chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was sore; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 01Mar2021 as single dose for covid-19 immunization. Medical history included having cancer twice and concomitant medications were not reported. Patient stated that her first dose was no problem at all, and her arm was sore for a couple of days, and that's it. Patient had an issue when she went to the  for second vaccine. She went to a  for her second dose and states that the nurse who was administering vaccines was very busy and distracted, the patient does not remember being stuck, but that the nurse just put a bandaid on her arm. No other bystanders were able to confirm administration of the vaccine, either. Patient does not believe she received her 2nd dose of Pfizer-Biontech Covid19 vaccine on 01Mar2021. She was asking if there was a clinical trial to evaluate a booster dose. The outcome for the event was unknown.   Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: 2 weeks later the urgent care facility told him he was positive to Covid; 2 weeks later the urgent care facility told him he was positive to Covid; Wasn't feeling well after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) via an unspecified route of administration on 11Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, he took 1st vaccine on 11Mar2021 and scheduled for the 2nd on 01Apr2021. Took 2 covid test on 09Mar2021 and came back negative. Wasn't feeling well after 1st dose. 2 weeks later the urgent care facility told him he was positive to Covid and has to isolate for 10 days.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has already received the first dose, she was diagnosed with COVID-19 8 days ago (15Mar2021). The second dose was originally scheduled (today) on 23Mar2021, but the doctor recommended waiting 30 days after the COVID-19 diagnosis before considering receiving the next dose. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Syphilis
Clinical narrative: Positive for syphilis; This is a spontaneous report from Pfizer Sponsored Patient Support Program. A non-contactable consumer (patient) reported that a male patient of unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (solution for injection/Batch/lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. In between the first and second shot of the dose the patient had experienced positive for syphilis, inquiring that it was a false report by the lab data and the patient refused to share the information. Outcome of the event was unknown.     No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, On and off phenomenon
Clinical narrative: chills; off and on; This is a spontaneous report from a contactable female consumer (patient herself) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 28Feb2021 and first dose was on 04Feb2021 via unspecified route of administration both as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced chills, off and on. Patient chills were elevated when she had taken Tylenol, as a therapeutic measure. Patient stated that she had an appointment with HCP tomorrow and would like to know anyone else had reported the same symptoms. Outcome of the events was unknown.    Information regarding batch/lot number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure abnormal, Cardiac disorder, Eye swelling, Peripheral swelling
Clinical narrative: started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Smear test, Swelling face
Clinical narrative: started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; started swelling in face ,hands, eyes; having arrhythmias and blood pressure issues; having arrhythmias and blood pressure issues; have continued to have. Cardiac issues; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), on 28Dec2020 06:30 PM into right arm at single dose for COVID-19 immunization in Hospital. Medical history included Migraines, high blood pressure that was controlled. Patient was not Pregnant at the time of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medication (medications the patient received within 2 weeks of vaccination) included hydrochlorothiazide and furosemide (LASIX [FUROSEMIDE]). patient took injection and started swelling in face, hands, eyes. Then started having arrythmias and blood pressure issues. She has continued to have. Cardiac issues as well as blood pressure problems. ill was hospitalized. Duration of hospitalization was 2 days. blood pressure and arrythmias. Patient was currently seeing cardiologist on April 14th to see what can be done. events start date and time was 28Dec2020 06:45 PM. It was unknown if the adverse event result in doctor or other healthcare professional office/clinic visit or Emergency room/department or urgent care. "Location of injection information is available for all vaccines received on the same date". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Lab test included Nasal Swab on 23Jan2021 with negative result. Treatment for the events included medication, in process of seeing a Cardiologist. Outcome of the events was not recovered. Serious criteria is hospitalized and life threatening.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of swelling in face, hands, eyes, arrhythmias, cardiac issue and blood pressure issues 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: Blood test, Chest X-ray, Fatigue, SARS-CoV-2 test, Urine analysis
Clinical narrative: After the first dose she experienced fatigue; This is a spontaneous report from a contactable consumer. A 76-years-old female patient 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 immunisation. The patient medical history and concomitant medications were not reported. The patient reported after the first dose she experienced fatigue on an unspecified date. 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 blood test: only slightly anemic, chest x-ray: unknown on Unknown, sars-cov-2 test: negative, urine analysis: unknown (put on antibiotics just incase there was something latent), viral test: negative and white blood cell count: 5.4 (Her doctor may start her on iron supplements). The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Viral test, White blood cell count
Clinical narrative: After the first dose she experienced fatigue; This is a spontaneous report from a contactable consumer. A 76-years-old female patient 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 immunisation. The patient medical history and concomitant medications were not reported. The patient reported after the first dose she experienced fatigue on an unspecified date. 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 blood test: only slightly anemic, chest x-ray: unknown on Unknown, sars-cov-2 test: negative, urine analysis: unknown (put on antibiotics just incase there was something latent), viral test: negative and white blood cell count: 5.4 (Her doctor may start her on iron supplements). The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immune thrombocytopenia
Clinical narrative: pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization.  Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization.  Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Burning sensation, Condition aggravated, Dermatomyositis, Erythema
Clinical narrative: pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization.  Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Immune thrombocytopenia, Platelet count decreased, Rash, Rash macular
Clinical narrative: pinprick blood rash all over/ diagnosed as immune thrombocytopenia; rash on chest and neck; fever; chills; headache; body ache; joint pain; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female (not pregnant) received the first dose (dose number 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202) via an unspecified route of administration in the left arm on 15Mar2021 08:15 AM at a single dose or COVID-19 immunization.  Medical history included Hashimoto's disease, pulmonary hypertension, obstructive sleep apnea, dermatomyositis. Concomitant medication(s) included escitalopram; tramadol; levothyroxine; all from Mar2021 (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to morphine. The patient was seen in the Emergency Room at a hospital on 20Mar2021 for pinprick blood rash all over the body on 16Mar2021; a doctor diagnosed it as immune thrombocytopenia from the Covid vaccine received 5 days earlier. On 16Mar2021, she had also been experiencing rash on chest and neck, fever, chills, headache, body ache, joint pain, fatigue, nausea for the past 5 days. The adverse event(s) result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the events included prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Loss of consciousness, Muscular weakness, Nausea
Clinical narrative: her legs gave away and she sat down on the floor and was unconscious; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; light pain in her head; legs gave away; This is as spontaneous report received from a contactable consumer (patients husband). A female patient on unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: not reported) via unspecified route on 23Mar2021 at 15:00 and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot/Batch number: not reported) on an unspecified date as single dose for COVID-19 immunization. Relevant medical history and concomitant medications were unkown. It was reported that the patient who received her second dose vaccine was fine until next day early morning. The following day in the morning the patient felt groggy and nauseated also her stomach acted funny while she was brushing. She tried to throw up but could not. Then her legs gave away and she sat down on the floor and was unconscious. The patients husband started to call 911 but his wife was only unconscious for a few seconds and then became alert again and had been fine since then except for a light pain in her head.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: her legs gave away and she sat down on the floor and was unconscious; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; light pain in her head; legs gave away; This is as spontaneous report received from a contactable consumer (patients husband). A female patient on unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: not reported) via unspecified route on 23Mar2021 at 15:00 and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot/Batch number: not reported) on an unspecified date as single dose for COVID-19 immunization. Relevant medical history and concomitant medications were unkown. It was reported that the patient who received her second dose vaccine was fine until next day early morning. The following day in the morning the patient felt groggy and nauseated also her stomach acted funny while she was brushing. She tried to throw up but could not. Then her legs gave away and she sat down on the floor and was unconscious. The patients husband started to call 911 but his wife was only unconscious for a few seconds and then became alert again and had been fine since then except for a light pain in her head.  Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Blood pressure measurement, Hypertension
Clinical narrative: severe anaphylactic shock; High blood pressure; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 23Feb2021 09:30 (Lot Number: EN6200) as single dose for covid-19 immunisation at age 84 years old. Medical history included low thyroid and allergies to grasses. The patient was not pregnant. The patient had no Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No other vaccine taken in four weeks. The patient previously received the first dose of BNT162B2 administered in left arm on 02Feb2021 09:30 AM (lot no: EC9265) for COVID-19 immunization. On 16Mar2021 09:15 AM, 15 minutes after eating usual breakfast: avocado/toast, coffee, almond milk, the patient went into severe anaphylactic shock: extreme itching on palms, red welts on body, explosive diarrhea, dizzy/fainted, extreme blood pressure drop to 60/XX, in/out of consciousnes, loss of bowel/urine. Rushed to ER. High blood pressure 7 days after (Mar2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, emergency room/department or urgent care and were considered life threatening illness (immediate risk of death from the event). Treatment given in the emergency room includes unknown (as reported), prednisone, Pepcid. Outcome of the event was unknown.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diabetic ketoacidosis
Clinical narrative: Diabetic ketoacidosis; This is a spontaneous report from a contactable consumer. A contactable consumer reported for her nephew.   A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 33-years-old)  at single dose for covid-19 immunisation.  Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, impaired gastric emptying from an unknown date and unknown if ongoing, ulcer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced diabetic ketoacidosis on an unspecified date.  The patient died on 21Mar2021 due to diabetic ketoacidosis.  An autopsy was not performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Diabetic ketoacidosis
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood insulin increased, Condition aggravated, Death, Diabetes mellitus, Diabetic ketoacidosis
Clinical narrative: Diabetic ketoacidosis; This is a spontaneous report from a contactable consumer. A contactable consumer reported for her nephew.   A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 33-years-old)  at single dose for covid-19 immunisation.  Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, impaired gastric emptying from an unknown date and unknown if ongoing, ulcer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced diabetic ketoacidosis on an unspecified date.  The patient died on 21Mar2021 due to diabetic ketoacidosis.  An autopsy was not performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Diabetic ketoacidosis
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis perforated, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: Seventeen days after my second dose, my appendix almost rupture and had to have surgery to remove it; Dose 1:17Feb2021; Dose 2: Feb2021; Dose 1:17Feb2021; Dose 2: Feb2021; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 at 02:30 (Lot Number: EN6200) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right in Feb2021 at 14:30 (Lot Number: EL9262), both (at the age of 68-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history was none. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient reported that: "seventeen days after my second dose, my appendix almost rupture and had to have surgery to remove it" on Mar2021. The event was serious, the patient was admitted to emergency room and was hospitalized for seventeen days after the event, the event was also assessed as life-threatening.  The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 09Mar2021.  Therapeutic measures were taken as a result of the appendix rupture and included surgery to remove it. The patient outcome of the event was recovering.  Follow-up attempts are possible. Further information is expected.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: The patient was only given the liquid component of Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00519175) and transmitted to Sanofi on 15-Mar-2021.  This case involves a 4 months old female patient who was only given the liquid component of 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ419AA, expiry date: 08-Mar-2022) via intramuscular route in the right thigh for prophylactic vaccination on 12-Mar-2021 (Product preparation issue)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included oral ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination  It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day).  The caller stated that a patient was given just the Diluent but not the vaccine and want to know what they need to do now and what were the recommendations. Recently a patient was only given the liquid component of PENTACEL.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired dose of PENTACEL was inadvertently administered/no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional.  This case involves a patient with unknown demographics who inadvertently received expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ190AAA, expiry date- 22-Feb-2021 via unknown route in unknown administration site for prophylactic vaccination on 17-Mar-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  Office manager reporting an expired dose of PENTACEL was inadvertently administered. Caller did not have any patient data available, requested caller to call back to provide.  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: dramatic increase in Rheumatoid Arthritis symptoms; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, in Feb2021 (reported as "last month"), as single dose, for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took tofacitinib (XELJANZ XR) for rheumatoid arthritis. The patient reported that she missed two weeks of XELJANZ XR last month (Feb2021) due to receiving COVID-19 vaccine. She said she experienced a dramatic increase in rheumatoid arthritis symptoms (unspecified date) as a result of this but she feels like overall Xeljanz XR is managing her rheumatoid arthritis well. The outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chest discomfort, Chills, Cough
Clinical narrative: back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Sleep disorder, Vaccination site pain, X-ray
Clinical narrative: back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Thrombophlebitis superficial, Vaccination site swelling
Clinical narrative: DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basilic vein; right arm swelling in the setting of receiving her Pfizer covid vaccine in the right arm 1 week prior; This is a spontaneous report received from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hyperlipidemia, acute pancreatitis, May-Thurner syndrome, and allergies: penicillin, IV contrast. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ), fenofibrate, and levothyroxine. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient was seen at the ED for right arm swelling in the setting of receiving her Pfizer COVID vaccine in the right arm 1 week prior. She was found to have a DVT (deep vein thrombosis) in right medial subclavian and superficial thrombosis in right proximal basilic vein. The events started on 17Mar2021 09:00. AE resulted in emergency room/department or urgent care. Patient was recovering from the events. Treatment for AEs include anticoagulation.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the DVT and other reported events, based on temporal relationship.  However the reported events may likely represent intercurrent medical conditions in this patient. There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Glossodynia, Nausea, Pain
Clinical narrative: tongue was swollen/The front half of her tongue was swollen and stinging; tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging; had white dots and a sore tip on the tongue; Sinus Pressure; Body Aches; Tired; Dizzy; Nausea; This is a spontaneous report from a contactable licensed practical nurse (LPN) reporting on behalf of physician. A 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 09Mar2021, at 39 years of age, (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient had no medical history; concomitant medications were not reported. On 09Mar2021, a few minutes after receiving the vaccine, the patient felt sinus pressure that lasted the rest of the day, she was tired and dizzy for two days and also had nausea for two days and body aches for the first 3 days, all assessed as non-serious. Then the patient stated that when she woke up on 11Mar2021, her tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging. The patient stated she did not feel as if though her throat was swollen, just her tongue, but it resolved after 3 days. These events were assessed as medically significant and the tongue swelling was what the reporter was mainly concerned about. There were no treatments, no medication was given, the patient was not seen in the Emergency Department, she was not hospitalized and was not admitted to an Intensive Care Unit. She visited the Physician Office on 15Mar2021 and Physician Assistant advised the patient not to get the second COVID vaccine. The event "sinus pressure" resolved on 09Mar2021, the events "Tired", "Dizzy" and "Nausea" resolved on 11Mar2021, the event "body aches" resolved on 12Mar2021, the events "tongue was swollen and had white dots and a sore tip on the tongue; the front half of her tongue was swollen and stinging" resolved on 14Mar2021.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported serious events 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Swollen tongue, Tongue disorder
Clinical narrative: tongue was swollen/The front half of her tongue was swollen and stinging; tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging; had white dots and a sore tip on the tongue; Sinus Pressure; Body Aches; Tired; Dizzy; Nausea; This is a spontaneous report from a contactable licensed practical nurse (LPN) reporting on behalf of physician. A 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 09Mar2021, at 39 years of age, (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient had no medical history; concomitant medications were not reported. On 09Mar2021, a few minutes after receiving the vaccine, the patient felt sinus pressure that lasted the rest of the day, she was tired and dizzy for two days and also had nausea for two days and body aches for the first 3 days, all assessed as non-serious. Then the patient stated that when she woke up on 11Mar2021, her tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging. The patient stated she did not feel as if though her throat was swollen, just her tongue, but it resolved after 3 days. These events were assessed as medically significant and the tongue swelling was what the reporter was mainly concerned about. There were no treatments, no medication was given, the patient was not seen in the Emergency Department, she was not hospitalized and was not admitted to an Intensive Care Unit. She visited the Physician Office on 15Mar2021 and Physician Assistant advised the patient not to get the second COVID vaccine. The event "sinus pressure" resolved on 09Mar2021, the events "Tired", "Dizzy" and "Nausea" resolved on 11Mar2021, the event "body aches" resolved on 12Mar2021, the events "tongue was swollen and had white dots and a sore tip on the tongue; the front half of her tongue was swollen and stinging" resolved on 14Mar2021.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported serious events 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 RAs, Ethics Committees, and Investigators, as appropriate.