chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia oral, Peripheral coldness, Pyrexia, SARS-CoV-2 test
Clinical narrative: I feel like Covid; tingling in around my tongue/ inside my cheeks / I had tingling or numbness in both lips; I had tingling or numbness in lips, both lips; i was really weak; I feel something hot in me; I feel fever; aching/pain; I feel like nervous; my brain is 'fog' / I felt something really hard in my body /I feel weird; I feel like I am not focused more; I feel like I want to scream; This is a spontaneous report from a contactable consumer. A 57-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: 301358A) via an unspecified route of administration on 18Sep2021, as DOSE 1 SINGLE for covid-19 immunization (age at vaccination 57-Years-old).  Patient medical history includes: The patient stated that pharmacy was not right. She already had COVID in January and she went to the hospital twice because her heartbeat went down to 40. She was afraid to take the medicine, the capsule. She was little bit depressed. Patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Patient concomitant medication was not reported. Patient stated that she was supposed to take the second dose today because it is 21 days on 09Oct2021. The patient wanted to know if she can take the second dose of vaccine today or tomorrow after all the symptoms and reaction she had after the first dose. On 18Sep2021, the day patient got her first dose of Covid-19 Vaccine, she felt something really hard in her body and then she felt tingling in around her tongue, tingling and numbing in both lips and inside her cheeks. Within 15 minutes, she was really weak and got up with turtle leg after the vaccination. She felt something hot in her, felt like she wanted to scream but she started breathing, felt weird, nervous, her heartbeat for a minute went to 40, down to 40, had fever, pain, aching, felt she was not focused, and she doesn't know for some reason her brain was fog. The patient reported that she tasted the vaccine, and it was something like tonic. She could feel how it tastes and that was when she started feeling weak and the numbness. She added she felt like COVID. The patient took 1 Tylenol (500 mg, 1 tablet at night) and Ibuprofen 200 mg, 2 pills as she wanted to sleep and had a lot of pain. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: I feel like Covid; tingling in around my tongue/ inside my cheeks / I had tingling or numbness in both lips; I had tingling or numbness in lips, both lips; i was really weak; I feel something hot in me; I feel fever; aching/pain; I feel like nervous; my brain is 'fog' / I felt something really hard in my body /I feel weird; I feel like I am not focused more; I feel like I want to scream; This is a spontaneous report from a contactable consumer. A 57-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: 301358A) via an unspecified route of administration on 18Sep2021, as DOSE 1 SINGLE for covid-19 immunization (age at vaccination 57-Years-old).  Patient medical history includes: The patient stated that pharmacy was not right. She already had COVID in January and she went to the hospital twice because her heartbeat went down to 40. She was afraid to take the medicine, the capsule. She was little bit depressed. Patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Patient concomitant medication was not reported. Patient stated that she was supposed to take the second dose today because it is 21 days on 09Oct2021. The patient wanted to know if she can take the second dose of vaccine today or tomorrow after all the symptoms and reaction she had after the first dose. On 18Sep2021, the day patient got her first dose of Covid-19 Vaccine, she felt something really hard in her body and then she felt tingling in around her tongue, tingling and numbing in both lips and inside her cheeks. Within 15 minutes, she was really weak and got up with turtle leg after the vaccination. She felt something hot in her, felt like she wanted to scream but she started breathing, felt weird, nervous, her heartbeat for a minute went to 40, down to 40, had fever, pain, aching, felt she was not focused, and she doesn't know for some reason her brain was fog. The patient reported that she tasted the vaccine, and it was something like tonic. She could feel how it tastes and that was when she started feeling weak and the numbness. She added she felt like COVID. The patient took 1 Tylenol (500 mg, 1 tablet at night) and Ibuprofen 200 mg, 2 pills as she wanted to sleep and had a lot of pain. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Scar
Clinical narrative: she just has scars left from it now; Shingles; This is a spontaneous report from a contactable consumer.   A 43-years-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EL9266,Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing mitral valve prolapse Verbatim: Mitral valve prolapse  she was diagnosed when she was 10 years old,unknown if ongoing herpes zoster Verbatim: Shingles she got shingles for the first time in her life when she was 19 years old. The patient's concomitant medications were not reported.On 20Feb2021 The patient experienced shingles, she just has scars left from it now on an unspecified date,she did visit her doctor with the shingles she had after the second dose of the Covid Vaccine,She says that it took her about a month to recovery. States she just had scars left from it now. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event.The clinical outcome of the event was recovered.  follow-up #1 (PRD/SRD 08oct2021)-new clinical information was added.  No follow-up attempts are needed. No further information is expected.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles after second dose of the COVID Vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This contactable consumer reported about co-workers sister. This report is 2 of 2. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date, as dose 1, single for COVID-19 immunization. Patient experienced shingles after her second dose of the COVID Vaccine and now worried about getting the third dose. Patient recently lost her father to COVID 19. And patient works as a dental hygienist. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriages; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's friend) reporting same event under the same suspect product for four patients. This is one of four reports. A female patient of unspecified age received bnt162b2 (Pfizer covid vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, Caller unwilling to complete the report) as dose number unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was pregnant. The patient blamed her miscarriage on the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375474 same report/drug/AE, different patients;US-PFIZER INC-202101375755 same report/drug/AE, different patients;US-PFIZER INC-202101375754 same report/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke the day after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient's daughter/son). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the day of vaccination, the patient had a stroke. The outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Fatigue, Feeling abnormal, Pain
Clinical narrative: Chest pain right side; I am having that pain, right side of the chest; I am feeling kind of tired; Some pain on right hand; the right hand and sometime my hand is on body pain and its going back.; Having kind of burning; getting worst because it's burning; I started feeling that lifted just like that.; Some pain on right hand; the right hand and sometime my hand is on body pain and its going back./feeling that kind of pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: FF2589) via an unspecified route of administration on 18Sep2021 (41-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration on 22Aug2021 (41-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. On 24Sep2021, the patient experienced chest pain right side, feeling kind of tired, some pain on right hand; the right hand and sometime my hand is on body pain and its going back, having kind of burning; getting worst because it's burning and started feeling that lifted just like that (feeling abnormal). The patient stated that last one week, he was feeling kind off chest pain, right side and some pain on right hand. The patient was feeling kind off tired but it was not continuously happening, it was just take rest, it was fine and if he did some walking or something, any activity, he was having kind off burning and that pain, right side of the chest, the right hand and sometime his hand is on body pain and its going back, that is the reason, the patient was like, after the 2nd dose only feeling kind of, the 1st week, he was feeling kind of may be tired or something, he did not thing about much but he really thought from last one week because it's really kind of it was more actually, so just wanted to check with it. The patient wanted to know what should be done and if it was like common. The patient never had such kind of things as he had after this vaccination. The patient was just trying to observe and then he started thinking, when it happens because he never had these kind off things because he was a sports person, Never know, the patient used to walk more but now from last one week, he was feeling that, one and thinking kind off getting worst because it's burning. The patient was doing cycling after 10 minutes of that, he started feeling that lifted just like that. Patient received no treatment for the events. The clinical outcome of the events were not recovered.  Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Chest pain right side; I am having that pain, right side of the chest; I am feeling kind of tired; Some pain on right hand; the right hand and sometime my hand is on body pain and its going back.; Having kind of burning; getting worst because it's burning; I started feeling that lifted just like that.; Some pain on right hand; the right hand and sometime my hand is on body pain and its going back./feeling that kind of pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: FF2589) via an unspecified route of administration on 18Sep2021 (41-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration on 22Aug2021 (41-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. On 24Sep2021, the patient experienced chest pain right side, feeling kind of tired, some pain on right hand; the right hand and sometime my hand is on body pain and its going back, having kind of burning; getting worst because it's burning and started feeling that lifted just like that (feeling abnormal). The patient stated that last one week, he was feeling kind off chest pain, right side and some pain on right hand. The patient was feeling kind off tired but it was not continuously happening, it was just take rest, it was fine and if he did some walking or something, any activity, he was having kind off burning and that pain, right side of the chest, the right hand and sometime his hand is on body pain and its going back, that is the reason, the patient was like, after the 2nd dose only feeling kind of, the 1st week, he was feeling kind of may be tired or something, he did not thing about much but he really thought from last one week because it's really kind of it was more actually, so just wanted to check with it. The patient wanted to know what should be done and if it was like common. The patient never had such kind of things as he had after this vaccination. The patient was just trying to observe and then he started thinking, when it happens because he never had these kind off things because he was a sports person, Never know, the patient used to walk more but now from last one week, he was feeling that, one and thinking kind off getting worst because it's burning. The patient was doing cycling after 10 minutes of that, he started feeling that lifted just like that. Patient received no treatment for the events. The clinical outcome of the events were not recovered.  Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest pain, Gait disturbance, Illness, Pain in extremity
Clinical narrative: enlarged heart; chest pain; became sick; had trouble walking; had left arm pain; turn blue; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient became sick right after receiving the Pfizer Covid vaccine and within a week of vaccination had trouble walking, began to turn blue, had left arm pain and chest pain. The patient was taken to the hospital for all events and diagnosed with an enlarged heart. The outcome of all events was unknown. The case was reported as serious due to hospitalization condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: enlarged heart; chest pain; became sick; had trouble walking; had left arm pain; turn blue; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient became sick right after receiving the Pfizer Covid vaccine and within a week of vaccination had trouble walking, began to turn blue, had left arm pain and chest pain. The patient was taken to the hospital for all events and diagnosed with an enlarged heart. The outcome of all events was unknown. The case was reported as serious due to hospitalization condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Approximately one week after receiving the first jab, I developed shingles.; This is a spontaneous report from a contactable Nurse (Patient). A 51-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, (Batch/Lot Number: EH9899), dose 1 intramuscular on 21Dec2020 (age at the time of vaccination was 51-year-old)) as dose 1, single for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient experienced approximately one week after receiving the first jab, she developed shingles on 31Dec2020. Patient was diagnosed at the same hospital that she works at, and where she received the vaccine. It was reported that, event resulted in emergency room visit. Patient did not have pregnancy at time of vaccination. Patient had no Known allergies. The patient had not received any other vaccine within 4 weeks and any other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination. Post vaccination, the patient underwent lab tests and procedures which included Covid test (Nasal Swab) was negative on an unspecified date. It was reported that patient took second dose of bnt162b2 (Lot number: EL 0142) via intramuscular route on 11Jan2021 for covid-19 immunisation. Treatment included Antiviral medication and topical lidocaine patches for the event. Outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Monoplegia, Muscle fatigue
Clinical narrative: My left leg will not work anymore; I can''t use my left leg; My foot started getting numb; my leg started getting tired; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), (BNT162B2, Formulation: Solution for injection, Batch/Lot Number EN6198) dose 1 single  via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced my left leg will not work anymore, I can't use my left leg, my foot started getting numb, my leg started getting tired reported. Patient  stated, "I am having some bad adverse effects of this COVID Vaccine that I took. My left leg will not work anymore, when I walked in there to get the vaccine, everything was fine, ever since then, I can't use my left leg.  It was reported that patient stated as the date they gave it to me, 01Mar2022 or something like that oh 21 I mean (further not clarified the date for first vaccine). Then I got the second shot. I got my second shot on 22Mar2021.When probed if the consumer started facing the side effects after the first or the second shot, Patient stated, I guess my leg started, my foot started getting numb, my leg started getting tired and then none of it wants to work right now and it kept getting progressive, progressively worse. The first shot I got went too bad, the second shot I got, it was even worse and a week down the road, it was even worse, 2 weeks down the road, it was even more worse, it keeps getting worse. The outcome for all events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient is dead but doesn't confirm if this was related to a Pfizer medication.; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 37-year old female patient received bnt162b2, via an unspecified route of administration on an unspecified date at age of 37-year old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported the patient was dead but doesn't confirm if this was related to a Pfizer medication. The patient died on an unspecified date. The event was fatal. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: patient is dead but doesn't confirm if this was related to a Pfizer medication
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Pyrexia
Clinical narrative: Positive for COVID.; Positive for COVID; Fever; Chills; Headache; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, on 21Apr2021 (Lot Number: ER2613) as dose 2, single; on 31Mar2021 (lot: ER2613) as dose 1, single, both at the age of 63-year-old for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. The patient experienced fever, chills, headache, cough on 06Oct2021 and positive for COVID on 07Oct2021. The patient underwent lab tests and procedures which included Nasal Swab Antigen Rapid: negative on 07Oct2021; Nasal Swab PCR: positive on 07Oct2021. No treatment received. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Positive for COVID.; Positive for COVID; Fever; Chills; Headache; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, on 21Apr2021 (Lot Number: ER2613) as dose 2, single; on 31Mar2021 (lot: ER2613) as dose 1, single, both at the age of 63-year-old for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. The patient experienced fever, chills, headache, cough on 06Oct2021 and positive for COVID on 07Oct2021. The patient underwent lab tests and procedures which included Nasal Swab Antigen Rapid: negative on 07Oct2021; Nasal Swab PCR: positive on 07Oct2021. No treatment received. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Discomfort, Drug ineffective, Fatigue, Headache
Clinical narrative: tested positive; tested positive; extreme vertigo; threw up five times like a fire hydrant; exhausted; nauseous; headache; nervous; uncomfortable; This is a spontaneous report from a contactable consumer via medical information team. This 54-year-old female consumer (patient) reported for herself.  A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included little overweight and doesn't drink or smoke or do drugs. The patient's concomitant medications were not reported. It was reported that on an unspecified date in 2021, patient experienced multiple adverse events after receiving the first dose of the Pfizer BioNTech Covid-19 Vaccine. She had extreme vertigo, threw up five times like a fire hydrant and once it was done, exhausted, nauseous, headache, nervous and uncomfortable. The reporter stated that she experienced multiple adverse events after receiving the first dose of the Pfizer BioNTech Covid-19 Vaccine. She stated that she had "extreme vertigo, threw up five times like a fire hydrant, and once it was done, exhausted, nauseous, and had a headache." The reporter stated she almost called 911. The reporter stated she is "pretty healthy, a little overweight, but doesn't drink or smoke or do drugs." The reporter stated that she went through Covid-19 and tested positive a month before, and then tested negative on 11Sep2021. The reporter stated that she did not receive monoclonal antibody treatment. She also stated that she feels nervous and uncomfortable about getting the second dose, and wants to find out how to get an exemption from the second dose. Patient did not receive monoclonal antibody treatment. The patient not received treatment for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date on 2021, sars-cov-2 test: negative on 11Sep2021. The outcome of the events covid-19 was recovered on 11Sep2021 and other events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness, Vertigo, Vomiting
Clinical narrative: tested positive; tested positive; extreme vertigo; threw up five times like a fire hydrant; exhausted; nauseous; headache; nervous; uncomfortable; This is a spontaneous report from a contactable consumer via medical information team. This 54-year-old female consumer (patient) reported for herself.  A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included little overweight and doesn't drink or smoke or do drugs. The patient's concomitant medications were not reported. It was reported that on an unspecified date in 2021, patient experienced multiple adverse events after receiving the first dose of the Pfizer BioNTech Covid-19 Vaccine. She had extreme vertigo, threw up five times like a fire hydrant and once it was done, exhausted, nauseous, headache, nervous and uncomfortable. The reporter stated that she experienced multiple adverse events after receiving the first dose of the Pfizer BioNTech Covid-19 Vaccine. She stated that she had "extreme vertigo, threw up five times like a fire hydrant, and once it was done, exhausted, nauseous, and had a headache." The reporter stated she almost called 911. The reporter stated she is "pretty healthy, a little overweight, but doesn't drink or smoke or do drugs." The reporter stated that she went through Covid-19 and tested positive a month before, and then tested negative on 11Sep2021. The reporter stated that she did not receive monoclonal antibody treatment. She also stated that she feels nervous and uncomfortable about getting the second dose, and wants to find out how to get an exemption from the second dose. Patient did not receive monoclonal antibody treatment. The patient not received treatment for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date on 2021, sars-cov-2 test: negative on 11Sep2021. The outcome of the events covid-19 was recovered on 11Sep2021 and other events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Myocardial injury
Clinical narrative: serious heart problem; high blood pressure; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), 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. On an unspecified date, the patient experienced serious heart problem and high blood pressure. It was reported that the patient was referred to her physician for treatment recommendations. The patient underwent lab tests and procedures on an unspecified date which included blood pressure measurement increased. The outcome of the events was unknown.  The lot number for the vaccine, was not provided and would be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Asthenia, Disturbance in attention, Faeces discoloured
Clinical narrative: Severe anxiety; Stomach hurts; Stool is black; Stomach bleeding; Caller states he has been awake for seven days and has not slept at all since; Weak; Tired; His concentration is shot; Scared; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 01Oct2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in Oct2021, the patient experienced stomach bleeding (medically significant) (patient thought he was having stomach bleeding), he had been awake for seven days and has not slept at all since. No sleep for 5 days now. He was really weak, tired, his concentration was shot and got scared, his stomach got hurt and stool was black. On 05Oct2021, he had severe anxiety. The patient went to see his doctor after the first couple of days, and the doctor checked his vitals but did not say anything else about his inability to sleep. Outcome of the event he had been awake for seven days and has not slept at all since was not recovered while for the other events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gastrointestinal haemorrhage, Insomnia
Clinical narrative: Severe anxiety; Stomach hurts; Stool is black; Stomach bleeding; Caller states he has been awake for seven days and has not slept at all since; Weak; Tired; His concentration is shot; Scared; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 01Oct2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in Oct2021, the patient experienced stomach bleeding (medically significant) (patient thought he was having stomach bleeding), he had been awake for seven days and has not slept at all since. No sleep for 5 days now. He was really weak, tired, his concentration was shot and got scared, his stomach got hurt and stool was black. On 05Oct2021, he had severe anxiety. The patient went to see his doctor after the first couple of days, and the doctor checked his vitals but did not say anything else about his inability to sleep. Outcome of the event he had been awake for seven days and has not slept at all since was not recovered while for the other events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: people that have gotten some of their shots have died of COVID; people that have gotten some of their shots have died of COVID; This is a spontaneous report from a contactable Other HCP and a consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  In a qualitative interview, when asked 'Are you aware of any COVID related activity from this manufacturer (Pfizer)'? the respondent said 'I know that people that have gotten some of their shots have died of COVID'. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information 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.; Reported Cause(s) of Death: People that have gotten some of their shots have died of COVID; People that have gotten some of their shots have died of COVID
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died 2 weeks after getting the vaccine; This is a spontaneous report from a contactable consumer. A female patient in her 30s received bnt162b2 (COMIRNATY), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. She died 2 weeks after getting the vaccine. Unknown if autopsy was done. Outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101353646 Same reporter/ drug/ event for different patients; Reported Cause(s) of Death: died 2 weeks after getting the vaccine
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neurological symptom
Clinical narrative: One week after getting vaccine I developed the Shingles even though I had Shingles vaccine; More than nine months after vaccination I am still experiencing the neurologic symptoms.; This is a spontaneous report from a Contactable Consumer (patient). A 91-Year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration, administered in right arm on 20Jan2021 at 14:00 (at the age of 91 years old) as a single dose for COVID-19 immunisation. The patient's medical history included arthritis, kidney disease, edema from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient having known allergies with Iodine, Sulfa, Morphine, Demerol, Ultram. The patient did not receive other vaccine in four weeks. The patient's concomitant medication included Synthroid (LEVOTHYROXINE SODIUM), Predisone (PREDNISONE), Lyrica (PREGABALIN), Xeljanz (TOFACITINIB CITRATE), Amlodipine (AMLODIPINE) for unknown indication start dates and stop dates were not reported. One week after getting vaccine on 04Feb2021 the patient experienced the shingles even though the patient had Shingles vaccine and more than nine months after vaccination the patient was still experiencing the neurologic symptoms. The patient got admitted to hospital for 3 days. The patient received bandages, valacyclovir as treatment. On 18Jul2021 the patient underwent lab tests and procedures which included SARS-CoV-2 antibody test (Nasal Swab) and the report was negative. The outcome of the events was recovered with lasting effects on unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's cousin) reported for a 37-year-old female patient (reporter's cousin) who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot/ number and Expiry date were unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had blood clot and died on an unspecified date. Reporter states that he as a cousin of 37 years old (patient) that passed away after getting the vaccine due to a blood clot. States she was forced to get the vaccine to protect her kids, and that is not the only person her knew that has died. It was not reported if an autopsy was performed. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Blood clot
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: his sister died from the covid vaccine; This is a spontaneous report from a non-contactable consumer (patient brother) reported for his sister that a female patient of an unspecified age received bnt162b2 (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. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported his sister died from the covid vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. This case was reported as serious due to death. Description of complaint: The efficacy isn't living up to what its states and Pfizer does not keep up with the numbers with who it injures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hypoaesthesia, Migraine, Paraesthesia
Clinical narrative: pulmonary embolism; one sided debilitating migraines; headaches; paresthesia; numbness; weakness on the entire right side of body; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2) at 23-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 18:00 (Batch/Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 immunization on 03Mar2021 at the age of 23-year-old (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Reported Event: started with one sided debilitating migraines and headaches, paresthesia, numbness, and weakness on the entire right side of body. Then hospitalized with a pulmonary embolism. The event onset date was Apr2021. The adverse event result in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The events received treatment included Heparin drip. The events were serious due to hospitalization, life threatening. The patient was hospitalized for events for 3 days. Since the vaccination, the patient had been tested for COVID-19: PCR on Sep2021 Negative (Nasal Swab). The event outcome was recovered with sequelae.    Follow-up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: pulmonary embolism; one sided debilitating migraines; headaches; paresthesia; numbness; weakness on the entire right side of body; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2) at 23-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 18:00 (Batch/Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 immunization on 03Mar2021 at the age of 23-year-old (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Reported Event: started with one sided debilitating migraines and headaches, paresthesia, numbness, and weakness on the entire right side of body. Then hospitalized with a pulmonary embolism. The event onset date was Apr2021. The adverse event result in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The events received treatment included Heparin drip. The events were serious due to hospitalization, life threatening. The patient was hospitalized for events for 3 days. Since the vaccination, the patient had been tested for COVID-19: PCR on Sep2021 Negative (Nasal Swab). The event outcome was recovered with sequelae.    Follow-up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died 2 weeks after getting the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's aunt) that a female patient of unspecified age received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Caller mentioned that there patients who passed away after taking the vaccine but no proof if caused by the vaccine. Caller said she knows someone in her 30s and her aunt who died 2 weeks after getting the vaccine. The patient died on an unspecified date. Outcome of the event was fatal. It was unknown if an autopsy was done.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101352464 Same reporter/ drug/ event for different patients; Reported Cause(s) of Death: died 2 weeks after getting the vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Pfizer gave the covid vaccine to the caller''s 37 year old cousin who died; This is a spontaneous report from a contactable consumer (reporter's cousin). A 37-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: 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. On an unspecified date, Pfizer gave the COVID vaccine to the reporter's 37 year old cousin who died The patient died on an unspecified date. It was not reported if an autopsy was performed.  Description of Product Complaint: The caller knows a nurse and said the only people in her 3 different shifts who have not been sick are all unvaxxed, all of the people who have been vaccinated are the ones with the virus. 11 percent of people in withheld are vaccinated and no one has COVID. 96 percent of people in withheld are vaccinated and 98 percent of them have COVID.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pfizer gave the covid vaccine to the caller''s 37 year old cousin who died
Age: 25.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient experienced COVID Symptoms; patient experienced COVID Symptoms; This is a solicited report based on information received by Pfizer from regulatory authority (MFR Control No.: 21K-163-4111720-00).   A contactable consumer (patient) reported that a 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly on 07Aug2021 (Batch/Lot number was not reported) at age of 25 years old as a single dose, 2nd dose intramuscularly on 28Aug2021 (Batch/Lot number was not reported) at age of 25 years old as a single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneously from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. The patient's medical history was not reported. There were no concomitant medications. The patient experienced covid symptoms in 2021 with outcome unknown. The action taken in response to the event for adalimumab was dose not changed.   Solicited report from the (country) by a consumer of a 25 years old female with an event Of non-serious covid symptoms with Humira (adalimumab). There was no reported Medical history. In 2021, the patient experienced covid symptoms. Pfizer biontech covid-19 Vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 07Aug2021, she received first dose covid-19 vaccine manufactured by Pfizer biontech. On 28Aug2021, she received second dose covid-19 vaccine manufactured by Pfizer BioNTech. Causality for Humira(adalimumab): The reporter's causality for the event of covid symptoms was not provided.  The reporter's assessment of the causal relationship of all 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.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the reported event is possibly related to the suspect drug in terms of drug ineffective.