chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Generalized aching/ body aches; Route Of Administration: Subcutaneous; This is a solicited report based on the information received by Pfizer from Regulatory Authority. (Mfr. Control No.: 21K-163-4109568-00).   Solicited report from the Regulatory Authority by a contactable 39-year-old female consumer (patient) with events of non-serious Rheumatoid arthritis flare up and body aches from Covid vaccine with Humira (Adalimumab) citrate free, subcutaneous, at unspecified dose and frequency, for moderate to severe rheumatoid arthritis. Medical history and concomitant medications were not reported. In 2021, the patient experienced body aches from Covid vaccine. In Sep2021, the patient experienced rheumatoid arthritis flare up. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 vaccine trial. On 06Mar2021, she received first dose of Covid-19 vaccine manufactured by Pfizer/BioNTech, lot number and expiry date: unknown, subcutaneous, at the age of 38-years-old, as dose 1, single, for Covid-19 vaccination. On 01Apr2021, she received second dose Covid-19 vaccine manufactured by Pfizer/BioNTech, lot number and expiry date: unknown, subcutaneous, at the age of 38-years-old, as dose 2, single, for Covid-19 vaccination. Outcome of the event rheumatoid arthritis flare up was not recovered, while for generalized aching/ body aches was unknown. The action taken in response to adalimumab was unknown. The reporter's causality for the event of rheumatoid arthritis flare up from the Covid vaccine was not provided, while for generalized aching/ body aches was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out but consider also possible contributory effects from patient's medical history of Rheumatoid arthritis. The case will be reassessed once new information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Injection site swelling
Clinical narrative: 10 hours post vaccination: onset of fever (100.4)?, chills, nausea, headache, neck pain, muscle aches. Continued for total of 24 hours but decreased appetite, injection site swelling and pain, along with swelling and pain under injection side arm
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: 10 hours post vaccination: onset of fever (100.4)?, chills, nausea, headache, neck pain, muscle aches. Continued for total of 24 hours but decreased appetite, injection site swelling and pain, along with swelling and pain under injection side arm
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 10 hours post vaccination: onset of fever (100.4)?, chills, nausea, headache, neck pain, muscle aches. Continued for total of 24 hours but decreased appetite, injection site swelling and pain, along with swelling and pain under injection side arm
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Immunisation
Clinical narrative: 10 hours post vaccination: onset of fever (100.4)?, chills, nausea, headache, neck pain, muscle aches. Continued for total of 24 hours but decreased appetite, injection site swelling and pain, along with swelling and pain under injection side arm
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tenderness, Vaccination site pain, Vaccination site swelling
Clinical narrative: 10 hours post vaccination: onset of fever (100.4)?, chills, nausea, headache, neck pain, muscle aches. Continued for total of 24 hours but decreased appetite, injection site swelling and pain, along with swelling and pain under injection side arm
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypertension, Malaise, Migraine, Palpitations
Clinical narrative: Started having severe heart palpitations, my body got really really hot, I felt really really sick, my blood pressure was high, and I started to have a migraine.  Started around 11pm  the day of injection and lasted until 5am the day after injection
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Ammonia decreased, Aspartate aminotransferase increased, Brain natriuretic peptide increased, Cold sweat
Clinical narrative: first 2 days after vaccination - soreness and weakness to left arm, then symptoms progressed to extreme fatigue and covid-like symptoms on 10/8 lost the ability to walk, unable to hold herself up on her legs - came into the hospital from 10/10-10/14 and discharged to a skilled nursing facility for rehabilitation. Increasing AMS and involuntary muscular movements - came back to hospital on 10/21, continues to have intermittent confusion, spasticity/involuntary movement to bilateral upper and lower extremities, episodes of diaphoresis and cool clammy skin, bilateral hands are cold and slightly discolored, patient states she feels like electricity is coursing through her arms and legs, feels like she's being shocked.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dyskinesia, Electric shock sensation, Fatigue, Full blood count
Clinical narrative: first 2 days after vaccination - soreness and weakness to left arm, then symptoms progressed to extreme fatigue and covid-like symptoms on 10/8 lost the ability to walk, unable to hold herself up on her legs - came into the hospital from 10/10-10/14 and discharged to a skilled nursing facility for rehabilitation. Increasing AMS and involuntary muscular movements - came back to hospital on 10/21, continues to have intermittent confusion, spasticity/involuntary movement to bilateral upper and lower extremities, episodes of diaphoresis and cool clammy skin, bilateral hands are cold and slightly discolored, patient states she feels like electricity is coursing through her arms and legs, feels like she's being shocked.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Glomerular filtration rate decreased, Hyperhidrosis, Liver function test increased, Malaise
Clinical narrative: first 2 days after vaccination - soreness and weakness to left arm, then symptoms progressed to extreme fatigue and covid-like symptoms on 10/8 lost the ability to walk, unable to hold herself up on her legs - came into the hospital from 10/10-10/14 and discharged to a skilled nursing facility for rehabilitation. Increasing AMS and involuntary muscular movements - came back to hospital on 10/21, continues to have intermittent confusion, spasticity/involuntary movement to bilateral upper and lower extremities, episodes of diaphoresis and cool clammy skin, bilateral hands are cold and slightly discolored, patient states she feels like electricity is coursing through her arms and legs, feels like she's being shocked.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Metabolic function test, Muscle spasticity, Muscular weakness, Pain in extremity
Clinical narrative: first 2 days after vaccination - soreness and weakness to left arm, then symptoms progressed to extreme fatigue and covid-like symptoms on 10/8 lost the ability to walk, unable to hold herself up on her legs - came into the hospital from 10/10-10/14 and discharged to a skilled nursing facility for rehabilitation. Increasing AMS and involuntary muscular movements - came back to hospital on 10/21, continues to have intermittent confusion, spasticity/involuntary movement to bilateral upper and lower extremities, episodes of diaphoresis and cool clammy skin, bilateral hands are cold and slightly discolored, patient states she feels like electricity is coursing through her arms and legs, feels like she's being shocked.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Skin discolouration, Troponin increased, Weight bearing difficulty
Clinical narrative: first 2 days after vaccination - soreness and weakness to left arm, then symptoms progressed to extreme fatigue and covid-like symptoms on 10/8 lost the ability to walk, unable to hold herself up on her legs - came into the hospital from 10/10-10/14 and discharged to a skilled nursing facility for rehabilitation. Increasing AMS and involuntary muscular movements - came back to hospital on 10/21, continues to have intermittent confusion, spasticity/involuntary movement to bilateral upper and lower extremities, episodes of diaphoresis and cool clammy skin, bilateral hands are cold and slightly discolored, patient states she feels like electricity is coursing through her arms and legs, feels like she's being shocked.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness and headache. self treat with otc tyenonol and rest
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Drug ineffective, Malaise, Nasal congestion
Clinical narrative: tested positive for Covid; tested positive for Covid; fever of 102; really bad congestion; cough; a feeling of crystalized snot in the back of her throat; didnt feel good; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Two days before (06Oct2021), patient was tested positive for COVID, a fever of 102, really bad congestion and cough, a feeling of crystalized snot in the back of her throat, and just didn't feel good. She started feeling better yesterday but then had a low fever this morning (08Oct2021). Outcome of fever was not resolved. Outcome of other events was resolving.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Suspected COVID-19, Throat irritation
Clinical narrative: tested positive for Covid; tested positive for Covid; fever of 102; really bad congestion; cough; a feeling of crystalized snot in the back of her throat; didnt feel good; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Two days before (06Oct2021), patient was tested positive for COVID, a fever of 102, really bad congestion and cough, a feeling of crystalized snot in the back of her throat, and just didn't feel good. She started feeling better yesterday but then had a low fever this morning (08Oct2021). Outcome of fever was not resolved. Outcome of other events was resolving.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diabetes mellitus, Diarrhoea
Clinical narrative: Diabetic; Diarrhea; This is a solicited report based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3923698-00). A contactable consumer (patient) reported for herself that a 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via intramuscular in 2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date at citrate free, from an unspecified date and ongoing, at citrate free for moderate to severe adult Crohn's disease. The patient's medical history and concomitant medications were not reported. There was no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient experienced diarrhea. In Apr2021, the patient experienced sick with diarrhea. In May2021, the patient experienced diabetic. The patient underwent lab tests and procedures which included blood test: blood sugar was in 400s on 11May2021. The action taken in response to the events for adalimumab was dose increased. In 2021, the sick with diarrhea resolved. The outcome of diabetic was unknown.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events diabetes mellitus and diarrhea and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer from Regulatory Authority (Manufacturer Control Number: 21K-163-4107859-00). A contactable 56-year-old female consumer (Patient) reported that:  Solicited report from the Regulatory Authority by a consumer of an adult female with an event of non-serious rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flare up. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received 1st and 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of rheumatoid arthritis flare up unknown onset was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) The reporter's causality for the event(s) of rheumatoid arthritis flare up unknown onset was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of event rheumatoid arthritis flare up cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Barrett's oesophagus
Clinical narrative: Gerd Barrett's Esophagus; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-4105453-00).   A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 18Mar2021 and dose 2 on 23Apr2021, both via intramuscular (Batch/Lot number was not reported) as single dose for COVID-19 vaccination at the age of 57-year-old; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (batch/lot number was not reported) to an unspecified date, at unspecified dose for psoriatic arthritis. In Feb2021, the patient experienced COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's concomitant medications were not reported.  On an unknown date in 2021, the patient experienced Gerd Barrett's Esophagus. The action taken in response to the event for adalimumab was unknown. Outcome of event was not recovered.  Causality for adalimumab: The reporter's causality for the event of Gerd Barrett's Esophagus with adalimumab was no reasonable possibility. The reporter's causality for the event of Covid with adalimumab was a reasonable possibility.  Causality for bnt162b2: The reporter's causality for the event of Gerd Barrett's Esophagus with bnt162b2 was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided the causal association between the event Gerd Barrett's esophagus with the usage of the vaccine BNT162B2 cannot be completely ruled out. The case will be reassessed once detailed 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Off label use
Clinical narrative: Shingles; Off label use; Booster; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ff2584), dose 3 via an unspecified route of administration, administered in arm left on 28Sep2021 12:00 (age at the vaccination was 39-year-old) as dose 3 (booster), single for covid-19 immunisation in pharmacy or drug store. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included, patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ek5730), via an unspecified route of administration, administered in arm left on 18Dec2020 12:00 (age at the vaccination was 37-year-old) for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: El1284), via an unspecified route of administration, administered in arm left on 04Jan2021 12:00 (age at the vaccination was 38-year-old) for covid-19 immunisation and had inappropriate schedule of product administration. The patient had off label use and booster on 28Sep2021 12:00. The patient experienced shingles on 08Oct2021 12:00. Timeframe between vaccination and starting of the event shingles was 10 days. Since the vaccination, the patient had not tested for COVID-19. The patient received treated with famciclovir for the event shingles. The outcome of the event shingles was resolving.  No follow up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101353180 Same drug/reporter/patient, different dose
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Biliary colic, Gallbladder disorder, Impaired quality of life
Clinical narrative: gallbladder problems /gallbladder completely destroyed; gallbladder problems/crawling on the floor with pain; have no energy; bloated; My quality of life is greatly diminished; This is a spontaneous report from an Agency from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. 3 months after taking vaccine, patient was crawling on the floor with pain and gallbladder completely destroyed. Now patient had no energy and was bloated continually. Patient's quality of life was greatly diminished to top it off. Outcome of no energy and bloated was not resolved. Outcome of other events was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Experienced COVID 19/On Feb2021, patient received 1st dose COVID-19 Vaccine/ On Feb2021, patient received 2nd dose COVID-19 Vaccine; Experienced COVID 19; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from regulatory authority (Manufacturer Control No: 21K-163-4108088-00).   Solicited report by a consumer of a 75-year-old elderly female with an event of non-serious COVID 19 with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced COVID 19. Pfizer BioNtech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer Biontech. On Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer Biontech. The reporter's causality for the event(s) of COVID 19 with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of COVID 19 with Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran) was possible.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: The possibility of COVID-19, Drug Ineffective cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Crying, Delirium, Dizziness
Clinical narrative: Pain in armpit (lymph node); vomiting; Involuntary minor convulsions; high fever spiked; delirium; crying and moaning; crying and moaning; sore arm at injection site; Chills; aches /moderate body aches; Nausea; General unwell feeling; light headedness; Sore arm within min of shot, eventually led to very sore arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), intramuscular in left arm on 07Oct2021 11:00 (at the age of 27-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 19Jan2021 (at the age of 26-years-old) as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 09Feb2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. Patient did not have any known allergies. The patient experienced involuntary minor convulsions, high fever spiked, delirium crying and moaning on 07Oct2021 20:30, sore arm within min of shot, eventually led to very sore arm on 07Oct2021 16:00, sore arm at injection site, chills, aches /moderate body aches, nausea, general unwell feeling, light headedness on 07Oct2021 20:30, vomiting on 08Oct2021 00:30 and pain in armpit (lymph node) on 08Oct2021 11:00. Patient reported to have fever ranged from low grade to 102 throughout the night from hour 10 to hour 21. Pain in armpit (lymph node) was noticed 24 hours post-dose and still persists 94 hours later. Still have a sore arm at injection site, but mild. Patient's husband almost brought her the hospital during one of high fever/crying/moaning/delirious episodes. Symptoms significantly worse than the flu. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of Involuntary minor convulsions, high fever spiked, delirium, crying and moaning, Sore arm within min of shot, eventually led to very sore arm, Chills and vomiting were resolved on an unspecified date. Nausea was resolved after 4 hours on 08Oct2021 00:30. Events aches /moderate body aches, General unwell feeling and light headedness were resolved on 10Oct2021 08:30. Event sore arm at injection site was resolving and Pain in armpit (lymph node) was not resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Malaise, Moaning, Nausea, Pain
Clinical narrative: Pain in armpit (lymph node); vomiting; Involuntary minor convulsions; high fever spiked; delirium; crying and moaning; crying and moaning; sore arm at injection site; Chills; aches /moderate body aches; Nausea; General unwell feeling; light headedness; Sore arm within min of shot, eventually led to very sore arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), intramuscular in left arm on 07Oct2021 11:00 (at the age of 27-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 19Jan2021 (at the age of 26-years-old) as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 09Feb2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. Patient did not have any known allergies. The patient experienced involuntary minor convulsions, high fever spiked, delirium crying and moaning on 07Oct2021 20:30, sore arm within min of shot, eventually led to very sore arm on 07Oct2021 16:00, sore arm at injection site, chills, aches /moderate body aches, nausea, general unwell feeling, light headedness on 07Oct2021 20:30, vomiting on 08Oct2021 00:30 and pain in armpit (lymph node) on 08Oct2021 11:00. Patient reported to have fever ranged from low grade to 102 throughout the night from hour 10 to hour 21. Pain in armpit (lymph node) was noticed 24 hours post-dose and still persists 94 hours later. Still have a sore arm at injection site, but mild. Patient's husband almost brought her the hospital during one of high fever/crying/moaning/delirious episodes. Symptoms significantly worse than the flu. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of Involuntary minor convulsions, high fever spiked, delirium, crying and moaning, Sore arm within min of shot, eventually led to very sore arm, Chills and vomiting were resolved on an unspecified date. Nausea was resolved after 4 hours on 08Oct2021 00:30. Events aches /moderate body aches, General unwell feeling and light headedness were resolved on 10Oct2021 08:30. Event sore arm at injection site was resolving and Pain in armpit (lymph node) was not resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Seizure, Vaccination site pain, Vomiting
Clinical narrative: Pain in armpit (lymph node); vomiting; Involuntary minor convulsions; high fever spiked; delirium; crying and moaning; crying and moaning; sore arm at injection site; Chills; aches /moderate body aches; Nausea; General unwell feeling; light headedness; Sore arm within min of shot, eventually led to very sore arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), intramuscular in left arm on 07Oct2021 11:00 (at the age of 27-years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 19Jan2021 (at the age of 26-years-old) as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), intramuscular on 09Feb2021 (at the age of 26-years-old) as dose 2, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. Patient did not have any known allergies. The patient experienced involuntary minor convulsions, high fever spiked, delirium crying and moaning on 07Oct2021 20:30, sore arm within min of shot, eventually led to very sore arm on 07Oct2021 16:00, sore arm at injection site, chills, aches /moderate body aches, nausea, general unwell feeling, light headedness on 07Oct2021 20:30, vomiting on 08Oct2021 00:30 and pain in armpit (lymph node) on 08Oct2021 11:00. Patient reported to have fever ranged from low grade to 102 throughout the night from hour 10 to hour 21. Pain in armpit (lymph node) was noticed 24 hours post-dose and still persists 94 hours later. Still have a sore arm at injection site, but mild. Patient's husband almost brought her the hospital during one of high fever/crying/moaning/delirious episodes. Symptoms significantly worse than the flu. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of Involuntary minor convulsions, high fever spiked, delirium, crying and moaning, Sore arm within min of shot, eventually led to very sore arm, Chills and vomiting were resolved on an unspecified date. Nausea was resolved after 4 hours on 08Oct2021 00:30. Events aches /moderate body aches, General unwell feeling and light headedness were resolved on 10Oct2021 08:30. Event sore arm at injection site was resolving and Pain in armpit (lymph node) was not resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pelvic pain, Somnolence
Clinical narrative: sleepy; terrible pelvic pain 24-36 hours; muscle pain in her pelvis area for 36hrs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular, administered in left arm on 15Feb2021 08:30 (unknown age at time of vaccination) as single dose for COVID-19 immunization. The patient medical history included eczema and small fibre neuropathy. Concomitant medications included ongoing dupilumab (DUPIXENT) taken for eczema; ongoing gabapentin (GABAPENTIN) taken for small fibre neuropathy. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 25Jan2021 08:30 for COVID-19 Immunization. The patient was sleepy the day after 2 shots had terrible pelvic pain 24-36 hours, heat aleve (pending clarification). She had muscle pain in her pelvis area for 36hrs. Onset date of the events was 16Feb2021. "Treatment: No" was also reported (pending clarification). The outcome of the events was recovered.   Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Loss of consciousness, Neck injury
Clinical narrative: Passed out after receiving a booster shot; Hit their head and neck on a dishwasher causing injury; Hit their head and neck on a dishwasher causing injury; This is a spontaneous report from a non-contactable consumer (patient). A 74-year-old (non-pregnant) female consumer reported that she received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided) on an unspecified date (at the age of 74-year-old) at a single dose for COVID-19 immunisation. The patient previously received the first and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot numbers unknown) on unspecified dates, at single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient passed out after receiving a booster shot and hit her head and neck on a dishwasher causing injury. The event required Emergency Room visit. The event was not resolved. No seriousness was provided.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drainage, Feeling abnormal, Productive cough, Rash, Respiratory tract infection
Clinical narrative: Respiratory infection; Foggy feeling in head; Productive cough; drainage; Generalized rash; This is a solicited report based on information received by Pfizer from a regulatory authority (Mfr. Control No.: 21K-163-4107716-00). A contactable consumer (patient) reported that a 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 18Sep2021 (vaccination age was 29 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) at Citrate free for moderate to severe chronic plaque psoriasis.  The patient's medical history and concomitant medications was not reported. In 2021, the patient experienced rash over entire body from vaccination. On 18Sep2021, the patient experienced brain fog felts like had since covid vaccination and sick with respiratory infection, coughing (Productive cough), drainage ongoing since vaccination. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The action taken in response to the event(s) for adalimumab was unknown. The outcome of generalized rash was recovering. The outcome of Productive cough, drainage and Respiratory infection was not recovered. The outcome of Foggy feeling in head was recovered with sequel in 2021  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: The event of Productive cough, drainage and Respiratory infection, Foggy feeling in head are assessed as possibly related to the suspect vaccine Comirnaty based on strong temporal association. As there is limited information in the case provided, the causal association between the event (generalised rash ) and the suspect drug cannot be excluded but consider also medical history of psoriasis.   "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I had a severe reaction of half-face paralysis (left side)/Bell syndrome; This is a spontaneous report from a contactable consumer (patient) reported for self. A 33-year-old patient of an unspecified gender received bnt162b2 (Pfizer COVID vaccine), dose 1 via an unspecified route of administration on 21Mar2021 at 33 years old (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Mar2021 patient took the first Covid vaccine (Pfizer) and immediately after 10 minutes had a severe reaction of half-face paralysis (left side). Patient rushed to the doctor who told to wait it out and see if it faded the next morning. Unfortunately, it worsened! Patient rushed to the ER where patient got treated for Bell syndrome. Today, seven months after, it had not fully passed and patient could still feel the paralysis in certain spots. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke afterwards.; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority Support, received from a non-contactable consumer (patient's friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose (dose number unknown) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a stroke afterwards. 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Interstitial lung disease, Oxygen saturation decreased, Oxygenation index
Clinical narrative: Hospitalized with low oxygenation/high pulse; Hospitalized with low oxygenation/high pulse; Interstitial lung disease; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 71-year-old non-pregnant female patient received BNT162B2 (BNT162B2 Formulation: Solution for Injection Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration on 25Feb2021 (at the age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine includes BNT162B2 (Pfizer Batch/Lot number: EL 9269. Expiration date: 31May2021) via unspecified route of administration on 06Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient medical history included type 2 diabetes mellitus, arthritis, Gastroparesis, hypertension, hyperlipidaemia, chronic kidney disease. Concomitant medication(s) included nabumetone; colecalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA); dexlansoprazole (DEXILANT); allopurinol taken for an unspecified indication. The patient experienced interstitial lung disease (medically significant) on 26May2021 and hospitalized with low oxygenation/high pulse (hospitalization) on an unknown date in 2021. Patient was First diagnosed with pneumonia 23Feb2021 (subsequent multiple times); hospitalized with low oxygenation/high pulse 12Apr-14Apr2021, started 24/7 oxygen; 04May2021 anesthesiologist asked what was wrong with lungs when awaiting transport to surgery for back operation; 26May2021 Pulmonologist diagnosed interstitial lung disease - stating likely never had pneumonia - started Prednisone 40 mg, one month on 21Jul2021, 20 mg, one month, dropped to 10 mg for one week. Restarted 20 mg and Micophenolate. So weak pulmonologist restarted 20 mg along with Micophenolate. Around 31Aug2021 declined in energy and stamina till barely can get to bathroom by self. Continuing through current. The patient underwent lab tests and procedures which included heart rate: high on an unknown date in 2021, oxygenation index: low unknown date in 2021, sars-cov-2 test: negative on 24May2021, sars-cov-2 test: negative on 18Jun2021, sars-cov-2 test: negative on 16Aug2021. Patient took BNT162B2 (Pfizer Batch/Lot No. FC3182) on 16Aug2021 as DOSE 3, SINGLE for covid 19 immunization. Therapeutic measures were taken as a result of events includes Antibiotic. Outcome of events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Hospitalized with low oxygenation/high pulse; Hospitalized with low oxygenation/high pulse; Interstitial lung disease; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 71-year-old non-pregnant female patient received BNT162B2 (BNT162B2 Formulation: Solution for Injection Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration on 25Feb2021 (at the age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine includes BNT162B2 (Pfizer Batch/Lot number: EL 9269. Expiration date: 31May2021) via unspecified route of administration on 06Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient medical history included type 2 diabetes mellitus, arthritis, Gastroparesis, hypertension, hyperlipidaemia, chronic kidney disease. Concomitant medication(s) included nabumetone; colecalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA); dexlansoprazole (DEXILANT); allopurinol taken for an unspecified indication. The patient experienced interstitial lung disease (medically significant) on 26May2021 and hospitalized with low oxygenation/high pulse (hospitalization) on an unknown date in 2021. Patient was First diagnosed with pneumonia 23Feb2021 (subsequent multiple times); hospitalized with low oxygenation/high pulse 12Apr-14Apr2021, started 24/7 oxygen; 04May2021 anesthesiologist asked what was wrong with lungs when awaiting transport to surgery for back operation; 26May2021 Pulmonologist diagnosed interstitial lung disease - stating likely never had pneumonia - started Prednisone 40 mg, one month on 21Jul2021, 20 mg, one month, dropped to 10 mg for one week. Restarted 20 mg and Micophenolate. So weak pulmonologist restarted 20 mg along with Micophenolate. Around 31Aug2021 declined in energy and stamina till barely can get to bathroom by self. Continuing through current. The patient underwent lab tests and procedures which included heart rate: high on an unknown date in 2021, oxygenation index: low unknown date in 2021, sars-cov-2 test: negative on 24May2021, sars-cov-2 test: negative on 18Jun2021, sars-cov-2 test: negative on 16Aug2021. Patient took BNT162B2 (Pfizer Batch/Lot No. FC3182) on 16Aug2021 as DOSE 3, SINGLE for covid 19 immunization. Therapeutic measures were taken as a result of events includes Antibiotic. Outcome of events was not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Within 4 hours I developed a covid rash and severe arm pain at the injection sight; Within 4 hours I developed a covid rash and severe arm pain at the injection sight; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FF8891), via an unspecified route of administration, administered in Arm Left on 08Oct2021 16:45 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. The patient's medical history included food allergy (Egg white) from an unknown date and unknown if ongoing. The patient received birth control medications within 2 weeks of vaccination. The patient receive flu shot within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously took Flu shots via an unspecified route of administration in arm on 09Sep2021 for immunization. On 08Oct2021 at 20:00 (within 4 hours) patient developed a covid rash and severe arm pain at the injection sight. Patient didn't received treatment for the events. Device Date: 11Oct2021. The clinical outcome of the events was recovering.   No follow-up attempts possible. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Vaccination failure
Clinical narrative: She had Covid in Aug 2021 even though she was vaccinated; Se had Covid in Aug 2021 even though she was vaccinated; covid related pneumonia; This is a non-interventional study report from a contactable consumer (patient) based on the information received by Pfizer from regulatory authority (Mfr. Control No.: 21K-163-4097505-00).  A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), intramuscularly on 01Mar2021 (at the age of 76 years) as dose 2, single for COVID-19 vaccination; and adalimumab (HUMIRA), subcutaneously from an unspecified date to Aug2021, at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) intramuscularly on 01Feb2021 (at the age of 76 years) as dose 1, single for COVID-19 Vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient experienced COVID in Aug2021 even though she was vaccinated. Patient had covid related pneumonia on an unknown date in Aug2021 and had to come off of Humira since Aug2021. She was initially in hospital for six days. It was reported that, patient took a break from Humira for a little while until covid test was negative. The patient underwent lab tests and procedures which included sars-cov-2 test: had covid on Aug2021. The action taken in response to the event for adalimumab was temporarily withdrawn on an unspecified date in Aug2021. The outcome of the events was unknown. Causality as per reporter with bnt162b2 was reported as possible for event COVID-19 and for COVID-19 pneumonia was not reported. The reporter's causality for the event of COVID with Humira, was a reasonable possibility and reporter's causality for the event of serious COVID related pneumonia was not provided. Causality as per Mfr. (Humira) was reported as no reasonable possibility for both the events.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and covid-19 pneumonia and the suspect drug BNT162B2.