chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Chills, Cold sweat, Condition aggravated
Clinical narrative: my asthma and allergies seemed to be triggered; chills; dizziness; chest pains; feeling of nausea; abdominal pain; bad headache/Today my head continues to hurt but my asthma and allergies seemed to be triggered; cold sweats; shortness of breath; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp.  A 51-years-old female Non Pregnant patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 21Sep2021 09:00 (Batch/Lot Number: Fe3592) as dose 1, single for covid-19 immunisation. Medical history included large intestine polyp, cough, dyspepsia, thyroid disorder, asthma, hypertension, iodine allergy. Concomitant medication(s) included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT). The patient previously took codeine and experienced drug hypersensitivity, Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] and experienced drug hypersensitivity, prednisone and experienced drug hypersensitivity.  The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced chills, dizziness, chest pains, feeling of nausea, abdominal pain, bad headache/today my head continues to hurt but my asthma and allergies seemed to be triggered, cold sweats, shortness of breath, diarrhoea, my asthma and allergies seemed to be triggered on 24Sep2021 with outcome of recovering. Treatment received for the adverse event Toradol, Reglan, Zofran, ECG 12 Lead, Lab test, Pretherapeutic measures were taken as a result of chills (chills), dizziness (dizziness), chest pains (chest pain), feeling of nausea (nausea), abdominal pain (abdominal pain), bad headache/today my head continues to hurt but my asthma and allergies seemed to be triggered (headache), cold sweats (cold sweat), shortness of breath (dyspnoea), diarrhoea (diarrhoea), my asthma and allergies seemed to be triggered (condition aggravated).  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: my asthma and allergies seemed to be triggered; chills; dizziness; chest pains; feeling of nausea; abdominal pain; bad headache/Today my head continues to hurt but my asthma and allergies seemed to be triggered; cold sweats; shortness of breath; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp.  A 51-years-old female Non Pregnant patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 21Sep2021 09:00 (Batch/Lot Number: Fe3592) as dose 1, single for covid-19 immunisation. Medical history included large intestine polyp, cough, dyspepsia, thyroid disorder, asthma, hypertension, iodine allergy. Concomitant medication(s) included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT). The patient previously took codeine and experienced drug hypersensitivity, Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] and experienced drug hypersensitivity, prednisone and experienced drug hypersensitivity.  The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced chills, dizziness, chest pains, feeling of nausea, abdominal pain, bad headache/today my head continues to hurt but my asthma and allergies seemed to be triggered, cold sweats, shortness of breath, diarrhoea, my asthma and allergies seemed to be triggered on 24Sep2021 with outcome of recovering. Treatment received for the adverse event Toradol, Reglan, Zofran, ECG 12 Lead, Lab test, Pretherapeutic measures were taken as a result of chills (chills), dizziness (dizziness), chest pains (chest pain), feeling of nausea (nausea), abdominal pain (abdominal pain), bad headache/today my head continues to hurt but my asthma and allergies seemed to be triggered (headache), cold sweats (cold sweat), shortness of breath (dyspnoea), diarrhoea (diarrhoea), my asthma and allergies seemed to be triggered (condition aggravated).  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Fatigue, Headache
Clinical narrative: Raised blood pressure 170/90; Nausea; Headache; Fever; Dizziness; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: 30130BT, Expiration date: Not reported), via an unspecified route of administration in right arm on 23Sep2021 (at the age of 40-years-old) as unknown dose, single for COVID-19 immunization in a pharmacy or drug store. The patient's medical history and concomitant medications were not reported. No relevant past drug history was reported. The patient 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. The patient experienced raised blood pressure of 170/90, nausea, headache, dizziness, fatigue and fever on 23Sep2021. These events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for these events and reported as no prolonged hospitalization. The case was reported as non-serious and the outcome of events was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Raised blood pressure 170/90; Nausea; Headache; Fever; Dizziness; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: 30130BT, Expiration date: Not reported), via an unspecified route of administration in right arm on 23Sep2021 (at the age of 40-years-old) as unknown dose, single for COVID-19 immunization in a pharmacy or drug store. The patient's medical history and concomitant medications were not reported. No relevant past drug history was reported. The patient 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. The patient experienced raised blood pressure of 170/90, nausea, headache, dizziness, fatigue and fever on 23Sep2021. These events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for these events and reported as no prolonged hospitalization. The case was reported as non-serious and the outcome of events was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Nervous system disorder
Clinical narrative: Gastrointestinal disorder; nervous system disorder; lymphatic system; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 26Jul2021 10:00 (age at the time of vaccination 38-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 05Jul2021 (age at the time of vaccination 38-years-old), as a single dose for COVID-19 immunization. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No known allergies. On 08Aug2021 13:00, the patient experienced Gastrointestinal disorder, nervous system disorder, and lymphatic system. On 18Sep2021, the patient underwent lab tests and procedures which included PCR, SARS-CoV-2 test: Negative, Nasal Swab. Adverse event resulted in emergency room/department or emergency room/department visit. No treatment was received for all adverse events. The outcome for all the events was not recovered.  Follow up (24Sep2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: translation of the complete attached Agency reports.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness neurosensory, Extra dose administered, Off label use, Tinnitus
Clinical narrative: Sudden Sensorineural Hearing Loss in left ear within 24 hour of receiving 3rd Pfizer Vaccine; Tinnitus in left ear; received a 3rd dose of the vaccine; received a 3rd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 70-year-old), dose 3 via an unspecified route of administration, administered in arm left on 06Sep2021 11:15 (Batch/Lot number was not reported) as DOSE 3, SINGLE for COVID-19 immunisation. The vaccine was given in a pharmacy or drug store.  Medical history included osteopenia treated with prolia; breast cancer and double mastectomy in 2007. Concomitant medications included ascorbic acid (VIT C); colecalciferol (VIT D3); calcium, magnesium (CALCIUM + MAGNESIUM); lipoic acid; silybum marianum (MILK THISTLE) and multivitamins. The patient previously took codeine and experienced nausea. Historical vaccine included BNT162B2 dose 1 and dose 2 on an unspecified date for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines within four weeks prior to COVID-19 vaccine. The patient had no covid prior vaccination. She had not been tested post vaccination. The patient experienced sudden sensorineural hearing loss in left ear within 24 hour of receiving 3rd pfizer vaccine and tinnitus in left ear on 07Sep2021 07:00 with outcome of not recovered. It was reported that the patient received a 3rd dose of the vaccine on 06Sep2021 11:15. Therapeutic measures were taken as sensorineural hearing loss and tinnitus in left ear with prednisone; IT Steroids. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Chest X-ray normal, Deafness neurosensory, Deafness unilateral
Clinical narrative: Sudden Sensorineural Hearing Loss in left ear within 24 hour of receiving 3rd Pfizer Vaccine; Tinnitus in left ear; received a 3rd dose of the vaccine; received a 3rd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 70-year-old), dose 3 via an unspecified route of administration, administered in arm left on 06Sep2021 11:15 (Batch/Lot number was not reported) as DOSE 3, SINGLE for COVID-19 immunisation. The vaccine was given in a pharmacy or drug store.  Medical history included osteopenia treated with prolia; breast cancer and double mastectomy in 2007. Concomitant medications included ascorbic acid (VIT C); colecalciferol (VIT D3); calcium, magnesium (CALCIUM + MAGNESIUM); lipoic acid; silybum marianum (MILK THISTLE) and multivitamins. The patient previously took codeine and experienced nausea. Historical vaccine included BNT162B2 dose 1 and dose 2 on an unspecified date for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines within four weeks prior to COVID-19 vaccine. The patient had no covid prior vaccination. She had not been tested post vaccination. The patient experienced sudden sensorineural hearing loss in left ear within 24 hour of receiving 3rd pfizer vaccine and tinnitus in left ear on 07Sep2021 07:00 with outcome of not recovered. It was reported that the patient received a 3rd dose of the vaccine on 06Sep2021 11:15. Therapeutic measures were taken as sensorineural hearing loss and tinnitus in left ear with prednisone; IT Steroids. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Full blood count abnormal, Hyperacusis, Magnetic resonance imaging normal, Platelet count decreased
Clinical narrative: Sudden Sensorineural Hearing Loss in left ear within 24 hour of receiving 3rd Pfizer Vaccine; Tinnitus in left ear; received a 3rd dose of the vaccine; received a 3rd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 70-year-old), dose 3 via an unspecified route of administration, administered in arm left on 06Sep2021 11:15 (Batch/Lot number was not reported) as DOSE 3, SINGLE for COVID-19 immunisation. The vaccine was given in a pharmacy or drug store.  Medical history included osteopenia treated with prolia; breast cancer and double mastectomy in 2007. Concomitant medications included ascorbic acid (VIT C); colecalciferol (VIT D3); calcium, magnesium (CALCIUM + MAGNESIUM); lipoic acid; silybum marianum (MILK THISTLE) and multivitamins. The patient previously took codeine and experienced nausea. Historical vaccine included BNT162B2 dose 1 and dose 2 on an unspecified date for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines within four weeks prior to COVID-19 vaccine. The patient had no covid prior vaccination. She had not been tested post vaccination. The patient experienced sudden sensorineural hearing loss in left ear within 24 hour of receiving 3rd pfizer vaccine and tinnitus in left ear on 07Sep2021 07:00 with outcome of not recovered. It was reported that the patient received a 3rd dose of the vaccine on 06Sep2021 11:15. Therapeutic measures were taken as sensorineural hearing loss and tinnitus in left ear with prednisone; IT Steroids. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Sudden Sensorineural Hearing Loss in left ear within 24 hour of receiving 3rd Pfizer Vaccine; Tinnitus in left ear; received a 3rd dose of the vaccine; received a 3rd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 70-year-old), dose 3 via an unspecified route of administration, administered in arm left on 06Sep2021 11:15 (Batch/Lot number was not reported) as DOSE 3, SINGLE for COVID-19 immunisation. The vaccine was given in a pharmacy or drug store.  Medical history included osteopenia treated with prolia; breast cancer and double mastectomy in 2007. Concomitant medications included ascorbic acid (VIT C); colecalciferol (VIT D3); calcium, magnesium (CALCIUM + MAGNESIUM); lipoic acid; silybum marianum (MILK THISTLE) and multivitamins. The patient previously took codeine and experienced nausea. Historical vaccine included BNT162B2 dose 1 and dose 2 on an unspecified date for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines within four weeks prior to COVID-19 vaccine. The patient had no covid prior vaccination. She had not been tested post vaccination. The patient experienced sudden sensorineural hearing loss in left ear within 24 hour of receiving 3rd pfizer vaccine and tinnitus in left ear on 07Sep2021 07:00 with outcome of not recovered. It was reported that the patient received a 3rd dose of the vaccine on 06Sep2021 11:15. Therapeutic measures were taken as sensorineural hearing loss and tinnitus in left ear with prednisone; IT Steroids. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke about 2 weeks after first dose; This is a spontaneous report from a contactable consumer.  A 74-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jun2021 (Batch/Lot Number: EW0191) and second dose via an unspecified route of administration on 15Jul2021 (lot# EW0191) both as single dose (at the age of 74) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included cerebrovascular accident from an unknown date and unknown if ongoing (a while back). There were no concomitant medications. The patient experienced stroke about 2 weeks after first dose on 09Jul2021. The outcome was recovering. It was reported the patient had stroke about 2 weeks after first dose and stroke less than 2 months after second dose and was hospitalized for stroke about 2 weeks after first dose from 2021 to an unknown date.   The treatment includes hospitalization and rehab. The outcome of the events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Drug hypersensitivity, Dyspnoea, Lip swelling
Clinical narrative: having an allergic reaction; Tongue and lips swelling; Tongue and lips swelling; covered in hives; itchy; trouble breathing; chest and back pains; chest and back pains; Stinging/stabbing; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: FF8841), via an unspecified route of administration in left arm on 21Sep2021 at 13:15 (at the age of 28 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient had no known allergies. There were no concomitant medications. The patient did not receive other medications in two weeks. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 22Sep2021 at 4:30 am she woke up around the morning after the shot having an allergic reaction. Tongue and lips swelling, covered in hives, itchy, trouble breathing. She used a primatene mist inhaler and chewed 50 mg of benedryl and began to get better shortly after. The next day she started having right side chest and back pains. Stinging/stabbing. Which have not subsided. Therapeutic measures were taken as a result of having an allergic reaction, tongue and lips swelling, covered in hives, itchy, trouble breathing, chest and back pains, stinging/stabbing. Treatment received at home from herself. No hospitalization required. Reporter considered events as non-serious. The chest and back pains, stinging/stabbing was not recovered, while with other events was recovering.  Follow-Up (30Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swollen tongue, Urticaria
Clinical narrative: having an allergic reaction; Tongue and lips swelling; Tongue and lips swelling; covered in hives; itchy; trouble breathing; chest and back pains; chest and back pains; Stinging/stabbing; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot Number: FF8841), via an unspecified route of administration in left arm on 21Sep2021 at 13:15 (at the age of 28 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient had no known allergies. There were no concomitant medications. The patient did not receive other medications in two weeks. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 22Sep2021 at 4:30 am she woke up around the morning after the shot having an allergic reaction. Tongue and lips swelling, covered in hives, itchy, trouble breathing. She used a primatene mist inhaler and chewed 50 mg of benedryl and began to get better shortly after. The next day she started having right side chest and back pains. Stinging/stabbing. Which have not subsided. Therapeutic measures were taken as a result of having an allergic reaction, tongue and lips swelling, covered in hives, itchy, trouble breathing, chest and back pains, stinging/stabbing. Treatment received at home from herself. No hospitalization required. Reporter considered events as non-serious. The chest and back pains, stinging/stabbing was not recovered, while with other events was recovering.  Follow-Up (30Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Seizure
Clinical narrative: Almost immediately lost vision; Had a seizure for about 5 seconds; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 26Sep2021 at 10:45 (Batch/Lot Number: FF2589) as dose 1, single (at the age of 22 years-old) for Covid-19 immunisation. Medical history was not reported. There were no concomitant medications. No other medications in four weeks. Pharmacy did not monitor after the vaccine was administered. The patient came out to the car and almost immediately lost vision and had a seizure for about 5 seconds on 26Sep2021 at 11:15 AM. The patient had no Covid prior to the vaccination and Covid was not tested post vaccination. No treatment was administered for the events. The outcome of the events was unknown. The events resulted in: Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I received both of my Pfizer Covid shots. I believe I had Covid few weeks back; I believe I had Covid few weeks back; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender (age 77, unit not specified) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. The patient's medical history includes COPD. The patient concomitant medications were not reported. On an unknown date, the patient had Covid few weeks back. It was reported that the patient received both Pfizer COVID shot and going to take part in Covid booster trial starting next week. The patient queried if any research going on about patient condition with regards to his level of immunization.  No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint injury
Clinical narrative: she twisted her ankle; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Right on 03Sep2021 as single dose for covid-19 immunisation. Medical history and concomitant medication were not none. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm left on 13Aug2021 at 14.00 as single dose for covid-19 immunisation that was not kept at proper storage temperatures that may have been thawed and then refrozen and experienced left arm sore and bruised. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the Pfizer covid vaccine. On unspecified date in Sep2021, she twisted her ankle. Therapeutic measures were taken as a result of she twisted her ankle and she started with diclofenac 75mg tablet, 1 tablet twice a day with food. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anger, Frustration tolerance decreased, Poor quality product administered, Product storage error
Clinical narrative: she twisted her ankle; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Right on 03Sep2021 as single dose for covid-19 immunisation. Medical history and concomitant medication were not none. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm left on 13Aug2021 at 14.00 as single dose for covid-19 immunisation that was not kept at proper storage temperatures that may have been thawed and then refrozen and experienced left arm sore and bruised. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the Pfizer covid vaccine. On unspecified date in Sep2021, she twisted her ankle. Therapeutic measures were taken as a result of she twisted her ankle and she started with diclofenac 75mg tablet, 1 tablet twice a day with food. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Head discomfort, Meniere's disease, Oral discomfort, Pyrexia
Clinical narrative: Menieres disease; Boil in mouth; Stomach ache; Head felt very heavy, spacey; Low grade fever 24 hours post injection.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 23Sep2021 at the age of 44-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Aug2021 at the age of 44-year-old as dose 1, single for covid-19 immunisation. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 24Sep2021, patient experienced boil in mouth, stomach ache, head felt "very heavy, spacey"; caused meniere's disease to act up.  low grade fever 24 hours post injection. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2021. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Menieres disease; Boil in mouth; Stomach ache; Head felt very heavy, spacey; Low grade fever 24 hours post injection.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 23Sep2021 at the age of 44-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Aug2021 at the age of 44-year-old as dose 1, single for covid-19 immunisation. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 24Sep2021, patient experienced boil in mouth, stomach ache, head felt "very heavy, spacey"; caused meniere's disease to act up.  low grade fever 24 hours post injection. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2021. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: The first time she had a "little flare up" that took her a couple of months to return to normal from; This is a spontaneous report from a contactable other health care professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included unable to get up or get out of bed, joint plus ligaments painful, little swollen places on the bottoms of feet, rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 2020 to an unspecified stop date. The patient experienced a little flare up that took her a couple of months to return to normal from. The outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the event Rheumatoid Arthritis and suspected drug cannot be excluded.  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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysmenorrhoea, Headache, Myalgia, Pyrexia
Clinical narrative: Excessive discharge of fresh flowing blood occurred from the vagina/I also had vaginal discharge of clotted blood; menstrual cramps; fever (102F); Chills; muscle aches; persistent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Sep2021 15:30 (Batch/Lot Number: EW0179) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included illness from Oct2020 to Nov2020 Identifiable symptoms of the COVID-19 disease. During that period of sickness, the patient's female reproductive cycle was not affected. Following the first shot of Pfizer on 17Sep2021 the patient started experiencing adverse effects.  It began approximately three (3) hours (18:30) following the shot. Excessive discharge of fresh flowing blood occurred from the vagina, which did not lessen until the following day.  In those first several hours of bleeding, the patient also had vaginal discharge of clotted blood.  For seven days, the patient continued to have minimal amounts of vaginal discharge and menstrual cramps. In relation to her menstrual cycle, these adverse side effects took place during the beginning of my proliferative phase. For approximately forty-eight (48) hours following the shot, the patient experienced similar side effects that have been previously reported by Pfizer: fever (102F), chills, muscle aches, and a persistent headache. The patient underwent lab tests and procedures which included pyrexia: 102 fahrenheit on Sep2021. The patient did not receive treatment for the events. It was unknown if patient had covid prior vaccination. The patient was not covid tested post vaccination. The outcome of the events was recovered in Sep2021.   Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Excessive discharge of fresh flowing blood occurred from the vagina/I also had vaginal discharge of clotted blood; menstrual cramps; fever (102F); Chills; muscle aches; persistent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Sep2021 15:30 (Batch/Lot Number: EW0179) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included illness from Oct2020 to Nov2020 Identifiable symptoms of the COVID-19 disease. During that period of sickness, the patient's female reproductive cycle was not affected. Following the first shot of Pfizer on 17Sep2021 the patient started experiencing adverse effects.  It began approximately three (3) hours (18:30) following the shot. Excessive discharge of fresh flowing blood occurred from the vagina, which did not lessen until the following day.  In those first several hours of bleeding, the patient also had vaginal discharge of clotted blood.  For seven days, the patient continued to have minimal amounts of vaginal discharge and menstrual cramps. In relation to her menstrual cycle, these adverse side effects took place during the beginning of my proliferative phase. For approximately forty-eight (48) hours following the shot, the patient experienced similar side effects that have been previously reported by Pfizer: fever (102F), chills, muscle aches, and a persistent headache. The patient underwent lab tests and procedures which included pyrexia: 102 fahrenheit on Sep2021. The patient did not receive treatment for the events. It was unknown if patient had covid prior vaccination. The patient was not covid tested post vaccination. The outcome of the events was recovered in Sep2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Erythema, Illness, Influenza like illness, Interchange of vaccine products, Lymphoedema
Clinical narrative: lymphedema in her left arm; her left arm that will become red and blotchy at times; slight redness on her arm; her left arm that will become red and blotchy at times; sick; The first two doses of her Moderna COVID vaccine; The first two doses of her Moderna COVID vaccine; she had the flu for about a day and a half; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and received influenza vaccine (FLU VACCINE VII; Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at DOSE NUMBER UNKNOWN, SINGLE for immunisation. Medical history included that she gets an injection for her bones every three months. The patient's concomitant medications were not reported. Patient previously received first and second dose of Moderna COVID-19 vaccine via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation which caused slight redness on her arm but no other reaction. The patient stated that when she received her booster shot she also got her flu vaccine. Patient stated she had quite the reaction to the combination of the two and felt like she had the flu for about a day and a half. Patient has lymphedema in her left arm that will become red and blotchy at times when she was sick. She thinks this was due to the flu vaccine or the combination of the two. The outcome of all 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, FLUX
Symptoms: Off label use, Rash macular
Clinical narrative: lymphedema in her left arm; her left arm that will become red and blotchy at times; slight redness on her arm; her left arm that will become red and blotchy at times; sick; The first two doses of her Moderna COVID vaccine; The first two doses of her Moderna COVID vaccine; she had the flu for about a day and a half; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and received influenza vaccine (FLU VACCINE VII; Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at DOSE NUMBER UNKNOWN, SINGLE for immunisation. Medical history included that she gets an injection for her bones every three months. The patient's concomitant medications were not reported. Patient previously received first and second dose of Moderna COVID-19 vaccine via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation which caused slight redness on her arm but no other reaction. The patient stated that when she received her booster shot she also got her flu vaccine. Patient stated she had quite the reaction to the combination of the two and felt like she had the flu for about a day and a half. Patient has lymphedema in her left arm that will become red and blotchy at times when she was sick. She thinks this was due to the flu vaccine or the combination of the two. The outcome of all the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding from 2nd injection site for hours.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 23Sep2021 20:30 (at the age of 45-year-old) (Lot Number: FC3184) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included low iron; borderline diabetic in 1990s and allergy to latex bandages & fruits strawberries, figs. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hypersensitivity, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01Sep2021 13:15 (at the age of 45-year-old) (Lot Number: FC3184) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced bleeding from 2nd injection site for hours on 23Sep2021 20:45. The patient did not receive treatment for the event. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Polymenorrhoea, Uterine spasm
Clinical narrative: period starting with heavy bleeding within 4 hours of the vaccination (5 days early).; period starting with heavy bleeding within 4 hours of the vaccination (5 days early).; Uterine cramping; Headache; This is a spontaneous report from a contactable other health care professional (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: 301308A and expiration date: not reported), via an unspecified route of administration, in Left Arm, on Sep2021 at 11:00 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunization in Pharmacy or Drug Store.  Medical history included depression, constipation and covid-19. The patient had no known allergies. Concomitant medications included venlafaxine and docusate. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On Sep2021, at 03:45 reported as within 4 hours of the vaccination, The patient experienced Uterine cramping and period starting with heavy bleeding (5 days early). Headache that has been daily for one week, comes back when medications wear off, does improve on tylenol and ibuprofen. The outcome of the events was recovering at time of report.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID reaction; COVID reaction; This is a spontaneous report from a non-contactable consumer via the Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced COVID reaction (drug ineffective). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in her legs after taking the covid vaccine.; This is a spontaneous report from a contactable physician. A adult non pregnant female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine and other medications the patient received within 2 weeks of vaccination. It was unknown whether the patient was diagnosed with covid prior to vaccination or was tested for COVID-19 post vaccination. The patient experienced neuropathy in her legs after taking the covid vaccine. Patient was seeing neurologist, who said that he is seeing several patients who are experiencing neuropathy after their covid shots. The reporter was not sure which vaccine patient took. The patient did not receive any treatment in response to the event. The outcome of the event was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and peripheral neuropathy cannot be completely excluded. 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, SARS-CoV-2 test, Vertigo
Clinical narrative: I was at an Urgent Care 3 days after my second dose, where I was diagnosed with Vertigo; After receiving both doses, I have been feeling fatigued/ tired; And extremely dizzy; Sometimes I get nauseous from the dizziness; This is a spontaneous report from a contactable other Health Care Professional (patient). A 33-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on 07Sep2021 06:45 (at the age of 33-year-old) (Lot Number: EN6202) as dose 2, single for COVID-19 immunization. The vaccine was administered in a hospital. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 16Aug2021 06:00 (at the age of 32-year-old) (Lot Number: not reported) as dose 1, single for COVID-19 immunization and experienced fatigue, dizziness and nausea. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient has been feeling fatigued and extremely dizzy. Patient was at an urgent care 3 days after her second dose, where she was diagnosed with vertigo. The patient reported that she never had any health issues. After over 2 weeks since vaccine dose 2, the patient was still experiencing symptoms and had thought that it would have just lasted the first few days of vaccination. The patient reported that she sometimes get nauseous from the dizziness. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the event vertigo and other reported events  and the suspect drug BNT162B2. 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.