chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness bilateral, Disease recurrence, Ear pain, Hyperacusis, Insomnia
Clinical narrative: hearing loss in both ears; hypersensitive to sound; painful; trouble sleeping; tinnitus; tinnitus; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 16:00 (Batch/Lot Number: er8727), age at vaccination of 62-years-old, as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:00 (Batch/Lot Number: ew0151), age at vaccination of 62-years-old, as single dose for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing (mild asthma), drug hypersensitivity from an unknown date and unknown if ongoing (allergies: sulfa drugs), tinnitus from an unknown date and unknown if ongoing (mild tinnitus diagnosed 10 years ago), deafness from an unknown date and unknown if ongoing (diagnosed 10 years ago). The patient received tetanus vaccine in left arm on 12Mar2021 within 4 weeks prior to the COVID vaccine (age at vaccination of 62-years-old). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported and hormone replace taken for an unspecified indication, start and stop date were not reported After the vaccine (both doses) tinnitus rose exponentially, and patient was diagnosed with hearing loss in both ears. Not sure when the additional hearing loss took place. The patient also become hypersensitive to sound, it was almost painful. The patient had trouble sleeping, listening to tv, music, going out to restaurants, etc because of this reaction. ENTs can only recommend hearing aids. After 9 weeks tinnitus has quieted a little bit but not back to pre vaccine level. 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 has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Treatments were given for the events (after first vaccine took a course of prednisone). Outcome for the events was unknown.  Follow-up attempts are possible. Further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: hearing loss in both ears; hypersensitive to sound; painful; trouble sleeping; tinnitus; tinnitus; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 16:00 (Batch/Lot Number: er8727), age at vaccination of 62-years-old, as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:00 (Batch/Lot Number: ew0151), age at vaccination of 62-years-old, as single dose for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing (mild asthma), drug hypersensitivity from an unknown date and unknown if ongoing (allergies: sulfa drugs), tinnitus from an unknown date and unknown if ongoing (mild tinnitus diagnosed 10 years ago), deafness from an unknown date and unknown if ongoing (diagnosed 10 years ago). The patient received tetanus vaccine in left arm on 12Mar2021 within 4 weeks prior to the COVID vaccine (age at vaccination of 62-years-old). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported and hormone replace taken for an unspecified indication, start and stop date were not reported After the vaccine (both doses) tinnitus rose exponentially, and patient was diagnosed with hearing loss in both ears. Not sure when the additional hearing loss took place. The patient also become hypersensitive to sound, it was almost painful. The patient had trouble sleeping, listening to tv, music, going out to restaurants, etc because of this reaction. ENTs can only recommend hearing aids. After 9 weeks tinnitus has quieted a little bit but not back to pre vaccine level. 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 has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Treatments were given for the events (after first vaccine took a course of prednisone). Outcome for the events was unknown.  Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Impaired self-care, Neurological decompensation, Renal failure
Clinical narrative: unable to care for self; Neurologic decline; Renal failure; This is a spontaneous report from a contactable physician. An 81-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  Medical history included hypothyroidism, neuropathy/drop foot from a knee surgery. No known allergies. Concomitant medications included thyroid meds and vitamins. The patient previously received first dose of bnt162b2 on unspecified date for COVID-19 immunisation.  Patient was not pregnant and not pregnant at time of vaccination. The patient experienced neurologic decline, unable to care for self, renal failure on 10Feb2021 with outcome of not recovered. No treatment received for events. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  neurologic decline and renal failure. 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
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Chills, Haematochezia, Headache
Clinical narrative: blood in her bowel movements; bowel movement were like sticky mucus; really bad stomach cramps; her bones were aching; headache; chills; This is spontaneous report from a contactable consumer reported for self. This 59-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration right arm on 15May2021 13:20 at the age of 59-year-old (Lot number: EW0175) as 2nd dose, single for covid-19 immunisation. Medical history included Uterine cancer from 1991 (reported as had about 30 years ago, as of 18May2021), she did have the Covid 19 virus in Mar2020. Concomitant products included paracetamol (TYLENOL 8 HOUR) for headache. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Left arm Lot number:ER8731 on 24Apr2021 12:15 PM at the age of 59-year-old for covid-19 immunisation and experienced sore arm. The second dose she received on Saturday, 15May2021 and Sunday morning, 16May2021, she had a bad headache and her bones were aching. Her concerns started yesterday, Monday, 17May2021 when she started getting real bad stomach cramps. And her bowel movements were not like normal bowel movements. Her bowel movements were like a sticky mucus. This morning, 18May2021, there was dark blood in her bowel movement. There was blood in the toilet. But on Sunday 16May2021 when she was getting the chills and stomach cramps (17May2021) and then the blood in her bowel movement this morning, 18May2021, she was concerned. She's asking if this is normal. The chills have gone away but she's still concerned since the sticky bowel movements and blood in her bowel movements started after she received the Covid 19 vaccine. Afterwards, she had headache and chills, but said it already subsided. She said her main concern was that she had really bad stomach cramps, and her bowel movement were like sticky mucus on 17May2021. AEs did not require a visit emergency room and physician office. Outcome of the event real bad stomach cramps, bowel movements were like a sticky mucus, blood in her bowel movements, bones were aching was not recovered. Outcome of the events headache and chills was recovered in May2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mucous stools
Clinical narrative: blood in her bowel movements; bowel movement were like sticky mucus; really bad stomach cramps; her bones were aching; headache; chills; This is spontaneous report from a contactable consumer reported for self. This 59-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration right arm on 15May2021 13:20 at the age of 59-year-old (Lot number: EW0175) as 2nd dose, single for covid-19 immunisation. Medical history included Uterine cancer from 1991 (reported as had about 30 years ago, as of 18May2021), she did have the Covid 19 virus in Mar2020. Concomitant products included paracetamol (TYLENOL 8 HOUR) for headache. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Left arm Lot number:ER8731 on 24Apr2021 12:15 PM at the age of 59-year-old for covid-19 immunisation and experienced sore arm. The second dose she received on Saturday, 15May2021 and Sunday morning, 16May2021, she had a bad headache and her bones were aching. Her concerns started yesterday, Monday, 17May2021 when she started getting real bad stomach cramps. And her bowel movements were not like normal bowel movements. Her bowel movements were like a sticky mucus. This morning, 18May2021, there was dark blood in her bowel movement. There was blood in the toilet. But on Sunday 16May2021 when she was getting the chills and stomach cramps (17May2021) and then the blood in her bowel movement this morning, 18May2021, she was concerned. She's asking if this is normal. The chills have gone away but she's still concerned since the sticky bowel movements and blood in her bowel movements started after she received the Covid 19 vaccine. Afterwards, she had headache and chills, but said it already subsided. She said her main concern was that she had really bad stomach cramps, and her bowel movement were like sticky mucus on 17May2021. AEs did not require a visit emergency room and physician office. Outcome of the event real bad stomach cramps, bowel movements were like a sticky mucus, blood in her bowel movements, bones were aching was not recovered. Outcome of the events headache and chills was recovered in May2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Inappropriate schedule of product administration, Lymphadenopathy, Renal neoplasm
Clinical narrative: swollen lymph nodes; she has a tumor on her kidney.; she had the first dose of the Pfizer covid 19 vaccine on 6Jan2021 and the second dose on 23Jan2021.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in right arm in a hospital facility on 23Jan2021 11:00 (at the age of 44-year-old) (Batch/Lot Number: Z9262) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included anxiety. The patient's family history includes her dad with diabetes and her mom had high blood pressure. Concomitant medication included hydroxyzine pamoate taken for anxiety from Sep2020 to an unspecified stop date. Historical vaccine includes the first dose of bnt162b2 (lot number: EJ1686) administered in the right arm on 06Jan2021 at 10:00 AM (at the age of 44-year-old) for COVID-19 immunization. The patient stated that she had the first dose of the Pfizer covid 19 vaccine on 06Jan2021 and the second dose on 23Jan2021. The patient had a computerized tomogram (CT) scan on 03Apr2021 and saw a specialist on 14May2021. The specialist informed her that she has a tumor on her kidney on 14May2021. Patient stated that she will see a surgeon on 08Jun2021. The patient stated that she wanted to avoid extra expenses and avoid surgery if this was related to the vaccine like swollen lymph nodes and mammograms. Patient wanted to know if this has been reported. The patient added that on 08Jun2021 she will be going to a kidney specialist; on 01Jun2021, she was scheduled for a magnetic resonance imaging (MRI) follow up. Patient also added previously that she was going to have a surgery for her stomach called lower anterior resection but now she does not know what will happen. Stated she has a follow up on 28May2021 to find out what he will do. Mentioned that the she went to see the stomach doctor for issues she was having with her stomach and he ordered the CT scan and then referred her to the kidney specialist. No further information provided regarding stomach issues. The event kidney tumor did not require emergency room visit. The patient visited physician office (stomach doctor) for issues with her stomach and he sent her for the CT scan and referred her to the kidney specialist. Furthermore, patient added she heard to wait a couple of weeks before or after the vaccine to get a mammogram and she thought she would ask about the CT and if anyone else had reported what she had with her kidney. The patient underwent lab test and procedure which includes CT scan on 03Apr2021 which showed kidney tumor. The patient had not yet recovered from kidney tumor while outcome of the other events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Renal impairment
Clinical narrative: A-fib; renal dysfunction; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration in Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included carbidopa and levodopa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In Mar2021, the patient experienced onset of A-fib and resultant renal dysfunction shortly after injection. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Cardioversion and medical management for the event A-fib. The outcome of the events was recovered on unspecified date.    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 events of Atrial Fibrillation and Renal Impairment and the suspect 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 drug 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Feeling abnormal, Gastric disorder, Hypoaesthesia
Clinical narrative: she felt dizzy first.; Within 2 minutes heart was racing; felt numb in stomach area; she couldn't sleep; She felt like contractions in her stomach, like cramping; her whole stomach area getting hard; Her legs/knees were weak.; felt weird; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 2 minutes of receiving the vaccine, heart was racing, felt numb in stomach area and felt weird. It lasted for two weeks. Primary care physician and cardiologist checked her out. It has been 6 weeks and was advised not to get the second dose. Should she get the dose? She feels like this is a severe reaction. She states she felt dizzy first. When she got home, she thought she was going to die.  She laid down and thought she was going to pass out. A few hours later, her heart was racing, and she couldn't sleep. Symptoms alternated between feeling dizzy and her heart racing. She felt like contractions in her stomach, like cramping, and her whole stomach area getting hard. Her legs/knees were weak. She's dealt with this for 4 weeks "really bad". An ultrasound was done, and her heart is fine.  The cardiologist said there is nothing to worry about. She feels better now since 6 weeks ago. She went to a cardiologist and her heart is fine, so it's nothing with her heart, but they don't know what it is. The extreme dizziness lasted for 4 weeks and it got a little better. Now she is kind of fine, she is not getting dizzy that bad anymore. Her heart is also fine, it's not that bad anymore. She was asking if she can get the second dose, can it happen again, and should she not take it? Her doctor told her she should wait. She went to her doctor who advised her to not receive the second dose of the vaccine. Should she take the risk of getting the second dose of the vaccine or maybe no? Her doctor doesn't know what to do. Now the first dose was 6 weeks ago, and she doesn't know how long she has to get the second dose. The patient underwent lab tests and procedures which included ultrasound scan: no result on an unspecified date. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscular weakness, Palpitations, Ultrasound scan
Clinical narrative: she felt dizzy first.; Within 2 minutes heart was racing; felt numb in stomach area; she couldn't sleep; She felt like contractions in her stomach, like cramping; her whole stomach area getting hard; Her legs/knees were weak.; felt weird; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 2 minutes of receiving the vaccine, heart was racing, felt numb in stomach area and felt weird. It lasted for two weeks. Primary care physician and cardiologist checked her out. It has been 6 weeks and was advised not to get the second dose. Should she get the dose? She feels like this is a severe reaction. She states she felt dizzy first. When she got home, she thought she was going to die.  She laid down and thought she was going to pass out. A few hours later, her heart was racing, and she couldn't sleep. Symptoms alternated between feeling dizzy and her heart racing. She felt like contractions in her stomach, like cramping, and her whole stomach area getting hard. Her legs/knees were weak. She's dealt with this for 4 weeks "really bad". An ultrasound was done, and her heart is fine.  The cardiologist said there is nothing to worry about. She feels better now since 6 weeks ago. She went to a cardiologist and her heart is fine, so it's nothing with her heart, but they don't know what it is. The extreme dizziness lasted for 4 weeks and it got a little better. Now she is kind of fine, she is not getting dizzy that bad anymore. Her heart is also fine, it's not that bad anymore. She was asking if she can get the second dose, can it happen again, and should she not take it? Her doctor told her she should wait. She went to her doctor who advised her to not receive the second dose of the vaccine. Should she take the risk of getting the second dose of the vaccine or maybe no? Her doctor doesn't know what to do. Now the first dose was 6 weeks ago, and she doesn't know how long she has to get the second dose. The patient underwent lab tests and procedures which included ultrasound scan: no result on an unspecified date. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Laboratory test
Clinical narrative: Grave's disease; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (Lot number: EN6208) as single dose for COVID-19 immunization. Patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 22Mar2021 at 12:45 (Lot number: EN6202) as single dose for COVID-19 immunization. Medical history included hoshimoto's; allergies, allergies to shrimp. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY) over the counter for allergies. The patient previously took erythromycin, cefazolin, methocarbamol that all experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that between patient first and second doses, her autoimmune disease swung from Hoshimoto's to Grave's disease on 15Mar2021 at 12:00. The patient had labs from January as a baseline and then labs from mid-March, both were unknown results. Patient had never been in hyperthyroid scenario previously so thought it worth mentioning just in case. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event including prescribed propranolol & methimazole. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid 19 in between doses; Diagnosed with Covid 19 in between doses/he is asymptomatic; This is a spontaneous report from a contactable other HCP. A 17-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: ER8736) via intramuscular on 26Apr2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had no prior vaccinations (within 4 weeks). The patient had Covid-19 PCR test with negative result on 19Feb2021. The patient received the Pfizer Covid 19 vaccine on 26Apr2021, and then was diagnosed with Covid 19 in between doses on May2021. The patient was scheduled for his second dose, the reporter asked if it should be delayed or if he could get it now. The patient was asymptomatic. Responded as attached below: Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. This recommendation applies to people who experience SARS-CoV-2 infection before receiving any vaccine dose and those who experience SARS-CoV-2 infection after the first dose of an mRNA vaccine but before receipt of the second dose. It was unknown when patient tested positive other than it was after 26Apr2021. There were no predisposing factors. The patient was due for the second dose yesterday (17May2021) and was asking if they need to wait for the second dose. The patient stated this appeared to be a not serious event; patient was not hospitalized and symptoms were mild and he was asymptomatic and had isolated for the 10 days. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, inefficacy of vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity between the first vaccine dose and the event onset. The case will be reevaluated should additional information become available.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Lower respiratory tract infection, Nasal congestion, Nasopharyngitis
Clinical narrative: cough; congestion; Scratchy Itchy Throat; chest cold; Head Cold; dizziness; nausea; This is a spontaneous report from a contactable consumer reported for herself. This 30-year-old patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 27Apr2021 13:30 (Lot Number: ER8735) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient felt a little bit of dizziness and nausea on 27Apr2021 (3-4 hours after vaccination), from which she recovered after 2 days. Currently, she is experiencing head cold 16May2021 18:00-19:00, chest cold, congestion, cough, and scratchy, itchy throat which started 16May2021 18:00, which she stated she got from her daughter. The event dizziness and nausea required a visit to Emergency Room. No Physician Office required. She would like to know if she may receive the 2nd dose of the covid vaccine although she currently has symptoms of a chest cold. She stated the congestion has worsened but they can still eat food, no nausea. Treatment for events chest cold, congestion, cough, head cold and scratchy, itchy throat included Vitamin C Pills, Drinking Vitamin C. The outcome of chest cold was unknown, outcome of dizziness and nausea was recovered on 29Apr2021, outcome of other events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Throat irritation
Clinical narrative: cough; congestion; Scratchy Itchy Throat; chest cold; Head Cold; dizziness; nausea; This is a spontaneous report from a contactable consumer reported for herself. This 30-year-old patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 27Apr2021 13:30 (Lot Number: ER8735) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient felt a little bit of dizziness and nausea on 27Apr2021 (3-4 hours after vaccination), from which she recovered after 2 days. Currently, she is experiencing head cold 16May2021 18:00-19:00, chest cold, congestion, cough, and scratchy, itchy throat which started 16May2021 18:00, which she stated she got from her daughter. The event dizziness and nausea required a visit to Emergency Room. No Physician Office required. She would like to know if she may receive the 2nd dose of the covid vaccine although she currently has symptoms of a chest cold. She stated the congestion has worsened but they can still eat food, no nausea. Treatment for events chest cold, congestion, cough, head cold and scratchy, itchy throat included Vitamin C Pills, Drinking Vitamin C. The outcome of chest cold was unknown, outcome of dizziness and nausea was recovered on 29Apr2021, outcome of other events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Haemoglobin, Heavy menstrual bleeding, Platelet count, Thrombocytopenia
Clinical narrative: thrombocytopenia (plt 92 000); menorrhagia; anemia (Hgb 11.8); This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 06May2021 07:00 (Batch/Lot Number: EW0T76) as single dose for COVID-19 immunisation. Medical history included acne. Historical vaccine INCLUDED 1ST dose of BNT162B2 (lot: ER8735) on 15Mar2021 via intramuscular in left arm for COVID-19 Immunization. The patient's concomitant medications were not reported. Patient experienced menorrhagia, thrombocytopenia (platelet 92 000), anemia (Hgb 11.8), all on 12May2021 with outcome of recovering. All events resulted in physician office visit. Treatment included iron supplement for anemia.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of thrombocytopenia. 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
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Hypersomnia, Lethargy, Lymph node pain, Swelling face
Clinical narrative: Face is swollen/face was puffy; complaining of pain in her throat glands/Glands under throat are painful; sleeping a lot; didn't really eat much; Very Lethargic; vomited once or twice/Vomiting; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for her daughter (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 13-years-old via an unspecified route of administration on 15May2021 15:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included ongoing reaction to bread. Concomitant medication included an unspecified anxiety medication. It was reported the patient received the first dose of the Pfizer COVID-19 vaccine on 15May2021, and the next day, 16May2021, she was sleeping a lot and vomited once or twice, didn't really eat much. This morning, 18May2021, she vomited and noticed face was puffy and complaining of pain in her throat glands, they will be taking her to her HCP this afternoon. Shee mentioned that she has had a reaction to bread, possible gluten intolerance, maybe yeast, and was asking if is there is yeast in the production of the vaccine. She got the vaccine on Saturday at 1530. It was further reported that for the first day or two she was very lethargic and vomiting on 15May2021. States they thought it was just a normal reaction. The reporter stated that today her daughter isn't in school again because she is vomiting, her face is swollen, and her glands under her throat hurt. States she is going to the doctor this afternoon. The patient did not recover from vomiting, was recovering from very lethargic while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Face is swollen/face was puffy; complaining of pain in her throat glands/Glands under throat are painful; sleeping a lot; didn't really eat much; Very Lethargic; vomited once or twice/Vomiting; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for her daughter (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 13-years-old via an unspecified route of administration on 15May2021 15:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included ongoing reaction to bread. Concomitant medication included an unspecified anxiety medication. It was reported the patient received the first dose of the Pfizer COVID-19 vaccine on 15May2021, and the next day, 16May2021, she was sleeping a lot and vomited once or twice, didn't really eat much. This morning, 18May2021, she vomited and noticed face was puffy and complaining of pain in her throat glands, they will be taking her to her HCP this afternoon. Shee mentioned that she has had a reaction to bread, possible gluten intolerance, maybe yeast, and was asking if is there is yeast in the production of the vaccine. She got the vaccine on Saturday at 1530. It was further reported that for the first day or two she was very lethargic and vomiting on 15May2021. States they thought it was just a normal reaction. The reporter stated that today her daughter isn't in school again because she is vomiting, her face is swollen, and her glands under her throat hurt. States she is going to the doctor this afternoon. The patient did not recover from vomiting, was recovering from very lethargic while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram normal, Dysstasia, Gait inability, Insomnia
Clinical narrative: Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could not lay down/sleep; Could not stand up/walk; Completely disabled in lower extremities; Could not walk w/o holding on to chair/counter; Something else going on with nerves; This is a spontaneous report from a contactable consumer(patient). This 57-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0153) at single dose on 14Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history was "none". Patient was completely healthy, no known allergies. Patient did not have covid prior vaccination.   No other vaccine in four weeks, prior to the COVID vaccine, no other medications in two weeks. Within 24 hours after Shot#1, patient could not walk without holding on to chair/counter. Within 48 hours, patient could not stand up/walk, pain from waist down so excruciating, patient began throwing up (lasted 3-4 days), could not lay down/sleep (for at least 3 weeks). Patient went to Emergency room, got x-rays, CT scans, blood workup, etc. All results normal.  Patient experienced undetermined cause of loss of mobility. 5 weeks later, patient was still unable to stand up on own, pain unbearable. No pain pills provided, just ibuprofen, Chiro adjusted her 3 times/week since, ice every 1-2 hrs, but it only able to alleviate some of the pain. Patient also reported something else going on with nerves. Patient needed to see a Nerve specialist. She was completely healthy/running/walking on day of shot and next day forward, completely disabled in lower extremities. Patient reported that she knew Shot 1 had done something damaging to her nerves. Adverse event start date was reported as 15Apr202110:00 AM, which resulted in Doctor or other healthcare Professional office/clinic visit, Emergency room/department or urgent care. Other treatment information was unknown. Patient did not have covid tested post vaccination. The report was assessed as non-serious. Outcome of the events was not resolved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal disorder, Nerve injury, Pain
Clinical narrative: Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could not lay down/sleep; Could not stand up/walk; Completely disabled in lower extremities; Could not walk w/o holding on to chair/counter; Something else going on with nerves; This is a spontaneous report from a contactable consumer(patient). This 57-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0153) at single dose on 14Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history was "none". Patient was completely healthy, no known allergies. Patient did not have covid prior vaccination.   No other vaccine in four weeks, prior to the COVID vaccine, no other medications in two weeks. Within 24 hours after Shot#1, patient could not walk without holding on to chair/counter. Within 48 hours, patient could not stand up/walk, pain from waist down so excruciating, patient began throwing up (lasted 3-4 days), could not lay down/sleep (for at least 3 weeks). Patient went to Emergency room, got x-rays, CT scans, blood workup, etc. All results normal.  Patient experienced undetermined cause of loss of mobility. 5 weeks later, patient was still unable to stand up on own, pain unbearable. No pain pills provided, just ibuprofen, Chiro adjusted her 3 times/week since, ice every 1-2 hrs, but it only able to alleviate some of the pain. Patient also reported something else going on with nerves. Patient needed to see a Nerve specialist. She was completely healthy/running/walking on day of shot and next day forward, completely disabled in lower extremities. Patient reported that she knew Shot 1 had done something damaging to her nerves. Adverse event start date was reported as 15Apr202110:00 AM, which resulted in Doctor or other healthcare Professional office/clinic visit, Emergency room/department or urgent care. Other treatment information was unknown. Patient did not have covid tested post vaccination. The report was assessed as non-serious. Outcome of the events was not resolved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could not lay down/sleep; Could not stand up/walk; Completely disabled in lower extremities; Could not walk w/o holding on to chair/counter; Something else going on with nerves; This is a spontaneous report from a contactable consumer(patient). This 57-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0153) at single dose on 14Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history was "none". Patient was completely healthy, no known allergies. Patient did not have covid prior vaccination.   No other vaccine in four weeks, prior to the COVID vaccine, no other medications in two weeks. Within 24 hours after Shot#1, patient could not walk without holding on to chair/counter. Within 48 hours, patient could not stand up/walk, pain from waist down so excruciating, patient began throwing up (lasted 3-4 days), could not lay down/sleep (for at least 3 weeks). Patient went to Emergency room, got x-rays, CT scans, blood workup, etc. All results normal.  Patient experienced undetermined cause of loss of mobility. 5 weeks later, patient was still unable to stand up on own, pain unbearable. No pain pills provided, just ibuprofen, Chiro adjusted her 3 times/week since, ice every 1-2 hrs, but it only able to alleviate some of the pain. Patient also reported something else going on with nerves. Patient needed to see a Nerve specialist. She was completely healthy/running/walking on day of shot and next day forward, completely disabled in lower extremities. Patient reported that she knew Shot 1 had done something damaging to her nerves. Adverse event start date was reported as 15Apr202110:00 AM, which resulted in Doctor or other healthcare Professional office/clinic visit, Emergency room/department or urgent care. Other treatment information was unknown. Patient did not have covid tested post vaccination. The report was assessed as non-serious. Outcome of the events was not resolved.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Hypertension, Malaise, Pain
Clinical narrative: She's thinking about not getting the second dose; Her blood pressure was "very high"; Her heart started beating very "strong"; Feeling unwell; Felt pain but did not specify where; Felt dizzy; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as 1st dose, single at 32 years old at the time of vaccination for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date on Apr2021 (reported as not sure if it is the correct date), three minutes after getting it, the patient started feeling unwell, she felt pain but did not specify where, she felt dizzy, her heart started beating very "strong", she was told at the clinic her blood pressure was "very high". The patient asked if she should get the second dose as she's thinking about not getting the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: She's thinking about not getting the second dose; Her blood pressure was "very high"; Her heart started beating very "strong"; Feeling unwell; Felt pain but did not specify where; Felt dizzy; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as 1st dose, single at 32 years old at the time of vaccination for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date on Apr2021 (reported as not sure if it is the correct date), three minutes after getting it, the patient started feeling unwell, she felt pain but did not specify where, she felt dizzy, her heart started beating very "strong", she was told at the clinic her blood pressure was "very high". The patient asked if she should get the second dose as she's thinking about not getting the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Palpitations
Clinical narrative: pulse go up to 180, even not being active; a racing heart rate ever since receiving the second Pfizer Covid vaccine; having chest pain; This is a spontaneous report received from a contactable nurse (patient). This 35-year-old female patient received the first dose of (BNT162B2, Lot number=EL3248) at single dose for COVID-19 immunisation on 23Jan2021 at 02:00 PM. Relevant history included  PCOS (Polycystic ovarian syndrome), seasonal allergies, migraines and known allergies: Aspartame and bee stings. Concomitant drugs included metformin, paracetamol (TYLENOL), multivitamin, aspirin, cetirizine hydrochloride (ZYRTEC). The patient previously received the first dose of BNT162B2, Lot number= EH9899, at single dose for COVID-19 immunisation on 02Jan2021. On 23Jan2021, the patient experienced chest pain and a racing heart rate ever since receiving the second Pfizer Covid vaccine. Her pulse would  go up to 180, even when she was not being active. No treatment was received. Outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: The contributory role of the suspect product BNT162B2, Lot number=EL3248) at single dose for COVID-19 immunisation to reported events is possible based on temporal association and known profile of the product.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Meningitis viral, SARS-CoV-2 test, Varicella zoster virus infection
Clinical narrative: Viral meningitis due to reactivation of the Varicella Zoster Virus.; Viral meningitis due to reactivation of the Varicella Zoster Virus.; This is a spontaneous report received from a contactable consumer(patient). This 58-year old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EW0161) at single dose on 16Apr2021 09:30 via an unknown route in left arm for Covid-19 immunization. Medical history included known allergies. No other vaccine in four weeks, no covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient received other medications in two weeks. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER2613) at single dose on 26Mar2021 11:00 AM, via an unknown route in right arm for Covid-19 immunization. Patient experienced adverse event of viral meningitis due to reactivation of the Varicella Zoster Virus on 16Apr2021 04:00 PM. The event resulted in Emergency room/department or urgent care. Treatment included intravenous Acyclovir every 8 hours from 20Apr2021- 21May2021. Outcome of the events was resolving. Since the vaccination, the patient had been tested for COVID-19. The report was assessed as non-serious.