chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Viral test, White blood cell count, X-ray
Clinical narrative: She is experiencing extreme fatigue and is still experiencing a fever; She is experiencing extreme fatigue and is still experiencing a fever; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included at the age of 76 received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19. On 2021, The patient reported she is experiencing extreme fatigue and is still experiencing a fever. Patient has received both doses of the Pfizer BioNTech Covid vaccine. After the first dose she experienced fatigue. However, after the second dose on 4Feb2021 she had a "fairly large response." She is still dealing with these side effects over six weeks later. She is experiencing extreme fatigue and is still experiencing a fever. Her temperature is usually normal in the morning and then raises to 100.5 to 101.2 in the evening. She has already seen her HCP several times and they have no recommendations. She has been tested for Covid and different viruses but they've all been negative. She's had a chest Xray, urinanalysis, put on antibiotics just incase there was something latent. She has had blood work done several times, her WBC was 5.4 and was only slightly anemic. Her doctor may start her on iron supplements. The patient underwent lab tests and procedures which included, body temperature: 100.5 to 101.2 on 2021 (100.5 to 101.2 in the evening), body temperature: normal in the morning on 2021, sars-cov-2 test: negative on 2021, urine analysis: unknown on 2021, viral test: negative on 2021 and x-ray: unknown on 2021 (She's had a chest Xray) and white blood cell count: 5.4 (Her doctor may start her on iron supplements). The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: ended up in the hospital and was having a hard time breathing; This is a spontaneous report from a contactable consumer (patient's son or daughter). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 23Feb2021, at a single dose, for covid-19 immunization. Medical history included covid from 30Oct2020. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 02Feb2021 for covid-19 immunization and experienced muscle pain, shivers and was lethargic. The patient got his 2nd dose on 23Feb2021. He ended up in the hospital and was having a hard time breathing on an unspecified date in 2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: bumps on lymph node; This is a spontaneous report received from a contactable consumer (patient). A 44 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) first dose on 03Mar2021 via an unspecified route of administration as single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. Patient stated that she was due to receive second dose but was reporting bumps on lymph node on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Infection, Leukaemia, Lymphoma, SARS-CoV-2 test
Clinical narrative: CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine.  AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine.  AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Abdominal tenderness, Biopsy lymph gland abnormal, Cough
Clinical narrative: CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine.  AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Diarrhoea, Diffuse large B-cell lymphoma, Faeces discoloured, Fluorescent in situ hybridisation negative
Clinical narrative: CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine.  AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunohistochemistry, Nausea, Weight decreased
Clinical narrative: CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine.  AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Infection, Leukaemia, Lymphoma, SARS-CoV-2 test
Clinical narrative: Diffuse large B cell lymphoma.  Died 03/25/2021.  See item 11 for additional details.  We became aware of the situation via a post on our social media page placed by the patient's daughter-in-law on or about 03/22/2021.  I reached the patient's son on 03/25/2021, and then we pursued information from the hospital.  The initial social media post suggested that the onset of cervical lymphadenopathy followed dose 1, but the hospitalist's history suggests it predated that ("8-10 weeks" prior to 03/18/2021 admission).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Diffuse large B cell lymphoma.  Died 03/25/2021.  See item 11 for additional details.  We became aware of the situation via a post on our social media page placed by the patient's daughter-in-law on or about 03/22/2021.  I reached the patient's son on 03/25/2021, and then we pursued information from the hospital.  The initial social media post suggested that the onset of cervical lymphadenopathy followed dose 1, but the hospitalist's history suggests it predated that ("8-10 weeks" prior to 03/18/2021 admission).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Abdominal tenderness, Biopsy lymph gland abnormal, Cough
Clinical narrative: Diffuse large B cell lymphoma.  Died 03/25/2021.  See item 11 for additional details.  We became aware of the situation via a post on our social media page placed by the patient's daughter-in-law on or about 03/22/2021.  I reached the patient's son on 03/25/2021, and then we pursued information from the hospital.  The initial social media post suggested that the onset of cervical lymphadenopathy followed dose 1, but the hospitalist's history suggests it predated that ("8-10 weeks" prior to 03/18/2021 admission).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Diarrhoea, Diffuse large B-cell lymphoma, Faeces discoloured, Fluorescent in situ hybridisation negative
Clinical narrative: Diffuse large B cell lymphoma.  Died 03/25/2021.  See item 11 for additional details.  We became aware of the situation via a post on our social media page placed by the patient's daughter-in-law on or about 03/22/2021.  I reached the patient's son on 03/25/2021, and then we pursued information from the hospital.  The initial social media post suggested that the onset of cervical lymphadenopathy followed dose 1, but the hospitalist's history suggests it predated that ("8-10 weeks" prior to 03/18/2021 admission).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunohistochemistry, Nausea, Weight decreased
Clinical narrative: Diffuse large B cell lymphoma.  Died 03/25/2021.  See item 11 for additional details.  We became aware of the situation via a post on our social media page placed by the patient's daughter-in-law on or about 03/22/2021.  I reached the patient's son on 03/25/2021, and then we pursued information from the hospital.  The initial social media post suggested that the onset of cervical lymphadenopathy followed dose 1, but the hospitalist's history suggests it predated that ("8-10 weeks" prior to 03/18/2021 admission).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Facial puffiness; Redness; Itching; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received First dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number and Expiry date was not reported) via unspecified route of administration on 15Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 22Mar2021, the patient experienced facial puffiness, redness and itching. Symptoms continue today with some improvement. The patient was asking if its possible to develop reaction on week later. The outcome of the events was recovering.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well at all; This is a spontaneous report from a contactable consumer (patient's wife) reported for her husband. A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, Reporter stated that her husband had very bad side effects after the first dose and was hospitalized and her husband was not feeling well at all. Outcome of the event was unknown.  Information related to lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Eating disorder, Neoplasm progression
Clinical narrative: She is hardly eating and forcing herself to eat; potential cancer spreading to the mesenteric membrane and omentum along with ascites present and getting worse/nodule below her laparoscopy scar (unspecified) and they think that is cancer; This is the spontaneous report received from Merck.  A contactable consumer reported a 68-year-old female patient received the first dose of 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 immunization. Medical history included ongoing metastatic uterine cancer, PD-L 1. The patient finished major surgery (unspecified) last May 2020, 6 rounds of doxorubicin hydrochloride (DOXIL) and CARBOPLATIN (maximum dosage allowed for weight as she was in good health otherwise) for unknown indication, 25 pelvic radiation treatments and 3 brachytherapy treatments (specific treatments and dates unknown). The patient was now on a break from all of her radiation treatments. About 3 weeks ago (in 2021), she noticed her abdominal muscles were sore. She was a distance swimmer and soreness was unusual. A week ago, she began feeling more bloated and gaining weight of 3 pounds around the abdomen. She started measuring her waist and it was growing (unspecified).CT scan on  11Feb2021 was read by a radiologist who reported potential cancer spreading to the mesenteric membrane and omentum along with ascites present and getting worse. Two oncologists also discussed the results and presented it to the tumor board for review and they were not positive about the radiologist report. She also had a nodule below her laparoscopy scar (unspecified) and they think that was cancer. The patient also was hardly eating and forcing herself to eat noted on unknown date. She was hopping KEYTRUDA can address this. She was inquiring about KEYTRUDA and if it would be okay to receive her second COVID-19 vaccine next week as she was also scheduled to receive her first dose of KEYTRUDA. Outcome of the event of hardly eating was unknown while not recovered for the remaining event.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The patient had a covid test on 15Mar2021 and tested positive.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 07Mar2021 as single dose for COVID-19 immunization. Medical history included exposure to sars-cov-2 on 10Mar2021. The patient's concomitant medications were not reported. The patient had a covid test on 15Mar2021 and tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Mar2021. The patient is scheduled for his second dose on 28Mar2021. The patient is asking if he is still eligible for the second dose. It will be 13 days from the positive COVID test. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: leukemia; This is a spontaneous report from a contactable consumer (patient) . A 71-year-old female patient received BNT162B2 (Pfizer-COVID-19 Vaccine, Formulation: Solution for injection; Batch/Lot number: Not reported), first dose via an unspecified route of administration on 05Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, stated she has leukemia and needs to go on treatment with Onureg, a low dose of 100 mg per day, starting Monday. She'll be getting her second shot of the Pfizer-COVID-19 Vaccine on Friday, and she asked if there could be a drug interaction between both treatments, there will be a 2-3 day difference between them. Stated "it has nothing to do with the COVID-19 vaccine" however she explained that leukemia cured and she was in remission prior to the COVID-19 vaccination. Responded per Full EUA PI Sections: 10 Drug Interactions; 5 Warnings and Precautions. LAB-1451-3.0. Outcome of event was recovered on an unspecified date in Mar2021.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Platelet count, Platelet count decreased, SARS-CoV-2 antibody test, White blood cell count
Clinical narrative: My platelet was low/decrease in platelet count after first dose/platelet was low 44 and 54; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that On 5Mar2021 patient received his first Pfizer injection. He had no effect, where he got the shot it bothered me a little bit. The following week he had a regular cardiologist appointment and got blood work the following Thursday. He reviewed the blood work himself and his platelet was low: 44. he have blood work and regularly it 200 normally. The only red mark is the platelet count. he called my PCP and they sent me for a CBC again. He had his 3rd one yesterday had not gotten the results. The WBC looks good but the platelet is 54 low. My PA sent mine to get a manual blood count under a microscope and will get the results maybe today or tomorrow. Friday, he was due for my 2nd pfizer vaccine. He was not sure if he was going to take it. If he did not take it, how long do he have before the 2nd shot is not good. He had some good antibodies already. 85% from the pfizer shot efficacy is what he read online. Anyone have advice for me to take or don't take until my platelets come up again questioned. The reason he was so cautious about this; there's a whole slew of information regarding platelets going down. There was a doctor he died as a result of that. His platelet he got down, a blood hemorrhage and died. There is a lot of information out there. If I don't have any preexisting conditions and took the first dose ok. but if I didn't get bloodwork done, I would have never known about this.  he knows this was rather new and no history.  We did not know what caused the platelet count to go down like this. The seriousness of the event was serious with seriousness criteria medical significant. Outcome of the event was unknown.   Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count, Platelet count abnormal
Clinical narrative: My platelet was low/decrease in platelet count after first dose/platelet was low 44 and 54; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that On 5Mar2021 patient received his first Pfizer injection. He had no effect, where he got the shot it bothered me a little bit. The following week he had a regular cardiologist appointment and got blood work the following Thursday. He reviewed the blood work himself and his platelet was low: 44. he have blood work and regularly it 200 normally. The only red mark is the platelet count. he called my PCP and they sent me for a CBC again. He had his 3rd one yesterday had not gotten the results. The WBC looks good but the platelet is 54 low. My PA sent mine to get a manual blood count under a microscope and will get the results maybe today or tomorrow. Friday, he was due for my 2nd pfizer vaccine. He was not sure if he was going to take it. If he did not take it, how long do he have before the 2nd shot is not good. He had some good antibodies already. 85% from the pfizer shot efficacy is what he read online. Anyone have advice for me to take or don't take until my platelets come up again questioned. The reason he was so cautious about this; there's a whole slew of information regarding platelets going down. There was a doctor he died as a result of that. His platelet he got down, a blood hemorrhage and died. There is a lot of information out there. If I don't have any preexisting conditions and took the first dose ok. but if I didn't get bloodwork done, I would have never known about this.  he knows this was rather new and no history.  We did not know what caused the platelet count to go down like this. The seriousness of the event was serious with seriousness criteria medical significant. Outcome of the event was unknown.   Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: My platelet was low/decrease in platelet count after first dose/platelet was low 44 and 54; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that On 5Mar2021 patient received his first Pfizer injection. He had no effect, where he got the shot it bothered me a little bit. The following week he had a regular cardiologist appointment and got blood work the following Thursday. He reviewed the blood work himself and his platelet was low: 44. he have blood work and regularly it 200 normally. The only red mark is the platelet count. he called my PCP and they sent me for a CBC again. He had his 3rd one yesterday had not gotten the results. The WBC looks good but the platelet is 54 low. My PA sent mine to get a manual blood count under a microscope and will get the results maybe today or tomorrow. Friday, he was due for my 2nd pfizer vaccine. He was not sure if he was going to take it. If he did not take it, how long do he have before the 2nd shot is not good. He had some good antibodies already. 85% from the pfizer shot efficacy is what he read online. Anyone have advice for me to take or don't take until my platelets come up again questioned. The reason he was so cautious about this; there's a whole slew of information regarding platelets going down. There was a doctor he died as a result of that. His platelet he got down, a blood hemorrhage and died. There is a lot of information out there. If I don't have any preexisting conditions and took the first dose ok. but if I didn't get bloodwork done, I would have never known about this.  he knows this was rather new and no history.  We did not know what caused the platelet count to go down like this. The seriousness of the event was serious with seriousness criteria medical significant. Outcome of the event was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she said she tested positive for Covid; she said she tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), 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. It was reported that patient tested positive for Covid on 13Mar2021, and her husband tested positive on 15Mar2021. The patient wanted to know if it would still be okay for her to receive the 2nd dose. The outcome of the events was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cerebrovascular accident, Fatigue, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: something like a stroke; her hands and feet got really cold; went numb on the injection side from her neck to her hands; went numb on the injection side from her neck to her hands/the side of her face went numb/numbness on the left hand in two fingers; the inside of her mouth and tongue went numb; tingling in her hands and feet; got tired; stomach felt weird; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 23Mar2021 as single dose for covid-19 immunisation. Medical history included reaction to pertussis as a baby. The patient's concomitant medications were not reported. Patient stated that she reported the side effects that patient had from the first dose of the Pfizer covid 19 vaccine yesterday on 23Mar2021. patient stated that not all of the symptoms have worn off and wanted to know if she should worry, see a neurologist or is it something like a stroke on an unspecified date in Mar2021. patient stated right after the vaccine her hands and feet got really cold, went numb on the injection side from her neck to her hands and the side of her face went numb on Mar2021. Patient reported that the inside of her mouth and tongue went numb. Patient stated she had tingling in her hands and feet, got tired, stomach felt weird and today her vision is weird and one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes on Mar2021, and patient still has a little tingling in her hands and feet and still has numbness on the left hand in two fingers but most has gone away. patient wanted to know if these are reported side effects. The outcome of the events was unknown.  Information on the lot number and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Paraesthesia, Peripheral coldness, Photophobia, Pupils unequal
Clinical narrative: something like a stroke; her hands and feet got really cold; went numb on the injection side from her neck to her hands; went numb on the injection side from her neck to her hands/the side of her face went numb/numbness on the left hand in two fingers; the inside of her mouth and tongue went numb; tingling in her hands and feet; got tired; stomach felt weird; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 23Mar2021 as single dose for covid-19 immunisation. Medical history included reaction to pertussis as a baby. The patient's concomitant medications were not reported. Patient stated that she reported the side effects that patient had from the first dose of the Pfizer covid 19 vaccine yesterday on 23Mar2021. patient stated that not all of the symptoms have worn off and wanted to know if she should worry, see a neurologist or is it something like a stroke on an unspecified date in Mar2021. patient stated right after the vaccine her hands and feet got really cold, went numb on the injection side from her neck to her hands and the side of her face went numb on Mar2021. Patient reported that the inside of her mouth and tongue went numb. Patient stated she had tingling in her hands and feet, got tired, stomach felt weird and today her vision is weird and one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes on Mar2021, and patient still has a little tingling in her hands and feet and still has numbness on the left hand in two fingers but most has gone away. patient wanted to know if these are reported side effects. The outcome of the events was unknown.  Information on the lot number and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: something like a stroke; her hands and feet got really cold; went numb on the injection side from her neck to her hands; went numb on the injection side from her neck to her hands/the side of her face went numb/numbness on the left hand in two fingers; the inside of her mouth and tongue went numb; tingling in her hands and feet; got tired; stomach felt weird; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; her vision is weird/one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 23Mar2021 as single dose for covid-19 immunisation. Medical history included reaction to pertussis as a baby. The patient's concomitant medications were not reported. Patient stated that she reported the side effects that patient had from the first dose of the Pfizer covid 19 vaccine yesterday on 23Mar2021. patient stated that not all of the symptoms have worn off and wanted to know if she should worry, see a neurologist or is it something like a stroke on an unspecified date in Mar2021. patient stated right after the vaccine her hands and feet got really cold, went numb on the injection side from her neck to her hands and the side of her face went numb on Mar2021. Patient reported that the inside of her mouth and tongue went numb. Patient stated she had tingling in her hands and feet, got tired, stomach felt weird and today her vision is weird and one of her eyes is dilating and constricting back and forth, hard to see, sensitive to light and pupils are still different sizes on Mar2021, and patient still has a little tingling in her hands and feet and still has numbness on the left hand in two fingers but most has gone away. patient wanted to know if these are reported side effects. The outcome of the events was unknown.  Information on the lot number and batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. Zonisamide, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 800 mg, (600 mg at night and 200 mg on the morning) for an unspecified indication; cannabidiol (CBD OIL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 7 mL, daily (4ml at night and 3 ml on the morning) for an unspecified indication. The patient medical history included ongoing seizure PMH of temporal epilepsy who has been having break through seizures since July 2020. The patient's concomitant medications were not reported It was reported that patient had received vaccine on Wednesday 17 2021 with no complaints after it until today Friday 19, 2021 at around 7 pm when he developed a seizure while working at his desk. We (the parents saw the end of it which looked more generalized than usual) and gave him 2 mg of Clonazepam, which is his usual rescue medication. He was awake after it and was able to do homework. The action taken in response to the events for Zonisamide and Cannabidiol was unknown. The outcome of the event was unknown.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Seizure
Clinical narrative: had a major seizure on day 8 of dose one despite nearly no history of seizures; I was tired after the first dose (26Feb2021) on days 2-3; This is a spontaneous report from a contactable consumer (patient).  A 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 26Feb2021 15:00 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization at doctor's office/urgent care. Medical history included atypical trigeminal neuralgia since 2009, complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, Epilepsy-prone and many more. The patient also had orthopedic knee surgery on 26Aug2020 which she had pain after surgery. She also had known allergies with Cephalosporins and elemental nickel. Concomitant medications included tapentadol (TAPENTADOL), amphetamine (AMPHETAMINE), and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ) all taken for unknown dates and indications. The patient stated that she was tired after the first dose (26Feb2021) on days 2-3 (Feb2021). She also had had a major seizure on day 8 of dose one (07Mar2021) despite nearly no history of seizures which require emergency room/department or urgent care visit. The seizure has been attributed to other issues by her doctor. The patient had no COVID-19 prior vaccination and was not tested post vaccination. The events were considered life threatening. The patient did not receive any treatments for the events. The patient recovered on unknown date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid afterward; tested positive for Covid afterward; This is a spontaneous report from a contactable other healthcare professional. This 67 year old  patient of unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on an unknown date in Feb2021 for COVID-19 vaccination. Concomitant medications were not reported. On an unknown date, the patient tested positive for COVID afterward. The patient is due to received the second dose on 16Mar2021 or 23Mar2021, The outcome of tested positive for COVID afterward was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Petechiae, Pyrexia, SARS-CoV-2 test
Clinical narrative: new onset cardiac murmur; fever; petechial rash; This is spontaneous report received from a contactable nurse. A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via intramuscular route on 11Mar2021 as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication received within two weeks included birth control. No other vaccine was received within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 23Mar2021, the patient experienced new onset cardiac murmur, fever, and petechial rash. The events resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). The patient had been tested for COVID-19 since the vaccination. She underwent COVID-19 nasal swab test on 23Mar2021 with negative result. Outcome of events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The information provided is limited and does not allow for a complete medical assessment.  Based on temporal association a contributory role of BNT162B2 to the reported events  cannot  be totally excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fatigue, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Right lower extremity DVT; Bilateral PE; Severe fatigue; This is a spontaneous report from a contactable physician. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269) via an unspecified route of administration on 25Feb2021 at a single dose for COVID-19 immunization. Medical history included Allergies: adhesive, CT scan dye & flu shot. Concomitant medication included rosuvastatin. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient also previously took Demerol, guaifenesin;phenylephrine hydrochloride (ENTEX), epinephrine, amoxicillin;clavulanic acid (AUGMENTIN) and experienced allergies. On 03Mar2021 17:15 the patient experienced severe fatigue, right lower extremity DVT, Bilateral PE. Events were considered serious, due to hospitalization for 1 day and life threatening. Treatment was received for the adverse event which included apixaban (ELIQUIS). The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 with unknown result on an unknown date. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. Outcome of the events was recovering.   Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.