chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indication for paxlovid: Treatment of COVID-19; Indication for paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 4, single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: I cannot take nsaids." (unspecified if ongoing), notes: known allergies: I cannot take nsaids.; "Gastroparesis with acid reflux" (unspecified if ongoing), notes: other medical history: Gastroparesis with acid reflux; "acid reflux" (unspecified if ongoing), notes: other medical history: Gastroparesis with acid reflux; "asthma" (unspecified if ongoing), notes: other medical history: asthma and allergies.; "allergies" (unspecified if ongoing), notes: other medical history: asthma and allergies; "Heart murmur" (unspecified if ongoing), notes: other medical history: Heart murmur. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication for paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: unknown) at the age of 23 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, vaccine location=Left arm), administration date: 30Jul2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset 01Sep2021, outcome "recovered with sequelae" (2021), described as "Frequent PVCs needing surgical intervention". The event "frequent PVCS needing surgical intervention". Was evaluated at the physician office visit. Therapeutic measures were taken as a result of ventricular extra systoles. Clinical course: The patient was not pregnant during the vaccination. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient received treatment Cardiac ablation for the adverse events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Additional information: Patient had no prior histories of heart attack problems. These spike proteins are firing throughout the human body. Reporter said how can that possibly be healthy or good. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date=31Dec2021; covid test result=Positive; covid test date=31Dec2021; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 05:00 (Lot number: ERV0168) at the age of 41 years as dose 1, single and administered in arm left, administration date 02Sep2021 05:00 (Lot number: FD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "covid test date=31Dec2021; covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Covid was tested post vaccination. No other vaccine was administered in four weeks or two weeks.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Demyelination, Multiple sclerosis, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 51 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 Lot # unknown, Location of injection: Arm, shoulder), administration date: 03Apr2021, when the patient was 50 years old, for Covid-19 Immunization, reaction(s): "cognitive issues". The following information was reported: MULTIPLE SCLEROSIS (hospitalization, medically significant), outcome "unknown", described as "after 2nd dose started developing physical issues that landed me in the hospital for 6 days and a diagnosis of multiple sclerosis."; DEMYELINATION (medically significant), outcome "unknown", described as "demyelination on my spinal cord and brain/demyelination of caller's spinal cord and brain"; CONTUSION (non-serious) with onset Apr2021, outcome "unknown", described as "sort of like bruises"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Caller is right handed and knows had soreness". The patient was hospitalized for multiple sclerosis (hospitalization duration: 6 day(s)). Clinical Course: Patient had concern that the Covid vaccine From company triggered demyelination on his spinal cord and brain. He had no issues prior to the vaccine in Apr2021. Patient read studies showing a possible link and would like to speak with someone at your company about this. Multiple sclerosis was not listed as something that was reported during the clinical trials for the vaccine. Post-authorization experience these reactions are reported voluntarily, Reason for no lot number: of Pfizer Covid-19 Vaccine: Patient does not have vaccine card available to provide this information. Patient was taking Pfizer Covid-19 Vaccine Required for his employer and just seemed like the right thing to do based on Covid. Patient does not want to provide address or email. HCP states the information was for his primary doctor, not a neurologist. Patient unable to provide NDC/lot/expiration first and second dose. He doesn't know exact date for sure. Unable to recall left or right arm, shoulder. He knows soreness is a side effect when went for the Pfizer Covid-19 Vaccine. The soreness began the day after receiving the second dose Pfizer Covid-19 Vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 51 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 Lot # unknown, Location of injection: Arm, shoulder), administration date: 03Apr2021, when the patient was 50 years old, for Covid-19 Immunization, reaction(s): "cognitive issues". The following information was reported: MULTIPLE SCLEROSIS (hospitalization, medically significant), outcome "unknown", described as "after 2nd dose started developing physical issues that landed me in the hospital for 6 days and a diagnosis of multiple sclerosis."; DEMYELINATION (medically significant), outcome "unknown", described as "demyelination on my spinal cord and brain/demyelination of caller's spinal cord and brain"; CONTUSION (non-serious) with onset Apr2021, outcome "unknown", described as "sort of like bruises"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Caller is right handed and knows had soreness". The patient was hospitalized for multiple sclerosis (hospitalization duration: 6 day(s)). Clinical Course: Patient had concern that the Covid vaccine From company triggered demyelination on his spinal cord and brain. He had no issues prior to the vaccine in Apr2021. Patient read studies showing a possible link and would like to speak with someone at your company about this. Multiple sclerosis was not listed as something that was reported during the clinical trials for the vaccine. Post-authorization experience these reactions are reported voluntarily, Reason for no lot number: of Pfizer Covid-19 Vaccine: Patient does not have vaccine card available to provide this information. Patient was taking Pfizer Covid-19 Vaccine Required for his employer and just seemed like the right thing to do based on Covid. Patient does not want to provide address or email. HCP states the information was for his primary doctor, not a neurologist. Patient unable to provide NDC/lot/expiration first and second dose. He doesn't know exact date for sure. Unable to recall left or right arm, shoulder. He knows soreness is a side effect when went for the Pfizer Covid-19 Vaccine. The soreness began the day after receiving the second dose Pfizer Covid-19 Vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Sinus tachycardia
Clinical narrative: Sinus tachycardia; Dose Number: 1 administration date 03Jan2022/Dose Number: 2 administration date 04Mar2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2022 12:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOL; DULOXETINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00), administration date: 03Jan2022, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: SINUS TACHYCARDIA (non-serious) with onset 05Mar2022 12:00, outcome "recovering", described as "Sinus tachycardia"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Mar2022, outcome "unknown", described as "Dose Number: 1 administration date 03Jan2022/Dose Number: 2 administration date 04Mar2022". The event "sinus tachycardia" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sinus tachycardia.  Additional information: No Other vaccine in four weeks. No covid prior vaccination.Patient was covid tested post vaccination covid test type post vaccination Nasal Swab test on 06Mar2022 with Covid test result Negative.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Eye injury, Facial paralysis, Pain
Clinical narrative: Permanent eye damage on the effected side due to the Bell; Bells palsy; Facial paralysis; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 03Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE INJURY (medically significant), outcome "not recovered", described as "Permanent eye damage on the effected side due to the Bell"; BELL'S PALSY (medically significant), outcome "not recovered", described as "Bells palsy"; FACIAL PARALYSIS (medically significant), outcome "not recovered", described as "Facial paralysis"; PAIN (non-serious), outcome "unknown", described as "Pain".  Clinical course: The patient has received the first dose of the Pfizer COVID-19 vaccine on 03Apr2021 and the second dose on 30Apr2021 and shortly after was diagnosed with Bell's palsy. The patient had lived with Bell's palsy/ facial paralysis for the past 11 months it causes pain and the patient had received permanent eye damage on the effected side due to the Bell's palsy. The patient was wanted to reach out to see if Pfizer offered any sort of compensation for the medical troubles, thank you so much.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: I received 2 dose of vaccine and a booster and I still got the covid virus.; I received 2 dose of vaccine and a booster and I still got the covid virus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "I received 2 dose of vaccine and a booster and I still got the covid virus.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Intentional product misuse, Myocardial infarction
Clinical narrative: has three vaccine at one time and died; heart attack; This is a spontaneous report from a contactable consumer. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose, for covid-19 immunisation. Patient received pneumonia vaccine (unspecified) and flu vaccine (unspecified) that day, she had three vaccine at one time. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: intentional product misuse (death), outcome "fatal", described as "has three vaccine at one time and died"; myocardial infarction (death), outcome "fatal", described as "heart attack". Patient passed away after receiving three vaccine; she had three vaccine at one time and died; she was found dead in her apartment. Patient had a heart attack. The patient date of death was unknown. The reported cause of death was myocardial infarction. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up. ; Reported Cause(s) of Death: heart attack
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer metastatic, Investigation
Clinical narrative: metastatic breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER METASTATIC (medically significant) with onset 2021, outcome "unknown", described as "metastatic breast cancer". The patient underwent the following laboratory tests and procedures: investigation: (2022) metastatic breast cancer.  Clinical course: Five months later patient received a diagnosis of metastatic breast cancer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation
Clinical narrative: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions; This is a spontaneous report from a contactable consumer from medical information team. An elderly patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose, for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: hypoxia (death), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200376657 the same reporter, product and similar adverse event in different patients; Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Illness, Pneumonia, Urinary tract disorder
Clinical narrative: Pneumonia; Shingles; Sick/Ill post-vaccines; UTD; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (051529).  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; ILLNESS (non-serious), outcome "unknown", described as "Sick/Ill post-vaccines"; URINARY TRACT DISORDER (non-serious), outcome "unknown", described as "UTD". Clinical Course Reports missing doses when she becomes ill post-vaccines. Happens with every vaccine she had ever gotten. She was UTD with COVID vaccines,pneumonia, and shingles, but does not get the flu shot because she gets sick.Suspect Product(s): XELJANZ TAB 5MG Start Date: 03Jan2019  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: Acute flaccid myelitis, Acute hepatic failure, Acute respiratory failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: ACUTE FLACCID MYELITIS (medically significant), outcome "unknown", described as "acute flaccid myelitis"; ACUTE RESPIRATORY FAILURE (medically significant), ACUTE HEPATIC FAILURE (medically significant), outcome "unknown" and all described as "acute respiratory failure and liver". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis
Clinical narrative: Having symptoms and one of the symptom is trophic lateral sclerosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant), outcome "unknown", described as "Having symptoms and one of the symptom is trophic lateral sclerosis". Clinical information reported that on reporter was calling on behalf of her cousin (consumer), who took the Vaccine in Aug that was Pfizer COVID-19 Vaccine and since then she (further not clarified) was having symptoms and one of the symptom was trophic lateral sclerosis (event captured as per verbatim), number and number of COVID-19 Vaccine was unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: vaccines are ineffective, but you are not allowing those of us that got all three and got COVID to participate; vaccines are ineffective, but you are not allowing those of us that got all three and got COVID to participate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "vaccines are ineffective, but you are not allowing those of us that got all three and got COVID to participate".  Clinical Information: Th patient got COVID vaccine at the end of Jan and stated the vaccines are not working.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: ineffectiveness of all of the vaccines cause me to wonder if these are all you're working on; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "ineffectiveness of all of the vaccines cause me to wonder if these are all you're working on"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "covid-19". Clinical Information: The patient got the initial two doses of the COVID vaccine and 6 months later the booster as well. Patient reported the ineffectiveness of all of the vaccines.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac amyloidosis, Plasma cell myeloma, SARS-CoV-2 test
Clinical narrative: Multiple myeloma; Cardiac amyloidosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6200) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Vaccination history included: Bnt162b2 (First dose, Lot. EN6208, in the left arm), for COVID-19 immunisation. The following information was reported: PLASMA CELL MYELOMA (disability, life threatening) with onset Apr2021, outcome "not recovered", described as "Multiple myeloma"; CARDIAC AMYLOIDOSIS (disability, life threatening) with onset Apr2021, outcome "not recovered", described as "Cardiac amyloidosis". The events "multiple myeloma" and "cardiac amyloidosis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. Therapeutic measures were taken as a result of plasma cell myeloma, cardiac amyloidosis (chemotherapy and medications).  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Rheumatoid arthritis
Clinical narrative: a bad side affect from covid19 vaccine-body on fire with RA; a bad side affect from covid19 vaccine-body on fire with RA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), BURNING SENSATION (non-serious), outcome "unknown" and all described as "a bad side affect from covid19 vaccine-body on fire with RA".  Additional information: It was reported, the patient had developed a bad side affect from covid19 vaccine-body on fire with RA.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: PT caught Covid after COVID vaccine; PT caught Covid after COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "PT caught Covid after COVID vaccine".  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 available information a contributory role of BNT162B2 to the reported events COVID-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pneumonia legionella, Psoriatic arthropathy, Sepsis
Clinical narrative: Sepsis; Legionnaire's disease; Psoriatic arthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4306423-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEPSIS (hospitalization, medically significant), outcome "unknown", described as "Sepsis"; PNEUMONIA LEGIONELLA (hospitalization, medically significant), outcome "unknown", described as "Legionnaire's disease"; PSORIATIC ARTHROPATHY (hospitalization, medically significant), outcome "unknown", described as "Psoriatic arthritis". The action taken for adalimumab was unknown. Clinical course: Patient was hospitalized for sepsis and pneumonia. She was diagnosed with Legionnaires' disease. After the second COVID vaccination she had really bothered psoriatic arthritis. On 04Jan2022 till 14Jan2022, she was on oxygen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Sepsis, Legionnaires Disease and Second Covid Vaccination Bothered Psoriatic Arthritis was not provided. Agency's opinion is that the events of Sepsis and Legionnaires Disease are not assessable. Agency's opinion is that there is no reasonable possibility that the event of Second Covid Vaccination Bothered Psoriatic Arthritis is related to Humira (Adalimumab).  Causality for Pfizer Biontech COVID-19 Vaccine (Tozinameran): The reporter's causality for the event Sepsis and Legionnaire's disease was not reported, that the event of Second Covid Vaccination Bothered Psoriatic Arthritis was not related   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 current available limited information in the case provided, the causal association between the events Sepsis, Legionnaires Disease and Second Covid Vaccination Bothered Psoriatic Arthritis and the use of suspect product BNT162B2 cannot be fully 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Infected neoplasm, Swelling
Clinical narrative: post inflammatory nodules; swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): GL-030122-5224 (RA).  A female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; hyaluronic acid (RESTYLANE), from 13Sep2021 (Batch/Lot number: unknown) to 01Feb2022. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTED NEOPLASM (non-serious) with onset 18Feb2022, outcome "unknown", described as "post inflammatory nodules"; SWELLING (non-serious) with onset 18Feb2022, outcome "unknown", described as "swelling". The action taken for hyaluronic acid was unknown. Therapeutic measures were taken as a result of infected neoplasm, swelling. Additional information: Patient /HCP reported post inflammatory nodules and swelling after Restylane Lyft, Restylane Defyne, Restylane, Refyne and Restylane Contour injections. Treatments given from 13Sep2021-01Feb2022. Adverse event started was reported as 18Feb2022. Pfizer Covid vaccine dates were reported as dose 1 on 02Feb2021 and dose 2 on 23Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hep B issue" (unspecified if ongoing); "BP issue" (unspecified if ongoing). The patient took concomitant medications which included blood pressure medicine and Meds for Hepatitis B liver issue. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "COVID-19 Treatment". Therapeutic measures were taken as a result of suspected covid-19 with Paxlovid from 04Mar2022 to 05Mar2022.  Clinical course: Metallic taste in mouth after taking Paxlovid. Also, discontinued over unknown drug to drug interactions with BP meds and Liver Meds. Patient has Hepatitis B issues.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthritis, Cerebrovascular accident, Fatigue, Headache, Psoriasis
Clinical narrative: Stroke; Fatigue flare up; Arthritis; Plaque psoriasis break out on left calf, left knee, and right knee; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4304137-00 (AbbVie).  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single, intramuscular, administration date 19May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 28Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke"; FATIGUE (non-serious), outcome "not recovered", described as "Fatigue flare up"; ARTHRITIS (non-serious), outcome "not recovered", described as "Arthritis"; PSORIASIS (non-serious), outcome "not recovered", described as "Plaque psoriasis break out on left calf, left knee, and right knee"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The action taken for adalimumab was dosage not changed. The reporter's causality for the event(s) of stroke and headache with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of fatigue flare up, arthritis, plaque psoriasis break out on left calf, left knee, and right knee with Humira (Adalimumab) was reasonable possibility. Unknown if the event abate after stopping drug. The reporter's causality for the event(s) of stroke, fatigue flare up, arthritis, plaque psoriasis break out on left calf, left knee, and right knee with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was not Reported. The reporter's causality for the event(s) of Headache with Humira (Adalimumab) 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 information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 13:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "High blood pressure and cholesterol" (unspecified if ongoing); "High blood pressure and cholesterol" (unspecified if ongoing); "recently diagnosed with diabetes" (unspecified if ongoing); "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19. Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN. The following information was reported: ALOPECIA (medically significant) with onset 20Jan2022 13:15, outcome "not recovered", described as "As with contacting Covid in Nov2020, 6 months after receiving Covid vaccination, I've experienced significant hair loss 6 months after the vaccine". Therapeutic measures were not taken as a result of alopecia. Clinical Course: Prior to vaccination, patient was diagnosed with COVID-19. She was experienced significant hair loss and an still continuing to lose hair. Her hair was at approximately half the volume as it was prior to the vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Ultrasound pelvis
Clinical narrative: bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pfizer! I received your booster shot in the middle of December, my first doses being in Moderna" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1), for COVID-19 immunization; Moderna (DOSE 2), for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset Jan2022, outcome "unknown", described as "bleeding". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: She had a sore arm a day or two after; She mentioned that it hurts every time she wakes up and gets out of bed.; terrific" joint pain on her shoulders and knees.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 ( booster),single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for Covid-19 immunization; Bnt162b2 (Dose 02), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a sore arm a day or two after"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "terrific" joint pain on her shoulders and knees."; PAIN (non-serious), outcome "unknown", described as "She mentioned that it hurts every time she wakes up and gets out of bed.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: having symptoms of multiple sclerosis after a week and a half of the first dose of the Pfizer COVID-19 vaccine and her symptoms increased after that; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: ER8732) at the age of 56 years as dose 1, single and administered in arm left, administration date 17Apr2021 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 12Apr2021, outcome "not recovered", described as "having symptoms of multiple sclerosis after a week and a half of the first dose of the Pfizer COVID-19 vaccine and her symptoms increased after that". The event "having symptoms of multiple sclerosis after a week and a half of the first dose of the pfizer covid-19 vaccine and her symptoms increased after that" was evaluated at the physician office visit. Therapeutic measures were taken as a result of multiple sclerosis. The patient was "having symptoms of Multiple Sclerosis after a week and a half of the first dose of the Pfizer COVID-19 vaccine and her symptoms increased after that". Patient had her Pfizer COVID-19 vaccine in Mar2021 and Apr2021 and was "officially diagnosed with Multiple Sclerosis in Jul2021". Patient was "started with "Ocrevus" which weakens the immune system according to caller". Patient "was administered with the Ocrevus infusion last November and she is due for another infusion at the end of April". Patient and husband were concern because of the possible effect of the Ocrevus to the immune system of caller and if it would affect her getting a booster dose of the Pfizer COVID-19 vaccine. Patient asked for information on administration of the Pfizer COVID-19 vaccine with people with a weakened immune system and with people taking immunosuppressants. Patient asked if her symptoms would get worse and if Pfizer recommends a larger dose for autoimmune deficiency specifically with Multiple Sclerosis. The patient was diagnosed with Multiple Sclerosis a week after the first dose of getting the Pfizer Covid 19 vaccine, and the symptoms of Multiple Sclerosis escalated after the second dose of vaccine. No vaccinations within four weeks prior to the first administration date of the suspect vaccine.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis
Clinical narrative: Felt like a constant cold/cold like symptoms; experienced Covid; experienced Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308322-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "experienced Covid"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Felt like a constant cold/cold like symptoms". The action taken for adalimumab was unknown.  Clinical Information: It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the event of Covid was not provided. The reporter's causality for the event of felt like a constant cold/cold like symptoms with Humira (Adalimumab) was a reasonable possibility.   The reporter's assessment of the causal relationship of the experienced Covid and Felt like a constant cold/cold like symptoms 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 bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.