chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Haemorrhage
Clinical narrative: Bleeding; This is a solicited report based on the information received by Pfizer (Mfr.Control No: 21K-163-4054205-00.) from a contactable consumer (patient).   Solicited report from a country by a consumer of a 69 year old female with an event of non-serious BLEEDING with HUMIRA (ADALIMUMAB). The patient had a relevant medical history of CONGESTIVE HEART FAILURE. In 2020, the patient experienced BLEEDING. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Unknown date , he received 1st dose COVID-19 Vaccine manufactured by Pfizer. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of BLEEDING with HUMIRA(ADALIMUMAB) was no reasonable possibility. On 24Aug2021, received updates to narrative description. Describe Reactions: 31Aug2021: Version one was created to change reporter First name from (with held) to (with held). The correction was done in 5% Sampling. BADWERX  Causality assessment: The Causality as per reporter between bleeding and ADALIMUMAB was No Reasonable possibility. The Causality as per reporter between bleeding and PFIZER BIONTECH COVID-19VACCINE (TOZINAMERAN) was Probable.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. 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: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a solicited report from a study based on information received by Pfizer from a company, manufacturer control number: 21K-163-4046327-00. A contactable 81-year-old female consumer (patient) reported that she received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) via intramuscular route of administration, dose 1 in Jan2021 (Batch/Lot number was not reported), dose 2 on 10Feb2021 (Batch/Lot number was not reported) both as single dose at the age of 81-year-old for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at CF for moderate to severe adult crohn's disease. Medical history included moderate to severe adult crohn's disease. There were no concomitant medications. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced covid-19 on unspecified date in 2021 with outcome of not recovered. The action taken in response to the event for adalimumab was unknown. Relevant laboratory & other diagnostic test included COVID-19 test: positive on unknown date in 2021.                                   Causality for Covid-19 with adalimumab as per reporter (Drug/Vaccine) was no reasonable possibility; with PFIZER BIONTECH COVID-19 as per reporter (Drug/Vaccine) was possible.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective, COVID-19 cannot be completely excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood test, Cardiac stress test, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: arrhythmia; tingling in left side of face that proceeded down left side of neck, and down into left leg; heart palpitations; 6 Abnormal EKG's; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 19Mar2021 15:45 (at the age of 64-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There were no Medical history and concomitant medications. The patient experienced arrhythmia (medically significant and hospitalization), tingling in left side of face that proceeded down left side of neck, and down into left leg (hospitalization), heart palpitations (hospitalization), 6 abnormal EKG's (hospitalization), all on 30Mar2021 08:00. The events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. All events received treatment. The patient was hospitalized for 1 days. Immediately experienced tingling in left side of face that proceeded down left side of neck, and down into left leg. Tingling sensation subsided 9:30pm. Within 10 days she began experiencing severe heart palpitations all day, every day. 6 Abnormal EKG's. Numerous tests revealed no heart disease. Cardiologist determined Covid Vaccine related arrhythmia. EKG's, Bloodwork, Nitroglycerin Stress Test. The patient was received the second dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 09Apr2021 09:45 (at the age of 65-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient underwent lab tests and procedures which included: Blood work and Nitroglycerin Stress Test: Unknown results; Numerous tests: no heart disease; EKG's: 6 Abnormal EKG's on 30Mar2021; Covid test: Negative on 29Jul2021. The outcome of the event Paraesthesia was recovered on 30Mar2021 21:30, others were not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Palpitations, Paraesthesia, SARS-CoV-2 test
Clinical narrative: arrhythmia; tingling in left side of face that proceeded down left side of neck, and down into left leg; heart palpitations; 6 Abnormal EKG's; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 19Mar2021 15:45 (at the age of 64-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There were no Medical history and concomitant medications. The patient experienced arrhythmia (medically significant and hospitalization), tingling in left side of face that proceeded down left side of neck, and down into left leg (hospitalization), heart palpitations (hospitalization), 6 abnormal EKG's (hospitalization), all on 30Mar2021 08:00. The events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. All events received treatment. The patient was hospitalized for 1 days. Immediately experienced tingling in left side of face that proceeded down left side of neck, and down into left leg. Tingling sensation subsided 9:30pm. Within 10 days she began experiencing severe heart palpitations all day, every day. 6 Abnormal EKG's. Numerous tests revealed no heart disease. Cardiologist determined Covid Vaccine related arrhythmia. EKG's, Bloodwork, Nitroglycerin Stress Test. The patient was received the second dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 09Apr2021 09:45 (at the age of 65-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient underwent lab tests and procedures which included: Blood work and Nitroglycerin Stress Test: Unknown results; Numerous tests: no heart disease; EKG's: 6 Abnormal EKG's on 30Mar2021; Covid test: Negative on 29Jul2021. The outcome of the event Paraesthesia was recovered on 30Mar2021 21:30, others were not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diplopia, Eye discharge, Vision blurred, Visual impairment
Clinical narrative: My eye sight is rapidly changing; Double vision/Seeing double up close and far away; Goop like substance in eyes; trouble focusing; Joint pain; This is a spontaneous report from a contactable consumer. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:00 (Lot Number: Er8727) at the age of 44-year-old as single dose for covid-19 immunisation. The patient had no known allergies. Other medical history reported as none. The patient previously received first dose of BNT162B2(lot number=En6208) on 23Mar2021 12:00 PM at the age of 44-year-old as single dose, in Arm Left for covid-19 immunisation. There were no concomitant medications. The patient had no covid prior vaccination, No covid tested post vaccination. The patient experienced "my eye sight is rapidly changing", double vision, trouble focusing, goop like substance in eyes, seeing double up close and far away, Joint pain on 20May2021 12:00 PM. Events serious as disability or permanent damage. No treatment received for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid Breakthrough; Covid Breakthrough;   This is a solicited report received from a contactable consumer (patient) based on information received by Pfizer from a company (Mfr. Control No. :21K-163-4058551-00). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Tozinameran), intramuscular on 20Mar2021 at the age of 44-year-old (Batch/Lot number was not reported) as dose 2, single, intramuscular on 27Feb2021 at the age of 44-year-old (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in Pre filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe ulcerative colitis.   The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a Covid -19 Vaccine Trial. The patient experienced covid breakthrough on Aug2021 with outcome of not recovered.  The action taken in response to the event for bnt162b2 was not applicable, for adalimumab was unknown. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. Covid Breakthrough reported as non-serious. Causality for Humira (Adalimumab): The reporter's causality for the event of Covid Breakthrough was not provided, for Pfizer Biontech Covid-19 Vaccine (Tozinameran) was Possible.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events COVID-19 and Drug ineffective cannot be totally excluded.The case will be reassessed if additional information becomes available
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: got the vaccine lost her baby a week later; This is a spontaneous report from a contactable other healthcare professional via the Pfizer-sponsored Program. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter informed that a mother (patient) that she knows who got the vaccine lost her baby a week later. The reporter thinks that the patient's physician may have already reported this. 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 the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his COVID PCR test came back positive; his COVID PCR test came back positive; This is a spontaneous report from a contactable consumer (patient's wife). A 66-year-old male patient received the unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date: not reported), via an unspecified route of administration on 27Aug2021 (Friday) as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis for which she was taking immunosuppressant medications. The patient's concomitant medications were not reported. On 01Sep2021 (Wednesday), the patient experienced COVID PCR test came back positive which was taken on Mon 30Aug. His wife had tested positive on 29Aug2021 (Sunday). He had no symptoms and felt fine. He had no fever no cold symptoms no weakness. Awareness date was 09Jan2021. The outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101148546 different patient, same drug and event
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I received the first dose of the Covid vaccine. I then contracted Covid; I received the first dose of the Covid vaccine. I then contracted Covid; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was contracted covid and received a Regeneron infusion. The patient was told that the infusion clinic had to start patient vaccinations over again in November, 90 days after the infusion. The outcome of the events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; hair loss; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 50-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 08:15 (at the age of 50-years-old) (Batch/Lot Number: EW0162) as dose 2, single and dose 1 via an unspecified route of administration, administered in left arm on 17Mar2021 08:15 (at the age of 50-years-old) (Batch/Lot Number: ER8727) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient previously experienced known allergies: Penicillin. The patient experienced ongoing hair loss from an unspecified date in Jun2021. The patient was tested positive for Covid-19 which was confirmed by the nasal swab test. The patient was exposed to vaccination failure scenario. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Therapeutic measures were taken as a result of hair loss; Prescription shampoo. The patient visited physician office for the treatment for hair loss. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Aug2021 post vaccination. The outcome of the hair loss was not recovered. The outcome of all the other event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Dizziness, Fibrin D dimer, Headache
Clinical narrative: Heart palpitations; Dizziness; High fever; Body aches; Injection sites pain; Headaches; Chest pain/chest burning; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181 Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 27Aug2021 09:00 (age at vaccination 39 years) as dose 2, single for covid-19 immunization. Medical history included Hypothyroidism. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE). The patient previously took bactrim and experienced allergy. The patient took historical vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485 Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 08:15 for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Aug2021 22:00 The patient experienced heart palpitations, high fever, body aches, injection sites pain, headaches, dizziness, chest pain/chest burning. The event heart palpitations and dizziness was serious (medically significant). Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerised tomogram thorax was unknown, fibrin d dimer was elevated. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia, Vaccination site pain
Clinical narrative: Heart palpitations; Dizziness; High fever; Body aches; Injection sites pain; Headaches; Chest pain/chest burning; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181 Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 27Aug2021 09:00 (age at vaccination 39 years) as dose 2, single for covid-19 immunization. Medical history included Hypothyroidism. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE). The patient previously took bactrim and experienced allergy. The patient took historical vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485 Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 08:15 for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Aug2021 22:00 The patient experienced heart palpitations, high fever, body aches, injection sites pain, headaches, dizziness, chest pain/chest burning. The event heart palpitations and dizziness was serious (medically significant). Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerised tomogram thorax was unknown, fibrin d dimer was elevated. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated
Clinical narrative: rheumatoid symptoms coming back; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program XELSOURCE. A 76-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at 11 mg for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced rheumatoid symptoms coming back on an unspecified date with outcome of unknown. Patient's doctor told her to stop taking tofacitinib citrate for 7 days after receiving the COVID vaccine. By the 4th day after stopping tofacitinib citrate she could feel her rheumatoid symptoms coming back. The action taken in response to the event for tofacitinib citrate was post-therapy.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted Covid-19 after having been fully vaccinated by the Pfizer vaccine; contracted Covid-19 after having been fully vaccinated by the Pfizer vaccine; This is a spontaneous report from a contactable Consumer. A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 Immunisation. The patient medical history and concomitant medications were not reported. Patient did not have covid prior to vaccination and no other vaccine was given in four weeks. The patient had tested covid post vaccination. It was reported that contracted covid-19 after having been fully vaccinated by the Pfizer vaccine on 01Sep2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 01Sep2021. No treatment was received for the events. The outcome of event was recovering.  Information on the Lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Vaccination site pain, Vision blurred, Visual field defect
Clinical narrative: When she looked at something, she had spots of blindness/seeing dots of light in her vision/ blind spots; she could not see the words/ When she closed her eye, she had a jagged line of light/vision is weird; field of vision was blurry/she had to concentrate really hard to focus on anything in her view; injection site hurt; having a hard time sleeping; headaches; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 30Aug2021 at 15:00 (Batch/Lot Number: FC3184) (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Vaccination facility type was pharmacy or drugstore. Medical history included heart palpitations and the patient had an adverse reaction to a vaccination as a young baby, but unsure which one. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included methadone for eight years but have never had any problems with vision or headaches. Methadone was taken for an unspecified indication, start and stop date were not reported (taken within two weeks). The patient did not receive any other vaccine in four weeks. The patient got the shot on Monday, 30Aug2021 at 3pm. That same evening, she noticed the injection site hurt. Then around 9:30-10 pm, she started seeing dots of light in her vision. When she tried to read something, she could not see the words. When she looked at something, she had spots of blindness. She could not see her significant others eye while looking at his face. When she closed her eye, she had a jagged line of light. After about an hour, the blind spots reduced, but around her field of vision was blurry. For two days after that, she felt as though she had to concentrate really hard to focus on anything in her view. That day was Thursday and she was having a hard time sleeping, headaches, and still feel as though her vision is weird. She went to the ER. The event resulted in Emergency room/department or urgent care. No treatment was received. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: When she looked at something, she had spots of blindness/seeing dots of light in her vision/ blind spots; she could not see the words/ When she closed her eye, she had a jagged line of light/vision is weird; field of vision was blurry/she had to concentrate really hard to focus on anything in her view; injection site hurt; having a hard time sleeping; headaches; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 30Aug2021 at 15:00 (Batch/Lot Number: FC3184) (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Vaccination facility type was pharmacy or drugstore. Medical history included heart palpitations and the patient had an adverse reaction to a vaccination as a young baby, but unsure which one. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included methadone for eight years but have never had any problems with vision or headaches. Methadone was taken for an unspecified indication, start and stop date were not reported (taken within two weeks). The patient did not receive any other vaccine in four weeks. The patient got the shot on Monday, 30Aug2021 at 3pm. That same evening, she noticed the injection site hurt. Then around 9:30-10 pm, she started seeing dots of light in her vision. When she tried to read something, she could not see the words. When she looked at something, she had spots of blindness. She could not see her significant others eye while looking at his face. When she closed her eye, she had a jagged line of light. After about an hour, the blind spots reduced, but around her field of vision was blurry. For two days after that, she felt as though she had to concentrate really hard to focus on anything in her view. That day was Thursday and she was having a hard time sleeping, headaches, and still feel as though her vision is weird. She went to the ER. The event resulted in Emergency room/department or urgent care. No treatment was received. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got your vaccine (against my better judgement) and still got the COVID.; Got your vaccine (against my better judgement) and still got the COVID.; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that your COVID vaccine was a waste of time. I have a good immune system, got your vaccine (against my better judgement) and still got the COVID. This now fits with my theory that the Democrats and Chinese created the virus to get rid of and big pharma went along knowing what a gold mine a new virus and vaccine would mean for the bottom line. Great job. The patient underwent lab tests and procedures which included sars-cov-2 test got covid on an unspecified date.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Headache/light headache; Fever; swollen on the right arm where they put the injection, very swollen and also red and hot; swollen on the right arm where they put the injection, very swollen and also red and hot; swollen on the right arm where they put the injection, very swollen and also red and hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A patient of unspecified age and gender received BNT162B2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 18Aug2021 (Lot Number: EW0173, Expiry date not reported) as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Headache (also reported as  light headache), fever and swollen on the right arm where they put the injection and it was very swollen and also red and hot. The patient was treated with Advil 200mg each, for every 8 hours. The outcome for the events was not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Stiff leg syndrome, Thrombosis, Ultrasound scan
Clinical narrative: pain in the back of her leg; leg is stiff where she has the blood clot.; blood clot; This is a spontaneous report from a contactable consumer.  An 81-year-old female patient received second dose of BNT162B2 on 17Aug2021 dose 2, single in left arm for Covid-19 immunisation at the age of 81-year-old. Medical history included issues with walking, she has fallen and broke her arm on 05Jul2021 (she went to the Emergency Room at 02:00 on 06Jul2021, she was then admitted to the hospital on 06Jul2021 and transferred to the main hospital), she went to the rehab on 12Jul2021. In Jul2021, the patient received BNT162B2 dose 1 for covid-19 immunisation at the age of 81-year-old. About a week before the report, the patient started experiencing pain in the back of her leg. She went to the orthopedic doctor for concern of a blood clot, an ultrasound was done that confirmed she did have a blood clot. The patient was prescribed blood thinner for 3 months. The patient experienced blood clot on 02Sep2021. Consumer reported that her leg was stiff where she has the blood clot. The patient visited physician office and emergency room for the events. Consumer reported that the patient has history of issues with her legs in general however she has never had a blood clot before. Consumer also reported history of issues with walking where she fell and broke her arm. She has also been to rehab and the hospital recently. On unknown date, ultrasound scan showed blood clot. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: his friend died 2 weeks after receiving Pfizer Vaccine; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date at unknown dose number, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Reporter stated that his friend died 2 weeks after receiving pfizer vaccine. Reporter wanted to know if vaccine was agency approved. Also wanted to know what the threshold was for number of people dying before Vaccine was pulled from market. It was not reported if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Clarified caller knows his friend died 2 weeks after receiving Pfizer Vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: Energy level never came back to what it was; Extreme fatigue; extreme bone ache; Received the second dose of the vaccine on 22Mar/ She was also diagnosed with Covid 14Aug; Received the second dose of the vaccine on 22Mar/ She was also diagnosed with Covid 14Aug; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer reported for herself.  A 64-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6207, Expiration date: unknown), via unspecified route, administered in right arm on 22Mar2021 (at the age of 64-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6203, Expiration date: unknown), via unspecified route, administered in left arm on 01Mar2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes High cholesterol from an unspecified date and unknown ongoing, Immunodeficiency from an unspecified date and unknown ongoing and concomitant medications includes EZETIMIBE 10 mg for an unspecified indication. On an unspecified date, a week after the vaccination, the patient experienced energy drops which never came back to what it was, Extreme fatigue, extreme bone ache and I guess same as body ache, but it was my bones, side-effects lasted for 3 weeks. On14Aug she was diagnosed with COVID. and she did have antibodies at that time, and she believes the vaccine kept her from getting bad. Treatment option was taken with Tylenol. The patient lab data includes SARS-CoV-2 test on 14Aug2021 and diagnosed with COVID. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Energy level never came back to what it was; Extreme fatigue; extreme bone ache; Received the second dose of the vaccine on 22Mar/ She was also diagnosed with Covid 14Aug; Received the second dose of the vaccine on 22Mar/ She was also diagnosed with Covid 14Aug; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer reported for herself.  A 64-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6207, Expiration date: unknown), via unspecified route, administered in right arm on 22Mar2021 (at the age of 64-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6203, Expiration date: unknown), via unspecified route, administered in left arm on 01Mar2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes High cholesterol from an unspecified date and unknown ongoing, Immunodeficiency from an unspecified date and unknown ongoing and concomitant medications includes EZETIMIBE 10 mg for an unspecified indication. On an unspecified date, a week after the vaccination, the patient experienced energy drops which never came back to what it was, Extreme fatigue, extreme bone ache and I guess same as body ache, but it was my bones, side-effects lasted for 3 weeks. On14Aug she was diagnosed with COVID. and she did have antibodies at that time, and she believes the vaccine kept her from getting bad. Treatment option was taken with Tylenol. The patient lab data includes SARS-CoV-2 test on 14Aug2021 and diagnosed with COVID. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal, Headache, Nausea, Pruritus
Clinical narrative: stroke; blood clot; feeling bad; headache all night; nausea; vomiting; feeling icky; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the 1st dose of BNT162B2 on an unknown date for Covid-19 immunisation and no events were reported. On 02Sep2021, the patient started feeling bad, had headache all night, experienced nausea and vomiting, and was feeling icky. She said had headache, nausea, and vomiting again last night. She said it has already been 5 days. With that, consumer wants to know how long the side effects last, if she needs to go to a hospital or if the side effects are signs of stroke or blood clot. The 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
Symptoms: Thrombosis, Vomiting
Clinical narrative: stroke; blood clot; feeling bad; headache all night; nausea; vomiting; feeling icky; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the 1st dose of BNT162B2 on an unknown date for Covid-19 immunisation and no events were reported. On 02Sep2021, the patient started feeling bad, had headache all night, experienced nausea and vomiting, and was feeling icky. She said had headache, nausea, and vomiting again last night. She said it has already been 5 days. With that, consumer wants to know how long the side effects last, if she needs to go to a hospital or if the side effects are signs of stroke or blood clot. The 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
Symptoms: Disease recurrence, Rheumatoid arthritis
Clinical narrative: States that her rheumatoid arthritis was in remission and there are several reasons why she may have been taken out of remission, but It could be because of receiving the Pfizer COVID vaccine.; States that her rheumatoid arthritis was in remission and there are several reasons why she may have been taken out of remission, but It could be because of receiving the Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On unspecified date the patient stated that her rheumatoid arthritis was in remission and there are several reasons why she may have been taken out of remission, but It could be because of receiving the Pfizer COVID vaccine. The outcome of the event was unknown.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Rheumatoid arthritis, Suspected COVID-19
Clinical narrative: Rheumatoid arthritis flare up; Covid-19; Covid-19; This is a solicited report from a non-Pfizer sponsored program from a contactable consumer (patient), based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3766578-00). Solicited report received by Abbvie from (unlisted country) by a consumer with events of non-serious. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Vaccination; and started to receive adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate Free for Moderate to severe Rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Nov2020, the patient experienced covid-19. On an unspecified date, the patient experienced rheumatoid arthritis flare up. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. The reporter's causality for the events of adalimumab was not provided, while of bnt162b2 was Possible.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided the lack of efficacy of the vaccine, BNT162B2 and rheumatoid arthritis flare up with the usage of the vaccine cannot be completely excluded. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: She said her friend had to be off work for several months.; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program COVAX US Support. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she had a friend who had an adverse reaction after receiving the vaccine. She said her friend had to be off work for several months on an unspecified date. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Extra dose administered, Off label use, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID; TESTED POSITIVE FOR COVID; bnt162b2 (BNT162B2), dose 3 on 21Aug2021; bnt162b2 (BNT162B2), dose 3 on 21Aug2021; This is a solicited report based on the information received by Pfizer (Mfr. Control Number: 21K-163-4054978-00) from a non-contactable consumer (patient).  A 50-year-old female patient received bnt162b2 (BNT162B2), dose 3 intramuscular on 21Aug2021 (Batch/Lot number was not reported, at age of 50 years old) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 vaccination; risankizumab (SKYRIZI [RISANKIZUMAB]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to 28Jun2021, at unspecified dose for moderate to severe chronic plaque. The patient medical history was not reported. The patient's concomitant medications were not reported. On 23Aug2021, the patient experienced tested positive for COVID. The action taken in response to the events for risankizumab was temporarily withdrawn on 28Jun2021. The outcome of events drug ineffective and COVID-19 was not recovered. Causality for bnt162b2: The reporter's causality for the event COVID-19 virus test positive was unrelated.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relation the events of Drug ineffective, COVID-19, off label use and extra dose administered are related to the suspect product of BNT162B2
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort, Malaise, Pyrexia
Clinical narrative: has a problem today not good; fever; headache; teeth ache; felt bad; arm can't lift up; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age reported for himself that he received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hepatitis disease of liver and constipation; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had a problem, reported as today, not good and had fever last night, headache and teeth ache. The patient could not go to walk. He stated that when he felt bad last night with fever, headache, and teeth ache, he took Tylenol but it did not help. The patient stated he had hepatitis disease of liver and had constipation and he told his doctor but they said that was ok no problem his doctor told him ok you wait until you're strong and then go to get vaccine. The patient stated when he told then he was not feeling good and asked if he had medicine which he could have that sounds good for headache, teeth ache and arm can't lift up. Therapeutic measures were taken as a result of fever, headache and teeth ache. The outcome of the events fever headache, teeth ache was not recovered while other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.