chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Soreness; consumer just took her temp about five minutes ago and it was little bit higher than it was, initially, it was like 101 point consumer wanted to say 2/fever was slightly higher than it was earlier; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for a 15-year-old female patient (Reporter's daughter). A 15-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on 17Jul2021 (Lot Number: EW0171) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection) on an unknown date for covid 19 immunization. Patient just took her second dose of the vaccine yesterday (17Jul2021) and this morning (18Jul2021), she experienced some soreness, a fever and nausea and consumer have given her some medication, she ate, she did take some Tylenol (treatment) and she rested. Then, consumer just took her temp about five minutes ago and it was little bit higher than it was, initially, it was like 101 point consumer wanted to say 2 (event captured as per verbatim). When paraphrased the concern, reporter stated that It was for his daughter. After she took the Tylenol, this was earlier in the morning, this morning (sentence incomplete). Reporter further stated, that his concern was what to do for her fever, some hours later, we were off in to the night, it was about 5 minutes to 10 her time. Her fever was slightly higher than it was earlier that morning when she took the Tylenol (treatment). They were just trying to get some advice on what they need to do because they were concerned that she was still having the fever and she also experienced some chills as well and nausea and headache on 18Jul2021. Consumer understood those were the side effects but they were trying to see, was this normal or did she need to see her pediatrician. Expiration date: Reporter stated that did not have an expiration date on here, he just have the card. Reporter was informed about Pfizer Medical Information department and provided with the number. Further probing could not be initiated reporter hung up the call abruptly. Hence, other details were unknown and limited information was available over the call. Outcome of the event, consumer just took her temp about five minutes ago and it was little bit higher than it was, initially, it was like 101 point consumer wanted to say 2/fever was slightly higher than it was earlier was not recovered while for other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pains since 2 days after receiving the vaccine and is currently still presen; This is a spontaneous report from a contactable consumer (wife) reporting on behalf of her husband.  A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 19Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient has experienced muscle pains since 2 days after receiving the vaccine (myalgia) and which currently still present on 21Jun2021. Caller wanted to know is this a side effect that has been reported before and how long will the side effect supposed to last. The outcome of the myalgia was not recovered.  Information about lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Candida infection, Dehydration, Feeling abnormal, Haemoglobin, Haemoglobin decreased
Clinical narrative: oxygen saturation drops down into the 60s and 70s/oxygen needs are now flucuating between 2 LPM and 4 LPM; Dehydration; Palpitations; kidney issues; feeling worse; Hemoglobin has been dropping from 13.4 down to 11.9; has continuous problem with candida; groin rash; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose (at the age of 79-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in 2021, patient had been feeling worse since getting his second covid shot in April. He stated he had to go to the emergency department due to dehydration, palpitations and kidney issues. His hemoglobin has been dropping from 13.4 down to 11.9. If he gets up and walks any distance his oxygen saturation drops down into the 60s and 70s. His oxygen needed were now fluctuating between 2 lpm and 4 lpm. He was put on a prednisone dose pack and was doing good until the day after it stopped, all the symptoms came right back. He also has continuous problems with candida and a groin rash. No further details provided. Therapeutic measures were taken as a result of oxygen saturation drops down into the 60s and 70s/oxygen needs were now flucuating between 2 lpm and 4 lpm, dehydration, palpitations, kidney issues, feeling worse, and hemoglobin has been dropping from 13.4 down to 11.9. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Palpitations, Rash, Renal disorder
Clinical narrative: oxygen saturation drops down into the 60s and 70s/oxygen needs are now flucuating between 2 LPM and 4 LPM; Dehydration; Palpitations; kidney issues; feeling worse; Hemoglobin has been dropping from 13.4 down to 11.9; has continuous problem with candida; groin rash; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose (at the age of 79-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in 2021, patient had been feeling worse since getting his second covid shot in April. He stated he had to go to the emergency department due to dehydration, palpitations and kidney issues. His hemoglobin has been dropping from 13.4 down to 11.9. If he gets up and walks any distance his oxygen saturation drops down into the 60s and 70s. His oxygen needed were now fluctuating between 2 lpm and 4 lpm. He was put on a prednisone dose pack and was doing good until the day after it stopped, all the symptoms came right back. He also has continuous problems with candida and a groin rash. No further details provided. Therapeutic measures were taken as a result of oxygen saturation drops down into the 60s and 70s/oxygen needs were now flucuating between 2 lpm and 4 lpm, dehydration, palpitations, kidney issues, feeling worse, and hemoglobin has been dropping from 13.4 down to 11.9. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231), dose 1 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 she had an allergic reaction on an unspecified date. It was reported that Caller would like to know if there are clinical trials she could volunteer for. She took the Pfizer vaccine when it first came out, and she had an allergic reaction. She was only able to take one, and not two. She was wanting to know if Pfizer was doing clinical trials for the booster, and if they are also doing anything for people that have had an allergic reaction to the vaccine. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Jul2021, the patient experienced fever. Patient reported that since morning patient don't have fever but temperature was constantly staying above 99 degrees Fahrenheit. Patient stated that "it is 99 but the thing is it is not going you know below 99, it is staying around 99, 99.2, 99.3 and so on". The patient underwent lab tests and procedures which included body temperature: 99 fahrenheit on 19Jul2021, body temperature: 99.2 fahrenheit on 19Jul2021, body temperature: 99.3 fahrenheit on 19Jul2021. Therapeutic measures were taken as a result of fever included some over the counter medicines (Further clarification unknown). The outcome of the event fever was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: rapid heart beats; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. stated she got the shot on 15Jul2021 and she has been having rapid heartbeats. On Jul2021, The patient experienced rapid heartbeats. The patient underwent lab tests and procedures which included heart rate: rapid heartbeats on Jul2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac function test, Chest pain, Dyspnoea, Fatigue
Clinical narrative: developed a mental delay; fatigue; weakness; shortness of breath; rapid pulse; chest pain; This is a spontaneous report from a Pfizer-sponsored program, via a contactable physician.   A 28-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 on an unknown date at a single dose for covid-19 immunisation.  On an unknown date, two weeks after the bnt162b2 vaccine, the patient developed a mental delay, fatigue, weakness, shortness of breath, rapid pulse, and chest pain. The events were further described as: patient developed fatigue, weakness, mental delay, shortness of breath, rapid pulse and chest pain (resembled pericarditis, cardiac workup negative as of now) 2 weeks after her second bnt162b2 vaccine. Per patient similar to POTS Syndrome (as reported). The patient underwent lab data and procedures which included cardiac workup: negative on an unknown date. The clinical outcome of all events was unknown.   The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: The contributory role of the suspect product bnt162b2 (COMIRNATY), to reported events is possible based on temporal association and known profile of the product.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Mental impairment
Clinical narrative: developed a mental delay; fatigue; weakness; shortness of breath; rapid pulse; chest pain; This is a spontaneous report from a Pfizer-sponsored program, via a contactable physician.   A 28-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 on an unknown date at a single dose for covid-19 immunisation.  On an unknown date, two weeks after the bnt162b2 vaccine, the patient developed a mental delay, fatigue, weakness, shortness of breath, rapid pulse, and chest pain. The events were further described as: patient developed fatigue, weakness, mental delay, shortness of breath, rapid pulse and chest pain (resembled pericarditis, cardiac workup negative as of now) 2 weeks after her second bnt162b2 vaccine. Per patient similar to POTS Syndrome (as reported). The patient underwent lab data and procedures which included cardiac workup: negative on an unknown date. The clinical outcome of all events was unknown.   The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: The contributory role of the suspect product bnt162b2 (COMIRNATY), to reported events is possible based on temporal association and known profile of the product.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain, Heart rate, Pain in extremity, Palpitations
Clinical narrative: A-fib alerts from my fitness/health tracking device.; heart palpitations/Sleeping HR of 102-133; Left arm and chest pain.; Left arm and chest pain.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Jul2021 10:30 (at the age of 59-year-old) (Batch/Lot Number: GW0198) as dose 1, single for covid-19 immunisation. Medical history included gastritis. The patient was not pregnant. Concomitant medications included omeprazole magnesium (PRILOSEC) and colecalciferol (VIT D) which were her medications in two weeks. The patient previously took amoxicillin and experienced allergies.  The patient had no other vaccine in 4 weeks. On 18Jul2021 at 12:00, the patient experienced heart palpitations and a-fib alerts from her fitness/health tracking device, and left arm and chest pain. On 19Jul2021, the patient experienced sleeping heart rate (HR) of 102-133. There was no treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was not covid tested post vaccination. Outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest discomfort, Dyspnoea, Electrocardiogram, Muscular weakness
Clinical narrative: Stated that it showed that she had sinus rhythm with arrhythmia.; stated that her chest got tight; shortness of breath; limb weakness for both arms/limb weakness for both legs; had palpitations; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (Pfizer Covid 19), intramuscular in the left deltoid on 08Jul2021 (Lot Number: EW0172) dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The events were described as follows: she had the Pfizer vaccine on 08Jul2021 had some sort of reaction from it. Stated that 12 minutes after, her chest got tight and lasted for two days. On 08Jul2021, she had shortness of breath, limb weakness for both arms and legs, palpitations and tachycardia. The patient asked if she should get the second vaccination. Stated that she had lasting effects of shortness of breath from her chest tightness. She visited with the doctor she worked with and had an electrocardiogram (EKG) on 09Jul2021. It showed that she had sinus rhythm with arrhythmia. The doctor told her that it was due to her breathing and he thought it was completely normal. Outcome of event arrhythmia was unknown, shortness of breath recovered on 12Jul2021, limb weakness for both arms/limb weakness for both legs recovered on 09Jul2021, chest got tight, palpitations and tachycardia recovered on 10Jul2021. Events assessed by reporter as serious. The reporter assessed the events as related to vaccine.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events shortness of breath, limb weakness, palpitations, tachycardia, chest tightness, and arrhythmia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: Stated that it showed that she had sinus rhythm with arrhythmia.; stated that her chest got tight; shortness of breath; limb weakness for both arms/limb weakness for both legs; had palpitations; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (Pfizer Covid 19), intramuscular in the left deltoid on 08Jul2021 (Lot Number: EW0172) dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The events were described as follows: she had the Pfizer vaccine on 08Jul2021 had some sort of reaction from it. Stated that 12 minutes after, her chest got tight and lasted for two days. On 08Jul2021, she had shortness of breath, limb weakness for both arms and legs, palpitations and tachycardia. The patient asked if she should get the second vaccination. Stated that she had lasting effects of shortness of breath from her chest tightness. She visited with the doctor she worked with and had an electrocardiogram (EKG) on 09Jul2021. It showed that she had sinus rhythm with arrhythmia. The doctor told her that it was due to her breathing and he thought it was completely normal. Outcome of event arrhythmia was unknown, shortness of breath recovered on 12Jul2021, limb weakness for both arms/limb weakness for both legs recovered on 09Jul2021, chest got tight, palpitations and tachycardia recovered on 10Jul2021. Events assessed by reporter as serious. The reporter assessed the events as related to vaccine.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events shortness of breath, limb weakness, palpitations, tachycardia, chest tightness, and arrhythmia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Ocular discomfort, Ocular vascular disorder
Clinical narrative: A little black dot in her left eye/like "broken blood vessels/ the veins are floating around"/Felt like something burst in her left eye; left eye felt like something was in it/ dot is moving around my eyeball/Every time she rolls her eye it is like something is stuck; left eye kind of felt like she had something in it, like a blood clot, there was a little dot there; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm (also reported as 'left shoulder upper arm') on 21Jul2021 13:00 (Batch/Lot number was not reported) at the age of 65 years, as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's mom had Alzheimer's, and her dad had heart attack. Concomitant medications included ongoing colecalciferol (VIT D) and ongoing regular multivitamin, both taken for an unspecified indication. The patient did not receive additional vaccines on same date of or within four weeks prior the Pfizer suspect. She does not ever get vaccines, does not get the flu shot and has never had the flu. The patient reported that she feels like something burst in her left eye. On 23Jul2021 around 07:00, she woke up because her left eye kind of felt like she had something in it, like a blood clot, there was a little dot there. She initially thought maybe she had dust or something in her eye so she rinsed her eye out with some eye drops (Lot: XD747, Expiry: Aug2023) and then went shopping but that didn't work. Every time she rolls her eye it was like something is stuck on there, looks like. She doesn't know, but like blood. When she returned home, around 11:00 am, the dot was still there, but smaller and it had kind of spread. It's now broken up like veins but at first it just started as just as little dot; that's why she thought maybe there was lint or something in her eye; but now it's like something burst, and she can see a little trail or something now. There's like "broken blood vessels/ the veins are floating around and the dot is moving around her eyeball when she reads or looks out her left eye." She called her Optometrist and is going to go in today to have her look at it, but has not had any physician's office visit, emergency room visit or hospitalization as of yet regarding this event. She called to ask if any other reports of side effects have been made like this with Pfizer-BioNTech Covid-19 Vaccine. She was on the fence about getting the Pfizer Covid vaccine and didn't want to take it, and now she was frustrated because of her left eye having problems. Outcome of the events was not recovered. The patient reported the events as non-serious.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nasopharyngitis, Pyrexia
Clinical narrative: Fever; Headache; Flu like symptoms; Cold; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number not provided), via an unspecified route of administration on 17Jul2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On 23Jul2021, the patient experienced Fever, Headache, Flu like symptoms, Cold.The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle discomfort
Clinical narrative: tiredness/exhaustion; chills; muscles feeling funny; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date July2021 (Wednesday) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19 from December2020. The reporter states that both she and her husband had the covid virus back in December. The patient's concomitant medications were not reported. On an unknown date, the patient experienced potential adverse event, tiredness/exhaustion, chills and muscles feeling funny. The reporter wanted to know if she could receive an antibody test to determine her immunity against the covid virus after receiving just one dose of the Pfizer BioNtech covid 19 vaccine. Also if these are normal and will they be worse after the second dose of the vaccine. The outcome of the events was unknown. There was no product quality complaint present.  Information on lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944029 Same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccine breakthrough infection
Clinical narrative: Vaccine breakthrough infection; has COVID; has COVID; This is a spontaneous report from a contactable consumer (patient's sister). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced vaccine breakthrough infection, and has COVID. It was reported that the consumer's brother who had the Pfizer COVID-19 vaccine and had breakthrough and has COVID and was hospitalized. The consumer did not want to do a report without the patient's permission. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Colonoscopy, Urticaria
Clinical narrative: lymphocytic colitis; hives across my mid-lower back.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8733 and expiration date: not reported), via an unspecified route of administration in left arm, on 25Mar2021 (at the age of 61 years old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as withheld. Medical history included osteoarthritis and gastroesophageal reflux disease (GERD) and hives which were previously developed with other antibiotics, without gastro-intestinal (GI) symptoms. The patient was allergic to erythromycin; trimethoprim, sulfamethoxazole (BACTRIM); clindamycin (CLEOCIN); rofecoxib (VIOXX); doxycycline; proparacaine; fleurescein; thiomersal (THIMERISAL) and codeine. Concomitant medications included famotidine (PEPCID AC) and melatonin (MELATONIN). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203 and expiration date: not reported), via an unspecified route of administration in left arm, on 01Mar2021 (at the age of 61 years old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Approximately one week after receiving the second vaccine, the patient developed hives across her mid-lower back and then started with GI symptoms that were ultimately diagnosed as lymphocytic colitis on 01Apr2021. The patient didn't had any prolongation of hospitalization and received treatment with budesonide following a colonoscopy with an unknown results in 2021. These events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering at the time of report.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives all over body -red, itchy Would call it severe; Hives all over body -red, itchy Would call it severe; Hives all over body -red, itchy Would call it severe; This is a spontaneous report from a contactable consumer (patient). A 15-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 21Jul2021 17:00 (Lot Number: EW0196) as dose 1, single (at the age of 15 years old) for COVID-19 immunization. Medical history included Mononucleosis dx (diagnosis) from 20Jun2021 to an unknown date and known allergies: Penicillin from an unknown date. Concomitant medications included atomoxetine (ATOMOXETINE) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]); both were taken for an unspecified indication, start and stop date were not reported. Reported that atomoxetine and excedrin were medications received by patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jul2021 19:00, the patient experienced hives all over body -red, itchy would call it severe. The adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of hives all over body -red, itchy would call it severe, treatment received were prednisone and ZIRTEK. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in limbs, arms, hands, legs knees, wrists and forearms; Pain in limbs, arms, hands, legs knees, wrists and forearms; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 19May2021 15:00 (at the age of 67 years old) as dose 1, single for covid-19 immunization. Medical history included known allergies to "Milo gram dye" (as reported). The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient previously took atorvastatin calcium (LIPITOR; reported as lipatour) and experienced allergy (also reported as known allergies).   The patient had no other vaccine in four weeks. The most recent COVID-19 vaccine was administered in a public health clinic. On 24May2021, the patient experienced pain in limbs, arms, hands, legs knees, wrists and forearms. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events which included increased dosage of prednisone 5mg to 7mg. The patient was not tested for covid post vaccination. The events were reported as medically significant. The outcome of the events was not recovered.   Information on the batch/lot has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I am experiencing dizziness.  Especially if I look up or down or turn my head fast or look left or right to fast.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Headache, body aches, muscle stiffness, tiredness
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hot flush, Nausea, Pain in extremity
Clinical narrative: Nausea, extreme pain in arm, felt like hot flashes, felt like someone hit me in the arm really really really really really really really hard, made my whole body feel like sludge.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling cold
Clinical narrative: Severe fatigue,  cough, chills for two days.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I started my menstrual period 2 weeks early, 4 days after COVID-19 Vaccine dose #1. Since it started, I have been bleeding for 3 weeks straight with drastic variations in blood volume every day. This is abnormal for me since my birth control has regulated my periods.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Mammogram, Ultrasound breast
Clinical narrative: Large lump developed in my right breast.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Neuralgia
Clinical narrative: muscle pain in his upper back between the shoulder blades/In my upper middle back, between my shoulder blades is very painful and it is like a muscle pain; It is limiting the movement of his left arm somewhat; he has sharp stabbing pain.; This is a spontaneous report from a contactable consumer (patient himself). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Jul2021 10:00 (age at vaccination: 63 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jul2021, the patient experienced severe muscle pain in his upper back between the shoulder blades/in my upper middle back, between my shoulder blades is very painful and it is like a muscle pain, it was limiting the movement of his left arm somewhat; on an unknown date in July2021, he had sharp stabbing pain. Pain was a little more than mild. It was limiting the movement of his left arm somewhat. He states it would be an issue with putting on a t shirt for the left arm. Sometimes he has sharp stabbing pain. He denies having fever. The patient was taking Tylenol for myalgia. It was quite severe. He had taken Tylenol twice already today. There was no pain at all at the injection site. The outcome of the events was not recovered. There was no product quality complaint (PQC) present.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocardial infarction
Clinical narrative: The pain was intense enough that I thought I was possibly having a heart attack.; Myocardia; chest pain lasting for approximately seven days.; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm (at the age of 31-year-old) on 25Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient had no medical history. Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. On 05May2021, the patient experienced myocardia and chest pain lasting for approximately seven days. The pain was intense enough that he thought he was possibly having a heart attack. It has since subsided. No treatment was received. The outcome of the event was recovered on an unspecified date in 2021.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had arm pain for 5 days I think; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself.  A female patient of an unspecified age first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain for 5 days she thinks on an unspecified date. The outcome of the event was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blindness, Confusional state, Dyspnoea, Feeling abnormal
Clinical narrative: Hallucinations; Feeling I was about to die; Felt my vision closing in; Paralyzed; My brain couldn't follow the tv program; Couldn't remember how to do simple tasks; An electric vibration sensation; Distinct tastes and smells; Distinct tastes and smells; Couldn't breathe; Couldn't speak or communicate; Confused; electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 09:00 (Batch/Lot Number: EN6203) as dose 2, single (at the age of 76 years) for covid-19 immunization. The patient's medical history included hypertension and chronic obstructive pulmonary disease (COPD) on an unknown date. The patient's concomitant medications were not reported. The patient received the first dose of COMIRNATY on 02Feb2021 at 09:00AM in the right arm (lot:EL9265) at the age of 76 years for Covid-19 immunisation. On 23Feb2021 18:00, the patient experienced hallucinations, feeling I was about to die, felt my vision closing in, paralyzed, my brain couldn't follow the tv program, couldn't remember how to do simple tasks, an electric vibration sensation, electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder, distinct tastes and smells, couldn't breathe, couldn't speak or communicate, and confused. The events were further reported as, around 6 pm the evening of the second dose the first event happened, followed by three more the next day. Patient's brain couldn't follow the tv program. He couldn't remember how to do simple tasks. He was having hallucinations, and couldn't distinguish between them and reality. The next day he had three or four experiences of an electric vibration sensation traveling up his left leg, into his arm, then the entering left side of his brain and through it to the right, then seemed to dissipate into his right shoulder. During that time he experienced several distinct tastes and smells all at once, and had the feeling he was about to die. He couldn't breathe, felt his vision closing in, and was completely paralyzed. He couldn't speak or communicate and was confused all day. Two weeks later, he thought it was going to happen again, and had to sit down suddenly. After this, He saw his doctor and they did scans and couldn't find anything. Patient was put on blood thinners. The patient underwent lab tests and procedures which included brain scan and sonogram in Feb2021 with unknown results. The outcome for all the events was recovered with sequelae in 2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Hand-arm vibration syndrome, Memory impairment, Near death experience, Paralysis
Clinical narrative: Hallucinations; Feeling I was about to die; Felt my vision closing in; Paralyzed; My brain couldn't follow the tv program; Couldn't remember how to do simple tasks; An electric vibration sensation; Distinct tastes and smells; Distinct tastes and smells; Couldn't breathe; Couldn't speak or communicate; Confused; electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 09:00 (Batch/Lot Number: EN6203) as dose 2, single (at the age of 76 years) for covid-19 immunization. The patient's medical history included hypertension and chronic obstructive pulmonary disease (COPD) on an unknown date. The patient's concomitant medications were not reported. The patient received the first dose of COMIRNATY on 02Feb2021 at 09:00AM in the right arm (lot:EL9265) at the age of 76 years for Covid-19 immunisation. On 23Feb2021 18:00, the patient experienced hallucinations, feeling I was about to die, felt my vision closing in, paralyzed, my brain couldn't follow the tv program, couldn't remember how to do simple tasks, an electric vibration sensation, electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder, distinct tastes and smells, couldn't breathe, couldn't speak or communicate, and confused. The events were further reported as, around 6 pm the evening of the second dose the first event happened, followed by three more the next day. Patient's brain couldn't follow the tv program. He couldn't remember how to do simple tasks. He was having hallucinations, and couldn't distinguish between them and reality. The next day he had three or four experiences of an electric vibration sensation traveling up his left leg, into his arm, then the entering left side of his brain and through it to the right, then seemed to dissipate into his right shoulder. During that time he experienced several distinct tastes and smells all at once, and had the feeling he was about to die. He couldn't breathe, felt his vision closing in, and was completely paralyzed. He couldn't speak or communicate and was confused all day. Two weeks later, he thought it was going to happen again, and had to sit down suddenly. After this, He saw his doctor and they did scans and couldn't find anything. Patient was put on blood thinners. The patient underwent lab tests and procedures which included brain scan and sonogram in Feb2021 with unknown results. The outcome for all the events was recovered with sequelae in 2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Scan brain, Sensory disturbance, Taste disorder, Ultrasound scan
Clinical narrative: Hallucinations; Feeling I was about to die; Felt my vision closing in; Paralyzed; My brain couldn't follow the tv program; Couldn't remember how to do simple tasks; An electric vibration sensation; Distinct tastes and smells; Distinct tastes and smells; Couldn't breathe; Couldn't speak or communicate; Confused; electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 09:00 (Batch/Lot Number: EN6203) as dose 2, single (at the age of 76 years) for covid-19 immunization. The patient's medical history included hypertension and chronic obstructive pulmonary disease (COPD) on an unknown date. The patient's concomitant medications were not reported. The patient received the first dose of COMIRNATY on 02Feb2021 at 09:00AM in the right arm (lot:EL9265) at the age of 76 years for Covid-19 immunisation. On 23Feb2021 18:00, the patient experienced hallucinations, feeling I was about to die, felt my vision closing in, paralyzed, my brain couldn't follow the tv program, couldn't remember how to do simple tasks, an electric vibration sensation, electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder, distinct tastes and smells, couldn't breathe, couldn't speak or communicate, and confused. The events were further reported as, around 6 pm the evening of the second dose the first event happened, followed by three more the next day. Patient's brain couldn't follow the tv program. He couldn't remember how to do simple tasks. He was having hallucinations, and couldn't distinguish between them and reality. The next day he had three or four experiences of an electric vibration sensation traveling up his left leg, into his arm, then the entering left side of his brain and through it to the right, then seemed to dissipate into his right shoulder. During that time he experienced several distinct tastes and smells all at once, and had the feeling he was about to die. He couldn't breathe, felt his vision closing in, and was completely paralyzed. He couldn't speak or communicate and was confused all day. Two weeks later, he thought it was going to happen again, and had to sit down suddenly. After this, He saw his doctor and they did scans and couldn't find anything. Patient was put on blood thinners. The patient underwent lab tests and procedures which included brain scan and sonogram in Feb2021 with unknown results. The outcome for all the events was recovered with sequelae in 2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hyperventilation, SARS-CoV-2 test, Seizure
Clinical narrative: Convulsions; Burning in nostrils; Hyperventilation; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 22Jul2021 14:00 (Lot Number: Ewo202), as single dose, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination the patient has not been diagnosed with COVID-19. Patient was not pregnant and was not pregnant at time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced convulsions (disability, medically significant) on 23Jul2021 with outcome of not recovered, burning in nostrils (disability) on 23Jul2021 with outcome of not recovered, hyperventilation (disability) on 23Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): unknown in Jul2021 (after vaccination).  No follow-up attempts are possible. No further information is expected.