chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Blood test, Paralysis, Renal failure
Clinical narrative: temporary partial paralysis.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:30 PM (at the age of 60 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, High Blood Pressure, Asthma, Lupus, Fibromyalgia, Bipolar, PTSD from an unknown date and unknown if ongoing. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), lisinopril (LISINOPRIL), gabapentin (GABAPENTIN), tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported. The patient has allergy to Sulfa, Ibuprofen, Heaprin, Lisinipril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 14Apr2021 at 01:00AM the consumer stated that she had the Pfizer first vaccine 02Apr after which I was hospitalized for back surgery. During my hospitalization my creatinine levels elevated, and I was diagnosed with Kidney Failure. Which doctors attributed to an allergy to my blood pressure medication Lisinipril. I also experienced temporary partial paralysis. I have taken Lisinipril for 5 years with no side effects. I had previous blood test with normal findings. The adverse event resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: temporary partial paralysis.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:30 PM (at the age of 60 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, High Blood Pressure, Asthma, Lupus, Fibromyalgia, Bipolar, PTSD from an unknown date and unknown if ongoing. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), lisinopril (LISINOPRIL), gabapentin (GABAPENTIN), tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported. The patient has allergy to Sulfa, Ibuprofen, Heaprin, Lisinipril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 14Apr2021 at 01:00AM the consumer stated that she had the Pfizer first vaccine 02Apr after which I was hospitalized for back surgery. During my hospitalization my creatinine levels elevated, and I was diagnosed with Kidney Failure. Which doctors attributed to an allergy to my blood pressure medication Lisinipril. I also experienced temporary partial paralysis. I have taken Lisinipril for 5 years with no side effects. I had previous blood test with normal findings. The adverse event resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
Clinical narrative: She took a test and her doctor told her the vaccine did not work; She took a test and her doctor told her the vaccine did not work; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included bone marrow transplant from 2019 (two years ago) and went through chemotherapy, and immunocompromised. The patient's concomitant medications were not reported. After the vaccination on unknown date in 2021, the vaccine did not work because she had low immunity after chemotherapy. She took a test on unknown date in 2021 and her doctor told her the vaccine did not work. Her doctor told her to wait until there was more information. Outcome of the events was unknown.   No follow-up attempts are possible. Information regarding the lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: I was having trouble breathing.; I felt like I was going to faint/I was dizzy.; I was dizzy and hot; I broke out in a sweat; This is a spontaneous report from a contactable consumer (patient). A 18-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0217), via an unspecified route of administration, administered in Arm Left on 26Jun2021 at 13:15 (at the age of 18-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no medical history and past drug history. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Jun2021 at 13:30, the patient experienced patient was having trouble breathing, felt like patient was going to faint, patient was dizzy and hot, patient broke out in a sweat. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Events resulted in Doctor or other healthcare professional office/clinic visit/physician Office Visit. No treatment was received for events. Patient had no prolonged hospitalization. On 27Jun2021, the outcome of events was resolved.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Inflammatory bowel disease
Clinical narrative: Lower bowel symptoms (bowel regions became inflamed); Cannot have bowel movements; This is a spontaneous report from a contactable consumer (patient's neighbour). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lower bowel symptoms (bowel regions became inflamed) and cannot have bowel movements. The consumer reported that my lower bowel regions became inflamed, and I had months of symptoms since. My neighbour just one block from here also was reporting same lower bowel symptoms. Cannot have bowel movements without laxatives and softeners, etc. The outcome of events was unknown.  Information about lot/batch number has been requested. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Atrial fibrillation, Electrocardiogram, Heart rate increased, Vomiting
Clinical narrative: flutter and AFIB; anxiety; threw up; her heart was racing; This is a spontaneous report from a contactable consumer (patient mother) reported patient (reporter daughter). A 22-year-old female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6205, Expiration date: Unknown), via an unspecified route in the right arm on 07Apr2021 (age at vaccination: 22-year-old) as a single dose for covid-19 immunization. Medical history included extreme immune system and seizures that only lasted about 2 years when she was a baby. The patient concomitant medications were not reported. Patient had issues when she was born, she was 3 weeks post term, she was adopted and when all the kids would get sick, she would always get the sickest. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, few days later she felt something and thought it was anxiety, 2 weeks after vaccination from 15May2021, she woke herself up threw up and saying that her heart was racing around 8:30 in the morning, so she went and got their finger monitor, and her heart rate was out of control, so they took her to the emergency room. They tried to get her heart rate down with medications and sent us to an electro physicist, and the rest is history. Patient has been an athlete her whole life, has been in great shape with no heart problems. She was taken to the ER and they captured flutter on the EKG and AFIB issues. Later she was hospitalized and ended up having cardiac surgery about a week ago at 13:00 (16Jun2021 to 17Jun2021). Caller states that her daughter was doing really well, they had to do an ablation. Caller states they saw the cardiologist today, her daughter may have bouts of palpitations, but has had nothing since 3 days after the surgery. Caller wanted to know if AFIB has been reported as a reaction. She received her second shot of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot Number: EN6199) in the right arm on 28Apr2021. They said she will recover completely, but it will take about 3 months. She will have to be followed by a cardiologist. The patient underwent lab test and procedure on 15May2021 which included flutter on the EKG. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Terrible joint pain. 1 month later still have terrible knee pain; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Ew0158), dose 1 via an unspecified route of administration, administered in left arm on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hiatal hernia and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID. Concomitant medication included pantoprazole (PANTOPRAZOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Er8729), via an unspecified route of administration administered in right arm on an unknown date as second dose, single dose for COVID-19 immunisation. Post vaccination, the patient had not been tested for COVID-19. On 06May2021, the patient experienced terrible joint pain and in 1 month later still had terrible knee pain (at the time of report). The patient did not receive treatment in response to the event. Outcome of the event was not recovered.  Follow up needed, further information was requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Has a strong pain in arm; The patient feels her arm is swollen; patient still doesn't have full range of motion in her arm; Had a fever 15 minutes after getting home, after receiving the first dose Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable Pharmacist. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: EW0181; Expiration Date: Aug2021) via an unspecified route of administration, administered in left arm on 15Jun2021 as dose 1, single for COVID-19 immunization (age at vaccination: 47 years). The patient's medical history and concomitant medications were not reported. On 15Jun2021, patient had fever 15 minutes after getting home, after receiving the first dose Pfizer Covid 19. On an unspecified date, patient experienced a strong pain in arm and felt her arm was swollen and the patient still did not have full range of motion in her arm. The patient was saying she cannot return to work. The patient took two Tylenol and the fever has continued since. Patient received the treatment for pain in arm and pyrexia, and outcome of this event was not resolved. The outcome of swollen arm and joint range of motion decreased was unknown.  No further information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Mass, Nerve injury
Clinical narrative: I am thinking like she having seizure; She is having chills real bad she is shaking; She is having chills real bad she is shaking; She says its 30 minute disturbing, its really bad; her nerves getting bad; She was having like some kind of lump/want to go to hospital ok what need to know, like a blood clot; Burning nose; She got so bad headache today; This is a spontaneous report from a Non-contactable consumer.   A 17-years-old-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Solution for injection, Lot Number and batch number was not provided), via unspecified route on an unspecified date as single dose for COVID-19 immunization. Patient not pregnant at the time of vaccination. The patient medical history and concomitant medication was not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Solution for injection, Lot Number and batch number was not provided), via unspecified route on an unspecified date as single dose for COVID-19 immunization. On an unknown date patient experienced seizure, kind of, like her nerves getting bad seizure, she had chills bad she was shaking, she says its 30-minute disturbing, it was really bad and on She got to get checked out, the shot we need to checked out. She was like no, So, trying to call around and trying to find out what was the latest you know what she said what the latest news like she heard about the blood clot whatever was like a thing, so, like is there anything going on like a chill or is this like a serious. She just trying to find out that how bad was this for a 17 old, she is shaking like, thinking like she had seizure, kind of like, like her nerves getting bad like that. She said it was s more like a culture I think she is trying to make like whatever she did not want to put in a bubble and x-ray and all the stuff. She said its 30-minute disturbing, it was really bad. She did not want to report it, she did not want to go to hospital ok what need to know, like a blood clot. Because they were the same, so if She was having like some kind of lump or something like that going on, then she could tell her need to get in there because everybody getting a lump, it turns out bad for them, So, that the information she calling to get the information of side effect on 24jun2021 she got so bad headache, bad headache like that. But people were getting headache getting worse something bad happening to the people that was her concern for her that is why she need the medical advice. It seems to that for effectiveness for like say adverse reaction, we able to call and hang her foot turn purple and they be like put through to like foot turn purple people line and we got everybody here with purple feet, we got here with burning noses. The outcome of all events were unknown.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Skin burning sensation, Tremor
Clinical narrative: I am thinking like she having seizure; She is having chills real bad she is shaking; She is having chills real bad she is shaking; She says its 30 minute disturbing, its really bad; her nerves getting bad; She was having like some kind of lump/want to go to hospital ok what need to know, like a blood clot; Burning nose; She got so bad headache today; This is a spontaneous report from a Non-contactable consumer.   A 17-years-old-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Solution for injection, Lot Number and batch number was not provided), via unspecified route on an unspecified date as single dose for COVID-19 immunization. Patient not pregnant at the time of vaccination. The patient medical history and concomitant medication was not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Solution for injection, Lot Number and batch number was not provided), via unspecified route on an unspecified date as single dose for COVID-19 immunization. On an unknown date patient experienced seizure, kind of, like her nerves getting bad seizure, she had chills bad she was shaking, she says its 30-minute disturbing, it was really bad and on She got to get checked out, the shot we need to checked out. She was like no, So, trying to call around and trying to find out what was the latest you know what she said what the latest news like she heard about the blood clot whatever was like a thing, so, like is there anything going on like a chill or is this like a serious. She just trying to find out that how bad was this for a 17 old, she is shaking like, thinking like she had seizure, kind of like, like her nerves getting bad like that. She said it was s more like a culture I think she is trying to make like whatever she did not want to put in a bubble and x-ray and all the stuff. She said its 30-minute disturbing, it was really bad. She did not want to report it, she did not want to go to hospital ok what need to know, like a blood clot. Because they were the same, so if She was having like some kind of lump or something like that going on, then she could tell her need to get in there because everybody getting a lump, it turns out bad for them, So, that the information she calling to get the information of side effect on 24jun2021 she got so bad headache, bad headache like that. But people were getting headache getting worse something bad happening to the people that was her concern for her that is why she need the medical advice. It seems to that for effectiveness for like say adverse reaction, we able to call and hang her foot turn purple and they be like put through to like foot turn purple people line and we got everybody here with purple feet, we got here with burning noses. The outcome of all events were unknown.  No follow-up attempts are possible. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother) via Pfizer sponsored program.   A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 (at the age of 39-years-old) as dose 1, single for covid-19 immunisation. Medical history included asthma the patient has had asthma all of her life, probably diagnosed with at age 5, covid-19 from Mar2020, the reporter had relatively little reaction to the Pfizer Covid Vaccine. The Reporter husband had a little bit of a fever that lasted maybe four hours after receiving the Pfizer Vaccine. The patient's sister had no reaction. The Reporter is not aware of anyone else who had a reaction. The Reporter clarifies she is referring to reactions from receiving the Pfizer Vaccine. The patient's concomitant medications were not reported. On 31Mar2021, the patient experienced headache. The patient had a mild headache after receiving the first dose Pfizer Covid 19 Vaccine. Maybe, the patient had a mild headache after receiving the first dose Pfizer Covid 19 Vaccine. The Reporter states she is sorry, the patient is lying down. The patient was asleep when the Reporter started the call with Agent and the patient is awake. After receiving the first dose Pfizer Covid 19 Vaccine, the headache started the next morning, 31Mar2021, and lasted two or three days. Reporter called behalf of her daughter (39 years old). Daughter received the first dose of the Pfizer BioNTech COVID-19 vaccine last 30Mar2021 and the second dose last 20Apr2021. Reporter mentioned that her daughter experienced headache after both doses of the vaccine. The Reporter states she is pro vaccine and the Reporter is not complaining about the Pfizer Covid 19 Vaccine. The Reporter wants to know what to do for her daughter, if Pfizer can help? Right now, 8 weeks may not seem like a log time, but this has been devastating for the caller's daughter. There is no light at the end of the tunnel right now. The caller states she realizes this is all the unknown and understands this is all unknown. The caller states she is feeling a little panicked there. The Reporter's daughter gets the Pfizer Covid 19 Vaccine and needs a shunt in her head. The caller is looking for suggestions. The Reporter states her daughter is seeing a doctor and the caller understands seeing a doctor for treatment. The Reporter states she felt like Pfizer needed to know what was going on with the s daughter. Can the Agent tell the Reporter r if other people are having this problem. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Mar2020. The patient had Covid the year before, around MAR2020. The outcome of the event headache was not recovered.  Follow up needed, further information was requested.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: The vaccine didn't work for me; Patient received first dose of vaccine on 05Mar2021 and 2nd dose on 16Mar2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received dose1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) on 05Mar2021 (batch/lot number: EN6203) and on 16Mar2021 (batch/lot number: EN6208), both the doses via an unspecified route of administration as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took immunosuppressants for chronic condition. It was reported that the patient received both the doses of vaccine first dose on 05Mar2021 and second dose on 16Mar2021 and stated that the vaccine didn't work for him/her. The reporter mentioned that he/she was looking at the list of studies for COVID 19 and wanted to participate in and stated that he/she takes immune suppressant info for a chronic condition and mentioned that he/she had no detectable level of antibodies after receiving both the doses of vaccine. Patient also stated that when people stopped wearing mask makes the world more difficult for him/her. He/she wants to be a part of a trial for a booster shot for those who has conditions like him/her. On an unspecified date the patient underwent lab tests and procedures which included blood test which result came back negative for anti-bodies for the IgG and IgM. The outcome of the events was unknown.  Any other additional information provided (sample size, etc.). Contact consent was obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-Hospitalization; Covid-Hospitalization; This is a spontaneous report from a non-contactable other health care professional. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 was not reported. The patient's concomitant medications included ocrelizumab (OCREVUS). The patient experienced Covid-Hospitalization. The patient underwent laboratory tests and procedures which included Covid-19 test shows positive on an unspecified date in 2021. The outcome of the event was unknown.   No further information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and the suspect drug.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: all tested positive for COVID; This is a spontaneous report from a contactable consumer or other non-health care professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), via an unspecified route of administration on 13Mar2021, as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Mar2021, the patient experienced all tested positive for covid. On 22Mar2021, the patient underwent lab tests and procedures which included Covid test: positive. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema to lips and Hives all over body; Angioedema to lips and Hives all over body; This is a spontaneous report from a contactable consumer or other non hcp. An 18-years-old patient of an unspecified gender received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 10:25 (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Floppy mitral valve, hypersensitivity, environmental allergy; all from 2012 to Ongoing. Family medical history includes hypertension and GERD. Concomitant medication(s) included oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for hypersensitivity from an unspecified start date and ongoing; paracetamol (TYLENOL) taken for pain from 05Apr2021 to 05Apr2021. On 06Apr2021, The patient experienced angioedema to lips and hives all over body. Patient received Benadryl 50mg and Claritin 10mg as treatment for adverse events. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diagnosed with COVID-19 on 30Jun2021 after receiving the covid vaccine; Diagnosed with COVID-19 on 30Jun2021 after receiving the covid vaccine; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in arm left on 11Feb2021 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. Patient was not diagnosed with Covid prior vaccination. Patient was Covid tested post vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK9231), via an unspecified route of administration, administered in arm left on 21Jan2021 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization. The patient diagnosed with COVID-19 after receiving the Covid vaccine on 30Jun2021. AE resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR test was positive, Molecular alere testing was positive (nasal swab) on 30Jun2021. The patient did not receive treatment for AE. Outcome of the events was recovering.; Sender's Comments: based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: already has 1 acquaintance who passed the msm and died; This is a spontaneous report from a contactable physician. This physician reported for an unknown patient.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and were not reported. The patient experienced already has 1 acquaintance who passed the msm and died on an unspecified date. Reporter stated, First of all, I want to say that I'm going to file an investigation against everything that's going on. when I chose Pfizer it was because you said the vaccine was good for patients and cancer, chronic diseases. I lived working paying my bills and taking care of my children until the day I got this vaccine. and then all my exams started to change. I know you don't want to be responsible for anything, because only money matters. already has 1 acquaintance who passed the msm and died. so what does pfizer do to support it? nothing? I'm like 1 vegetable and what are you going to do for me? Somehow I'm going to sue you because a lawyer also finds fault with you for that. very disappointed and living hell and even depression because of my health. The patient died on an unspecified date. It was not reported if an autopsy was performed.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of Death.  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: Died
Sex: U
Vaccine: COVID19
Symptoms: Tourette's disorder
Clinical narrative: Tourette's tics have worsened; This is a spontaneous report from a contactable consumer (patient's mother). A child patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included Tourette's tics. The patient's concomitant medications were not reported. On an unspecified date, child had received the Covid-19 Vaccine, and since then their Tourette's tics had worsened. The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Malaise, Pain in extremity
Clinical narrative: Had Covid back in January. We all three did; Had Covid back in January. We all three did; Arm is real sore; He did not feel good; sick at home; This is a spontaneous report from a Non-contactable consumer reporting on behalf of her husband consumer (patient).A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. The patient medical history included COVID-19. The patient concomitant medications were not reported. On unspecified date, the patient experienced arm was real sore and he did not feel good, sick at home. Reporter stated that "my arm hurts and I had ran fever, I had a diarrhoea, I was so sick I could hardly get out of my chair. I was sick for 3 days and that my arm is still sore, my husband's arm is real sore, but he did not feel good. My daughter got the shot same day we did, Friday. Her arm had swollen, her lymph node underneath her arm was swollen and she can hardly move her arm. She is in lot of pain. And it says if we had any side effects to report it. This was our first shot. I had Covid back in January. We all three did (Further clarification unknown). But I had to be hospitalized because I had the Covid, it was scary, it was like I will die. I had pneumonia with it. My husband and daughter were sick at home. I lost, my brother passed away due to Covid and my brother-in-law had Covid. But we did have a side effect. I usually run like a low grade temperature 96 or a 97 and I ran 99.2." The outcome of the events was unknown.  QR Comment: MI concern acknowledged in First case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: a physician administered an expired Pentacel to a baby, No AE; Initial information received on 01-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via Medical Information number: 00665242.  This case involves an unknown age and gender baby who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] by a physician (Expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 01-Jul-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ350AAA, expiry date: 22-JUN-2021 via an unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Medical Assistant reports she does not have patient information. She is working from home and the information was also just called in to her. Adverse Event (AE) Reporting AE event: A physician administered an expired Pentacel to a baby. Date of AE: today. Given by: Unknown, Product used".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm is red, hot, itchy, and swollen.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Oedema, Pruritus
Clinical narrative: Anaphylaxis. Also continued local edema and itchiness
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Died of COVID-19 illness on 05/05/2021
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Fatigue, Headache, Injection site discomfort
Clinical narrative: Sore and uncomfortable injection site Fatigue Chills Headache Bouts of nauseousness Currently 37 weeks pregnant. Have not delivered at this time and baby is still active. Due date is 7/26/21
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: Sore and uncomfortable injection site Fatigue Chills Headache Bouts of nauseousness Currently 37 weeks pregnant. Have not delivered at this time and baby is still active. Due date is 7/26/21
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Alanine aminotransferase increased, Anticoagulant therapy, Aspartate aminotransferase increased, Aspiration bone marrow
Clinical narrative: Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blast cells present, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood culture negative, Cellulitis
Clinical narrative: Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chemotherapy, Culture urine negative, Cytomegalovirus test positive, Deep vein thrombosis, Erythema
Clinical narrative: Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flow cytometry, Full blood count, HIV antibody negative, Haemoglobin decreased
Clinical narrative: Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex test negative, Injected limb mobility decreased, Pain in extremity, Pancytopenia, Peripheral swelling
Clinical narrative: Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, SARS-CoV-2 test negative, Serology test, Transaminases increased, Transfusion
Clinical narrative: Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal, White blood cell count decreased
Clinical narrative: Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood magnesium normal, Computerised tomogram head normal, Differential white blood cell count normal, Electrocardiogram normal
Clinical narrative: Pt received her 2nd Moderna COVID 19 vaccine on 4/16/2021. She has a history of crohn's disease with ileostomy managed with over the counter vit D and immodium and chronic kidney disease. She was admitted to the hospital on 6/29/21 with a witnessed, new onset seizure. Her MRI brain and CT brain were negative. EKG normal, glucose was normal. magnesium was normal, cbc and cmp were normal. She does not use alcohol or smoke or use drugs. She had no recent illness or infection. she had no fever and normal vital signs. She was on no new medication or over the counter medication or supplements. She arrived with a lip laceration and significant bilateral tongue bruising. She was discharged home on 6/20/21 to follow up with neurology for an EEG as EEG was not available while hospitalized. She has never had a seizure in her life. Neurology was consulted and did not recommend anti seizure medication at this time.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Lip injury, Magnetic resonance imaging head normal, Metabolic function test normal, Oral contusion
Clinical narrative: Pt received her 2nd Moderna COVID 19 vaccine on 4/16/2021. She has a history of crohn's disease with ileostomy managed with over the counter vit D and immodium and chronic kidney disease. She was admitted to the hospital on 6/29/21 with a witnessed, new onset seizure. Her MRI brain and CT brain were negative. EKG normal, glucose was normal. magnesium was normal, cbc and cmp were normal. She does not use alcohol or smoke or use drugs. She had no recent illness or infection. she had no fever and normal vital signs. She was on no new medication or over the counter medication or supplements. She arrived with a lip laceration and significant bilateral tongue bruising. She was discharged home on 6/20/21 to follow up with neurology for an EEG as EEG was not available while hospitalized. She has never had a seizure in her life. Neurology was consulted and did not recommend anti seizure medication at this time.