chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Bell's Palsy symptoms; Right sided facial paralysis; Inability to close the right eye; Right sided facial numbness; Lop-sided smile; Patient received Pfizer COVID vaccine 01Mar2021,15Mar2021; This is a spontaneous report from a contactable Nurse. A 45-year-old female patient received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for COVID-19 immunization and received POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 26Jul2021. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 on 01Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. On 30Jul2021, patient experienced Bells Palsy symptoms, right sided facial paralysis, inability to close the right eye, right sided facial numbness, and lop-sided smile. The patient was treated with Valacyclovir 1000mg TID for 5 days, and Medrol dose pack 4 mg X 6 days. The outcome of event Inappropriate schedule of vaccine administered was unknown and for other events 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 currently available information the possibility of causal association between the event bells palsy and facial paralysis and the suspect drug BNT162B2  cannot be ruled out. 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: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: developed hearing loss in his right ear; This is a spontaneous report from a contactable consumer (patient's parent).  A 15-year-old male patient (reporter's son) received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter's family and reporter had all been vaccinated with BNT162B2, about 6 to 7 weeks later reporter's son who was a healthy 15-year-old developed hearing loss in his right ear. Reporter had sent him to an ear, nose, and throat (ENT), he was on steroids medication, but he still had not recovered the doctors could not figure out why he lost his hearing. Reporter had spoken to several others who have lost their hearing after testing positive with COVID. Reporter liked to speak with someone regarding a connection. Therapeutic measures were taken as a result of event and included treatment with steroids. The outcome of event was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hot flush, Night sweats
Clinical narrative: hot flashes; night sweats; extremely heavy menstrual periods; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 13:00 (Batch/Lot Number: ER8733) as dose 2, single (age at vaccination 37-year-old) for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on Mar2021, administration site (Left arm), administered at 01:00 PM (age at vaccination 37-year-old), lot number EN6204 for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. The patient was not pregnant at the time of vaccination. On 02Apr2021, the patient experienced hot flashes, night sweats, extremely heavy menstrual periods. Adverse event: New gynecological symptoms: hot flashes, night sweats, extremely heavy menstrual periods. Patient did not received treatment for events.The outcome for all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anaemia, Dehydration, Fatigue, Illness
Clinical narrative: Heart palpitations/if she didn't get enough rest or sleep she would get minor heart palpitations; Extreme tiredness for days; Extreme arm swelling at the site of the injection; I got sick again; I have GI issues; I am still not feeling well; Heart palpitations could be due to dehydration, anemic; she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side; Heart palpitations could be due to dehydration, anemic; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FL3181) via an unspecified route of administration on 17Aug2021 (at the age of 68-year-old) as a single dose for COVID-19 immunization. Patient medical history include E. Coli UTI from Jul2021 to Aug2021 and she has so many drug allergies and Mild reaction. She had taken other medications for this. Concomitant medication included ergocalciferol (VIT D [ERGOCALCIFEROL]). On 17Aug2021, patient experienced extreme arm swelling at the site of the injection like a balloon, extreme tiredness fur days for the next 2-3 weeks from 18Aug2021. On 20Aug2021 she suffered heart palpitations when she didn't sleep well the night before. Heart palpitations started on 20Aug2021, could be due to dehydration and anaemia started on an unspecified date in 2021. Last night she got sick again. she have GI issues from 2021 but it was never diagnosed. Terrible night last night. She was sick for two hours, and hour and half. She still not feeling well. She was supposed to get her 2nd dose on 07Sep2021 afternoon but that was exactly 2 weeks to her mammogram and she read that you can't get the vaccine that close to a mammogram so she didn't get it. her allergies she thought this was mild and good, but she doesn't know if she can get this again but worse with the 2nd dose. She also has been having issues and she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side since 2021. She usually sleeps on her left side and lately she has had to sleep on her right side because she can't sleep on the left side because of the vaccine, and she doesn't know if the vaccine restricts blood vessels or not. The seriousness of events was reported as non-serious by the reporter. The outcome of the event extreme tiredness was resolved on Aug2021 while palpitation on an unspecified date in 2021 and for other events it was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations, Sciatica, Vaccination site swelling
Clinical narrative: Heart palpitations/if she didn't get enough rest or sleep she would get minor heart palpitations; Extreme tiredness for days; Extreme arm swelling at the site of the injection; I got sick again; I have GI issues; I am still not feeling well; Heart palpitations could be due to dehydration, anemic; she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side; Heart palpitations could be due to dehydration, anemic; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FL3181) via an unspecified route of administration on 17Aug2021 (at the age of 68-year-old) as a single dose for COVID-19 immunization. Patient medical history include E. Coli UTI from Jul2021 to Aug2021 and she has so many drug allergies and Mild reaction. She had taken other medications for this. Concomitant medication included ergocalciferol (VIT D [ERGOCALCIFEROL]). On 17Aug2021, patient experienced extreme arm swelling at the site of the injection like a balloon, extreme tiredness fur days for the next 2-3 weeks from 18Aug2021. On 20Aug2021 she suffered heart palpitations when she didn't sleep well the night before. Heart palpitations started on 20Aug2021, could be due to dehydration and anaemia started on an unspecified date in 2021. Last night she got sick again. she have GI issues from 2021 but it was never diagnosed. Terrible night last night. She was sick for two hours, and hour and half. She still not feeling well. She was supposed to get her 2nd dose on 07Sep2021 afternoon but that was exactly 2 weeks to her mammogram and she read that you can't get the vaccine that close to a mammogram so she didn't get it. her allergies she thought this was mild and good, but she doesn't know if she can get this again but worse with the 2nd dose. She also has been having issues and she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side since 2021. She usually sleeps on her left side and lately she has had to sleep on her right side because she can't sleep on the left side because of the vaccine, and she doesn't know if the vaccine restricts blood vessels or not. The seriousness of events was reported as non-serious by the reporter. The outcome of the event extreme tiredness was resolved on Aug2021 while palpitation on an unspecified date in 2021 and for other events it was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Encephalitis autoimmune, Headache, Meningitis bacterial
Clinical narrative: start having a seizure; continued to cry for headaches; the doctors say she has thyroid; bacterial meningitis; then viral meningitis; autoimmune encephalitis; vomit a few times; chills; headaches/continued to cry for headaches; This is a spontaneous report from a contactable consumer or other non hcp (parent). An 18-year-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 02Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation at the age of 18-year-old.  The patient medical history was none. No covid prior vaccination. The patient previously received dose 1 (Batch/Lot number was not reported) on 12Aug2021. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced chills and headaches on 02Sep2021, vomit a few times on 05Sep2021, start having a seizure and continued to cry for headaches on 08Sep2021, the doctors say she has thyroid, bacterial meningitis, then viral meningitis, autoimmune encephalitis on 08Sep2021. The patient was hospitalized for 13 days and hospitalization was prolonged as a result of the events. Therapeutic measures taken as a result of events included steroids, IVIG etc. Outcome of events was not recovered. Covid tested post vaccination with unknown result. The clinical course was reported as: On 02Sep202, after the patient took it she got the chills, headaches continuously until she vomit a few times on the Sunday at her dad 05Sep2021 and then she went to work on 08Sep2021 she start having a seizure the ambulance brought her to (Hospital Name Withheld) they released her then she continued to cry for headaches now she is at (Hospital Name Withheld) the doctors says she as thyroid, bacterial meningitis, then viral meningitis now autoimmune encephalitis all that reacted from the vaccine as per doctors. The events resulted in Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.  The lot number for, BNT162B2, was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Meningitis viral, SARS-CoV-2 test, Seizure, Thyroid disorder, Vomiting
Clinical narrative: start having a seizure; continued to cry for headaches; the doctors say she has thyroid; bacterial meningitis; then viral meningitis; autoimmune encephalitis; vomit a few times; chills; headaches/continued to cry for headaches; This is a spontaneous report from a contactable consumer or other non hcp (parent). An 18-year-old female non-pregnant patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 02Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation at the age of 18-year-old.  The patient medical history was none. No covid prior vaccination. The patient previously received dose 1 (Batch/Lot number was not reported) on 12Aug2021. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced chills and headaches on 02Sep2021, vomit a few times on 05Sep2021, start having a seizure and continued to cry for headaches on 08Sep2021, the doctors say she has thyroid, bacterial meningitis, then viral meningitis, autoimmune encephalitis on 08Sep2021. The patient was hospitalized for 13 days and hospitalization was prolonged as a result of the events. Therapeutic measures taken as a result of events included steroids, IVIG etc. Outcome of events was not recovered. Covid tested post vaccination with unknown result. The clinical course was reported as: On 02Sep202, after the patient took it she got the chills, headaches continuously until she vomit a few times on the Sunday at her dad 05Sep2021 and then she went to work on 08Sep2021 she start having a seizure the ambulance brought her to (Hospital Name Withheld) they released her then she continued to cry for headaches now she is at (Hospital Name Withheld) the doctors says she as thyroid, bacterial meningitis, then viral meningitis now autoimmune encephalitis all that reacted from the vaccine as per doctors. The events resulted in Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.  The lot number for, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on trunk after 1st dose recurring with second dose; This is a spontaneous report from a contactable other health professional. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers and expiry dates not reported), via unspecified routes of administration, on unspecified dates as dose 1, single and dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives on trunk after first dose recurring with second dose on unspecified date. 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Hypoaesthesia, Malaise
Clinical narrative: almost passing out for many hours.; left side of my face went completely numb; I was light headed; I began throwing up and fever; I began throwing up and fever; Sense of unwell feeling not too long after receiving shot; Chills; brain fog; muscle spasms in my arm; This is a spontaneous report from a contactable other HCP (patient)  A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 18:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation  .  Age at vaccination : 28years.The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 26Jan2021 (at the age of 28 years) in arm left Batch/lot number: PAA156051 on 26Jan2021 01:00 PM. Facility where the most recent COVID-19 vaccine was administered: Othe.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccineMedical history included concussion, egg intolerance.    The patient's concomitant medications were not reported.  Upon second dose , on 1Feb2021,  My left side of my face went completely numb. Extremely concerned considering this is typical of a stoke patient. I was light headed and almost passing out for many hours. After waiting Multiple Hours I drove 2 minutes and had to stop. My family was concerned and call the police. I had to get a ride home. I began throwing up and fever. Sense of unwell feeling not too long after receiving shot. Chills, brain fog, muscle spasms in my arm that received the shot.Seriousness criteria provided: Life threatening.No treatment received . The outcome of the events was unknown.Additonal information :The patient was not diagnosed with Covid-19 prior to vaccination; The patient has not been tested for Covid-19 since the vaccination.  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 the events 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Near death experience, Pyrexia, Vomiting
Clinical narrative: almost passing out for many hours.; left side of my face went completely numb; I was light headed; I began throwing up and fever; I began throwing up and fever; Sense of unwell feeling not too long after receiving shot; Chills; brain fog; muscle spasms in my arm; This is a spontaneous report from a contactable other HCP (patient)  A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 18:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation  .  Age at vaccination : 28years.The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 26Jan2021 (at the age of 28 years) in arm left Batch/lot number: PAA156051 on 26Jan2021 01:00 PM. Facility where the most recent COVID-19 vaccine was administered: Othe.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccineMedical history included concussion, egg intolerance.    The patient's concomitant medications were not reported.  Upon second dose , on 1Feb2021,  My left side of my face went completely numb. Extremely concerned considering this is typical of a stoke patient. I was light headed and almost passing out for many hours. After waiting Multiple Hours I drove 2 minutes and had to stop. My family was concerned and call the police. I had to get a ride home. I began throwing up and fever. Sense of unwell feeling not too long after receiving shot. Chills, brain fog, muscle spasms in my arm that received the shot.Seriousness criteria provided: Life threatening.No treatment received . The outcome of the events was unknown.Additonal information :The patient was not diagnosed with Covid-19 prior to vaccination; The patient has not been tested for Covid-19 since the vaccination.  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 the events 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.
Sex: M
Vaccine: COVID19
Symptoms: Death, Immunisation, Off label use
Clinical narrative: Pt received booster Covid vaccine and died the next morning in his sleep; Pt received booster Covid vaccine and died the next morning in his sleep; Pt received booster Covid vaccine and died the next morning in his sleep; This is a spontaneous report from a contactable physician via a sales representative.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received booster Covid vaccine and died the next morning in his sleep. The patient died on an unspecified date. An autopsy was being performed and results were not provided. It is believed the booster was Pfizer but that needs to be confirmed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events off label use, immunization and death and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pt received booster Covid vaccine and died the next morning in his sleep
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 47-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date of Apr2021 patient experienced new onset alopecia areata. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered. No follow-up attempts are possible information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Circulatory collapse, Dyspnoea, Malaise, Pulmonary embolism
Clinical narrative: They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; collapsed in the bathroom at 10pm; He was having trouble breathing. He collapsed in the bathroom at 10pm; he wasn't feeling well; This is a spontaneous report from a contactable consumer (patient's son). A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 14Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at the age of 57-year-old. Medical history included alcoholism, seizures. There were no concomitant medications. The patient experienced cardiac arrest on 23Sep2021, pulmonary embolism on 23Sep2021, trouble breathing and collapsed in the bathroom at 10pm in Sep2021, wasn't feeling well in Sep2021. The patient died on 23Sep2021. An autopsy was not performed. The outcome of wasn't feeling well was unknown, outcome of other events was fatal. The clinical course was reported as: his father died yesterday, and the only difference recently in his health was that he got the COVID vaccine. His father died 9 days later on 23Sep2021. The coroner denied an autopsy. The hospital denied an autopsy. His father was not obese or diabetic, and he was only 57 as healthy as a horse. His father had gotten the vaccine, and said he wasn't feeling well to his girlfriend. He was having trouble breathing. He collapsed in the bathroom at 10pm. They called an ambulance who did everything they could do to bring him back. They pronounced his dad dead 23 minutes after midnight on 23Sep2021. They said it was cardiac arrest, but the reporter thinks it was a pulmonary embolism. His dad was not COVID positive. His father did have a history of alcoholism. Any time he would try to quit drinking, he would drink too much water out of compulsion since he couldn't drink beer. He would flush his system so much that he would deplete his sodium. His dad would get seizures every time he quit drinking. He tried to tell his dad that he needed to drink the normal amount of water. He can't just sit there and drink that much water to replace all the beer he drank. It would flush his system of all that sodium.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Reported Cause(s) of Death: They said it was cardiac arrest; but the caller thinks it was a pulmonary embolism; He was having trouble breathing. He collapsed in the bathroom at 10pm
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage subcutaneous
Clinical narrative: developed bleeding spot on hand and fingers same side as injection/ Left side hand and fingers had several spots, 3 or 4 of the fingers and on the palm. Several spots. All together like 8 spots; positive D- dimer; This is a spontaneous report from a contactable physician.   A 75-years-old male patient received bnt162b2 (BNT162B2, PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, in arm left on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strange reaction after getting the second dose of the Pfizer covid vaccine. The patient asked if he can get the third dose or not. He described the reaction as within 24 hours after the second dose, he developed what looked like a bleeding spot on his hand, on the palm of the hand and fingers, on the same side he received the injection/ left side hand and fingers had several spots, 3 or 4 of the fingers and on the palm. several spots. all together like 8 spots. It was not painful or raised. He had bloodwork done that showed a positive d dimer and he had no other symptoms. The bleeding spot disappeared within 24 hours. The patient received first dose of bnt162b2 (BNT162B2, PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. The patient's lab data included positive D- dimer. The outcome of the event bleeding spot on his hand, on the palm of the hand and fingers was recovered on an unknown date and of the event showed a positive d dimer was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Haemorrhage subcutaneous and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: Arthralgia, Blood test normal, Condition aggravated, Gait disturbance, Incomplete course of vaccination
Clinical narrative: her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up; her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up; stated the pain in the wrist and hand is a 12 in pain; could hardly walk; joint pain/pain in her left hip and neck/joint pain in her left arm and wrist/neck, hip, shoulder and elbow pain; pain in  her left hip and neck; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 74-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history included MOS surgery (Micrographic skin surgery). The patient's concomitant medications were not reported. The patient stated that she took Humira and two months after she had an outbreak of skin cancer. The patient stated that she had her 44th removal and had 8 to 10 MOS surgeries noting it started over 2 years ago and is still ongoing. The patient had the first dose of the Pfizer COVID 19 vaccine about two months ago. The patient stated that her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up noting it got so bad she could hardly walk on an unspecified date. The patient reported that starting 2 to 3 weeks ago, she began to have joint pain. The patient reported joint pain in her left arm and wrist. The patient stated it has gotten worse in the past 3 to 4 days. The patient stated she could not use her left wrist in 3 days. The patient also reported pain in her left hip and neck. The patient reported the neck, hip, shoulder and elbow pain was better that day. The patient stated that the pain in the wrist and hand was a 12 in pain. The patient stated that the severity was about 5 days and going on for 2-3 weeks. The patient stated that she was having a rough time. The patient reported that the pain was flipping from the right arm and neck and the next day it was somewhere else, noting it flips from one side to the other. The patient stated that she could not use her right arm at all. The patient stated her blood tests came back ok on an unspecified date. The patient asked if other people reported the same joint pain and how long did it last. The patient wanted to know if it was going to go away. The patient wanted to know what she could do about the pain and asked if she just has to deal with it. The patient was referred to HCP. It was reported that it had been over 42 days since the first dose and patient had not received the second dose. The outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Neck pain, Neuropathy peripheral, Pain in extremity
Clinical narrative: her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up; her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up; stated the pain in the wrist and hand is a 12 in pain; could hardly walk; joint pain/pain in her left hip and neck/joint pain in her left arm and wrist/neck, hip, shoulder and elbow pain; pain in  her left hip and neck; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 74-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history included MOS surgery (Micrographic skin surgery). The patient's concomitant medications were not reported. The patient stated that she took Humira and two months after she had an outbreak of skin cancer. The patient stated that she had her 44th removal and had 8 to 10 MOS surgeries noting it started over 2 years ago and is still ongoing. The patient had the first dose of the Pfizer COVID 19 vaccine about two months ago. The patient stated that her neuropathy had only been numbness and tingling until that point and when she had the vaccine it flared up noting it got so bad she could hardly walk on an unspecified date. The patient reported that starting 2 to 3 weeks ago, she began to have joint pain. The patient reported joint pain in her left arm and wrist. The patient stated it has gotten worse in the past 3 to 4 days. The patient stated she could not use her left wrist in 3 days. The patient also reported pain in her left hip and neck. The patient reported the neck, hip, shoulder and elbow pain was better that day. The patient stated that the pain in the wrist and hand was a 12 in pain. The patient stated that the severity was about 5 days and going on for 2-3 weeks. The patient stated that she was having a rough time. The patient reported that the pain was flipping from the right arm and neck and the next day it was somewhere else, noting it flips from one side to the other. The patient stated that she could not use her right arm at all. The patient stated her blood tests came back ok on an unspecified date. The patient asked if other people reported the same joint pain and how long did it last. The patient wanted to know if it was going to go away. The patient wanted to know what she could do about the pain and asked if she just has to deal with it. The patient was referred to HCP. It was reported that it had been over 42 days since the first dose and patient had not received the second dose. The outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal pain, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: kind of difficulty swallowing or numb; numb is associated with difficulty in swallowing; having some tingling in her mouth; soring in the throat; pain moving up radiating up to the ear; tingling thumb; This is a spontaneous report from a contactable pharmacist. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in Arm Left on 25Sep2021 (Batch/Lot Number: FC3183; Expiration Date: Oct2021) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced having some tingling in her mouth kind of difficulty swallowing or numb, numb was associated with difficulty in swallowing of but an increased hard time swallowing so they gave the patient some Benadryl 25 mg as treatment. The patient had difficulty in swallowing, some soring in the throat, tingling thumb and pain moving up radiating up to the ear. The events occurred on 25Sep2021. Her second dose was scheduled on 16Oct2021. The outcome of the events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Inflammation, Musculoskeletal discomfort, Pain
Clinical narrative: Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; Her neck has bothered her and is got Inflamed after getting the dose and also her auto immune information got worse.; pain; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 02Aug2021 (at the age of 76-years-old) at dose 1, single in the right arm for COVID-19 immunisation. Medical history included thyroid disorder. Concomitant medication included steroids for thyroid disorder, and aniprazol. On an unspecified date in 2021, after the patient got the first dose of Pfizer COVID-19 vaccine, the patient stated that her neck bothered her and got inflamed. Also, her auto immune information got worse. The patient had pain. The patient did not receive the second dose due to this. Due to the events, the patient was treated with two injections in her neck and spine. The patient was waiting to get an abrasion in her neck on 04Oct2021, because of the pain (started on an unspecified date on 2021). The patient's inflammation increased a lot after the vaccination. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable pharmacist (patient's mother) via the regulatory authority.  This pharmacist reported similar events for 5 patients. This is the 3rd of 5 reports.   A 19-year-old female patient received BNT162B29 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on 27Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 20Sep2021, she tested positive for COVID, and didn't receive the second dose. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202101275398 same reporter, same drug, same event, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; She says this was the sickest she has been in twenty years; This is a spontaneous report from a contactable pharmacist (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17May2021  as DOSE 2, SINGLE, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical his-tory and concomitant medications were not reported. On 20Sep2021, the patient reported she, her husband, and her other two daughters also tested positive for Covid. She stated this was the sickest she has been in twenty years. The patient underwent lab tests and procedures which included COVID test positive on 20Sep2021. The outcome was unknown for the events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Amendment: This Amendment report is being submitted to amend previously reported information (To update narrative leadline): This is a spontaneous report from a contactable pharmacist (patient self) via the Medical Information Team.  This pharmacist reported similar events for 5 patients. This is the 4th of 5 reports.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test, Sinus disorder
Clinical narrative: Contracted COVID/COVID-19 positive; Contracted COVID/COVID-19 positive; sinuses felt weird; This is a spontaneous report from a contactable consumer.  A 23-year-old (also the age at time of vaccination) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and then in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE both given intramuscularly for COVID-19 immunization at the Pharmacy or Drug Store. Medical history included cat and dog allergy. Concomitant medications were not reported. The patient had no COVID prior vaccination. In Sep2021, the patient mentioned that he contracted COVID as his sinuses "felt weird", dry throat, and mild headache. The patient had positive COVID-19 test in Sep2021. He had negative COVID-19 test in Sep2020, Jan2021, Feb2021, Apr2021 and May 2021. The patient did not received any treatment for the events and recovered in 2021.   Information regarding the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: reports taking 5mg once daily 23Aug2021 through 13Sep2021 for covid vaccine.  during this time patient reports an outbreak of shingles; This is a spontaneous report from a contactable other hcp from a Specialty Pharmacy. A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Aug2021 (at the age of 78-year-old) as dose 1, single; dose 2 via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported) as dose 2, single, both doses for COVID-19 immunization; tofacitinib citrate (XELJANZ, Batch/Lot number was not reported) 5 mg at a dose of 5 mg twice daily via oral route from on an unspecified date in Oct2020 and ongoing, another dose at 5 mg once daily, via oral route on an unspecified date in 2021 for rheumatoid arthritis. The patient medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced reports taking 5mg once daily 23aug2021 through 13sep2021 for covid vaccine. During this time patient reports an outbreak of shingles. Describe Event, Problem or Product Use Error: patient reports taking 5mg once daily 23Aug2021 through 13Sep2021 for covid vaccine, md aware. During this time patient reports an outbreak of shingles. patient reports that she is now back on xeljanz taking her normal dose of 5mg twice daily, but she cannot remember the date she restarted her normal dose. md aware. no further information or details reported. The action taken in response to the event for tofacitinib citrate was unknown. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, General physical health deterioration, Mental impairment, Weight decreased
Clinical narrative: declined fast mentally and physically and died in July; declined fast mentally and physically and died in July; he was a downward slope cognitively; weight loss; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Per reporter, "mother's boyfriend was better than her cognitively and would get them to events and meals etc. They were both vaccinated the same days with Pfizer. From about that time, he was a downward slope cognitively like mini strokes often and declined fast mentally and physically and died in Jul2021. Very, very odd. I hope things like that get studied as well. A few weeks ago, I was pondering the unusual occurrences in my head and then dawned on me to perhaps report. Maybe nothing, but could be studied in Real World Data. Not sure the medical diagnosis since my mother's boyfriend was not our family, but talking to him there was an obvious and rapid change. He used to be the first to the musical events at their facility as he loved to sing and dance and would get my shy mother up there with him harmonizing and dancing with him. The facility would often make sure (Name) would participate because he added to the entertainment with his singing and dancing. He just declined so fast. First, I noticed the weight loss, but when we could finally get inside the facility and actually have real visits he was so "out there" the few months before he died". The patient died on Jul2021. It was unknown if autopsy was performed.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: he was a downward slope cognitively; weight loss; declined fast mentally and physically and died in July; declined fast mentally and physically and died in July