chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Pyrexia, White blood cell count
Clinical narrative: high fever almost 103-104; lots of pain in her chest; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "ankylosing spondylitis" (unspecified if ongoing), notes: ankylosing spondylitis; "rheumatoid arthritis" (unspecified if ongoing), notes: rheumatoid arthritis (primary); "Crohn's secondary" (unspecified if ongoing), notes: Crohn's secondary.; "white blood cell used to be low but now not sure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever almost 103-104"; CHEST PAIN (non-serious), outcome "unknown", described as "lots of pain in her chest". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: patient reports that she had to stop taking Xeljanz XR last year after getting her covid-19 (corona virus) vaccines (2 doses) for 2 months, her rheumatoid arthritis was on and off after stopping, patient had severe side-effects from covid-19 (second dose) - high fever almost 103-104, and lots of pain in her chest. patient reports her white blood cell used to be low but now not sure. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, fever, headache
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Condition aggravated, Swelling
Clinical narrative: For the initial vaccination I had head swelling and migraines and for the booster shot, mild head swelling and colitis flare
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait inability, Influenza virus test, Pain in extremity
Clinical narrative: Chills, could not walk, dizziness, red rash with soreness on left upper thigh
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, SARS-CoV-2 test
Clinical narrative: Chills, could not walk, dizziness, red rash with soreness on left upper thigh
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity
Clinical narrative: Delayed hypersensitivity reaction at vaccine site
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red circle around injection site-no treatment has been given as he shows no discomfort from it.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Cervix disorder
Clinical narrative: Felt like I was in labor. My cervix dilated and my back hurt like crazy.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Electromyogram normal, Fear, Hypoaesthesia, Limb discomfort
Clinical narrative: I had the second Moderna Vaccine administered on January 14th 2022, at the Pharmacy. After the 2nd Modern vaccine was administered, both of my eyes became blurry, I was not sure if I was going to be able to drive home. After almost thirty minutes, I had no choice, but to slowly drive myself home. Ever since that day, my vision has not returned back. I went to my optomalogist, on February 24th, she noticed the deteriorate change from my last visit of October 30th, 2021. My vision is getting worst, ever since having the 2nd vaccine. Since the end of June, they are getting more blurry I?m starting to see double and blurry pupils when looking into the mirror. I have not been able to see the bottom of my eyes lids to add eye liner, sine the 2nd vaccine. I?m getting very scared of the drastic change since January 14th.  After the 2nd Vaccine, I also had problem with my left arm and hand to my fingertips, the same arm both Moderna Vaccine was administered to. A week after the 2nd vaccine, my left arm became numb, crampy, painful and weak, I had to visit my primary doctor, which suggested I visit my Neurologist which ordered several X-rays and EMG test. They were no able to find the problem. Several weeks ago, early June 2022, the problem with the arm went away for now. Currently, I am very concern for my vision, they seems to be getting worst. I need to know how many people have suffered these side effects from the Moderna vaccine and what treatment is available for the ongoing major deteriorating problem with my eyesight and if there is a solution and treatment.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscular weakness, Pain in extremity, Vision blurred, X-ray normal
Clinical narrative: I had the second Moderna Vaccine administered on January 14th 2022, at the Pharmacy. After the 2nd Modern vaccine was administered, both of my eyes became blurry, I was not sure if I was going to be able to drive home. After almost thirty minutes, I had no choice, but to slowly drive myself home. Ever since that day, my vision has not returned back. I went to my optomalogist, on February 24th, she noticed the deteriorate change from my last visit of October 30th, 2021. My vision is getting worst, ever since having the 2nd vaccine. Since the end of June, they are getting more blurry I?m starting to see double and blurry pupils when looking into the mirror. I have not been able to see the bottom of my eyes lids to add eye liner, sine the 2nd vaccine. I?m getting very scared of the drastic change since January 14th.  After the 2nd Vaccine, I also had problem with my left arm and hand to my fingertips, the same arm both Moderna Vaccine was administered to. A week after the 2nd vaccine, my left arm became numb, crampy, painful and weak, I had to visit my primary doctor, which suggested I visit my Neurologist which ordered several X-rays and EMG test. They were no able to find the problem. Several weeks ago, early June 2022, the problem with the arm went away for now. Currently, I am very concern for my vision, they seems to be getting worst. I need to know how many people have suffered these side effects from the Moderna vaccine and what treatment is available for the ongoing major deteriorating problem with my eyesight and if there is a solution and treatment.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - has been chronic and continuos ever since.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was past BUD, no adverse symptoms reported
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Biopsy, Blood test, Bundle branch block right, Cardiac stress test
Clinical narrative: The tech originally administered the vaccine in my left arm. I could feel the vaccine going into me, and then it started shooting out the back of the needle. The tech stated the needle was defective. I think this was both tech error and the needle defective. She proceeded with readministering a new vaccine  (as stated above) in my right arm.      That evening I had severe pain in both arms. (I continue to this day  have intermittent pain in both arms) By Monday, I did not feel well, I was very tired, did not sleep well, and was very exhausted. (this continues to be an issue as well) I have had spotting , bleeding  and premenstrual symptoms, even though I went thru menopause 1 1/2 years ago. I went to a cardiologist as I was having pain in my arms, back and chest, and have been diagnosed with RBBB.    I think the two doses of the covid booster have really effected me. The fatigue has been terrible and it has effected mu quality of life.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Fatigue, Haemorrhage
Clinical narrative: The tech originally administered the vaccine in my left arm. I could feel the vaccine going into me, and then it started shooting out the back of the needle. The tech stated the needle was defective. I think this was both tech error and the needle defective. She proceeded with readministering a new vaccine  (as stated above) in my right arm.      That evening I had severe pain in both arms. (I continue to this day  have intermittent pain in both arms) By Monday, I did not feel well, I was very tired, did not sleep well, and was very exhausted. (this continues to be an issue as well) I have had spotting , bleeding  and premenstrual symptoms, even though I went thru menopause 1 1/2 years ago. I went to a cardiologist as I was having pain in my arms, back and chest, and have been diagnosed with RBBB.    I think the two doses of the covid booster have really effected me. The fatigue has been terrible and it has effected mu quality of life.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Malaise, Needle issue, Pain in extremity, Poor quality sleep
Clinical narrative: The tech originally administered the vaccine in my left arm. I could feel the vaccine going into me, and then it started shooting out the back of the needle. The tech stated the needle was defective. I think this was both tech error and the needle defective. She proceeded with readministering a new vaccine  (as stated above) in my right arm.      That evening I had severe pain in both arms. (I continue to this day  have intermittent pain in both arms) By Monday, I did not feel well, I was very tired, did not sleep well, and was very exhausted. (this continues to be an issue as well) I have had spotting , bleeding  and premenstrual symptoms, even though I went thru menopause 1 1/2 years ago. I went to a cardiologist as I was having pain in my arms, back and chest, and have been diagnosed with RBBB.    I think the two doses of the covid booster have really effected me. The fatigue has been terrible and it has effected mu quality of life.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Quality of life decreased, Ultrasound scan vagina
Clinical narrative: The tech originally administered the vaccine in my left arm. I could feel the vaccine going into me, and then it started shooting out the back of the needle. The tech stated the needle was defective. I think this was both tech error and the needle defective. She proceeded with readministering a new vaccine  (as stated above) in my right arm.      That evening I had severe pain in both arms. (I continue to this day  have intermittent pain in both arms) By Monday, I did not feel well, I was very tired, did not sleep well, and was very exhausted. (this continues to be an issue as well) I have had spotting , bleeding  and premenstrual symptoms, even though I went thru menopause 1 1/2 years ago. I went to a cardiologist as I was having pain in my arms, back and chest, and have been diagnosed with RBBB.    I think the two doses of the covid booster have really effected me. The fatigue has been terrible and it has effected mu quality of life.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Rash erythematous, Rash papular
Clinical narrative: Raised, red, swollen rash around injection site. About 1.5 inches wide and 3/4 inch tall.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Condition aggravated, Dizziness, Fatigue
Clinical narrative: I started having extreme tiredness and lack of energy. I felt like a cold, I had a runny nose and I had a cough. It was not severe. I did not run a fever. These symptoms lasted for  five days. I am still getting tired and it has been seven days. I still have the congestion like a cold. I still am getting , I feel like in the afternoon I feel like I need to take a rest or a short nap.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pain, Somnambulism
Clinical narrative: I started having extreme tiredness and lack of energy. I felt like a cold, I had a runny nose and I had a cough. It was not severe. I did not run a fever. These symptoms lasted for  five days. I am still getting tired and it has been seven days. I still have the congestion like a cold. I still am getting , I feel like in the afternoon I feel like I need to take a rest or a short nap.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cough, Fatigue, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: I started having extreme tiredness and lack of energy. I felt like a cold, I had a runny nose and I had a cough. It was not severe. I did not run a fever. These symptoms lasted for  five days. I am still getting tired and it has been seven days. I still have the congestion like a cold. I still am getting , I feel like in the afternoon I feel like I need to take a rest or a short nap.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea
Clinical narrative: I started having extreme tiredness and lack of energy. I felt like a cold, I had a runny nose and I had a cough. It was not severe. I did not run a fever. These symptoms lasted for  five days. I am still getting tired and it has been seven days. I still have the congestion like a cold. I still am getting , I feel like in the afternoon I feel like I need to take a rest or a short nap.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, SARS-CoV-2 test positive, Wound infection
Clinical narrative: 6/16 45-year-old female with history of hypertension, hyperlipidemia, epilepsy on Lamictal, GERD, developmental delay, bicuspid aortic valve presented to the ER with fatigue, no appetite, left-sided chest pain for 1 week.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Decreased appetite, Fatigue, SARS-CoV-2 test positive
Clinical narrative: 6/16 45-year-old female with history of hypertension, hyperlipidemia, epilepsy on Lamictal, GERD, developmental delay, bicuspid aortic valve presented to the ER with fatigue, no appetite, left-sided chest pain for 1 week.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Pyrexia, Vomiting
Clinical narrative: Started with fever 30-45 nubs after vaccination. Then body ice cold 12 hrs later. Started vomiting and that continued Friday 6/3/22 - Sunday 6/5/22.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Pyrexia, Vomiting
Clinical narrative: Started with fever 30-45 nubs after vaccination. Then body ice cold 12 hrs later. Started vomiting and that continued Friday 6/3/22 - Sunday 6/5/22.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: bleeding between periods
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 44-year old  patient was administered with a dose in his right arm; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 44-year-old male patient who received Herpes zoster (Shingrix) (batch number 3BD53, expiry date unknown) and (batch number 53LK5, expiry date unknown) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTPA VACCINE).   On 17th June 2022, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 17th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 25-JUN-2022 and 27-JUN-2022 Reporter's comment: This adverse event was reported and submitted by a GlaxoSmithKline sales representative. This may be a duplicate case since the sales representative might have already reported. This adverse event was late because it came in over the weekend. Due to medical information guidelines, this adverse event was reported even when another GlaxoSmithKline representative was first to hear about it. Doctor stated that a colleague at her's mistakenly administered a Shingrix vaccine to a 44-year old patient in his right arm. The patient was not immune compromised.  The patient also received a Tdap in his left arm on the same visit. The doctor thought that these lot numbers were for both Shingrix components, not the Tdap vaccine).  The patient did not experience any adverse Events. The reporter consented to follow-up. Additional Supportive Information: The 44 years old patient received dose of Shingrix vaccine, which led to Inappropriate age at vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Lymphocyte count, Pneumonia cytomegaloviral, Polymerase chain reaction, SARS-CoV-2 antibody test
Clinical narrative: Cytomegalovirus infection/CMV Pneumonitis; This is a literature report for the following literature source(s):  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Type of transplant-Heart" (unspecified if ongoing), notes: Time since transplant-9 months; "Nonischemic cardiomyopathy" (unspecified if ongoing); "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing), notes: 4 months; "Admission" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression, notes: 500 mg; twice a day; Mycophenolate for Immunosuppression, notes: 500 mg; twice a day; Prednisone for Immunosuppression, notes: 5 mg. Vaccination history included: Bnt162b2, for COVID-19 immunization.  The following information was reported: PNEUMONIA CYTOMEGALOVIRAL (hospitalization, medically significant), outcome "unknown", described as "Cytomegalovirus infection/CMV Pneumonitis". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: No; Lymphocyte count: 1.01, notes: Units: Unknown; Polymerase chain reaction: 272 IU/ml; SARS-CoV-2 antibody test: Negative; Transplant evaluation: +-; White blood cell count: 8.3, notes: Units: Unknown. Therapeutic measures were taken as a result of pneumonia cytomegaloviral.  No follow-up attempts are needed. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Pneumonia Cytomegalovirus and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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. Linked Report(s) : PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Transplant evaluation, White blood cell count
Clinical narrative: Cytomegalovirus infection/CMV Pneumonitis; This is a literature report for the following literature source(s):  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Type of transplant-Heart" (unspecified if ongoing), notes: Time since transplant-9 months; "Nonischemic cardiomyopathy" (unspecified if ongoing); "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing), notes: 4 months; "Admission" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression, notes: 500 mg; twice a day; Mycophenolate for Immunosuppression, notes: 500 mg; twice a day; Prednisone for Immunosuppression, notes: 5 mg. Vaccination history included: Bnt162b2, for COVID-19 immunization.  The following information was reported: PNEUMONIA CYTOMEGALOVIRAL (hospitalization, medically significant), outcome "unknown", described as "Cytomegalovirus infection/CMV Pneumonitis". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: No; Lymphocyte count: 1.01, notes: Units: Unknown; Polymerase chain reaction: 272 IU/ml; SARS-CoV-2 antibody test: Negative; Transplant evaluation: +-; White blood cell count: 8.3, notes: Units: Unknown. Therapeutic measures were taken as a result of pneumonia cytomegaloviral.  No follow-up attempts are needed. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Pneumonia Cytomegalovirus and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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. Linked Report(s) : PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus infection, Lymphocyte count, Polymerase chain reaction, SARS-CoV-2 antibody test, White blood cell count
Clinical narrative: Cytomegalovirus infection; This is a literature report.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing), notes: Time since transplant-14 mo; "HIV nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression; Mycophenolate for Immunosuppression, notes: 250 mg BID; Prednisone for Immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation.  The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 15 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Lymphocyte count: 1.02, notes: Admission; Polymerase chain reaction: 1285 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 3, notes: Admission. Therapeutic measures were taken as a result of cytomegalovirus infection.; Sender's Comments: Based on available limited information and the drug temporal relationship, the causality between the events  Cytomegalovirus infection, and the suspect drug "BNT162B2" cannot be completely excluded. Case will be reviewed further on receipt of FU information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Myelin oligodendrocyte glycoprotein antibody-associated disease, Myelitis transverse
Clinical narrative: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Transverse Myelitis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (medically significant), outcome "unknown"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse Myelitis".  The lot number for [generic name], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200013127 Same drug and different event/patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body mass index, Body temperature, Heart rate, Imaging procedure
Clinical narrative: Superficial thrombophlebitis (Mondors disease); This is a literature report.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "nonsmoker" (unspecified if ongoing); "obstetric" (unspecified if ongoing), notes: delivery of a now 9-year-old son through Cesarean section, without any complication. Concomitant medication(s) included: NIFEDIPINE. The following information was reported: PHLEBITIS SUPERFICIAL (hospitalization), 1 week after the suspect product(s) administration, outcome "recovered", described as "Superficial thrombophlebitis (Mondors disease)". The event "superficial thrombophlebitis (mondors disease)" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 140/97 mmHg; Body mass index: 39.7, notes: Units: kg/m2; Body temperature: 37 Centigrade; Heart rate: 84; Imaging procedure: 2, notes: the left breast was assigned a BIRADS-2 category; Inspection of the left breast: 3 linear creases in the left breast, notes: 1 vertical in the lateral aspect and 2 horizon- tal in the superior and inferior aspects of the left breast; did not reveal any abnormality; left axillary vein was examined: no evidence of deep vein thrombosis; Mammogram: showed fatty breasts with no abnormalities; showed fatty breasts with no abnormalities; Oxygen saturation: 100 %; Respiratory rate: 18; Ultrasound breast: showed thrombosed superficial veins, notes: with absent flow and loss of compressibility; Ultrasound Doppler: lack of flow in the tubular structure thrombophleb; Ultrasound scan: no suspicious finding to suggest breast cancer, notes: or lymphoma and ruled out other considerations; superficial thrombophlebitis corresponding to the, notes: sites of the creases; showed no evidence of lymphadenopathy. Therapeutic measures were taken as a result of phlebitis superficial.; Sender's Comments: Based on the available information in the case, the causal association between the event phlebitis superficial and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Laboratory test, Mammogram, Oxygen saturation, Phlebitis superficial
Clinical narrative: Superficial thrombophlebitis (Mondors disease); This is a literature report.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "nonsmoker" (unspecified if ongoing); "obstetric" (unspecified if ongoing), notes: delivery of a now 9-year-old son through Cesarean section, without any complication. Concomitant medication(s) included: NIFEDIPINE. The following information was reported: PHLEBITIS SUPERFICIAL (hospitalization), 1 week after the suspect product(s) administration, outcome "recovered", described as "Superficial thrombophlebitis (Mondors disease)". The event "superficial thrombophlebitis (mondors disease)" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 140/97 mmHg; Body mass index: 39.7, notes: Units: kg/m2; Body temperature: 37 Centigrade; Heart rate: 84; Imaging procedure: 2, notes: the left breast was assigned a BIRADS-2 category; Inspection of the left breast: 3 linear creases in the left breast, notes: 1 vertical in the lateral aspect and 2 horizon- tal in the superior and inferior aspects of the left breast; did not reveal any abnormality; left axillary vein was examined: no evidence of deep vein thrombosis; Mammogram: showed fatty breasts with no abnormalities; showed fatty breasts with no abnormalities; Oxygen saturation: 100 %; Respiratory rate: 18; Ultrasound breast: showed thrombosed superficial veins, notes: with absent flow and loss of compressibility; Ultrasound Doppler: lack of flow in the tubular structure thrombophleb; Ultrasound scan: no suspicious finding to suggest breast cancer, notes: or lymphoma and ruled out other considerations; superficial thrombophlebitis corresponding to the, notes: sites of the creases; showed no evidence of lymphadenopathy. Therapeutic measures were taken as a result of phlebitis superficial.; Sender's Comments: Based on the available information in the case, the causal association between the event phlebitis superficial and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Ultrasound Doppler, Ultrasound breast, Ultrasound scan
Clinical narrative: Superficial thrombophlebitis (Mondors disease); This is a literature report.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "nonsmoker" (unspecified if ongoing); "obstetric" (unspecified if ongoing), notes: delivery of a now 9-year-old son through Cesarean section, without any complication. Concomitant medication(s) included: NIFEDIPINE. The following information was reported: PHLEBITIS SUPERFICIAL (hospitalization), 1 week after the suspect product(s) administration, outcome "recovered", described as "Superficial thrombophlebitis (Mondors disease)". The event "superficial thrombophlebitis (mondors disease)" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 140/97 mmHg; Body mass index: 39.7, notes: Units: kg/m2; Body temperature: 37 Centigrade; Heart rate: 84; Imaging procedure: 2, notes: the left breast was assigned a BIRADS-2 category; Inspection of the left breast: 3 linear creases in the left breast, notes: 1 vertical in the lateral aspect and 2 horizon- tal in the superior and inferior aspects of the left breast; did not reveal any abnormality; left axillary vein was examined: no evidence of deep vein thrombosis; Mammogram: showed fatty breasts with no abnormalities; showed fatty breasts with no abnormalities; Oxygen saturation: 100 %; Respiratory rate: 18; Ultrasound breast: showed thrombosed superficial veins, notes: with absent flow and loss of compressibility; Ultrasound Doppler: lack of flow in the tubular structure thrombophleb; Ultrasound scan: no suspicious finding to suggest breast cancer, notes: or lymphoma and ruled out other considerations; superficial thrombophlebitis corresponding to the, notes: sites of the creases; showed no evidence of lymphadenopathy. Therapeutic measures were taken as a result of phlebitis superficial.; Sender's Comments: Based on the available information in the case, the causal association between the event phlebitis superficial and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood creatinine, Blood immunoglobulin G, Blood pressure measurement, Cytomegalovirus infection
Clinical narrative: Cytomegalovirus infection; generalized weakness; fatigue; hypotension; This is a literature report for the following literature source(s):   A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing), notes: Time since transplant-18 mo,  deceased donor kidney transplantation (D+/R-); "Diabetic nephropathy" (unspecified if ongoing); "end-stage renal disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "uncomplicated surgical recovery" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression; Prednisone for Immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 18 days after the suspect product(s) administration, outcome "unknown"; ASTHENIA (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "generalized weakness"; FATIGUE (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown"; HYPOTENSION (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood creatinine: 1.6 mg/dl, notes: elevated; 1.1 mg/dl, notes: baseline; Blood immunoglobulin G: None of the recipients developed, notes: SARS-CoV-2 in response to vaccination; Blood pressure measurement: hypotension; DNA antibody: 41000 IU/ml, notes: after 3 wk; Lymphocyte count: 0.67, notes: Admission; Polymerase chain reaction: 3.11 IU/ml, notes: million; 415 IU/ml, notes: 1 wk later; 3110000 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 5.2, notes: Admission. Therapeutic measures were taken as a result of cytomegalovirus infection, asthenia, fatigue, hypotension. He was transitioned to oral valganciclovir and his blood CMV PCR was 415 IL/Ml one week later. The patient remains on prophylactic valganciclovir with undetectable blood CMV DNA PCR. The lot number for the vaccine, [BNT162B2 ], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: DNA antibody, Fatigue, Hypotension, Lymphocyte count, Polymerase chain reaction
Clinical narrative: Cytomegalovirus infection; generalized weakness; fatigue; hypotension; This is a literature report for the following literature source(s):   A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing), notes: Time since transplant-18 mo,  deceased donor kidney transplantation (D+/R-); "Diabetic nephropathy" (unspecified if ongoing); "end-stage renal disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "uncomplicated surgical recovery" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression; Prednisone for Immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 18 days after the suspect product(s) administration, outcome "unknown"; ASTHENIA (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "generalized weakness"; FATIGUE (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown"; HYPOTENSION (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood creatinine: 1.6 mg/dl, notes: elevated; 1.1 mg/dl, notes: baseline; Blood immunoglobulin G: None of the recipients developed, notes: SARS-CoV-2 in response to vaccination; Blood pressure measurement: hypotension; DNA antibody: 41000 IU/ml, notes: after 3 wk; Lymphocyte count: 0.67, notes: Admission; Polymerase chain reaction: 3.11 IU/ml, notes: million; 415 IU/ml, notes: 1 wk later; 3110000 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 5.2, notes: Admission. Therapeutic measures were taken as a result of cytomegalovirus infection, asthenia, fatigue, hypotension. He was transitioned to oral valganciclovir and his blood CMV PCR was 415 IL/Ml one week later. The patient remains on prophylactic valganciclovir with undetectable blood CMV DNA PCR. The lot number for the vaccine, [BNT162B2 ], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, White blood cell count
Clinical narrative: Cytomegalovirus infection; generalized weakness; fatigue; hypotension; This is a literature report for the following literature source(s):   A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing), notes: Time since transplant-18 mo,  deceased donor kidney transplantation (D+/R-); "Diabetic nephropathy" (unspecified if ongoing); "end-stage renal disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "uncomplicated surgical recovery" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for Immunosuppression; Prednisone for Immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (medically significant), 18 days after the suspect product(s) administration, outcome "unknown"; ASTHENIA (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "generalized weakness"; FATIGUE (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown"; HYPOTENSION (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood creatinine: 1.6 mg/dl, notes: elevated; 1.1 mg/dl, notes: baseline; Blood immunoglobulin G: None of the recipients developed, notes: SARS-CoV-2 in response to vaccination; Blood pressure measurement: hypotension; DNA antibody: 41000 IU/ml, notes: after 3 wk; Lymphocyte count: 0.67, notes: Admission; Polymerase chain reaction: 3.11 IU/ml, notes: million; 415 IU/ml, notes: 1 wk later; 3110000 IU/ml, notes: CMV highest; SARS-CoV-2 antibody test: Negative; White blood cell count: 5.2, notes: Admission. Therapeutic measures were taken as a result of cytomegalovirus infection, asthenia, fatigue, hypotension. He was transitioned to oral valganciclovir and his blood CMV PCR was 415 IL/Ml one week later. The patient remains on prophylactic valganciclovir with undetectable blood CMV DNA PCR. The lot number for the vaccine, [BNT162B2 ], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, an association between the reported event and the suspect product BNT162B2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200004629 Same article/ drug/event and different patient;