chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain in extremity
Clinical narrative: immunocompromised; received the 3rd dose; received the 3rd dose; asthma; sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).   A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/Lot number was not reported), dose 3 via an unspecified route of administration on 16Aug2021 (at the age of 64 years), as DOSE 3, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included BNT162B2 in May2021 for covid-19 immunization (Patient initially received 2 doses of Pfizer COVID 19 vaccine in May2021). The patient stated, initially received 2 doses of Pfizer COVID 19 vaccine in May2021. She received the 3rd dose of the Pfizer COVID 19 vaccine 2 days ago. She would like to know how much protection she had against Delta variant. She read on the news efficacy was 42% some other says 95%. Patient was not sure if she was considered immunocompromised as she had asthma. She also developed sore arm after the 3rd dose. The patient was concerned whether 3rd dose of the vaccine give a positive result for rapid antigen test. She had a cruise travel and it required her to have an antigen test. The clinical outcome of the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Rheumatoid arthritis
Clinical narrative: Headache; Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4031079-00). A non-contactable consumer (patient herself) reported for a 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Batch/Lot number was not reported) as dose 1, single and on an unspecified date (Batch/Lot number was not reported) as dose 2, single; both intramuscular for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneously from an unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency for moderate to severe rheumatoid arthritis. The patient's medical history included moderate to severe rheumatoid arthritis. Concomitant medications were not reported. The reporter was reporting non-serious rheumatoid arthritis flare up and headache with adalimumab (HUMIRA). On an unknown date, the patient experienced headache. In Jul2021, the patient experienced rheumatoid arthritis flare up. Pfizer BioNTech Covid-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date she received first and second dose of COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. Outcome of rheumatoid arthritis flare up was recovered in 2021 while headache was recovered on an unspecified date.   Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of rheumatoid arthritis flare up and headache with adalimumab (HUMIRA) was a reasonable possibility.   The reporter's assessment of the causal relationship of the event 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 on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information, obscure temporal relationship and possible contributory effects from concomitant use of adalimumab which can manifest events of  Rheumatoid arthritis flare up and headache,a causal association with suspect drug bnt162b2 was assessed as unrelated.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, FLUX
Symptoms: Pharyngeal swelling, Product use issue, Pruritus
Clinical narrative: swelling in her throat; Itching; got the COVID vaccine, flu shot same day; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation; influenza vaccine (FLU), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. Reporter was calling about the Pfizer COVID vaccine. His wife (patient) got the COVID vaccine and she was experiencing swelling in her throat and itching on an unspecified date. Got a flu shot same day (unknown date) and got Benadryl. Outcome of the events were unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Malaise, Peripheral swelling, Somnolence
Clinical narrative: Drowsy; Not feeling good; Redness on arm; Swelling on arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included influenza vaccine (FLU VACCINE VII). The patient had been feeling drowsy and not feeling good. He was experiencing redness and swelling on his arm and he cant pick it up. He can pick it up but not like normal. He got a flu shot same day and went to with held and got Benadryl. The outcome of all events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oedema genital, Rash
Clinical narrative: skin rash to all of his body; inflammation to genital area; This is a spontaneous report from a contactable consumer (patient). A 27-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7484), via an unspecified route of administration on 29Jul2021 as dose 2, single for covid-19 immunization (age at vaccination 27 years). Medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an unspecified route of administration on 08Jul2021 as dose 1, single (age at vaccination 27 years) for covid-19 immunisation. The patient was very healthy before the vaccine. The patient experienced skin rash to all of his body and inflammation to genital area on an unspecified date in 2021. The patient stated that, he has had a side effect after getting the second dose of Pfizer-BioNTech COVID-19 vaccine of a skin rash and inflammation to genital area that has lasted more than two weeks and was not going away. He said that the doctor said they cannot understand what it was and how to treat and told him to take allergy pill which he took Benadryl for two weeks and it was not working and it was not going away. Caller clarified that it was a skin rash to all of his body and inflammation to genital area are the same, they are not better or not worse. He says that the problems were not going away. Therapeutic measures taken as a result of events included treatment with Benadryl. The outcome of the events was not recovered.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Inflammation, Rash
Clinical narrative: skin rash to all of his body; inflammation to genital area; This is a spontaneous report from a contactable consumer (patient). A 27-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7484), via an unspecified route of administration on 29Jul2021 as dose 2, single for covid-19 immunization (age at vaccination 27 years). Medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an unspecified route of administration on 08Jul2021 as dose 1, single (age at vaccination 27 years) for covid-19 immunisation. The patient was very healthy before the vaccine. The patient experienced skin rash to all of his body and inflammation to genital area on an unspecified date in 2021. The patient stated that, he has had a side effect after getting the second dose of Pfizer-BioNTech COVID-19 vaccine of a skin rash and inflammation to genital area that has lasted more than two weeks and was not going away. He said that the doctor said they cannot understand what it was and how to treat and told him to take allergy pill which he took Benadryl for two weeks and it was not working and it was not going away. Caller clarified that it was a skin rash to all of his body and inflammation to genital area are the same, they are not better or not worse. He says that the problems were not going away. Therapeutic measures taken as a result of events included treatment with Benadryl. The outcome of the events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Oral herpes, Oropharyngeal blistering, Oropharyngeal pain
Clinical narrative: Sore throat with blisters in back of throat; Sore throat with blisters in back of throat; cold sore; fatigue; mild cough; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was FC3181), via an unspecified route, administered in left arm on 17Aug2021 16:00 (at the age of 32-year-old) at dose 1, single for COVID-19 immunization. Medical history includes PCOS, anxiety, depression, high blood pressure, sleep apnea, insulin resistance. Concomitant medications includes escitalopram oxalate (LEXAPRO), lisinopril, hydrochlorothiazide, metformin, all drugs received within two weeks of vaccinations. The patient previously took Bactrim and had Allergies. The patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination patient was not tested for COVID-19. On 17Aug2021 16:30, the patient experienced Sore throat with blisters in back of throat, cold sore, fatigue, mild cough. The patient did not receive treatment for all events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer. An unknown age female patient received BNT162B2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot number were not reported) dose 2 via an unknown route of administration on 20Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient past drug therapy included BNT162B2 for COVID-19 immunisation on an unspecified date. The patient experienced UTI on an unspecified date. Caller stated that she received both doses of the Pfizer COVID-19 vaccine, her second one being administered on 20Feb2021 and has recently experienced a rough UTI. Caller stated that she was not prone to getting them and was wondering if they are connected to the vaccine. She stated that two of her family members have also had UTIs around the same time, within a month or so. She stated that she just recently went through a UTI, and she was not prone to them and it was a tough one. She stated she has to be on three different types of medications before it knocked it out and it lasted about two weeks. Caller stated that one family member was in the hospital and the reason was originally for a UTI, and her sister-in-law had to go to the emergency room for a UTI. She was looking for any connection to the vaccine and UTIs in the 55 year and older population. Caller stated she was curious if the vaccine has a part in it. Caller states they are around the same age. Caller stated she doesn't wish to complete a report for the 2 additional family members. Caller stated she will talk to them about that, she knows it was about the same time. Caller stated the one family member was hospitalized for the UTI, but now there are several other things. Caller stated that family member was in her early 80s, so she has other things happening also. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070858 same reporter/drug/AE with different patient;US-PFIZER INC-202101069940 same reporter/drug/AE with different patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure ambulatory increased, Blood test, Chest X-ray, Dizziness
Clinical narrative: Heart attack; Dizzy; Blood pressure up; Weak and tired; Left arm in pain; Weak and tired; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 59267-1000-02), via an unspecified route of administration, administered in Arm Right on 12Aug2021 11:00 (at the age of 70-years-old) as dose 1, single for covid-19 immunization. Medical history included chronic pain, Covid-19 and IV contrast from an unknown date and unknown if ongoing. The patient received unspecified concomitant medications. The patient previously took tramadol and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On12Aug2021 12:00, the patient experienced first day headache second to present dizzy, nausea, blood pressure up, weak and tired. She thought she was having heart attack as she had left arm in pain and went to emergency room. This took place on 6 day of receiving vaccine had been in touch with her doctor since Monday. The adverse event resulted in emergency room/department or urgent care. The patient received treatment in result of adverse events was blood work and X-RAY of chest. The patient underwent lab tests and procedures which included blood test: unknown results, chest x-ray: unknown results on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myocardial infarction, Nausea, Pain in extremity
Clinical narrative: Heart attack; Dizzy; Blood pressure up; Weak and tired; Left arm in pain; Weak and tired; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 59267-1000-02), via an unspecified route of administration, administered in Arm Right on 12Aug2021 11:00 (at the age of 70-years-old) as dose 1, single for covid-19 immunization. Medical history included chronic pain, Covid-19 and IV contrast from an unknown date and unknown if ongoing. The patient received unspecified concomitant medications. The patient previously took tramadol and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On12Aug2021 12:00, the patient experienced first day headache second to present dizzy, nausea, blood pressure up, weak and tired. She thought she was having heart attack as she had left arm in pain and went to emergency room. This took place on 6 day of receiving vaccine had been in touch with her doctor since Monday. The adverse event resulted in emergency room/department or urgent care. The patient received treatment in result of adverse events was blood work and X-RAY of chest. The patient underwent lab tests and procedures which included blood test: unknown results, chest x-ray: unknown results on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Eye injury, Fall, Nervousness, Rash
Clinical narrative: Patient was really nervous to begin with; After receiving second dose within 2-3 minutes patient fell from chair face on hitting her head against the floor and a minor cut on the outer eye was observed.; After receiving second dose within 2-3 minutes patient fell from chair face on hitting her head against the floor and a minor cut on the outer eye was observed.; The arms and neck area broke out into rash.; This is a spontaneous report from a contactable pharmacist. A 15-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via intramuscular, administered in left arm on 18Aug2021 16:45 (age at vaccination was 15years) (Batch/Lot Number: ew0185) as dose 2, single for covid-19 immunization at pharmacy or drug Store. Medical history included drug hypersensitivity to penicillin from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. It was unknown that the patient had been tested for COVID-19 since the vaccination. The patient received first dose bnt162b2 (BNT162B2), dose 1 via intramuscular, administered in left arm on 27Jul2021 (Batch/Lot Number: ew0186) as dose 1, single for covid-19 immunization and did not experienced any reaction. On 18Aug2021 Patient was nervous to begin with. After receiving second dose within 2-3 minutes patient fell from chair face on hitting her head against the floor and a minor cut on the outer eye was observed. The arms and neck area broke out into rash. gave her a benadryl tablet, tylenol for the fall, and we iced the eye and monitored patient for 30 minutes. The patient's mom took patient to the ER where she was getting a CT scan done for the eye. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient received benadryl, tylenol, and iced the area as treatment. The event nervousness was medically significant. The patient underwent lab tests and procedures which included computerized tomogram: unknown on unspecified date in Aug2021 CT scan done for the eye. The outcome of the events was unknown.; Sender's Comments: based on the close temporal relation ship the causality between the events rash , fall , eye injury and the suspect vaccine BNT162B2 cannot be ruled out The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Experienced a flare up; This is a spontaneous report from a contactable nurse and a contactable consumer via a Pfizer-sponsored program. A 57-year-old non-pregnant female patient 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 (at the age of 57 years old) for COVID-19 immunization; and tofacitinib citrate (XELJANZ XR), oral from Feb2020 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. Medical history included rheumatoid arthritis. Concomitant medications were not reported. When the patient got her covid vaccines (reported as "covered vaccines") she had to go off her medicine for a week each time and experienced a flare up noticed a difference. The action taken in response to tofacitinib citrate was unknown. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known disease pathophysiology, the event is assessed as unlikely related to the suspect drugs and more likely due to the pre-existent disease. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Acute transverse myelitis; This is a spontaneous report from a contactable Physician.  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 39-year-old) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced acute transverse myelitis on an unspecified date with outcome of unknown.   The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Myelitis transverse cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Drug ineffective, Suspected COVID-19
Clinical narrative: Her father has COVID 19 and was Vaccinated with the Pfizer vaccine in Feb; Her father has COVID 19 and was Vaccinated with the Pfizer vaccine in Feb; diarrhea; This is a spontaneous report from a non-contactable consumer via a Pfizer representative reported for father. A 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Feb2021 at single dose for COVID-19 immunisation. Medical history included Covid-19. Concomitant medication was not reported. The patient had COVID 19 and was Vaccinated with the Pfizer vaccine in Feb. He had cough and diarrhea. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: acute kidney injury (now chronic) due to receiving his 2nd dose of the Pfizer vaccine; This is a spontaneous report from a contactable consumer.  A consumer (patient's parent) reported that a 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The consumer reported that the patient suffered acute kidney injury (now chronic) due to receiving his 2nd dose of the Pfizer vaccine. He used to be able to play basketball and run around the block without having to worry about his kidneys. He can now do neither simply because he wanted to protect himself and others. 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Pericardial effusion, SARS-CoV-2 test
Clinical narrative: 5mm of fluid around heart; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Aug2021 at 11:00 (Lot Number: FA7484) as dose 1, single for COVID-19 immunization.  Medical history included coconut allergy from an unknown date. The patient did not have COVID-19 prior to vaccination. Concomitant medication included estradiol (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. On 12Aug2021, the patient had shortness of breath that has lasted a week. CT from the patient's ER visit on 12Aug2021, showed 5 mm of fluid around the heart and was prescribed Voltaren as treatment. The patient had a COVID-19 nasal swab test on 18Aug2021 with a negative result. The outcome of the event 5mm of fluid around heart was recovering while the outcome of the event shortness of breath was recovered on Aug2021.   No follow-up attempts are possible. No further information is expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I was vaccinated in March - I tested positive for COVID last week.; I was vaccinated in March - I tested positive for COVID last week.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 28-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 24Mar2021(at the age of 28-year-old) as dose number unknown single on 19Aug2021 for covid-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that she was vaccinated in march , tested positive for covid last week (12Aug2021). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Aug2021 Nasal Swab, sars-cov-2 test: positive on 12Aug2021 Nasal Swab, sars-cov-2 test: positive on 13Aug2021 Nasal Swab. The patient did not receive treatment for the resulted events. The clinical outcome of events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: after receiving the first dose, the patient's lymph nodes swell up and was painful; after receiving the first dose, the patient's lymph nodes swell up and was painful; This is a spontaneous report from a contactable pharmacist. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Facility where the COVID vaccine administered was reported as doctor's office/urgent care. Medical history was none. The patient's concomitant medications were not reported. No known drug allergies. COVID prior vaccination was reported as no and not tested for COVID post vaccination. The patient after receiving the first dose, lymph nodes swell up and was painful on 07May2021. The patient was hospitalized for 25 days for the reported events. Patient went to his primary MD who recommended a scan and was told okay to get the second dose. Patient didn't get the scan but received 2nd dose per MD recommendation. The patient received unknown treatment for events. The outcome of the event was reported as not resolved.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pain, lymphadenopathy and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-202101075144 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Brain neoplasm, Lymphadenopathy, Muscular weakness, Neoplasm, Pain in extremity
Clinical narrative: he has a brain tumor; His developed weakness and pain in his legs; developed weakness and pain in his legs; multi lymph nodes in his body swell up and was painful; multiple other tumors in his body; This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization at Doctor's office/urgent care. Medical history and concomitant medications were not reported. No known drug allergies. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced lymph nodes swell up and was painful. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 07May2021, the patient experienced brain tumor and multiple other tumors in his body, developed weakness and pain in his legs, and multi lymph nodes in his body swell up and was painful. It was reported that patient went to his primary MD who recommended a scan and was told okay to get the second dose. Patient didn't get the scan but received 2nd dose per MD recommendation. He was admitted to the hospital and found out he has a brain tumor and multiple other tumors in his body. Adverse events resulted in hospitalization for 25 days. Treatment received was reported as unknown. The outcome of all the events was not recovered at the time of report.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of brain tumor, tumors, weakness and pain in legs and multi lymph nodes in the body swell up and was painful cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes 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.,Linked Report(s) : US-PFIZER INC-202101075130 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: tested positive for Covid19; tested positive for Covid19; sick; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date in late Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid19 a couple of weeks later, has been sick for about 2 1/2 weeks. Patient would like to know that when he can get second dose. The patient underwent lab tests and procedures which included Covid-19 (sars-cov-2 test): positive on an unspecified date in Aug2021. The outcome of the event was reported as unknown.  No follow-up attempts are possible; 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 Drug Ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, COVID-19, Drug ineffective, Headache
Clinical narrative: Covid test name post vaccination: PRC, Covid test result: Positive; Covid test name post vaccination: PRC, Covid test result: Positive; Headache; Stiffness; Soreness in neck; Knees/Hips; Back; Insomnia; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that:  A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (at the age of 37-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior vaccination it was unknown and post vaccination, the patient was tested for COVID-19. On an unspecified date, the patient experienced covid test name post vaccination: prc, covid test result: positive (medically significant), headache, stiffness, soreness in neck, knees/hips, back, insomnia. The patient underwent lab tests and procedures which included PRC: positive on unspecified date. Case was reported as serious. It was unknown, if patient received treatment for the events except covid-19 event. The clinical outcome of events covid test name post vaccination: prc, covid test result: positive was unknown and other events were recovered with sequel on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal stiffness, Neck pain, SARS-CoV-2 test
Clinical narrative: Covid test name post vaccination: PRC, Covid test result: Positive; Covid test name post vaccination: PRC, Covid test result: Positive; Headache; Stiffness; Soreness in neck; Knees/Hips; Back; Insomnia; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that:  A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (at the age of 37-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior vaccination it was unknown and post vaccination, the patient was tested for COVID-19. On an unspecified date, the patient experienced covid test name post vaccination: prc, covid test result: positive (medically significant), headache, stiffness, soreness in neck, knees/hips, back, insomnia. The patient underwent lab tests and procedures which included PRC: positive on unspecified date. Case was reported as serious. It was unknown, if patient received treatment for the events except covid-19 event. The clinical outcome of events covid test name post vaccination: prc, covid test result: positive was unknown and other events were recovered with sequel on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough CV19 + on 19Aug2021; Breakthrough CV19 + on 19Aug2021; This is a spontaneous report from a contactable other hcp. A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via intramuscular route of administration, administered in Arm Right on 27Jan2021(at the age of 57-years-old)  DOSE 1, SINGLE, patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via intramuscular route of administration, administered in Arm Right on 15Feb2021 (at the age of 57-years-old) as DOSE 2, SINGLE for covid-19 clinic. The patient medical history was not reported. The patient's concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Prior to vaccination, it was unknown was the patient diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient experienced breakthrough COVID-19 positive on 19Aug2021. Therapeutic measure were taken as no as a result of event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Aug2021 (Nasal Swab). Outcome of event was Not recovered.  No routine follow-up attempts are foreseen for reports received from WEB. Information about lot number has already obtained. No further info is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The patient was getting COVID despite of having had the Covid vaccine.; The patient was getting COVID despite of having had the Covid vaccine.; This is a non-interventional study report from a marketing program name not available received from a non-contactable consumer.   A 64-year-old male patient (Age at vaccination 64 years) received BNT162B2 (BNT162B2), intramuscular, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history includes psoriasis. Concomitant medication included risankizumab (SKYRIZI [RISANKIZUMAB]) taken for psoriasis from an unspecified start date and ongoing. It was reported that the patient was getting covid despite of having had the covid vaccine on 05Aug2021. The events were reported as serious-medically significant. Outcome of the events was unknown.  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 the known safety profile of the vaccine BNT162B2, a temporal relation between the events( Drug ineffective, Covid19) and the administration of the vaccine cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Extra dose administered, Off label use
Clinical narrative: I swear of ulcerative colitis at my booster third shot; booster third shot has been administered; booster third shot has been administered; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: en0171) via an unspecified route of administration on 18Aug2021 (age at vaccination 44-years-old) as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single and dose 2 single for covid-19 immunization. On 19Aug2021, the patient stated that she swear of ulcerative colitis at her booster third shot. On 18Aug2021, the patient administered booster third shot. The outcome of the event of ulcerative colitis was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage urinary tract, Heavy menstrual bleeding, Hot flush, Inappropriate schedule of product administration, Postmenopausal haemorrhage
Clinical narrative: I started my period; It has been very heavy, bright red and with clots; It has been very heavy, bright red and with clots; First dose 21Jul2021 and Second dose on 21Jul2021; hot flashes; This is a spontaneous report from a contactable consumer (reported herself). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), on 21Jul2021 17:00 (age at vaccination was 51-year-old, lot number: FA7484) as dose 1, single and on 21Jul2021 (lot number: FD8448) as dose 2, both via an unspecified route of administration, administered in arm right for covid-19 immunisation in pharmacy or drug store. Medical history included frequent hot flashes, after approximately 6 months with no menstrual cycle. The patient received concomitant medications which were unspecified, received within in two weeks of vaccination. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that after approximately 6 months with no menstrual cycle and frequent hot flashes. The patient started her period on 05Aug2021. It has been very heavy, bright red and with clots. She was still bleeding as of today 19Aug2021. The patient had hot flashes on an unknown date in 2021. She was not having any cramping and her hot flashes have been gone since 02Aug2021. No treatment medication was received for the adverse events. The outcome of the event of Hot flashes was recovered on 02Aug2021 and all other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 after the COVID-19 vaccination; tested positive for COVID-19 after the COVID-19 vaccination; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported different events for 4 patients. This is 1 of 4 reports.   A 64-year-old female patient received bnt162b2 (formulation: solution for injection; NDC number: unknown; expiry date: unknown), dose 1 via an unspecified route of administration on 12Mar2021 (Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 02Apr2021 (Lot number was not reported) as dose 2, single (at the age of 64 years) for covid-19 immunisation. Medical history included diabetes from 2014 and its ongoing. It has been about 7 years since she has had diabetes. She is not on insulin. She controls it with exercise and diet. There were no concomitant medications. The patient reported that she tested positive for covid-19 after the covid-19 vaccination on 03Aug2021. Patient confirms that she tested positive for the delta variant on 03Aug2021 and 16Aug2021 was the last day of her isolation. Her first dose was on 12Mar2021 and her 2nd dose was on 02Apr2021. Probed for NDC, lot number and expiry date and she say she has them in her phone, but she can't really read them. She sees that it says Pfizer, but she can't really see what it says beside that. Therapy start date populated as the date for the caller's first COVID vaccine and the therapy stop date populated as the date for the caller's second COVID vaccine. The reason that she got tested is because the caller's husband tested positive on 02Aug2021 and so herself got the quick test and it was negative on 02Aug2021 but then had tested positive on 03Aug2021 and had sore throat and symptoms. The patient underwent lab tests which included delta variant which showed positive on 03Aug2021 and quick test showed negative on 02Aug2021 and positive on 03Aug2021. The outcome of the event COVID-19 was recovered on 16Aug2021.  Caller reporting on herself mentioned that she had her Pfizer COVID vaccines and then tested positive for the delta variant of COVID on 03Aug2021 and 16Aug2021 was the last day of her isolation. The caller's first dose was on 12Mar2021 and her 2nd dose was on 02Apr2021. Probed for NDC, lot number and expiry date and she says she has them in her phone but she can't really read them. She sees that it says Pfizer but she can't really see what it says beside that.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Linked Report(s): US-PFIZER INC-202101077101 Same reporter/ drug/ event for different patients; US-PFIZER INC-202101077103 Same reporter/ drug/ event for different patients.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Heart rate, Heart rate increased
Clinical narrative: Heart fluttering; Resting heart rate increase when sitting down; Tightness in chest; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7485), via an unspecified route of administration on 03Aug2021 (age at vaccination: 46 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart fluttering, resting heart rate increase when sitting down and tightness in chest; all on 07Aug2021. It was reported that received first dose on 03Aug2021. Before vaccine she was fine. Resting heart rate is increasing when just sitting down. Having fluttering sometimes throughout the day. Get little tightness in her chest, not extreme, just a little it. When sitting down, the highest heart rate got to was 210. Heart rate was 170 when she works out. Average heart rate is 170-210 when it spikes while she is sitting down. It spike today and while resting heart rate was 134. Right now heart rate was 82. Really her heart rate should be 90-100 resting. Heart rate spikes throughout the day. Medical Intervention/treatment include she is going for an echocardiogram next Thursday. She hasn't worked out since this started because she is concerned. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.