspecified route of administration on 25Jun2021 as a single dose for COVID-19 immunization. A patients medical history and concomitant medications were not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on an unspecified route of administration and an unspecified date as dose 1, single, for COVID-19 immunization and experienced arm hurts. Consumer don't know if this was the side effect, but consumer was sick for about a week. Consumer got the second shot on 25Jun2021 on Friday morning, that Sunday on 27Jun2021, consumer started feeling a little odd but, in the morning, consumer was throwing up, consumer could not hold water down and that lasted for about day and a half and since then on an unspecified date in Jun2021, consumer had been very dizzy and nauseous, it was finally starting to go away. Consumer had not been able to go doctor yet because Consumers car broke down and it has been like about a week. Consumer stated, it was only after the 1st shot, the only thing was that my consumers hurts more than like a normal shot, Consumer did not have any fever or anything but second shot it was consumer did not feel as bad but then few days later on an unspecified date, consumer started getting very ill and vertigo. The outcome of event I started feeling a little odd and I started getting very ill and vertigo was unknown. The outcome of event throwing up was recovered on an unspecified date in Jun2021. The outcome of event very dizzy and nauseous was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: getting very ill. and vertigo; I started getting very ill. and vertigo; I started feeling a little odd; throwing up; very dizzy and nauseous; very dizzy and nauseous; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0217 and Expiration date: Sep2021) via an unspecified route of administration on 25Jun2021 as a single dose for COVID-19 immunization. A patients medical history and concomitant medications were not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on an unspecified route of administration and an unspecified date as dose 1, single, for COVID-19 immunization and experienced arm hurts. Consumer don't know if this was the side effect, but consumer was sick for about a week. Consumer got the second shot on 25Jun2021 on Friday morning, that Sunday on 27Jun2021, consumer started feeling a little odd but, in the morning, consumer was throwing up, consumer could not hold water down and that lasted for about day and a half and since then on an unspecified date in Jun2021, consumer had been very dizzy and nauseous, it was finally starting to go away. Consumer had not been able to go doctor yet because Consumers car broke down and it has been like about a week. Consumer stated, it was only after the 1st shot, the only thing was that my consumers hurts more than like a normal shot, Consumer did not have any fever or anything but second shot it was consumer did not feel as bad but then few days later on an unspecified date, consumer started getting very ill and vertigo. The outcome of event I started feeling a little odd and I started getting very ill and vertigo was unknown. The outcome of event throwing up was recovered on an unspecified date in Jun2021. The outcome of event very dizzy and nauseous was recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurts more than like a normal shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm hurts more than like a normal shot. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Myalgia, Paraesthesia, Vaccination site hypoaesthesia
Clinical narrative: Having muscle and I would say joint pain; Having muscle and I would say joint pain; Numbness continue in my right arm where I received the vaccine; Tingling in my upper arm and it still continues; They are still there and actually worsening; I started feeling the pain and the numbness and tingling in my upper arm; This is a spontaneous report from a contactable consumer (patient reported for himself). A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0164), via intramuscular route of administration, administered in deltoid right (right shoulder) on 22Apr2021 at 12:30 PM (at the age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included disability (patient stated, well I am on disability. I am disabled). The patient's concomitant medications were not reported. the patient did not receive any other vaccine 4 weeks prior to COVID shot. The patient previously took gabapentin and neurontin, both drugs for disability; first dose of bnt162b2 for COVID-19 immunization. The patient experienced having muscle and I would say joint pain, numbness continue in my right arm where I received the vaccine, I started feeling the pain and the numbness and tingling in my upper arm was reported as worsened, they are still there and actually worsening on an unspecified date in 2021. Patient stated, I was calling because I received the vaccine in May and I am still having muscle and I would say joint pain and numbness continue in my right arm where I received the vaccine. I am calling, its about 2 months 3 months now should those effects be feeling. When probed whether these adverse events took place after the first Pfizer COVID shot or Second. Patient stated, Second. When probed for the exact date for the onset of adverse events, Patient stated, Well I had the second dose on 22Apr2021. I would say two weeks later I started feeling. The day I had the injection I felt it. It was two days then it kind of went away but then like almost I would say 7 days later I started feeling the pain and the numbness and tingling in my upper arm and it still continues. Date and time for second COVID shot: Patient stated, 22Apr2021 (22Apri2021). I would say 12:30 pm. Patient stated, they are still there and actually worsening. I feel like its worsening because its happening more. (confirmed as worsening). The patient did not receive any treatment for the events. Outcome of the events was not recovered.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Having muscle and I would say joint pain; Having muscle and I would say joint pain; Numbness continue in my right arm where I received the vaccine; Tingling in my upper arm and it still continues; They are still there and actually worsening; I started feeling the pain and the numbness and tingling in my upper arm; This is a spontaneous report from a contactable consumer (patient reported for himself). A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0164), via intramuscular route of administration, administered in deltoid right (right shoulder) on 22Apr2021 at 12:30 PM (at the age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included disability (patient stated, well I am on disability. I am disabled). The patient's concomitant medications were not reported. the patient did not receive any other vaccine 4 weeks prior to COVID shot. The patient previously took gabapentin and neurontin, both drugs for disability; first dose of bnt162b2 for COVID-19 immunization. The patient experienced having muscle and I would say joint pain, numbness continue in my right arm where I received the vaccine, I started feeling the pain and the numbness and tingling in my upper arm was reported as worsened, they are still there and actually worsening on an unspecified date in 2021. Patient stated, I was calling because I received the vaccine in May and I am still having muscle and I would say joint pain and numbness continue in my right arm where I received the vaccine. I am calling, its about 2 months 3 months now should those effects be feeling. When probed whether these adverse events took place after the first Pfizer COVID shot or Second. Patient stated, Second. When probed for the exact date for the onset of adverse events, Patient stated, Well I had the second dose on 22Apr2021. I would say two weeks later I started feeling. The day I had the injection I felt it. It was two days then it kind of went away but then like almost I would say 7 days later I started feeling the pain and the numbness and tingling in my upper arm and it still continues. Date and time for second COVID shot: Patient stated, 22Apr2021 (22Apri2021). I would say 12:30 pm. Patient stated, they are still there and actually worsening. I feel like its worsening because its happening more. (confirmed as worsening). The patient did not receive any treatment for the events. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Emotional disorder, Headache
Clinical narrative: Horrible chemical smell started about 3 days after my 2nd shot; It is ongoing and is driving me crazy; Nothing tastes or smells as it should.; Nothing tastes or smells as it should; I've also had headaches which is not normal for me at all.; had a normal reaction the day after each shot - fever, chills, headache; had a normal reaction the day after each shot - fever, chills, headache; This is a spontaneous report from a contactable consumer (patient). An elderly non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19May2021 as dose 2, single; and the patient previously received first dose of bnt162b2 (Lot Number: EW0164), via an unspecified route of administration, administered in right arm on 26Apr2021 as dose 1, single; both for COVID-19 immunisation in pharmacy or drug store. Prior to vaccination, patient did not receive any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for covid. Medical history included known allergy to Penicillin, and patient was diagnosed with COVID-19 in Nov2020. The patient's concomitant medications were not reported. It was reported patient experienced a normal reaction the day after each shot - fever, chills, headache. On 20May2021, the day after second vaccination patient experienced headaches which was not normal for her at all, and had a normal reaction of fever and chills.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Horrible chemical smell started about 3 days after my 2nd shot; It is ongoing and is driving me crazy; Nothing tastes or smells as it should.; Nothing tastes or smells as it should; I've also had headaches which is not normal for me at all.; had a normal reaction the day after each shot - fever, chills, headache; had a normal reaction the day after each shot - fever, chills, headache; This is a spontaneous report from a contactable consumer (patient). An elderly non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19May2021 as dose 2, single; and the patient previously received first dose of bnt162b2 (Lot Number: EW0164), via an unspecified route of administration, administered in right arm on 26Apr2021 as dose 1, single; both for COVID-19 immunisation in pharmacy or drug store. Prior to vaccination, patient did not receive any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for covid. Medical history included known allergy to Penicillin, and patient was diagnosed with COVID-19 in Nov2020. The patient's concomitant medications were not reported. It was reported patient experienced a normal reaction the day after each shot - fever, chills, headache. On 20May2021, the day after second vaccination patient experienced headaches which was not normal for her at all, and had a normal reaction of fever and chills.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: Diagnosed with Paroxysmal supraventricular tachycardia; This is a spontaneous report from a contactable consumer (patient) communicated to Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on unspecified date as dose number unknown single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that after use of product patient was diagnosed with paroxysmal supraventricular tachycardia on unknown date. The outcome of event was unknown.   Information about lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 62-year-old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 62-year-old) as single dose for Covid-19 immunization. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. On an unspecified date in Apr2021, the reporter stated that the patient experienced sore sensations in his joints after dose 2 of the Pfizer Covid 19 vaccine. The event assessed as serious (medically significant). The reporter stated the event result Doctor or other healthcare professional office/clinic visit. It was unknown if patient receive any treatment for the event. Outcome of the event was not recovered.  Information about lot/batch number requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation, Pain
Clinical narrative: For 3 months it was very painful to bend down, reach up, lean forward, sit, lay on my side or stomach, and carry anything over a couple of pounds.; It got worse right after her second vaccine; At that 3 month point I went back to my doctor and got a steriod injection, but it did not help the inflammation.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261, 38-years-old at the time of vaccination), via an unspecified route of administration, administered in arm right on 05Mar2021 at 11:45, as single dose for covid-19 immunization. Medical history included endometriosis, polysystic ovarian syndrome, irritable bowel syndrome (IBS) and wheat intolerance. 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. No known allergies. Concomitant medications included fish oil; colecalciferol (VITAMIN D); fluoxetine hydrochloride (PROZAC); acetylsalicylic acid, caffeine, salicylamide (BC) and multivitamins. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261, 38-years-old at the time of vaccination), via an unspecified route of administration, administered in arm left on 10Feb2021 at 11:45, as single dose for covid-19 immunization. It was reported that she developed costochondritis two weeks after her first vaccine. It was hard to breathe, and she was in intense pain. She was a teacher and would lay on her classroom floor during her plan time because the pain was so bad. On an unknown date it got worse right after her second vaccine. A week after her second dose, doctor started her on a steroid pack, and at that point she was able to breathe better. For 3 months it was very painful to bend down, reach up, lean forward, sit, lay on my side, or stomach, and carry anything over a couple of pounds. At that 3 month point she went back to her doctor and got a steriod injection, but it did not help the inflammation. The next week she did start taking 500 mg of curcumin twice a day, and that has helped decrease her pain level. Now (5 months after the vaccine) she was able to do more physical tasks, but still couldn't do things like carry a basket of laundry without being in pain for hours afterward. For the past 6 weeks she had been off work, and rest has also helped her heal. Adverse events resulted in doctor or other healthcare professional office/clinic visit. As treatment patient underwent X-ray and received steroid pack, steroid injection. Outcome of the events was resolving.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report from a contactable consumer from a lay media report reporting events for 3 patients. This is patient 3 of 3. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. Medical history included bone cancer. The patient's concomitant medications were not reported. On an unspecified date the patient experienced swollen lymph nodes. The outcome of event was unknown. The patient underwent lab tests and procedures which included chest CT scan performed : swollen lymph nodes in one armpit on an unspecified date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021845045 Same article / same event / different patient;US-PFIZER INC-2021845051 Same article / same event / different patient
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood magnesium, Blood magnesium decreased, Diarrhoea, Dyspepsia
Clinical narrative: I loss 7 pounds due to my diarrhea; my food is not digested everything I eat is not digested; Diarrhea; Magnesium low; my heart skip beat like it was skipping one beat skip; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 66-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 66-year-old). Medical history included diabetes mellitus from an unknown date, and blood pressure high from an unknown date. Concomitant medications included metformin (METFORMIN) 1000 mg twice a day taken for diabetes mellitus, from an unknown start date; and lisinopril (LISINOPRIL) 10mg taken for hypertension, from an unknown start date. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:00, as DOSE 1, SINGLE for covid-19 immunization (at the age of 66-year-old).   On 15Apr2021, the patient experienced diarrhea like for two weeks, 2-3 times a day and then patient started on probiotic (Further clarification unknown), then patient was ok for like 4 weeks and now patient was having diarrhea everyday once or twice. And that caused patient's magnesium to go down, it was also reported he experienced heart skip beat like it was skipping one beat skip, skip and patient ended up in emergency, but patient's magnesium was low because of diarrhea they did stool test everything came back negative, DNA stool test the other test. The patient reported that he lost 7pounds of weight due to the diarrhea during the 3 months prior to this report (last 3months). The patient had lab test on an unknown date which included blood cholesterol results were less than 139, blood magnesium was low, full blood count results unknown, A1C (glycosylated haemoglobin) was 6.9, Stool analysis was also negative, patient had weight loss in 3months. On an unknown date, the patient also experienced that food was not digested every-thing he eat was not digested. The patient had to take therapeutic measures and the patient was on probiotic but it was not helping. The outcome of the events was unknown.   Follow-up attempts were completed. No further information was expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extrasystoles, Full blood count, Glycosylated haemoglobin, Stool analysis, Weight
Clinical narrative: I loss 7 pounds due to my diarrhea; my food is not digested everything I eat is not digested; Diarrhea; Magnesium low; my heart skip beat like it was skipping one beat skip; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 66-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 66-year-old). Medical history included diabetes mellitus from an unknown date, and blood pressure high from an unknown date. Concomitant medications included metformin (METFORMIN) 1000 mg twice a day taken for diabetes mellitus, from an unknown start date; and lisinopril (LISINOPRIL) 10mg taken for hypertension, from an unknown start date. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:00, as DOSE 1, SINGLE for covid-19 immunization (at the age of 66-year-old).   On 15Apr2021, the patient experienced diarrhea like for two weeks, 2-3 times a day and then patient started on probiotic (Further clarification unknown), then patient was ok for like 4 weeks and now patient was having diarrhea everyday once or twice. And that caused patient's magnesium to go down, it was also reported he experienced heart skip beat like it was skipping one beat skip, skip and patient ended up in emergency, but patient's magnesium was low because of diarrhea they did stool test everything came back negative, DNA stool test the other test. The patient reported that he lost 7pounds of weight due to the diarrhea during the 3 months prior to this report (last 3months). The patient had lab test on an unknown date which included blood cholesterol results were less than 139, blood magnesium was low, full blood count results unknown, A1C (glycosylated haemoglobin) was 6.9, Stool analysis was also negative, patient had weight loss in 3months. On an unknown date, the patient also experienced that food was not digested every-thing he eat was not digested. The patient had to take therapeutic measures and the patient was on probiotic but it was not helping. The outcome of the events was unknown.   Follow-up attempts were completed. No further information was expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: I loss 7 pounds due to my diarrhea; my food is not digested everything I eat is not digested; Diarrhea; Magnesium low; my heart skip beat like it was skipping one beat skip; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 66-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 66-year-old). Medical history included diabetes mellitus from an unknown date, and blood pressure high from an unknown date. Concomitant medications included metformin (METFORMIN) 1000 mg twice a day taken for diabetes mellitus, from an unknown start date; and lisinopril (LISINOPRIL) 10mg taken for hypertension, from an unknown start date. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:00, as DOSE 1, SINGLE for covid-19 immunization (at the age of 66-year-old).   On 15Apr2021, the patient experienced diarrhea like for two weeks, 2-3 times a day and then patient started on probiotic (Further clarification unknown), then patient was ok for like 4 weeks and now patient was having diarrhea everyday once or twice. And that caused patient's magnesium to go down, it was also reported he experienced heart skip beat like it was skipping one beat skip, skip and patient ended up in emergency, but patient's magnesium was low because of diarrhea they did stool test everything came back negative, DNA stool test the other test. The patient reported that he lost 7pounds of weight due to the diarrhea during the 3 months prior to this report (last 3months). The patient had lab test on an unknown date which included blood cholesterol results were less than 139, blood magnesium was low, full blood count results unknown, A1C (glycosylated haemoglobin) was 6.9, Stool analysis was also negative, patient had weight loss in 3months. On an unknown date, the patient also experienced that food was not digested every-thing he eat was not digested. The patient had to take therapeutic measures and the patient was on probiotic but it was not helping. The outcome of the events was unknown.   Follow-up attempts were completed. No further information was expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Diarrhoea, Stool analysis
Clinical narrative: I loss 7 pounds due to my diarrhea; my food is not digested everything I eat is not digested; Diarrhea; Magnesium low; my heart skip beat like it was skipping one beat skip; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 66-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 66-year-old). Medical history included diabetes mellitus from an unknown date, and blood pressure high from an unknown date. Concomitant medications included metformin (METFORMIN) 1000 mg twice a day taken for diabetes mellitus, from an unknown start date; and lisinopril (LISINOPRIL) 10mg taken for hypertension, from an unknown start date. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:00, as DOSE 1, SINGLE for covid-19 immunization (at the age of 66-year-old).   On 15Apr2021, the patient experienced diarrhea like for two weeks, 2-3 times a day and then patient started on probiotic (Further clarification unknown), then patient was ok for like 4 weeks and now patient was having diarrhea everyday once or twice. And that caused patient's magnesium to go down, it was also reported he experienced heart skip beat like it was skipping one beat skip, skip and patient ended up in emergency, but patient's magnesium was low because of diarrhea they did stool test everything came back negative, DNA stool test the other test. The patient reported that he lost 7pounds of weight due to the diarrhea during the 3 months prior to this report (last 3months). The patient had lab test on an unknown date which included blood cholesterol results were less than 139, blood magnesium was low, full blood count results unknown, A1C (glycosylated haemoglobin) was 6.9, Stool analysis was also negative, patient had weight loss in 3months. On an unknown date, the patient also experienced that food was not digested every-thing he eat was not digested. The patient had to take therapeutic measures and the patient was on probiotic but it was not helping. The outcome of the events was unknown.   Follow-up attempts were completed. No further information was expected.