chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Pollakiuria
Clinical narrative: Have to pee constantly.; Pain and burning while urinating; This is spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0178 and expiration date not provided), via an unspecified route of administration, in arm left, on 26May2021 18:15  (at the age of 51-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were "none". Patient was not diagnosed with COVID-19 prior to vaccination. Patient had no known allergies, no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 27May2021, the patient had to pee constantly, and had pain and burning while urinating. The adverse event result in doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of events and included treatment with antibiotics. The outcome of the events was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Haemorrhagic stroke, Headache, Nausea, Vomiting
Clinical narrative: Hemorrhagic stroke/bleeding in his brain; He was feeling nauseous and had a very bad headache; He was feeling nauseous and had a very bad headache; Vomitting; This is a spontaneous report from a contactable consumer.  A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension. Concomitant medication included unspecified blood pressure medications. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Apr2021 (Batch/lot number: EW0161) as COVID-19 immunization. Then, the 2nd dose on 06May2021. On that same day of 06May2021, he was feeling nauseous and had a very bad headache. He brushed it off as a side effect of the vaccine because that was listed as a common side effect of the vaccine on the CDC website. So, he did not seek medical attention for 5 days. It was later reported that the he suffered a hemorrhagic stroke that day after the COVID-19 vaccine administration. The patient was in the ICU after waiting 5 days to seek medical attention because the supposed to cause headaches, nausea and vomiting. But the nausea and vomiting was from his stroke, not from the normal side effect of the vaccine. They were suspecting that the bleeding in his brain started on the 07May2021. The patient had bunch of blood work (unknown results) done since the past two weeks. Outcome of the events were unknown
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cerebral disorder, Confusional state, Fatigue, Lethargy
Clinical narrative: Episodes of confusion and loss of thought continue, with no seeming trigger.; Episodes of confusion and loss of thought continue, with no seeming trigger.; Exhaustion; Extreme lethargy and loss of brain function. Barely functioned for 24hr.; Extreme lethargy and loss of brain function. Barely functioned for 24hr.; Week after shot were days where different joints would ache, very old injuries were brought back; This is a spontaneous report from a contactable consumer (patient). A 70 years old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Mar2021 19:30 (Lot Number: ER2613) at age of 70 years old as 2nd dose, single for covid-19 immunisation.  Medical history included possible lactose intolerance developing.   The patient previously took the first dose bnt162b2 on 01Mar2021 for covid-19 immunization at age of 70 years old and took Flu vaccine for Immunization.  The patient's concomitant medications were not reported.  No trauma at injection site, no different than annual flu vaccine. Symptoms noticed after second injection next morning on 24Mar2021 07:15. Extreme lethargy and loss of brain function. Barely functioned for 24hr. Week after shot were days where different joints would ache, very old injuries were brought back in Mar2021. To date there are sudden bouts of lethargy or exhaustion. Episodes of confusion and loss of thought continue, with no seeming trigger. Talked with Doctor and was told to monitor conditions. Take ibuprofen as needed. No treatment received for events.  The outcome of event Episodes of confusion and loss of thought continue was not recovered; outcome of other events was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: Episodes of confusion and loss of thought continue, with no seeming trigger.; Episodes of confusion and loss of thought continue, with no seeming trigger.; Exhaustion; Extreme lethargy and loss of brain function. Barely functioned for 24hr.; Extreme lethargy and loss of brain function. Barely functioned for 24hr.; Week after shot were days where different joints would ache, very old injuries were brought back; This is a spontaneous report from a contactable consumer (patient). A 70 years old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Mar2021 19:30 (Lot Number: ER2613) at age of 70 years old as 2nd dose, single for covid-19 immunisation.  Medical history included possible lactose intolerance developing.   The patient previously took the first dose bnt162b2 on 01Mar2021 for covid-19 immunization at age of 70 years old and took Flu vaccine for Immunization.  The patient's concomitant medications were not reported.  No trauma at injection site, no different than annual flu vaccine. Symptoms noticed after second injection next morning on 24Mar2021 07:15. Extreme lethargy and loss of brain function. Barely functioned for 24hr. Week after shot were days where different joints would ache, very old injuries were brought back in Mar2021. To date there are sudden bouts of lethargy or exhaustion. Episodes of confusion and loss of thought continue, with no seeming trigger. Talked with Doctor and was told to monitor conditions. Take ibuprofen as needed. No treatment received for events.  The outcome of event Episodes of confusion and loss of thought continue was not recovered; outcome of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chills, Dyspnoea, Gait disturbance, Somnolence
Clinical narrative: congestive heart failure; Could not walk more; Short of breath/cannot breathe good; Chills; sleeping all day; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27May2021 (lot number was not reported), as 2nd dose, single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the second COVID-19 shot on 27May2021 (Thursday). On 28May2021 (Friday), the patient started getting the side effects. The patient wanted to go to the store and tried to walk there. The patient could not walk more and did not know quarter of the block, so the patient took a cab there. The patient was short of breath. It was reported that the patient has congestive heart failure (onset date not reported) and has been sleeping all day. The patient experienced chills but did not have fever, diarrhea, aches and pains. The patient tried to go to sleep but could not breathe good. The patient asked if the shortness of breath is a serious side effect from the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling drunk, Headache
Clinical narrative: Dry sick; Felt drunk out of my mind; Felt like had pneumonia or the flu; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell for about five days; Diarrhea; Vomiting; Arm pain; Felt like had pneumonia or the flu; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26May2021 10:30 (at 27-year-old) (Batch/Lot Number: EW0171) as 1st dose, single in arm left for COVID-19 immunisation. It's unknown if the patient was pregnant. The patient's medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. On 26May2021, injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell existed for about five days; and diarrhea, vomiting, arm pain occurred. It's felt like had pneumonia or the flu. Side effects hit her later that night about 9pm and she felt drunk out of her mind by 10:30 pm dry sick. No treatment received for the events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Malaise, Myalgia, Nausea
Clinical narrative: Dry sick; Felt drunk out of my mind; Felt like had pneumonia or the flu; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell for about five days; Diarrhea; Vomiting; Arm pain; Felt like had pneumonia or the flu; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26May2021 10:30 (at 27-year-old) (Batch/Lot Number: EW0171) as 1st dose, single in arm left for COVID-19 immunisation. It's unknown if the patient was pregnant. The patient's medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. On 26May2021, injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell existed for about five days; and diarrhea, vomiting, arm pain occurred. It's felt like had pneumonia or the flu. Side effects hit her later that night about 9pm and she felt drunk out of her mind by 10:30 pm dry sick. No treatment received for the events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pneumonia, Vaccination site pain, Vomiting
Clinical narrative: Dry sick; Felt drunk out of my mind; Felt like had pneumonia or the flu; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell for about five days; Diarrhea; Vomiting; Arm pain; Felt like had pneumonia or the flu; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26May2021 10:30 (at 27-year-old) (Batch/Lot Number: EW0171) as 1st dose, single in arm left for COVID-19 immunisation. It's unknown if the patient was pregnant. The patient's medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. On 26May2021, injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell existed for about five days; and diarrhea, vomiting, arm pain occurred. It's felt like had pneumonia or the flu. Side effects hit her later that night about 9pm and she felt drunk out of her mind by 10:30 pm dry sick. No treatment received for the events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Loss of consciousness
Clinical narrative: My son had sharp chest pain, difficulty breathing & lost consciousness briefly.; My son had sharp chest pain, difficulty breathing & lost consciousness briefly.; My son had sharp chest pain, difficulty breathing & lost consciousness briefly.; This is a spontaneous report from contactable consumer (parent). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20May2021 13:30 (Lot Number: EW0179, at age of 13 years old) as single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); montelukast sodium (SINGULAIR). The patient previously took azithromycin and experienced allergy. The patient experienced had sharp chest pain, difficulty breathing & lost consciousness briefly on 23May2021 11:30. The event result in Doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient received treatment for events and visit pediatrician & EKG. Had been referred to a cardiologist. The outcome of events was recovered in May2021.  Further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Condition aggravated, Feeling abnormal
Clinical narrative: It definitely triggered my AutoImmune Disease (Hashimotos).; it can trigger Auto-Immune disease flare-ups; brain fog; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in arm left on 29May2021 15:00 (Lot Number: EW0168) at 45-year-old as single dose covid-19 immunisation. Medical history included Hashimotos from an unknown date. The patient concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient previously took atropine and experienced drug allergy. The patient historical vaccine included bnt162b2 dose 1 via an unspecified route of administration, administered in Arm Left on May2021 (Lot Number: EW0167) at age of 45-year-old as single dose for covid-19 immunisation. It definitely triggered AutoImmune Disease (Hashimotos). Within 24 hours the patient was extremely cold; especially extremities and unable to get warm. Neck swelled, and had brain fog for 24 hours. The patient was familiar with these symptoms from before she had them under control. She never had fever/chills; she took my temperature often. None of this was life-threatening or serious by any means; the patient was only reporting to have a record that it can trigger Auto-Immune disease flare-ups. The patient did not experience any of the other "typical' vaccine symptoms. The Adverse Event started from 30May2021, 12:00 PM. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Recovered on 31May2021 12:00.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Loss of personal independence in daily activities, Migraine, Nausea
Clinical narrative: Intractable migraine; Head pain; Heart rate gets extremely high; almost passed out; Nauseated; Vomit; I have not been able to function normally in 6 weeks; Fevers off and on; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 15Apr2021 10:00 (at the age of 32 years old) (lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included endometriosis, asthma, known allergies to IV contrast dye. No Covid prior vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); escitalopram oxalate (LEXAPRO); ondansetron (ZOFRAN). The patient previously took chlorhexidine gluconate / isopropanol (CHLORAPREP) and experienced allergies, doxycycline and experienced allergies, cefalexin monohydrate (KEFLEX) and experienced allergies, received the first dose of bnt162b2 on 24Mar2021 10:00 at the age of 32 years old for COVID-19 immunization. An intractable migraine began after receiving her second dose of the vaccine. She had not struggled with migraine until the second dose of the vaccine. Less than a week after the vaccine, her migraine was still so bad she sought emergent treatment at the hospital emergency room. She underwent several invasive tests before neurology narrowed down the cause to her vaccine. It has now been 46 days and she have been hospitalized 3 times and her head pain has not abated. None of the usual medications for migraine work. It was so bad that her heart rate got extremely high, she saw black. She almost passed out. She was nauseated and vomited. She had not been able to function normally in 6 weeks. She got fevers off and on. Adverse events start date was 15Apr2021 13:00. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Duration of hospitalization was 9 days. The patient underwent lab tests and procedures, which included Nasal Swab: Negative on 27May2021. Therapeutic measures were taken as a result of events and included treatment with nerve block injections, steroids, DHE, seizure med. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Intractable migraine; Head pain; Heart rate gets extremely high; almost passed out; Nauseated; Vomit; I have not been able to function normally in 6 weeks; Fevers off and on; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 15Apr2021 10:00 (at the age of 32 years old) (lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included endometriosis, asthma, known allergies to IV contrast dye. No Covid prior vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); escitalopram oxalate (LEXAPRO); ondansetron (ZOFRAN). The patient previously took chlorhexidine gluconate / isopropanol (CHLORAPREP) and experienced allergies, doxycycline and experienced allergies, cefalexin monohydrate (KEFLEX) and experienced allergies, received the first dose of bnt162b2 on 24Mar2021 10:00 at the age of 32 years old for COVID-19 immunization. An intractable migraine began after receiving her second dose of the vaccine. She had not struggled with migraine until the second dose of the vaccine. Less than a week after the vaccine, her migraine was still so bad she sought emergent treatment at the hospital emergency room. She underwent several invasive tests before neurology narrowed down the cause to her vaccine. It has now been 46 days and she have been hospitalized 3 times and her head pain has not abated. None of the usual medications for migraine work. It was so bad that her heart rate got extremely high, she saw black. She almost passed out. She was nauseated and vomited. She had not been able to function normally in 6 weeks. She got fevers off and on. Adverse events start date was 15Apr2021 13:00. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Duration of hospitalization was 9 days. The patient underwent lab tests and procedures, which included Nasal Swab: Negative on 27May2021. Therapeutic measures were taken as a result of events and included treatment with nerve block injections, steroids, DHE, seizure med. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Pain, Pulmonary thrombosis
Clinical narrative: blood clots in my lungs; chest/back pains; chest/back pains; pain; This is a spontaneous report from a contactable consumer. This contactable consumer (Patient) reported via mail that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient received the first dose on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took morphine. I was in the hospital Friday through Sunday getting treatments for blood clots in my lungs. I started having chest/back pains four days after getting my second Covid vaccination shot. The shots were from Pfizer. I went from being a strong, healthy person to one that was racked with pain and put on morphine in just a matter of days. My primary doctor said that he was going to report my case. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Monocyte count, Monocyte count increased, Neutrophil count, Neutrophil count decreased
Clinical narrative: Atrial Fibrillation; Low WBC; Low RBC; Low Neutrophils/Low Neutrophils Absolute; High Monocytes; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on Feb2021 (Lot Number: EP6955) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on Feb2021 at 13:00 (Lot Number: en6198) as single dose for covid-19 immunization. On 30Mar2021, the patient experienced atrial fibrillation, low white blood cell (WBC), low Red blood cell (RBC), low neutrophils, high monocytes, low neutrophils absolute. The events resulted in doctor or other healthcare professional office/clinic visit. 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 was not pregnant. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, Red blood cell count decreased, White blood cell count, White blood cell count decreased
Clinical narrative: Atrial Fibrillation; Low WBC; Low RBC; Low Neutrophils/Low Neutrophils Absolute; High Monocytes; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on Feb2021 (Lot Number: EP6955) as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on Feb2021 at 13:00 (Lot Number: en6198) as single dose for covid-19 immunization. On 30Mar2021, the patient experienced atrial fibrillation, low white blood cell (WBC), low Red blood cell (RBC), low neutrophils, high monocytes, low neutrophils absolute. The events resulted in doctor or other healthcare professional office/clinic visit. 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 was not pregnant. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bone scan, COVID-19, Computerised tomogram, Contusion, Erythema
Clinical narrative: get sick again; Arm was red & bruised; Arm was red & bruised; it's still sore today; left arm swole; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered in Arm Left on 07May2021 11:00 (at unknown age) as single dose for COVID-19 immunization. Medical history included Breast cancer from Mar2020 and ongoing, COVID-19 Dec2020. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) from 19Apr2021; antibiotics from 19Apr2021, Steroid cream From 19Apr2021 For Pain. The Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) at 16Apr2021 11:00 AM at left arm as single dose for COVID-19 immunization and had Fever, Chills, No appetite, Arm was sore. The patient had Left arm swole (Disability, Medically Significant) on 08May2021. Seriousness Criteria: Persistent/significant. Patient called Pfizer because it was time for second shot. Was hesitant because patient just barely got over first shot. Patient's oncologist said it was ok so took second shot. Got sick all over again. Arm was red bruised like before used rest of steroid cream. It's Still sore today but much improvement. The patient underwent lab tests and procedures which included Bone scan 2021: Unknown results, CT scan 2021: Unknown results, X-ray 2021: Unknown results. COVID-19 Dec2020: Positive. Emergency room visit for left arm swole. Treatment received for left arm swole, Arm was red bruised like. The outcome of the event left arm swole was recovered on 22May2021, for other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: get sick again; Arm was red & bruised; Arm was red & bruised; it's still sore today; left arm swole; This is a spontaneous report from a contactable consumer (patient). A 67-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered in Arm Left on 07May2021 11:00 (at unknown age) as single dose for COVID-19 immunization. Medical history included Breast cancer from Mar2020 and ongoing, COVID-19 Dec2020. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) from 19Apr2021; antibiotics from 19Apr2021, Steroid cream From 19Apr2021 For Pain. The Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) at 16Apr2021 11:00 AM at left arm as single dose for COVID-19 immunization and had Fever, Chills, No appetite, Arm was sore. The patient had Left arm swole (Disability, Medically Significant) on 08May2021. Seriousness Criteria: Persistent/significant. Patient called Pfizer because it was time for second shot. Was hesitant because patient just barely got over first shot. Patient's oncologist said it was ok so took second shot. Got sick all over again. Arm was red bruised like before used rest of steroid cream. It's Still sore today but much improvement. The patient underwent lab tests and procedures which included Bone scan 2021: Unknown results, CT scan 2021: Unknown results, X-ray 2021: Unknown results. COVID-19 Dec2020: Positive. Emergency room visit for left arm swole. Treatment received for left arm swole, Arm was red bruised like. The outcome of the event left arm swole was recovered on 22May2021, for other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient was affected with Covid-19; patient was affected with Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 and dose 2 both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was an non citizen and living. Patient took Pfizer COVID vaccine (both shots) at Patient traveled in the month of April. Now patient was affected with Covid-19 here and slowing recovering. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal blood spotting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 08Mar2021 (Lot Number: EN6202, at the age of 63-year-old) as single dose for covid-19 immunisation.  Medical history included abnormal cervical papanicolaou smear, ongoing eustachian tube dysfunction, ongoing Factor V Leiden Thrombophilia, ongoing hearing loss, laparoscopic Gynecology (GYN) surgery in 2007, an outpatient surgery to scrap the walls of her uterus similar to a dilation and curettage (D&C) in 2005, blood clots, excessive bleeding, ongoing Factor V Leiden heterozygote. Concomitant medication included ongoing multivitamins. Soon after her first vaccine on 08Mar2021 she started vaginal blood spotting. She had not had a period for over 15 years. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested COVID positive a few weeks after receiving his first vaccine; tested COVID positive a few weeks after receiving his first vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an intramuscular route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for Covid-19 immunisation. Other vaccine in four weeks was unknown. The patient medical history and concomitant medications were not reported. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. On an unspecified date, the patient had tested covid positive a few weeks after receiving his first vaccine (adverse event was tested COVID positive a few weeks after receiving his first vaccine). Once all virus symptoms were gone, he was advised by the clinic in, to go ahead and get his second shot (approx 1 week after virus symptoms cleared). The patient was diagnosed with COVID-19, prior vaccination. The patient has been tested for COVID-19, since the vaccination was unknown. The vaccine second dose was given on 20May and within several days, On 23May2021, the patient had extremely lethargic and experienced chest pains. During a visit to local urgent care he was told he had a heart attack. Following an echocardiogram, he ended up having a triple bypass to clear the blockage found. He does have some family history of heart disease but was unaware of any issues with his own health and had not experienced any symptoms prior to this incident). The event resulted in doctor or other healthcare professional, office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unspecified date. The outcome of events was recovered on an unspecified date.   Information on Lot/Batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: Blood Clots in left leg; This is a spontaneous report from a contactable 74-year-old male consumer (patient) reported for himself that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733) via an unspecified route of administration into the left arm on 07Apr2021 (at the age of 73-year-old) as single dose for COVID-19 immunisation. The patient medical history included blood pressure and blood disorder. Concomitant medications included lisinopril for blood pressure and baby aspirin to keep his blood thin. He started taking lisinopril 10-15 years ago. His blood pressure was under control with it. He stated he has been taking baby aspirin for years. Doctor advised him to quit taking it while he was taking Eliquis. He stopped taking it on 20Apr2021 when he was diagnosed with blood clots. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205, Expiry date: unknown) via an unspecified route of administration into the left arm on 17Mar2021 as single dose for COVID-19 immunisation. He stated that on 07Apr2021 he received his second shot. On 20Apr2021, the patient reported of blood clots in left leg that showed up after the Pfizer Covid vaccine which was continuing. Never had a blood clot in his life until now. On 20Apr2021, he went to the doctor and was told he had blood clots in left leg. His doctor sent him to the emergency room for testing. The doctor told him he was on blood thinners until August and put him on Eliquis. On 20Apr2021, test results showed sonogram positive for blood clots in left leg. He was not admitted to the hospital as there were no beds available. They were full and kept him there for about 6-8 hours and sent him home. Report was not related to a study or programme. The patient took Pfizer Covid-19 Vaccine because of COVID-19. Investigation assessment done. Patient provided age at time of blood clot diagnosis as 74. No further information provided. No additional vaccines were administered on same date of the Pfizer suspect nor any prior vaccinations within four weeks. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chronic lymphocytic leukaemia stage 0, Drug specific antibody
Clinical narrative: Has CLL, chronic lymphocytic leukemia, stage 0; She is producing very few antibodies; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. She received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had CLL (chronic lymphocytic leukaemia stage 0) after received the both doses of the Pfizer-BioNTech COVID-19 vaccine. She explained she took antibody tests and her haematologist explained that she must act as if she had not been vaccinated. She asked if a third dose of the vaccine is recommended for immunocompromised patients. FAQ-Pfizer stated the need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. Failed to explain that the study excluded participants who were immunocompromised from section "18.1 Efficacy in Participants 16 Years of Age and Older" of the Full EUA PI, LAB#, revised: 19May2021. She was encouraged for HCP consultation. The patient underwent lab tests and procedures which included antibody test with unknown results. The outcome of both events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Experienced appendicitis and had to remove appendix; This is a spontaneous report from a contactable reporter. A consumer reported for the female patient (reporter's granddaughter).  A female patient of an unspecified age received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced appendicitis and had to remove appendix on an unspecified date. The reporter was curious about what to do with her granddaughter (consumer), 3 weeks is today, after she got her first Covid vaccination (Covid Vaccine) and she experienced appendicitis and she had to have her appendix removed. Today is exactly three weeks. The reporter want to know, when is it safe for her to get her second shot, and she is at home and it's been full 3 weeks." Reporter was informed about Pfizer Medical Information Department. The outcome of the event was unknown.     Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: Muscular and joint pain; Muscular and joint pain; Lethargic; Looks like she is under anesthesia; Feeling exceedingly drained/tiredness; Her entire body is in pain; Dizziness; Jabbing pains under the arms and in her head; Jabbing pains under the arms and in her head; Weakness; Experienced swollen glands/glands got swollen; Swelling in her armpits; This is a spontaneous report from a contactable consumer. This consumer reported for 19-year-old female patient (reporter's daughter) that: A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0185 and expiry date: 31Aug2021), second dose via an unspecified route of administration on 03Jun2021 in her upper left arm, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 13May2021 (Lot Number: EW0168/EJ6795 and expiry date: 31Aug2021) in her upper left arm, single dose for COVID-19 immunisation. The patient experienced swelling in her armpits in Jun2021. On 03Jun2021 (started almost on the onset of injection), experienced weakness. In Jun2021 (started probably 2 days ago on 04Jun2021 or 05Jun2021), experienced swollen glands. On 05Jun2021, jabbing pains under the arms in her gland and inside of her head (took Tylenol and it dissipated but it was worse now than in the beginning). On 06Jun2021, feeling exceedingly drained, tiredness, dizziness and entire body was in pain. Reporter stated like this was muscular and joint pain and her daughter was very lethargic. It was informed that the last night was the hardest and her daughter describes this pain feeling like she has an elephant on top of her. On 07Jun2021 (around 3am), looks like she was under anaesthesia. The patient was experiencing pain, weakness, and tiredness which made her look like she belongs in the hospital. Reporter stated her daughter has no fever or vomiting but she has made sure her daughter has stayed on tylenol products, and fully hydrated with pedialyte. The patient taking normal medications along with Tylenol with a little bit of codeine. She had consulted briefly with her pharmacist but not taken Motrin as per pharmacist instruction. She had been drinking 3 full pedialytes per day. Now she was down for the count again and it looks like she just got the shot again and now it was the 7th day and she kind of predicted it would go on for 3 to 4 days. When patient got the vaccine she was right smack in the middle of her menstrual cycle which was rough enough on her but now her cycle was over and she was still down for the count. Reporter had concerned as her daughter takes other medications. Nothing changed her daughter and had been on the same medication for other things and it has been standard and has been on them for a year. The patient had no fever, she just took it 5 minutes ago and it was normal. The outcome of the events muscular and joint pain, lethargic were unknown rest all were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Receiving the second dose due to heavy bleeding; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of unspecified age received the second dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Lot Number and Expiry Date were not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient took historical vaccine dose 1 of BNT162B2 on an unknown date for Covid-19 immunisation. It was reported that on an unknown date patient experienced heavy bleeding or extended periods. Patient was hospitalized after receiving the second dose due to heavy bleeding. Reporter asked that was there any data or studies relating to this issue. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Thrombosis
Clinical narrative: COVID-19 positive after vaccination.; COVID-19 positive after vaccination.; Had a clot and thrombectomy; This is a spontaneous report from contactable other-HCP (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on unspecified as a single dose for COVID-19 immunization. Patient's medical history included thrombectomy and concomitant medication was not reported. On an unspecified date, patient had COVID-19 positive after vaccination and had a clot and thrombectomy. Treated with Xaralto and had another clot. Event took place after use of product. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information currently provided the lack of efficacy of the administered vaccine BNT162B2 and also the causal association between the reported event clot with the usage of the vaccine cannot be excluded. The contributory role of the patient's medical history needs to be taken into consideration. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and have contracted covid.; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: en5318), via an unspecified route of administration on an unspecified date and second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: el8982), via an unspecified route of administration on an unspecified date as SINGLE DOSE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on unspecified date, the reporter had 3 people that were fully vaccinated with the Pfizer covid 19 vaccine and had contracted covid. He asked if there were any issues with specific lot numbers: el8982, en5318. He did not have any information to provide for the people. The seriousness of the events reported as non-serious by reporter. The outcome of the events was reported as unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect vaccine,Linked Report(s) : US-PFIZER INC-2021669273 same reporter/drug/event, different patient;US-PFIZER INC-2021665561 same reporter/drug/event, different patient
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Light-headed/Dizzy; Fatigue; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0172, Expiry date: unknown), via an unspecified route of administration on 01May2021 as 2nd dose, single dose for covid-19 immunisation. Patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: ER8731), via left upper arm in the muscle on 10Apr2021 as 1st dose, single dose for covid-19 immunisation. Patient medical history included influenza from 2019 to an unknown date went back in 2019, last year in January, they said she had influenza and sent her home and the patient's concomitant medications were not reported. The patient experienced tested positive for covid-19 on 04Jun2021, light-headed on an unspecified date, dizzy on an unspecified date, fatigue on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test it was positive on 04Jun2021 positive for Covid-19. Outcome of the event was unknown.  Follow-up attempts are needed. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flares after both covid vaccines; This is a spontaneous report received from Pfizer sponsored program. A contactable other HCP and consumer reported that a 57-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, on an unknown date in Apr2021 as a single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. On an unknown date in Apr2021 patient's rheumatoid arthritis flares, after both COVID vaccines, with some improvement noted. Patient required oral steroids post first COVID vaccine and MD administered steroid injection post second COVID injection. The outcome of event was recovering.  Information on the Lot/Batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Rheumatoid arthritis flare up " and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.