chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was tested for COVID and she tested positive for the virus; was tested for COVID and she tested positive for the virus; This is a spontaneous report from a contactable consumer.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization.  Medical history included cancer, she had her stomach or whatever operated on.  The patient's concomitant medications were not reported.  The patient was tested for covid and she tested positive for the virus on 24Jan2021, she felt terrible, but she was still just in her home, with like a plastic covering over her door. She was instructed to just take paracetamol (TYLENOL) and Zinc. The outcome of the events was unknown. Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Suicide attempt
Clinical narrative: attempted to kill herself; acting differently; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient's parent) reported a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization this morning (03Feb2021). Medical history included: autism, depression and anxiety. Concomitant medication was not reported. The patient experienced acting differently and she attempted to kill herself after the first dose of the vaccine today (03Feb2021). Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.  Information on Lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration at Right Arm on 27Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced right arm pain on 28Jan2021. The date of her second schedule dose on 17Feb2021. The outcome was recovered on 28Jan2021.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal disorder, Vomiting
Clinical narrative: Gastrointestinal issues; threwup/vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (patient's daughter).  A 96-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9264, expiry date unknown) in the hospital via an unspecified route of administration on 28Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient was concomitantly taking hydrochlorothiazide (manufacturer unknown) for blood pressure.  It was reported that the patient seemed to be okay after receiving the first vaccination when they came home that day but today, Saturday, 30Jan2021, 2 days later, she has had some gastrointestinal issues, she threw up this morning in her bed and now she has a case of diarrhea. The patient doesn't seem to have any fever, she is cool. She doesn't seem to have any respiratory problems but mostly this is gastrointestinal problems. The patient is alert but she had a bout of vomiting and diarrhea on 30Jan2021. The reporter was wondering if the agent had any thoughts about whether or not this was the reaction to the vaccine or something else. The patient did not receive treatment for the events.  The outcome of the events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a non-contactable consumer (reporting for himself).  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE (right arm, dose 1) for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms from an unspecified date. Patient did not have COVID prior vaccination. Patient was not tested post vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced vomiting on 30Jan2021. No treatment was provided. Event outcome was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262 and expiration date not provided), via an unspecified route of administration (left arm) second dose on 28Jan2021 11:00 at single dose for Covid-19 immunization. The patient's medical history included Seasonal allergies, allergic asthma, Allergies: Penicillin, and Allergies: Grapefruit. The patient was not pregnant at the time of vaccination. The patient's concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE). The patient's historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 expiration date not provided) first dose on 07Jan2021 left arm (age at the time of vaccination was 31-year-old) for Covid-19 immunization. On 29Jan2021 11:00, the patient experienced Swollen lymph nodes (left armpit). The patient did not received treatment for the event. The outcome of the event was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, Dizziness, Liver function test, Migraine
Clinical narrative: I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown.   Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain in the joint of the arm that the shot was given and in the shoulder/Throbbing in the shoulder; Pinky finger was red and swollen; Pinky finger was red and swollen /Finger is swollen down to the knuckle; Very uncomfortable; Reluctant to use that arm because it is painful; This is a spontaneous report from a contactable consumer reporting for her husband.   A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246, expiry date unknown) via an unspecified route of administration on 26Jan2021 at single dose into his arm (shoulder) for COVID-19 immunization.  Medical history included wheelchair user, nephrectomy on an unspecified date, previous immunotherapy (unspecified medication, first dose in Dec2019, second dose in Mar2020) and side effects (Bullous pemphigoid, it's blistering of the skin) from the immunotherapy. The patient had a test for kidney function in Jan2021, results not reported. The patient received the vaccine on 26Jan2021 and he experienced severe pain in the joint of the arm that the shot was given, in his shoulder and his pinky finger was red and swollen and that finger was swollen down to the knuckle. He was very uncomfortable and he said it was throbbing in the shoulder and he was reluctant to use that arm because it was painful. The event onset date was 29Jan2021. The patient was given paracetamol (TYLENOL) as treatment. The result of the events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Renal function test
Clinical narrative: Severe pain in the joint of the arm that the shot was given and in the shoulder/Throbbing in the shoulder; Pinky finger was red and swollen; Pinky finger was red and swollen /Finger is swollen down to the knuckle; Very uncomfortable; Reluctant to use that arm because it is painful; This is a spontaneous report from a contactable consumer reporting for her husband.   A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246, expiry date unknown) via an unspecified route of administration on 26Jan2021 at single dose into his arm (shoulder) for COVID-19 immunization.  Medical history included wheelchair user, nephrectomy on an unspecified date, previous immunotherapy (unspecified medication, first dose in Dec2019, second dose in Mar2020) and side effects (Bullous pemphigoid, it's blistering of the skin) from the immunotherapy. The patient had a test for kidney function in Jan2021, results not reported. The patient received the vaccine on 26Jan2021 and he experienced severe pain in the joint of the arm that the shot was given, in his shoulder and his pinky finger was red and swollen and that finger was swollen down to the knuckle. He was very uncomfortable and he said it was throbbing in the shoulder and he was reluctant to use that arm because it was painful. The event onset date was 29Jan2021. The patient was given paracetamol (TYLENOL) as treatment. The result of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing acid reflux, ongoing Meniere's disease, and unspecified health issues. Concomitant medication included rivaroxaban (XARELTO). On 25Jan2021, a couple of days later from vaccination, the patient had nausea. She wanted to know if the nauseous feeling had to do with the vaccine or the acid reflux or the Meniere's. The patient asked whether she should get the second shot if she is not feeling well on 13Feb2021, which is when she is supposed to get the second shot. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing acid reflux, ongoing Meniere's disease, and unspecified health issues. Concomitant medication included rivaroxaban (XARELTO). On 25Jan2021, a couple of days later from vaccination, the patient had nausea. She wanted to know if the nauseous feeling had to do with the vaccine or the acid reflux or the Meniere's. The patient asked whether she should get the second shot if she is not feeling well on 13Feb2021, which is when she is supposed to get the second shot. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Lacrimation increased, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient's wife.  A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Jan2021 (at the age of 68-years-old) as a single dose for COVID-19 vaccination.  The patient's medical history included stroke on an unknown date. It was also reported that the patient was exposed to someone diagnosed with COVID-19 after receiving the vaccination (Jan2021); but the patient had not been tested for COVID-19.  Concomitant medications were not reported.  In Jan2021, after the vaccination, the patient experienced watery eyes, runny nose, a slight cough, and stomach pain.  The patient went to the walk-in clinic for the watery eyes and runny nose. He was given unspecified medication for the slight cough.  The clinical outcomes of the watery eyes, runny nose, and slight cough were recovered in Jan2021; while that of the stomach pain was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiratory failure, Respiratory failure, SARS-CoV-2 test
Clinical narrative: respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care, hospitalization, and patient died.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association.  More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality assessment.   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 RA, IEC, as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller's mother received both doses of the Pfizer covid vaccine; within a month of receiving the vaccine, the caller's mother died.; This is a spontaneous report from a contactable consumer reported for the mother.   A female patient of unknown age received both doses of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown dates at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Within a month of receiving the vaccine, the patient died. It was unknown if an autopsy was performed.   Information on the Lot/Batch number has been requested ; Reported Cause(s) of Death: within a month of receiving the vaccine, the caller's mother died
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bladder disorder, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak,  I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none.  There were no concomitant medications.  The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered.   The information on the batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Near death experience, Pain in extremity, Vomiting
Clinical narrative: At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak,  I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none.  There were no concomitant medications.  The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered.   The information on the batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Defaecation urgency, Dizziness, Dysstasia, Gait inability, Hyperhidrosis
Clinical narrative: At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak,  I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none.  There were no concomitant medications.  The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered.   The information on the batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Micturition urgency, Nausea, Paralysis
Clinical narrative: At 4am I woke up sweating/sweating profusely; nausea/extremely nauseous; dizziness/dizzy/extremely dizzy; vomit; lost bladder control; I was very weak,  I couldn't wipe. I couldn't hold a cloth/had no hand strength; terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life; a little arm pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at deltoid left on 26Jan2021 at 13:20 (at the age of 73 years) at single dose for COVID-19 immunization. The patient medical history was none.  There were no concomitant medications.  The patient reported a little arm pain on 26Jan2021, I woke up sweating/sweating profusely, nausea/extremely nauseous, dizziness/dizzy/extremely dizzy and vomit , all on 27Jan2021 at 4:00; lost bladder control, terrified, I thought I was dying never experienced anything like this in my life/ she did not know if she was dying, she thought she it was possible, she never felt that way in her life, and those are classic heart attack symptoms, she had no cardio and respiratory symptoms; I was very weak, I couldn't wipe. I couldn't hold a cloth/had no hand strength, all on 27Jan2021. Therapeutic measures were taken as result of little arm pain an included treatment with aspirin. The patient outcome of the events was recovered.   The information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Unresponsive to stimuli
Clinical narrative: Fever; unresponsive; This is a spontaneous report from a non-contactable consumer.   An elderly male patient received the second BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 11Feb2021 for covid-19 immunisation .  The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 12Feb2021, the patient developed fever, unresponsive. The events required a visit to the emergency room. The patient  was hospitalized and condition was life threatening. Therapeutic measures were taken as a result of fever and unresponsive. The outcome of the events was not recovered.   No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: faint; slightly dizzy; weak; This is a spontaneous report from a contactable nurse (patient). A 92-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL9262), intramuscular in the left arm on 01Feb2021 12:30 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 02Feb2021 16:00, the patient faint, slightly dizzy, weak and had to grab counter. Within 5-10 minutes it was gone and she was feeling fine. The patient added that it would have been serious if she hit the floor, but she did not. The outcome of the events was recovered on 02Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events faint, slightly dizzy and weak with BNT162b2 can not 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.
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: deafened her for ten minutes; This is a spontaneous report from a contactable consumer patient. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient got the vaccine on an unspecified date and it deafened her for ten minutes. She was not sure if that was a side effect that she should be worried about. The patient recovered from the event on an unspecified date.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and bright red/Felt like my head was on fire; Body ache all night; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 02Feb2021 at single dose (Right arm) for COVID-19 immunization. Medical history included Mild Asthma and Known allergies: Penicillin, Sulfa, Levoquin. Patient is not pregnant. Concomitant medication included prednisone (short course). The patient previously took bnt162b2 for COVID-19 immunization {product=COVID 19, brand=Pfizer,lot number=EJ1686, lot unknown=False, administration date=12Jan2021, vaccine location=Right arm, dose number=1}. It was reported that the patient started light headed, then sharp chest pain, fluttering heart, hard to take a breath. Face turned hot and bright red. Felt like my head was on fire. Body ache all night. Started happening about 3 hours after vaccine dose. Events started on 02Feb2021 13:00. Did not go to ER, no treatment. Stayed home and rested. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: fluttering heart; Started light headed; sharp chest pain; hard to take a breath; Face turned hot and bright red/Felt like my head was on fire; Body ache all night; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265, expiry date: unknown), via an unspecified route of administration on 02Feb2021 at single dose (Right arm) for COVID-19 immunization. Medical history included Mild Asthma and Known allergies: Penicillin, Sulfa, Levoquin. Patient is not pregnant. Concomitant medication included prednisone (short course). The patient previously took bnt162b2 for COVID-19 immunization {product=COVID 19, brand=Pfizer,lot number=EJ1686, lot unknown=False, administration date=12Jan2021, vaccine location=Right arm, dose number=1}. It was reported that the patient started light headed, then sharp chest pain, fluttering heart, hard to take a breath. Face turned hot and bright red. Felt like my head was on fire. Body ache all night. Started happening about 3 hours after vaccine dose. Events started on 02Feb2021 13:00. Did not go to ER, no treatment. Stayed home and rested. The outcome of the events was recovering.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Hypoaesthesia, Muscular weakness
Clinical narrative: dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, SARS-CoV-2 test
Clinical narrative: dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Chest X-ray, Condition aggravated, Pneumonia, Pneumothorax
Clinical narrative: Hospitalized in Jul2020 for this with double pneumonia; Hospitalized in Jul2020 for this with double pneumonia; left lung collapsed; for another chest X-ray to see the damage that COVID has done; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (age at vaccination was reported as "in her 50s" received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported) and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (Manufacturer unknown, lot number and expiration date were not reported); both via unspecified routes of administration on unspecified dates at a single dose for immunization. Medical history included pneumonia for 7 times. Family history includes father has heart disease; has a defibrillator; pacemaker and celiac disease. Cancer runs in her family. All of her sisters have had breast cancer, all of her cousins have had breast cancer, all 3 of her aunts died of breast cancer; and another aunt died of leukemia myeloma acute. It was reported that the patient was hospitalized in Jul2020 for double pneumonia, left lung collapsed. Because had double pneumonia and collapsed lung she has to see a pulmonologist for another chest X-ray to see the damage that COVID has done (pending clarification). It was mentioned that the patient had pneumonia like 7 times in the past so she is susceptible. Because of this history she has gotten the pneumonia vaccine and Prevnar 13 vaccine. Prevnar 13 when she was too young, in her 50s like 4-5 years ago because had pneumonia so many times. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Echocardiogram, Fall, Hip fracture, SARS-CoV-2 test
Clinical narrative: fell and broke his hip; fell and broke his hip; tested positive for COVID-19; This is a spontaneous report from a contactable consumer.  An 80-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot EL1283, expiry date 30Apr2021), intramuscular in right arm on 22Jan2021 10:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing Parkinson's disease diagnosed in Jan 2018 and the Neurologist said that the patient probably had it for 6-8 years; ongoing hypertension (its been years); had cardiac and thyroid disorder. The patient was on unspecified medication for his thyroid. The patient fell and broke his hip on 02Feb2021 08:30 and was hospitalized. It was reported that he will have a surgery. The patient underwent laboratory test Sars-cov-2 test: positive on 02Feb2021, weight: 170-175 lbs on unknown date. He also had an echocardiogram a couple of weeks ago (2021) because he was seeing a new heart doctor. The doctor did say that he had a mild leaky aorta and will continue just the medication he was on. He was scheduled to receive the second vaccine on 12Feb2021. The outcome of events was unknown.  No further details were provided or obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: fell and broke his hip; fell and broke his hip; tested positive for COVID-19; This is a spontaneous report from a contactable consumer.  An 80-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot EL1283, expiry date 30Apr2021), intramuscular in right arm on 22Jan2021 10:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing Parkinson's disease diagnosed in Jan 2018 and the Neurologist said that the patient probably had it for 6-8 years; ongoing hypertension (its been years); had cardiac and thyroid disorder. The patient was on unspecified medication for his thyroid. The patient fell and broke his hip on 02Feb2021 08:30 and was hospitalized. It was reported that he will have a surgery. The patient underwent laboratory test Sars-cov-2 test: positive on 02Feb2021, weight: 170-175 lbs on unknown date. He also had an echocardiogram a couple of weeks ago (2021) because he was seeing a new heart doctor. The doctor did say that he had a mild leaky aorta and will continue just the medication he was on. He was scheduled to receive the second vaccine on 12Feb2021. The outcome of events was unknown.  No further details were provided or obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Delirium, Flushing, Myalgia
Clinical narrative: delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.    On 28-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route were not provided; lot# was S038700 and expiration date was 12-JAN-2021) 0.5 milliliter after temperature excursion for prophylaxis (product storage error). No additional adverse event (AE) was reported.         The administered doses experienced a temperature excursion at -13.8 degree Celsius and time frame for temperature excursion was 41 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No additional AE reported; PROQUAD was administered on 2/3/2021 and expired on 1/19/2021; This spontaneous report was received from a patient of unknown age referring to himself/herself. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.      On 03-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were not provided; lot# was S022917 and expiration date was 19-JAN-2021) 0.5 ml for prophylaxis (expired product administered). No additional adverse event (AE) was reported (no adverse event). The outcome of the events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: chronic herpes zoster; postherpetic neuralgia; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prevention of shingles (herpes zoster).  On an unspecified date, subsequent to the patient vaccination, the patient presented herpes zoster and post herpetic neuralgia. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not present prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: zoster related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old patient, gender unspecifed. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 26-MAY-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions at a pharmacist. On an unspecified date, the patient experienced injury to themselves (Ill-defined disorder). On an unspecified date, the patient was treated by a health care provider. The outcome of the event injury to themselves (Ill-defined disorder) was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AEs; Inappropriate schedule of vaccine administered; This spontaneous report as received from a pharmacist referring to a 22-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      The pharmacist stated that the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) too soon. The first dose of 0.5 milliliter of varicella virus vaccine live (oka/merck) (VARIVAX) was received 18-JAN-2021 and the second dose (0.5 milliliter) on 26-JAN-2021 for prophylaxis (strength, vaccination scheme frequency, route of administration, lot number and expiration date were not reported). No additional adverse events reported.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous report as received from a consumer refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.    On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route and site of administration, lot# and expiry date were not reported) for prophylaxis.  On an unknown date, the patient experienced Bell's Palsy. The outcome of Bell's Palsy was unknown.   The causality between the event Bell's Palsyand zoster vaccine live (ZOSTAVAX) was not provided.   Upon on internal review, Bell's Palsy was considered to be medically significant.